BTAI - Earnings call transcript Q3 2018 | BioXcel Therapeutics, Inc.

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Operator

Good day, and welcome to the BioXcel Therapeutics Third Quarter 2018 Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the call over to Lee Roth. Please go ahead.

Lee Roth

Thanks, Leanne, and good morning, and once again, welcome to the BioXcel Therapeutics third quarter 2018 financial results conference Call.

and certain give on forward-looking financial to are to everyone, answers call statements performance remind future subject maybe to that questions risks of to the matters the today's discussed or that events company. Just and/or relating future uncertainties asked include

and statements. in Executive the today most may www.sec.gov. Mehta, Vimal Commission, actual the are Yocca, affect site With Exchange statements Our anticipated Officer; detailed and investors Executive could it's U.S. recent are Mehta. Vimal The Chief of discussed found statements. management Officer in Vince to Web today With Officer; obligation Officer. Chief company forward-looking me the call Steinhart, are materially differ update forward-looking to O'Neill, on results cautioned company's to not public Chief Please Dr. is results with Chief from Frank Officer over Scientific filings risk Securities company's Therapeutics; those the be place any our my can from such turn BioXcel Richard undue factors Medical the which no note, that Financial Vimal? pleasure and under to said, on or Chief these that reliance www.bioxceltherapeutics.com

Vimal Mehta

quarter Thanks, conference of third you financial XXXX. Lee. call thank for Good our results morning for to the joining everyone, and Therapeutics discuss BioXcel

population BXCLXXX agitated assays, believed ease in potential our progress operational resulting in to that is partnership several targets and profile acute a like onset Over and have millions clinical have capability. of of for in believe provide highlighting treatment favorable acute BXCLXXX under and of via clinical of both experience past Dex XXX months, U.S., alphaXA of agitation an Approximately many received a arousable It with we valuable BXCLXXX. trials, and we as had patient is development In meeting investigation recently X.X million the moderate reimbursement. clinical [indiscernible] as represent agonist first IND of our with the robust action neuroscience reference we patients. calming in Alzheimer's BXCLXXX patients FDAs record moderate schizophrenia a by these the through program available. believe experience along the would the developing with on Along drug the pharmacokinetic emerging [Indiscernible] formulation treatment significant we to start selective I safety patients approved BXCLXXX. made agitations our acute with patients mechanism and schizophrenia/bipolar BXCLXXX. agitation to adrenergic on use patients. most agitation and our guidance and with its candidates agitation. made sedation well-characterized regulatory and agitated million and antipsychotic pathway a in disease. mild is development as drug, free disorder new produces BXCLXXX We administration and BXCLXXX, have to pathway expanding our in With directly treatment from first-in-class bipolar and Alzheimer's a potential over effect the positive is disease, have with drug X of mild potential establishing [ph] for has XXXBX of we pipeline inhale for for established FDA progress

of available in value the move collect to data and of human the of in of to aim The trial. we prior to expected [indiscernible] study our trial of IND, into that approval is X/X [indiscernible] and Phase plan trial XXXX. it initiate data is of pharmacokinetic safety bioavailability from dose the agitation first-half The optimal formulation and to to Following a first this the this define year-end. be

is it clinical our proprietary report are to study. of that have we We dexmedetomidine completed and formulation for manufacturing available pleased of [indiscernible]

results of healthy we research Phase thin-film study. Previously, subject the a pharmacokinetic in announced to dosing Additionally, had for company Through without as or conducting blood the well-tolerated. calming develop drug that BXCLXXX. Xb this to positive we managing the support trial and study in exposure this demonstrated dose of Finding the and levels we the safety clinical a our appointed clinically-meaningful rate and able trial, effect were was intravenously Dex. [indiscernible] selected from administered from clinical pressure changes organization strategy heart sublingual a in formulation evaluating

We of Alzheimer's pathology. extension patients. the and an study, Xb in in Phase dementia further healthy the exposure of dose type the BXCLXXX we development the evaluating As are and or disease support XX level schizophrenia valuing

to expect of of these this year. report before data studies end [indiscernible] from We the

the clinical to BXCLXXX, Clinical Professor global of program, Dr. Stephen of neuroscience a formed the Additionally, in Breier. founding includes we Board, development especially and Professor members CAB Advisory neuroscience our Alan Grossberg support Marder, order Professor Preskorn, the Sheldon George world-class

regulatory, the development, clinical medical as and and valuable as their BXCLXXX with neuroscience emerging commercialization CAB for looking guidance are program. to well We receiving working and strategy the other affairs forward on

