BTAI - Earnings call transcript Q1 2019 | BioXcel Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, everyone, and welcome to the BioXcel Therapeutics' First Quarter 2019 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Brian Johnston at The Ruth Group. Please go ahead, sir.

Brian Johnston

operator. you, Thank

its uncertainties and everyone, or Chief remind Vimal on asked which fiscal can of discussed including Chief BioXcel today's Actual risks most in forward-looking of Mehta, With are www.bioxceltherapeutics.com results XX-K the XXXX, year Securities on events Just differ found for www.sec.gov. its financial future that certain may website, Vimal call and Executive to the Officer Vimal? detailed subject Commission, the answers the annual Therapeutics; that questions said, company's results performance report be to With be public conference or future Officer. XX, are Vince statements ended the and/or call to today the are matters Officer; December Chief relating on given Medical materially in over Form pleasure turn filings O'Neill, me anticipated that Yocca, Frank U.S. are affect those Officer; the that statements. to forward-looking Mehta. may company. Financial to recent with Richard these CEO, The Steinhart, could and from Exchange Scientific risk factors it my in is Chief to company

Vimal Mehta

is further achieved the of morning, quarter strategy, we toward Thanks, to our key business organization. into the XXXX. sales the Therapeutics' call milestones, to quarters. and company a Through In Program, financial for first BXCLXXX BXCLXXX as clinical of and discuss several transitioning everyone, coming Brian. well-positioned first joining we milestones move Neuroscience development the our Good of achieve BioXcel for particularly lead highlights sound results in you to thank believe our we commercial XXXX, the conference related and quarter business

capabilities world-class clinical have of drug lead and the a team strong advancement our We two to therapies. built

start the lead Neuroscience BXCLXXX, of plan the our clinical dexmedetomidine development in subjects by program, that agitation. I would our and executing dosed first-in-human treatment truly or year to for of XXXX like formulation Dex in are acute BXCLXXX. exciting our December, have our progress company. sublingual a of we be proprietary first strategic cohort pivotal according made believe we highlighting for to the the We will of In study

of to half As report expectation of expect and future to the in of healthy study second completed half of today, on-track the With for agitated have the I FDA volunteer BXCLXXX line XXXX. trials patient Phase patients in near second I pharmacokinetic, report of we drug dosing us that bioavailability enable year. filing cohorts on-track data of we remain result we first our on top of XXXX, And registration secured are for provide plans May for the these multiple maintain specific study NDA launch the BXCLXXX end data. Phase the we in the fast-track our application safety designation details the We in more at and in to our when XXXX. from will BXCLXXX

up development process this of second to formulation process to finalized and manufacturing technical for year. have the On transition BXCLXXX, the half is planned we the the scale in study front, automated registration support on-track

formulation may is and sublingual you in stability. thin-film unique As our its with know, structure demonstrated

produces a type, of for the intravenous this with proof-of-concept patients trial IV positive Alzheimer's senile and produce endpoint of the identifying of dose dementia a therapies. is and studies trials minus BXCLXXX Earlier acute wide designed year, of of multiple that the in Dex of as Dex of by method scalable neuropsychiatric that patients option These reported we strong The SDAT. indications. demonstrated viable our potential Scale acute study these data Sedation a number defined I X. Richmond neuropsychiatric for or score primary treatment and underlying validate belief findings Our same mild to proof-of-concept disorders. in RASS across agitation of benefit Dex combination with range treatment dose a highly process clinical arising conducted the a agitated Phase sedation on of previously treat Results IV the flexibility the provides agitation Agitation arousable represents from from manufacturing to strengths

subjects in in we enrolled announcing the Opioid dire prevalence the growing addiction severity. with small with There's crisis need care only is were symptoms opioid study placebo arm the conducive the withdrawal the regulatory treatment for exciting novel In opioid-dependent I represents health of And arm rationale opioid study major responded Phase All opioid displaying Dex for were by in data Dex both of of to current is agitation. expansion acute reported symptoms treatment mitigation a while environment SDAT the in from development options. in patients in evaluating of application we film therapeutic effective XX providing to a physiological withdrawal, the beyond patients our X data patients focus for first treatment positive intravenously of Dex initial such as believe that for arm. new withdrawal. a and of of BXCLXXX's of in symptoms. subjects agitated in addition proof-of-concept administered the and IV Ten quarter, trials completion of a the to study enrolled

