BTAI - Earnings call transcript Q3 2019 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to BioXcel Therapeutics' Third Quarter 2019 Earnings Conference Call and Audio Webcast.

Before we start, I would like to inform you 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 These may Company's are factors in the with recent XX-Q its XXXX, XX, can www.sec.gov. be website, report including ended its which Commission, on or Exchange quarterly period and on Securities Form www.bioxceltherapeutics.com for found the September quarterly on

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

Vimal Mehta

our quarter joining call everyone, business time and We we thank BioXcel results. third as you, financial to appreciate discuss today Thank Good Therapeutics' quarter for discuss operator. morning, highlights you for of everyone's conference results and our attention the and third XXXX.

we in quarter. have pipeline this We our made clinical very are with initiatives the progressing pleased tremendous strategic advances and

like To achieved we milestones discuss begin, the neuroscience months. our have and BXCLXXX, clinical would to I program, major over past the lead

is dexmedetomidine, This the thin a Just proprietary film effect action everyone, remind rapid is onset designed of candidate of BXCLXXX treatment administered to sedation. a be of formulation and to without calming produces easily for have our acute Dex, that or excessive agitation.

cause which therefore, often of limited demonstrated and, BXCLXXX that their can from announced from Ib side excessive of acute with a trial our for treatment the this score. reduction topline July, durable trial This of positive patients use. We agitation the its believe Phase options, outcome in that treatment with XXX impact primary is endpoint differentiated In BXCLXXX in schizophrenia. we effects met data result current sedation unwanted study rapid and like

Phase the and patients readout, of year. fourth data with we acute pivotal III in study schizophrenia during successful bipolar this quarter this agitation plan to With initiate

half are result, currently first We that endpoint. results XXXX. as these we And a studies a two-hour in believe will the we topline of short in report are with duration fortunate

the BXCLXXX first second submit we our to Following half to for Phase be XXXX. expect NDA able during our III trials, of

in opioid confident solid our and and indications. dementia other filing BXCLXXX lay follow-on initial that are NDA will withdrawal a We indications foundation for

In the we Phase for agitation treatment we the acute patients, agitation, agitation plan studies and for addition, genetic disorders. parallel with to initiate the potential with of limited trial of treatment in and examine options schizophrenia other Phase of In the III XXXX. for neuropsychiatric BXCLXXX in treatment Alzheimer's Ib/II agitation of acute disease for bipolar fourth a to dementia, quarter in continue

should Moreover, market Success launched clinical indication read We of both neuroscience our also we the program BXCLXXX. XXXX. as initiatives development of this out first for study excited potential in for to are expect clinical the our current will expand expand significantly that half strategic have this in BXCLXXX. could two

investigating in BXCLXXX injury the agitation. that avoid hyperarousal increasing to enhance treatment is to our caregiver to problematic state the digital cause prevention with to approach sense feasibility that behavior and patients measures agitation. of the alert device the of of be conjunction and are should at individual's we technology to and development First, necessary serve used the can of take of of the onset escalation Using the can patient to technology, the caregiver. the This treat device

substance number the for which the programs, is and the This Yale therapeutic With indications underserved additional brain received as to University. directed the research PTSD grant U.S. agitation is of of collaboration BXCLXXX in BXCLXXX treat to to are maximum disorders order an to of area, in patients. possible traumatic committed with injury. we Defense, grant medical Department investigate of with use we exploration with planning treatment initiative second congressionally in a and related Our have alcohol

of systemic innate action. would our clinical our dual mechanism immuno-oncology of I program, orally activator discussion BXCLXXX, the or like to that, available With with move to immunity

study Ib/II for currently neuroendocrine BXCLXXX cancer, Phase prostate Keytruda double Our of is combination ongoing. treatment-emergent tNEPC, and

Prostate the the we at initial safety second Scientific tolerability cohort first is cohort. fully Cancer A the serious or in presented October, nearly from cohort data and In Retreat. Foundation enrolled. toxicities observed events No dose-limiting Annual were adverse

announce additional data the to escalation to of XXXX dose efficacy of fourth in and portion the trial expect the before trial. We from safety transitioning second stage the quarter of the portion

are BXCLXXX with of establish stage tumor the Initial checkpoint of of efficacy full the inhibitor a The the of may an results types. modalities of safety immunity several I-O readouts in of activator the with data portion multiple the across expected innate XXXX. in second combination the half first of help potential combining trial trial