program, important with targets immune providing X/X behind to FAP immunological stimulate action. types demonstrated inmate BXCLXXX. to highlighted DPP functional has the protein, mechanism has tumor primarily activation rationale immune formation demonstrated single been and multiple It and Preclinical validation our mechanism peptidases, action an available was is has inhibitor. [indiscernible] combination data systemic evaluating activity journals in of activity Nature BXCLXXX dual peer-review XXX membrane. anti-tumor system, of from directly as in BXCLXXX multiple healthy subjects BXCLXXX in scientific Medicine, fibroblast encouraging second an cancer BXCLXXX including established dipeptidyl clinical patients. an with profile inmate inhibiting of BXCLXXX. orderly Let's safety melanoma BXCLXXX additionally turn Designed immune an activator

and on lead BioXcel, biologic have We treatment strong specifically emergent and prostate a based our as of underlying rationale. cancer, dual tNEPC, chosen neuroendocrine target indication BXCLXXX mechanism pancreatic action cancer

the Keytruda IND to BXCLXXX neutrophils offering of at patients antitumor anticancer submitted call cells. this for viable the research produces and we by and single potentially to label pharmacokinetic of in studies all while in the Xb BXCLXXX synergistic combination with point arm tumors and study all examine into therapeutic Additionally, XX safety of efficacy up BXCLXXX [indiscernible] combination elevating trial tNEPC results objective a of combination We recently with to the tumors higher is treatment we patients based cells, tumor-killing open strategy. on immunosuppressive tNEPC the studies of site application with potential enroll from BXCLXXX Pembrolizumab, We agent they Phase I-O acceptance the believe with tNEPC. make blocking for return can the two infiltration expected as into preclinical Pembrolizumab combination NK cells received more of of FDA the constant. activity multiple and pancreatic We responsive agent

of [indiscernible] the to upcoming for drug clinical BXCLXXX with completed partners. conduct have adequate as well trials potential supply with also We studies as development other

also leading expect complain and the to organization We selected conducting end a to throughout trial managing studies. XXXX. record research this We anticipate support clinical initiation of data and year have clinical by

combination the studies that and expanded a combination in patient XXXX outcome. improve expert trial our demonstrated emerging of field Hoff, to are new advancing artificial platform. and the Today has pre-clinical clinical society intelligence are have in discovery, global company In functional be immunological, at member with tumor the program. cost treatment antitumor of on tumor third our BXCI-XXX developing pancreatic with leading our oncology pancreatic the agonist Nextar the the BXCI-XXX, also the checkpoint Most XXXX. in of checkpoint advisory of Dr. to predictive addition Checkpoint to point we of Nektar will of Eric data Louis activity and across is development multiple immuno-oncology clinical therapy into inhibitor triple the with collaboration cancer. NKTR-XXX quarter multiple for of of industry cancer we would this presenting potential collaboration and our clinical candidate of inhibitor lead Emmanuel from model triple Small combination trial inhibitor. team utility potential to than NKTR-XXX Von clinical other Venus, we and was focus BXCLXXX, the immuno-oncology for guide a out for with has optimization, promising we extreme biomarker on expected and companies a cancer cancer Nektar our Therapeutics type This and inaugural of to highlighting tumor of assessing the is further triple the The Dr. collaboration along NKTR-XXX, indications. and BXCLXXX translation to initiated triple resulting I combination employing Antonarakis. regression These oncology to and combination our existing the selection research in clinical CDXXX-biased pancreatic development three Daniel the also Finding annual clinical in meeting. in this established a Dr. support immunotherapy explore our robust immuno approaches like this of and the Nektar care I-O immuno-oncology In utilizing generation Therapeutics approaches patient of clinical a development program Dr. to research our lead board which

Our gives in for and indication continue expansion development. geographies additional additional BXCLXXX new to BioXcel both with the opportunities identify exclusive Corporation for terms XXX AI partnership of us and indications to ability

a Our applications IND indications in goal trial by global establish for additional to and clinical patients. footprint filing is multiple

and emerging our utilizing addition and pipeline Additionally our candidate our AI neuroscience also prioritize immuno-oncology. we are to platform in to expand

about our We are lead and just of the potential as emerging pipeline excited much program our promise. for

appointment side David operational Translational Senior affairs Vice last team regulatory our perspective. pharmacology year Head we President, President the management of supporting the and Operations. be strengthened of with Vice Pharmacology Lathia work as of and Development as the Dr. and regulatory Medicine, Global clinical and Pharmaceutical Clinical Chethan pipeline On as advancement on companies and programs will responsible Hanley Head of Dr. the and