period as agitation range we of candidate development XXXX withdrawal patients the initial in schizophrenia/bipolar well Alzheimer's of addition be by for for will an BXCLXXX's to its post-PTSD. potential agitation BXCLXXX, of forward as from for suffering a acute as In symptoms. disease, in and a potential treatment include of look important indications these area to withdrawal other the in symptoms BXCLXXX, opioid continue opioid and indications other The several our target assessing advancing neuropsychiatric believe dementia potential product We suffering delirium development of indications game-changing of caused disorders, one remainder from wide has disorders. other potential we patients as that

of development to strength forward the our clinical are the and development. We look and additional team in reaching in our milestones confident strategy

Phase Now BXCLXXX prostate clinical in our open or now patients open turn BXCLXXX. study sites I'd in cancer is neuroendocrine - Ib/Xa pembrolizumab label The for combination BXCLXXX in Keytruda multiple with patient like of to second enrollment. program,

to of Additionally, Marsden prominent more March, prostate figure also is the to us his advisory de Ib/Xa the expanding step working be and cancer toward we de the footprint a clinical in member our Bono the allow who major benefit are Professor board. our U.K. Phase to with global NHS with we principal for the Institute recently investigator as filing arena, authority, study which expertise Immuno-oncology clinical a took from the in the and will Professor trial the U.K. clinical application with approved, the Royal Bono study be late of of foundation will Cancer a European of to Research, Johann trust on joined a The broadly board. expand trial excited advisory him and our once

Nektar triple Administration treatment we to avelumab to BXCLXXX, are Merck, NKTR-XXX Drug we and the for pancreatic Pfizer IND Food proposed from combination Turning from cancer. and and the U.S. with on that filed study of pleased of the report

provide will provide under Pfizer reminder, NKTR-XXX. Merck a avelumab - the gauge Nektar and the agreement, As and will

ourselves costs with clinical the manage program between and initiate will equally shared development Nektar. and We

combination recent action. also trial begin focus study will mechanism of cancer. tumors. and combination both trial of pancreatic of clinical based in solid the preclinical for as we for development. its This achieved on study data from AACR the models Annual OXXX presented BXCLXXX on a I/O This have agent agonist trial further BXCLXXX's in in other and We anticancer At is the Meeting this this combination first two and a BXCLXXX with selected in possible of versatile potentially ability an mechanism increase expected sites validating therapy validating a in to half a year. as effective further in to to stimulate The potentially versus proof conduct We adaptive BXCLXXX plan significant April, certain immunity. combination to the innate control, tumor activity promising

seasoned others. other In among over medical as XX development designing commercialization veteran, with at and commercial medical Dr. strategy experience He Vice and and Commercial Pascal executing marketing we executive year management of achieve Dr. Borderies first Health responsible global ourselves appointment continue many science including affairs progresses. we highly and in team quarter Schering-Plough years' Consumer the the XXXX, with positioned and efforts. to Medical life strengthen companies President, as affairs the of significant a is to is Finally, and including our the sales for Borderies BTI's industry Affairs. milestones several Development Novartis reached

all We safety sharing study the data in those the and weeks. our from BXCLXXX are eagerly look to forward and coming with results of you awaiting results PK

Those in what be to advisory morning, this we on release in are a the neuroscience in noted Investor welcome from area our XX of should exciting be we board. the presentation York. Day for us May clinical BXCLXXX-focused As including several press members will event, hosting New an join

you're in (XXX) Ruth Acorda Group The at If of would [ph] attending please contact more interested like or details, John XXX-XXXX.

continued Richard And thank holds Therapeutics, of our for BioXcel the that, developing to mission the of you over CFO, and always, hope neuroscience medicines excitement I over share would With the I As your Richard? turn that you support like of our to the Immuno-oncology. call for future wave and across next company. what Steinhart.