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

sufficient the in Finally, we and a the we through milestones. We III bipolar funding other the agitation key us take our sheet to proceeds of with disease, growth public of stock. in data strengthened million our in BXCLXXX schizophrenia raising have believe that balance in treatment quarter patients to Phase studies readouts for of $XX addition through common acute now offering in

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

Richard Steinhart

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

of $X.X a compared of third approximately we quarter to reported loss of the third million of for the a $X million net XXXX. quarter For loss net XXXX,

trial and $X.X the by two primarily costs, an drug XXXX. was Research activities, professional approximately lead same candidates. with expenses development in product increase of fees XXXX the third $X.X expansion our period quarter increased million compared development research for driven personnel The approximately totaled clinical to associated expenses, for and of including million

for due quarter million $X payroll-related as in third compared increase and expenses approximately the associated million with XXXX professional was third operating company. administrative $X.X the a to of expenses, were The and to approximately and XXXX. payroll quarter of additional General costs public fees primarily

The total of results September operating as approximately include of of expenses $X.X million period the non-cash in and We to as $XXX,XXX expenses third cash had million approximately compared stock-based in XX, Total for $X.X the operating XXXX. cash equivalents of for were approximately XXXX quarter approximately compensation. XXXX XXXX. $XX.X million same

burn cash to forward candidates. as our two we expect leading progress drug We going increase

concludes financial XXXX. That of review third the our quarter

like call Now the for back further to Vimal Vimal? to turn any comments. I'd

Vimal Mehta

Richard. Thanks,

we remainder made both with We quarter remain ability and during progress this year strategic on this are confident clinical have pleased execute the our and the into in and plans our for to XXXX. of

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

Operator

will Our Markets. from session. the Please we BMO you. with Capital be Ladies conducting Do question with your of gentlemen, Thank [Operator comes first Kim proceed and a now question-and-answer Instructions] line question.

Do Kim

my taking morning. Good Thanks for questions.

Phase study for what you for collecting potential those the of kind Vimal, when dose for the you activation? First, this data are will provide of XXX, signals these biomarker or for And Ib I report immune safety think and year? cohort you results for X cohorts inflammation later

Vimal Mehta

year. to the and add by cohort we is the Yocca, Vince our O'Neill, and like my this I'd Do. Thanks SVP today, for intend that, our Chief who I'm Medical joined Officer; SVP Scientific Officer. who results Chief Frank provide second Yes, to two of colleagues, and is

he Vince? will biomarker, question to For pass so Vince, the on about elaborate it. can it I on regarding your

Vincent O'Neill

Yes. Do. Thanks

from we will, So to has said, profile the fact, in prostate full-size add can just to Vimal study. so a capture what

actually, portion biopsies. are all addition, portion, required patients efficacy in necessarily – the our the to efficacy of within have In not safety,

second a the on option biopsy have of therapy. We

substantially the So we do study. into have biomarkers built

Do Kim

expect the you And active a signs first stable of great. milligram that do that Okay, to much is in X.X how dose? And you dose? how of in would you step-up the the X.X cohort, milligram And consider the saw efficacy disease, meaningful? see

Vincent O'Neill

Yes.

cohorts fundamentally two So the safety as I would safety view outcomes. cohorts with first definitely

it efficacy. but wouldn't, certainly patients make seeing So on from remained on to I rush that there, to claims is true all study,

to number cohorts it's it's doing from view. that that really, And the not primarily said, patients. mean, sure of would but a – a I'm two small safety see no we're I progressing, point I to think patients clean extrapolate efficacy. I from nice of first

need we think I patients. more some

Do Kim

what could efforts clinical Phase Okay. enrolling do start-up to to screening before the and patients? is in Thank XXX, for you. start you the left III trial And

Vimal Mehta

FDA II of we a the step confident very it. the meeting trial FDA, having that end our believe start this are and initiating feel and we to we in So After about interaction, year, with key their we trial. Phase is intend

Do Kim

for and what force, could bit little your you a maybe sales be need? about you of you strategy Will looking of infrastructure talk XXX. commercialization kind would And partners, size regional for

Vimal Mehta

So develop commercialize. the that's much develop a don't great to the drug. question, particularly Do. have to we in In U.S., or U.S., capability we have capability drug outside And Japan, this

we started Europe. partner and So potentially have potential in Japan exploring

partners, for is So regional that and we ongoing. are effort looking

requirements In and of mapping terms infrastructure, to a commercialize activities drug. started have doing commercialization the out kind what it the infrastructure we will be of commercial pre-commercialization

this where drug places a sold. is to it specialized But – needs be

exact in months, expect able provide be that best needed and of So too in will we will to in guidance the everybody we large, few penetration don't get the but on the sales be next number be rep to number U.S. to the marketplace. more

Do Kim

Okay. for my Thanks taking questions.