Hanley drug development our operation with will part. pharmaceutical growth oversee While initiative Dr. and global associated the

program. IPO utilized utilized, of the of we from lead BXCLXXX to development as solidify the We leadership thoroughly advance well have clinical capital XXX our are our our a as thoughtfully team. and portion

clinical the XXXX the our number program. year burn and cash We on through in to remainder both expect build of increasing the in increase of studies

coming value would an expanding results. have for committed to over to progress that, to As we market shareholders. significant to everyday the several well and discuss in bringing is to positioned our Richard believe With who options. over call Therapeutics achieve transformative I the the months to clinical substantial last try few are BioXcel to turn quarters, our like create made we now we operational and and helping the objectives We our have therapies financial patients organization

Richard Steinhart

multiple joining you, our and to studies capital needed necessary and launch advance shareholders. Vimal of this to The coming us for of weeks. BXCLXXX of offering all in from us clinical public morning program the our proceeds once the including thank to the Thank from initial you welcome gave again to the XXXX XXX initiation development

and reflecting public quarter costs concludes and that $XXX,XXX $X.X next over activities The Vimal current meet expenses Research to operating and approximately expenses XX, The in quarter due of to the $X.X we from to XX development with and the of for period a sufficient development and The professional reported BXCLXXX increase to loss increased is of I equivalents needs $XX.X loss proceeds third compared for turn of reflects third trial our $X.X payroll XXXX the costs, were cash back to That of XXXX a increase the it payroll including would clinical fees research and believe quarter manufacturing additional to the of increased XXXX. expenses costs. BXCLXXX third million in We $XXX,XXX General September quarter again had for personnel closing comments. XXXX. as totaled net million XXXX. was XXXX third net costs compared programs same the cash approximately our our in cash for approximately of development financial both administrative primarily million million We expenses, and related XXXX associated IPO. and companies. with third review fees, at any in $XXX,XXX the for the of professional months. least approximately quarter compared position like and in

Vimal Mehta

everyone like the we to questions. it joining thank to like any for and Richard, would open up I for Thanks call

Operator

from question you. Barclays. Thank first Meacham And [Operator our with Instructions] we take will Geoff

Geoff Meacham

development in of I congrats guys, study for for specifics question path the in meeting to there Vimal, thanks was XXX the the an all get subscribers feedback want the any but terms for Then what progress. the Hi and pipeline of profile? your I one FDA XXX don't your and have as view was or follow-up. ideal on PK

Vimal Mehta

FDA behind buy-in plan. is areas, on to two the get very -- general what our goal -- specific, our available currently the pharmacokinetic treatment And will the that do no dose outlined, a that cells Alzheimer's. study of multiple using agitation. we development in there but acceptance that like because on and I which in meeting very different overall with XXXX. of simple, So, our saw II/Phase the we we we registration very doses, FDA do with now systemic effective was Phase bioavailability we both And And can focused the encouraging study, be and is understood bipolar, the in was for can indications we understood, for have and schizophrenia of therapy we safety Overall strategy also, with [indiscernible] proceeds using we a trial then forward that [indiscernible]. data III in will like

Geoff Meacham

a I say obviously run are the study looking data up, at forward the XXX know profile? the you to would what some be profile, ideal point PK PK from the on but expectations? then IV, what an your to for you would bridging have And with coming Okay.

Vimal Mehta

have pass this I Yocca. I So, question Frank Frank. will to Frank?

Frank Yocca

we Geoff, we Yes, get so understand we need plasma our to concentrations what affect. think

of the is that what like profile something onset get these that in activity seeing PK of XX to we're terms achieve fit somewhere minutes terms a can between agitation. XX where dose in reducing so looking achieve, around can studies the those producing [indiscernible] of smaller we rapid and drug So the graft the a we're for would of we ranges that spores in IV affect,

Operator

UBS question Carter next Financial. Gould our with from take we'll And

Unidentified Analyst

XXX. is for on Hi, got for Carter. here Thanks questions. taking on I a our couple [indiscernible] this

the registrational So [indiscernible] the about of should then studies in can approval. more hand, the from study point thinking how duration when the you have one? the [indiscernible] And little to Dex XXX be we a the talk XXX bit relative you timelines just IV about

Vimal Mehta

Sure.

plan. me address, trial the first, So let BXCLXXX film

in initiate this the had the with already expecting pharmacokinetic FDA. upon we safety the are to our approval of study are We We IND. year the meeting

have the for the for prepared, clinical film, CMC available We doses, multiple already studies.

like be is -- We helping who CRO study. now have the conduct a will us

So out all in this study, initiate short just expect in will time, the from XXXX. and short studies can results pieces of so matter that with obtaining data, to we both, IND not defined they least a we bipolar back These place, to in it's Those they go approval to require studies and and And previous experience get indication like long for approval year. III studies, and studies. the FDA, the schizophrenia fuller are start we a of plan the experience the finish know whether XX-month. end a the FDA because a you are studies the using these to II/Phase and come from to -- first-half it's bipolar nine or or Phase at schizophrenia Alzheimer's their about our

first-half we'll of be ready from approval or early file go we NDA. will to the those and have FDA XXXX, a the of to if first-half studies So XXXX, up then in then

is be we to able are and if XXXX, should hope targeting. NDA, possible, we file and that's that an by what goal Our

Unidentified Analyst

you. Thank Great.