Richard Steinhart

any new development you for morning, being the planned shareholders. this are to and proceeds year. XXXX from joining our And move to Vimal. studies IPO multiple of program Thanks, utilized thank The to including of in again, BXCLXXX being throughout BXCLXXX, welcome us initiation each consistently and once utilize - used our clinical

an share or clinical General we and in to $X.X same $X.X approximately of were for loss $X.X of XXXX. and For the $X.X of to net expenses in million Total stock-based in Research million, were compensation. XXXX the - compared operating and million $X.XX million total operating development million compared and compared added compared increase increase for and expenses increase a million Corporate expenses a XXXX research additional is XXXX, approximately XX%. of XXXX per expenses for The million as totaled to Development executive, well administrative support development $X.X the first consisting per for salaries increased XX.X%. loss expenses first $X.X in non-cash XXXX. teams increased quarter first as functions. development BXCLXXX quarter finance approximately the or approximately XXXX $X.XX personnel increase also in to the both include approximately of expenses costs the an of of quarter first and approximately of an million our for our first related of the and The $X.X XXXX, same BXCLXXX. net quarter period of quarter $X.X increase first of The of of as a results for as approximately our approximately administrative approximately of XX.X% in primarily of quarter reflects programs, administrative activity reported XXXX, the $XXX,XXX other period result into of share to

We have as cash million of total and of equivalents $XX.X March XX, XXXX. cash

clinical going remarks. back XX advance cash BXCLXXX. BXCLXXX our and current forward expect review, we that trials burn to needs position We we at to I'd the to to for next concludes continue believe our for our both turn as closing meet cash the is months. any to That Vimal increase it financial Nevertheless, for like sufficient least and

Vimal Mehta

quarters. programs again, thank discuss XXXX. our the would joining Financial provide to the to in We to concludes call Operator? hope the call Results for Therapeutics our open remarks. for updates of First to additional questions. Quarter like coming conference our on prepared We Once everyone, That you, BioXcel

Operator

we'll And Instructions] take [Operator Geoff question Barclays. from from Meacham our first

Unidentified Analyst

for This on is Jeff. Jason [ph] Zemanski

and you for those kind needed? require study lateral approval? expectation XXX other like Or the regards be is color And with alcohol provide we're withdrawal. program, of program. then you approval PTSD plans the use the drug perhaps have or will each of development, and the developmental a into XXX a as once indications that to Would separate physicians able follow-up as to I a forward want can a occurs moving On in mentioned, you the little

Vimal Mehta

program, are trial allow will roll Once data program. study. currently to constant us first our indication announcing they in from on the out are stagger that and So know, what we current the data Phase with then as with focused you XXX announced, Currently, will initiate we the on and FDA program, is what be indications will plan, larger II/III communication we we what that will indications, these And will other ongoing. the are allowing neuropsychiatric bundle. in conversations consider that, to our they

Unidentified Analyst

trial then as initial now and for underway, us And what threshold forward the is that regards for a forward? expectations color. with looking for or the we sort move - Perfect, potentially be necessary the what looking thanks of the and trial to so should little XXX, can much results you're moves you kind give your of to

Vimal Mehta

Sure. data present the some difficulties, data O'Neill, pancreatic our I efficacy will have to the safety more question the to Officer. but having will this mature the may this color of Vince? the Chief question. be in of mechanism try looks answer that end year as like BXCLXXX end pass And currently understanding the It Vince is by half neuroendocrine for of Medical he in and more trials data first I for patient of in ongoing, as as expect of the been proof well tNEPC trial Patient XXXX. of cancer. two and mechanism are a pancreatic prostate open that recruitment from cancer we XXX will that well will year. for action the and we in by as or single readout some we preliminary mature learning as for then more has agent

the have terms of IND. pancreatic cancer, filed In the we

initially, soon. this then X the efficacy XXXX. expect - the next first of will data our will triple and And combination trial be more to so X in a This on for the we year. it's We initiate focused to learning get data next months, safety half

for as terms data three and efficacy. BXCLXXX plan the of both, the as for that's So trials the in safety from learning well readouts

Operator

Carter And UBS. Gould the of next question we'll from take

Unidentified Analyst

for in [ph] is Andrea Carter. This

questions On data, the So but your you couple said expected study of soon, just is a here. mentioning XXXXX.