Operator

you. Thank

Karnauskas question Please proceed question. the your Robyn line from of with SunTrust. next Our comes with

Minh Vong

to This Thank bit guess, PK/PD Vong with more on a for quarter. about on you XXX, is Thanks my taking you. I for ongoing this regards questions congrats Minh Hi, everyone. first, progress modeling? little the Robyn. and can your talk

if on any dose reduction of us or through – reduction and you've the a identify of transient if clinically agitation you is in where agitation see balancing can even drowsiness and to linear, with thinking effects the you've if you've you seen understand maybe been efficacy, degree Can how you're seen duration correlation if help drowsiness? maybe able meaningful

Vimal Mehta

the our Frank. question. will address leading is CSO Thanks XXX the question for Frank Minh. program. and that He

Frank Yocca

Yes. Hi, Minh.

for the Ib, is talking did even you has do see now in at as will? right more is of we response we example, PK/PD. events, Phase minimal events. adverse highest adverse that dose thorough And say, definitely the fairly that, What understanding two we we have and told how you're So what if an data dose, a know, you about us the extrapolate basically the

the even in to IV, quite So to been up of PK/PD, well. it's holding terms relating back

the in right our really events. basically, essence the performed that of reducing which XXX top very So severe dose, is belief dose, agitation now in adverse well the was

like we very dose much. that So actually

it really So held – true. has up modeling quite the

Minh Vong

mean, can on option? strong incorporate into this watches can XXX through in to talk device? given devices, that they a that? any experience it if And Great, just initiation these Are or wearing comment And you those on they're wearing patients question devices like thinking one own? to sites you're to I your how does or have familiar can patient device, anything on or you geriatric other used whose population, have about How be? if a remove bit thank their with then you you.

Frank Yocca

we're what developing, population, I concept, can We're exactly exactly if which now what of about the right that the of thinking to will? a say about So okay. our kind kind terms that of how fit using you what we're a is would drive elderly what device, that, wearable, hyperarousal, in is

others who Now realize would prior event are you can there full-blown that benefit to of building thinking that. lines you actually a along event are agitation They as these issue or it from the becoming that if predict the the agitation clearly well.

the we doing what is is that, event to tight which hyperarousal event, closely basically very So that believe sympathetic activity. we're is to tied

different we can skin in a of that conductance. believe ways, And up including we the pick number

correlation I And to remove focus agitation will be these give able an they of the it. hard have would goal then on there's that we that type increases event. can't think of very to definitely patient to wearable So in is elderly once sure that, the down some to a we now and our we show biomarkers right make between

Minh Vong

you pancreatic? going is Great. remind then us Thank the update that any run-in And on, from to there last XXX in safety can quick you. of be follow-up

Frank Yocca

data next we it year. this So won't that see year, study from will

Minh Vong

Great. Thanks much so everyone.

Operator

you. Thank

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

Sumant Kulkarni

Good have thanks questions of them. couple a taking I morning. for and

to FDA? II The first the of Phase you one more point meeting have end what is At clarity XXX. the do of on with scheduling expect on

Vimal Mehta

if the meeting, not have the we scheduling initiate the this very the shortly, FDA with we intend that what we but, to have are on that looking or We year. clarity is trial communicated

we given So interaction the well that that date with the believe exact FDA will progressing just allow date FDA when is. things we meeting haven't us, the are but

Sumant Kulkarni

place? that potential on seen data immunity focused next or tNEPC, fledgling XXX. At And And has what know but think other potential you on there. you We've do in question NEPC this you're already sort effort my that have then Sure. we without safety pancreatic yourself of the uses? and you innate can distracting more explore activators from combinations is point

Vimal Mehta

great a Sumant. question, That's

think potential as I a of of this progressing chosen are mentioned, are pass we thinking so Once step opportunities. was in combination indications, other have how we have can we with two he these this this program, besides, we question that safety will on establishment path. safety checkpoint we I Keytruda safety key to you to like with about immune XXX complete like and have more data once on success checkpoint like in have demonstrated, XXX, inhabitor. established large we that Vince, explore with elaborate

Vincent O'Neill

Sure. Thanks, Sumant.