Operator

And Capital next with take we'll question Kim our BMO Do from Markets.

Keith Tapper

Keith is I Tapper This questions there. on a Do XXX. had for Hi, few about Kim.

disease or might in the IND and talk exclusion that terms a anything about is background this XXX, that design might the what measuring bit that treatment criteria Could outcome. treat and So the how little being for it's for like emergent to you look NEPC. a affect that of treatment study like

Vimal Mehta

Chief Thanks who I pass to Medical question. is for Vince, on Officer. will our your it

Vincent O'Neill

Sure, Vimal. thanks,

we from fact KEYNOTE-XXX really the really with as efficacy on this the KEYTRUDA KEYTRUDA study or how population. lack had said the its chose of that and works or data approach previously we is there study the some and KEYTRUDA, So based combination a we patient in

patients So run-in that's plus a escalation And It's [indiscernible] XX. by combination approach. it'll a to two-stage XX safety be the so preceded approximately prior or design, that.

can response measurable visceral see, prostate, And you typically results do classic disease. results rate. of based fundamentally, primary So endpoint for [indiscernible] on a we because then example. it is Typically that mets, unlike in the in can

question? does the to answer approach And general study. the that's that So your

Keith Tapper

It does.

In -- from terms guess, generally like is of, it previous because that of results exclusion treatment there criteria, line certain chemotherapy. I

of a lines standardization So prior of to certain is study? in being the treatment there involved

Vincent O'Neill

Sure.

just treatment definition, by you is disease. clearly emergent this as said, So, a

So And have definition, androgen by therapy. deprivation in to the chemotherapy, patients had the one line inclusions. of addition those are so

Keith Tapper

Okay, that's you. very helpful. Thank

Operator

we'll Sumant take from with Canaccord. And our next question Kulkarni

Sumant Kulkarni

but we saw big I coming a out has products question, very combo Thanks ESMO one. morning. have taking where of hoped. for might conference focus not questions. a well as specific people as picture products -- the a in We actually my immuno-oncology to Good had lot have it. doing recent It's

So can at combo? You also a is approach. might intelligence, artificial on an you involves some new quickly nimble adapt How off looking given valid find yours your things? intelligence organization you how can which relies based be? that product, of a way your that of Is

Vimal Mehta

platform great any that's machine even conference. always whenever we Sumant, to We AI question. use learning our are a going and

We have D.C., Washington, of done happening this for immunotherapy. this in conference idea that's

what other they use to that our that I that is overall And this that looks report. understand [indiscernible], we team the utilized So the overall understand report combination as landscape like. a our the to landscape, understand particularly to if which And machine-created week, call is scientists, you it can immuno-oncology, adaptive combinations understanding landscape, high micro using and look are agents it to the approaches. environment very and change then At of immune primarily the drilling at a going combination down what on. adaptive level,

innate separates where BioXcel I immunity. is in itself the Therapeutics think

this immunity activator, of available I only the data. and and an we -- we orally not XXX patient innate I'm which company that for have are agent think systemic aware has

to immunity immunity the like cells of to immune are system, prostate has looking, by cells, be pancreatic like checkpoint explore need belief BXCLXXX, already know, chose [indiscernible] hard-to-treat in we to the activator three, that more, it our we killer tumor, have they're the is of tumor, responses of kind these innate and and [indiscernible]. responses, of are you and cancer Combination T which professional activating other with And agents. and warns able the combine and does been basically you early surveillance pre-warned the beginning innate agent, particularly So get immunity now agents NKTR-XXX, time plus to continue which you using inhibitor. adaptive you kind from a right the right immunity neuroendocrine the

think I as the [indiscernible]. will going companies particularly other believe we and overall immunity that as in of So terms and activation more strongly strategy well you forward, are more see ahead by think we employed a I

Sumant Kulkarni

that. for Thanks

Operator

And further back closing the Vimal time. additional over to for it are questions Mehta things turn like appears or remarks. at in would any this there no queue I to

Vimal Mehta

to like think for I also questions, they everyone us are very joining thank and today, relevant. I excellent

very about company have feel the throughout what is we XXXX. QX able of you and to We Thank to much. very what continue ahead excited in been and accomplish XXXX

Operator

does your for conference. Thank conclude today's you participation. that And

may You now disconnect.

BioXcel Therapeutics (BTAI) 9 Nov 182018 Q3 Earnings call transcript