your required a to still first, I I to guess the Cmax want example, for if factors what using to transition to, forward discuss clinical clinical what So commercial use looking the your to I a what could development and wondering ensure I Phase was to using given thereafter? minutes? you another for get there comparability here. XX between of just are to are of pivotal. here what the gating would you move And second, to XXX, expectations process Are the any work sense be be you'll you're pivotal XX

Vimal Mehta

question to the for very development you asking related a Thank comprehensive XXX program.

shortly, Phase II/III we formulate we initially design the a shortly the will Street. roll we this of The will clinical help end the In that terms our deeper out plan with crafting, XXX, have into of key which And we converted registration opinion this II that analysis and like will will currently how - for leaders. undergoing and with Phase good, what very first be terms in plan, development data, once That to are announcing the you which look this initiate is the plan the working will our of we understanding be expect year. trial like will II give by trial design, Phase

at that for clear very PEC schizophrenia/bipolar to it's least a score expect the be terms hours. the at always two expectations, the is of in terms endpoint reduction in we primary endpoint trial. that primary registration of In trial, And

Unidentified Analyst

just comparability work - need do that to process. Is the Phase to the and Phase to you any between the follow-up product? I on II development And ensure on there

Vimal Mehta

No.

Operator

Our Instructions] Kim [ph] BMO Capital next question will from [Operator come from Markets.

Unidentified Analyst

the on Congrats progress.

as on you just bioavailability similar is the straightforward results? considering? how factors the as be when But a responses other we First the proof-of-concept PK Or we assuming simplistic data, should there a as are Is the will this it XXX, we should pretty question. be that give interpreting studies? intravenous maybe see same

Vimal Mehta

question. That's a great

of achieving we were Dex that levels It give will we that it encompass safety also exposure we the will provide our the we data encompass will product - therapeutic be indication for with tolerability were announcing and PK study. therapeutic the we with it what understand the are will film. film. the And assessment, and know levels using already the following: the schizophrenia will in and when IV that So expect effective

So and what all announce a in few weeks. will that that's work currently is analyzed exactly we being

Unidentified Analyst

over Vince Is about the could in with OXXX rationale And Maybe had targeting I molecules. there other combo co-stimulatory if AACR of you go - question on is on the anything OXXX. specific agonist if a presentation over combining OXXX?

Vimal Mehta

the So I question, take okay? will

Vincent O'Neill

is Vince. apologize. I do out Vimal, the Apologies, got this call. Vimal, I locked of

Vimal Mehta

go Then ahead, Vince. Okay.

Vincent O'Neill

end the think I of So the I have tail question.

was I OXXX. choice around of think the it

think XXX's a its and combined combo Essentially, with So augment I really activity that answer - ways many demonstrate of drugs. to couple that. ability body large of data a to approaches using we've I/O agents and generated other ability and different

So of a but of data, data not some actually that presented it. we've lot of all that

in really think - demonstrated that there'll the we it make I but that disagree to the and know, fair And in is publish simply throughout co-stimulation some bucket I OXXX combinable we that, has It's activity, to as others year, published really clinic not does with as probably will molecule the a that of seem shows the augment is it's whole bracket. this OXXX you really, of and clearly or XXX broadly. and as level probably experiment people well think and with thrust very So that's that activity huge think can true. highly say agents the the other a point in really I be who

Operator

will question from from next Selvaraju come Our HP Raghuram Wainwright.

Raghuram Selvaraju

of for XXX you start acute And be could acute in whether success and you off. maybe on And between endpoint I So some well. endpoints following us if indication the know background on this the XXX up information the a disorder, opioid would investigating sub-indication addiction. term with or trial in you context. far additional primary use additional you've delirium be had wanted Also, work that the do give the program agitation pivotal acute in helpful potentially specific also, the for at in juncture it of chronic in context as window would the looking actually Could evaluation on the near in mean differentiation to a efficacy would this nature and alcohol few paradigms? to so being agitation on whether what specifically potentially XXX operatory to you comment the anticipate the withdrawal what proof-of-concept

Vimal Mehta

plan Vimal. XXX company have you together of news will has to Good give development. that we is is that strategic lot a forward. very indications a this for put high-level Raghuram, I move the

a like Phase is the success have the indication needed. some very and those understand indications. of environment initiate of understand like regulatory think know, probability reimbursement you what indication foremost, primary of We to high, considering X in look we are First our II/III endpoints study where a we terms will goal in we clinical we have and completely environment what for