checkpoint well I think So in who other hot tumors will prior drug tumors in I've or warm that words, alluded the calls, on be in perform those either hot interested XXX I'm inhibition. or are progressed will context there. to as of tumors. we confident the once testing had In patients

from STING TLR. looking recent updates SITC and Just the had we presentations, at

that does And the think it I inhibition. is using this to to resistance drug, can XXX checkpoint beautifully seem you feasible fact So itself lends think an I that reverse it and mechanism. just possible We're setting. oral that certainly

very So actually, said I subsequently. think more and of hear before, you we setting an about and test soon those planning questions that types to are in IST will I

Sumant Kulkarni

last then again, my XXX. Got it. on question, And

long combo going Nektar combo? to do safety in the last, you get On on triple Pfizer how triple can the study expect trial cancer, pancreatic run-in you so and the

Vincent O'Neill

Yes.

to the been maybe because So explain to avelumab The just bempeg study hasn't before. design and that. of was done that combine

some titrate to up, then that. plan. And and so was have there's XXX with And that really least data XXX, the requirement added clearly at a safety

separate data probably – agents. Pfizer. is the partners our this And think to get it Is decided of study by we've wait Phase for didn't run I two make those Ib a run sense two from and reason, that with to being

has to expect study that they year, and But or their made Pfizer as though. I open. is safety to to know And so that that, get data. open It when, study is just whether full next whether And announcements don't be rather, will ongoing. stress

Sumant Kulkarni

Thank you.

Operator

Thank you.

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

Edward Marks

on questions. Good taking the morning. Ram. This appreciate Edward I Marks is you for

I'm initiation For III full key year. that to be is happen are later endpoint with going the this that XXX, wondering, mentioned to to study? likely this the long enrollment complete enrollment? initiation's Phase it most in secondary pivotal of how what take you likely after And that

Vimal Mehta

you want Frank, do to take that?

Frank Yocca

Yes.

time we Phase know, study So a as Ib period. you quick in completed very the

we full problem. end see enrollment a period. of see start as are five-month So almost the a If completion year, and we don't the this study, of to we study as the within four the enrollment planning we in occurring

about And So for on I'm both excited separate very we're studies as that. that's – go well for would that talking schizophrenia bipolar. both about as that

Vimal Mehta

what about is be? question secondary our Frank, endpoint, also, will secondary like And the endpoint

Frank Yocca

Yes.

the we to the really how patients really really we and well respond, CGI. works treatment endpoint. key So secondary because how be as to critical But use we secondary that the – they use That's the it is endpoints, the measurement, going secondary our secondary endpoint. the talks a think ACES in

psychiatric always sort if you studies, rear, most you will, lot tells the but about up brings in patients feel treatment. how the it As after of CGI a the

Edward Marks

that Okay. is Thank with to be the before Phase so then because proof-of-concept in schizophrenia? or Alzheimer's you. after trial data XXX quickly, Ib released study Phase And is that slated agitation maybe happening III

Frank Yocca

going to an was the the So present if talking we that about actually you're when we're into ACNP abstract have accepted. so data,

be XX, the and this is I believe there. X will ACNP, year, through So presented December it

Edward Marks

you've forward strategic about to do plans that just SITC to of any last bempeg question building XXX pursue additional of with IL-X the you that. novel from with of modalities the XXX, in combination any question seeing combinations, that And some targeting recently? Look excellent. have development on Okay, on final then sort maybe after seen information

Vincent O'Neill

to It also partners. the So at that's to to as to at have earlier a I true immediate think But SIC. we it's don't It's the really studies. potential any data that plans probably is And the number presented low combinations is we will preclinical be way branch as looking have out, well-respected dollar these say tends for pursue combination true previously, haven't we done pursued. of say to AST data, probably I where novel institutions. on. company-sponsored said I nice signal company, again, setting mechanism a

Frank Yocca

And the other easy many other combines really point, it's the by fact taken once-daily beautifully that's very agents, combines an combine. to of course just remains oral – virtue, with XXX again, that

Edward Marks

I Okay. detail. you. that appreciate Thank

Operator

Thank additional back concluding pass for to you. additional management comments. to so like time, questions floor at we It any appears the I'd this over have no

Vimal Mehta

call Thank questions. you Thank and you, please out today. have great any our again reach day, to joining if us Have a you. for additional

Operator

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

BioXcel Therapeutics (BTAI) 14 Nov 192019 Q3 Earnings call transcript