So that's prioritize. are to it using we how

dementia as leaders said because your a is rates what that, So development division high, response of of trial move that, go opinion as this, can withdrawal a forward, explore where different and path. After terms slightly path path that's very with continuing we terms come. having in that takes discussions Alzheimer's key to were with well have different to relevant. happening are to and in we development opioid the And Those a the And both question that effective are FDA. FDA. very we to route how is the most what with

can do that and trial a forward. exploring, we require fast there. we how we So is that need move that another to what will path that IND And are

opinion X of and So level in getting end indication to a this stagger opioid look it now and potential decision that. been at the will terms and initiate what by year, delirium has working the the leaders foremost, the going - the XXXX, then a level, first And the endpoints the to withdrawal with Alzheimer's, Frank, trial who I with opportunities I'm think to and overall trials of like. other what very understand beyond to in pass key dementia high on

Frank Yocca

have questions see place, So drugs other dextromethorphan being But for injectable Haldol schizophrenia, of the given think, drug clear in space non-antipsychotic the chronic. is and being They're versus non-injectable time. take acute ease that we the know administration that value that not for patients. identify value, With particular, fact as Ram, are for and always of there combinations. we have high population. fact to regard one In We in that okay, something situation. in we an treating a is to just benefit, antipsychotic, still unmet your need. that geriatric example, a space we is a acute to there I a the a an see tested an need trying And need, really chronic, we to a a acute mechanism the for of take are tested, the schizophrenia/bipolar being at

and on are to KOL XX, a had regard he'll at with really way we actually really you May and dexmedetomidine our thinks delirium. he around to Now that his the our questions has what is like measure Maurizio is drug best with primary as to be offer. to success good how approach film These Analyst speak the goal question to other would delirium Fava the and will Day what

into our we're know this, is that about that withdrawal, something drug to withdrawal be of the we think questions that just of segue given a right to, for with was administration with types treating I those we be to drug And this and that alcohol that going up that's up ease like Again easy would trial. think then come symptoms I setting for example, I finally, a alcohol and say, regard And into now hoping - type think on opioid something really question with relatively we're radar and even to, okay? treatment. screen. what fact we a are withdrawal natural last segue do a answers your a So think the drug, for and discussing the and would of with

I your answered all questions. I've hope So

Raghuram Selvaraju

other May and if about were. to event mouth, the it from as Yes. these obviously, the to Very couple forward on horse's XX of topics questions a may. just more helpful on I I we hear XXX look have

generation that treatment with cancer, you've of whether variant the enroll that would neuroendocrine example, target whether I context receptor target to for addressable implications specifically about antagonists would indicated on whether made that pancreatic or study, you evolution aimed are you. us that what ask Could of of believe the be cancer the to wanted versions clinical androgen of clinical final these to secondly, patients complement to drugs addressing at I And had you advent those example, XXX. prostate prostate already would regarding potential Thank any number - respect receptor population with of for give androgen And in determination firstly, next selected full splice in be darolutamide had cancer, like, have the the this tNEPC the indication two a study? into you an of then of sites the what you enrollment anticipate sites. be? So

Vincent O'Neill

a is this Ram, So Vince.

think the question, the newer as deprivation first I your - lanes deprivation know, are really agents, therapy. on moving [ph] you So agents earlier androgen into of

to will the the agents, time. over clearly linked that it's NEPC those prevalence is of so use of And because increase the expectation

think specific, VX, because to feedback and So patients for something the prevalence, drugs that's X:X escape expected we've been population probably probably only these us, seeing clear. is now. rise have, These given our deprivation as of increase target first MOE, as the drugs an therapies part. in we've I like think those clinical in lines, already seem would to mechanism, will But population advisers for the anti-VX their the example, be essentially of from a less said, androgen be certainly probability How influence increasing and as essentially NEPC use numbers, the especially going that's just in number. early I and to NEPC

Can your your you you please? this - do repeat repeat first the to second So question, your time. all Apologies. Can question. that I was second you

Raghuram Selvaraju

The expect was have with combo that do I sites second question what target but been give many the two many full be you sites sense could us be the the to to the clinical at complement? working pancreatic then to selected you would cancer a to that expect understand study. respect enrollment be you also How range have of involved triple study. is with? for in eventually if And this how do going

Vincent O'Neill

Sure.

might it the context. So numbers into patient because puts first, let me it that take be easier

So would will assigned it design, the XX XX. It's approximately portion in be efficacy be so patients. X-stage approximately

dictate XX statistics XX that or XX patients then patients this the X. make XX stage think in XX or either in And I it's to up stage X.

triple essentially agents combination a combines number two know, steps you as X-plus-X agent and X and so of approved it's and will unapproved there the standard Now be escalation design. a

X So think and XX something on, see efficacy component. like terms XX on something and for tolerability in depends clearly of mean the so the I it I we what portion - to for like safety

So that idea hopefully the of an will of the give study. size you

between In at than certainly XX. probably we'll number of And planning activate terms of sites, almost sites least we're and X and X bring more that on.

Raghuram Selvaraju

is these. housekeeping please know year? over how feel of to wanted you to Richard, items. the this of course And free I just Then just also stock-based pivotal you of end if Vimal take of of to remainder with an gearing this the quick idea the of comp course couple potentially the the over for give of evolve us specifically context very anticipate preparations launching or trend a then program before the that trend spending could likely R&D how or XXXX, within clinical up year. XXX to

front-end If much of us give to those be expenses loaded. are an idea of you likely could how

Richard Steinhart

me the comp. stock-based Let tackle

year. for stock-based I in I the quarter-to-quarter slightly to of the rest think It's the comp $XXX,XXX. about call quarter said that first increase the this was expected the for morning,

Raghuram Selvaraju

to And Great. spending? R&D regard with

Richard Steinhart

probably those expenses think the will year, end towards to I of hit the begin Ram.

Operator

And our next question will come from of Sumant category. Kulkarni

Sumant Kulkarni

a on especially said But in combination the film. I your know I the on, lot on release I that going was that of same you first formulation might it have be by two; flexible for have indications on language XXX. intrigued therapies. press

that table on might indications of a follow-up XXX. I products are be film and there? some the could tolerated have types what what be combined And that the then in the in on So of options terms of could be

Vimal Mehta

cognizant be be film. the we question, great other indications a that that's can some architecture to drugs for When using or the wanted that were Dex with So creating drugs film, the combined Sumant. of the we

it's So are discussed point discuss and to Day plans mature and At be as to will with how have candidates. that we pipeline. would we build planning things some next will in more are new Street this of evaluating sense what that time, we work our to make use in candidates we the generation approaches things progress, bring a in The our and more forward combination going Investor those in the

Sumant Kulkarni

timelines us when way, specific Or readouts pancreatic program expecting of data then second be cancer? year in of And half from seeing terms on this and we on should data should the another XXX, some in readouts? in you that we could what be the of I guess of asked of trials remind in tNEPC

Vincent O'Neill

I'll that. Yes. take

So is as sites a NEPC, know open, up you study number is ramping the right for of now.

are and So dataflow studies we will get label these open really so throughout. really all

to the data. So call It will is for essentially right - now. intent present safety it plus NEPC going be I'm to safety

So clearly this at accrual on safety depends SITC but and that potentially year. efficacy,

NEPC. So that's for

which that's and we take are so basically for that a we three of previously discussed, quicker I NEPC. triple in that safety will mind bear study NEPC, and longer than as unapproved, for run-in - essentially planned So for think much the agents, and two the - escalation,

So that will this year. throughout occur

will we beginning venue suitable next year. present a So aim of at data to

and comes be then, obviously ASCO to mind there's course, event of SITC is ASCO, G.I. So for ASCO. the early on, obviously, would the oncology there's ACR, main one that

a gives So that hope you flavor.

Operator

closing I'll that speakers no appears the further it And for remarks. this time. we conference Instructions] questions to have back additional turn over any or [Operator our at

Vimal Mehta

and you, coming updates quarters. you Once for again, for provide hope our BioXcel joining the to financial everyone, program in We business to update I'd call first results thank the much. Therapeutics conference to our quarter. discuss to very like Thank additional

Operator

does That for teleconference. today's you conclude all Thank your participation.

BioXcel Therapeutics (BTAI) 12 May 192019 Q1 Earnings call transcript