BTAI - Earnings call transcript Q2 2019 | BioXcel Therapeutics, Inc.

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Operator

Good morning, and welcome to BioXcel Therapeutics Second 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 listen-only mode. At the request of company we will open the conference up for question 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-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 June quarterly on

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

Vimal Mehta

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

program, in believe positive Phase the directly This pivotal to III recent quarter our potential proved program be trial as neuroscience of results the BXCLXXX, such reported in to trial. Ib lead Phase clinical our our as advancing we driving

excited the planned. Immuno-oncology are We as in key which advance met our BXCLXXX, program, by and to several also milestones continues progress made

the second half and confident strategy business execute plans. to ability development we XXXX, to and our our our in upon remain strategic of growth Looking

initiatives progress development I start to by executing highlighting neuroscience program, our we would have made, the strategic BXCLXXX. like in clinical that

Just or thin-film proprietary Dex. everyone, to dexmedetomidine remind BXCLXXX formulation of is our

XXX BXCLXXX six-hour the patients May assessing XX observed for period. BXCLXXX placebo-controlled, total Following trial, randomized, evaluated multicenter we schizophrenia double-blind, the XXXX, announcement treatment in U.S. and In of of Ib of initiated study patients. of we treatment over positive bioavailability an this and efficacy healthy option acute volunteers, Phase a the a agitation in schizophrenia in Phase agitated results study of BXCLXXX the safety from a as Ib efficacy

of as score. doses to of During the the referred endpoint to the Component microgram primary randomized XX, to X. and PEC trial, XXX groups To study, PANSS BXCLXXX Excitatory the we commonly X administered XX, XXX XX, utilize measure we

leveraged agitation completed short we measured. secondary acute study and results in the July. evaluation of endpoints are Additionally, ACES, in and as proved This of that announced easily Scale, we duration quantifiable Typically, for began sedation. that studies and our from May have Agitation-Calmness evidence Evaluation agitation are

Top at the delivered at when were also compared meaningful regulatory XX, calming measured in our statistical to belief and our two significant be with statistically the showed statistically ACES by endpoint option XX, consistent three viable the data measured and dosages that the study was agitation agitation for five trial, and placebo separation certain the XXX line represents a placebo met endpoint. tested microgram PEC doses. BXCLXXX score in reductions sustained in Phase XXX XXX demonstrated hours. at safe from dosages, Ib as score findings significant These at dosages. well the the from Of corroborate significance clinically during scale, Furthermore, treatment showed BXCLXXX which high XXX the and results BXCLXXX the hour two also primary for BXCLXXX and reduction rapid with a shown PEC micrograms endpoint tolerated. the

pivotal severe advancing recorded data trial adverse across during Ib the directly results III our strongly Phase effects trial no recorded dose studies. believe BXCLXXX range. As entirety indicated, warrants We that the Phase to program successful of were our

clinical had the discussions BXCLXXX. high-level on During the for with IND meeting we plan overall with pre FDA the FDA,

or the schizophrenia used XXX hours the III of feedback Ib with enrolling endpoint, We at efficient approved believe recently measure derisked. as we in on request capital and II pool. the PEC bipolar clinical as referred other plan disorder to We optimize which approximately and trial, plan to pre-Phase results III two patient XXX Phase late to obtain additional and with development patients sufficiently completed will XXX end-of-Phase study. is meeting with our to of in XXX this Now trials primary the are be reduction clinical In its Phase anticipate stage to the we program. each studies FDA also keeping meeting, in agents as of rapid,

XXXX this study of expect the the fourth quarter will initiated during We be readout in first anticipate half to a data of XXXX. and follow

to to to we process of support previously, BXCLXXX an Phase discussed As have III the needs. up already manufacturing automated scale production transitioned

of Ib half data during and be BXCLXXX positive second will manufacturing, Phase automated the a believe to NDA demonstrated in As able submit result we for we trial the XXXX. first of our our

of driving disorders. addition scope neuropsychiatric We're agitation of a initiate in of to we the treatment Phase efficacy working as its fourth clinical quarter BXCLXXX continue in for Alzheimer's trials, through other currently in In a XXXX. the development trial agitated Ib patients the disease/dementia to to evaluate option

and development in strategic treatment in putting delirium also as place to option opioid plans are withdrawal. treatment We hyperactive test for acute BXCLXXX a

ahead the lie us, to We noninvasive, pursue that developing goal to treatment of continue acute by motivated target we opportunities agitation. are rapid-onset our many a of and well-tolerated

by vision to made our upon strategic execute this our confident quarter plan. and pleased during remain the ability truly are We and achievements in our

switching Now BXCLXXX. clinical and gears Immuno-oncology our lead second to program,

neuroendocrine portion double safety treatment-emergent BXCLXXX in expected trials have efficacy patients We clinical of in combination cancer, currently clinical of enrolling in X-stage for half second which the the by be program. the Multiple of U.S. are portion and A patients the of XXXX. is escalation the prostate a followed tNEPC. up trial, treated will the and data-readout been in Keytruda,

was clinical Healthcare we trial Regulatory Earlier with effort CTA, Agency, in products MHRA, our U.K. accepted. an the filed and global which Medicines in the year, application, footprint, to a expand

and from We us authority. clinical to for local will U.K. our BXCLXXX development into CTA expect of combination novel Keytruda enable the sites, plan This to activate to U.K. subject approval expand double clinical this

of the This agents triple the bempegaldesleukin Pfizer safety application X-stage of combination Immuno-oncology the to a followed received by is Nektar with drug from the avelumab triple XXXX. from authorization KGaA, and efficacy on BXCLXXX, new and Moving combination Merck that and has be investigational an for of will FDA the first portion in data the readout from escalation expected ongoing. trial of half

As a reminder, be with clinical shared managing will costs the initiating and agreement, BTI Nektar. development the under program responsible with BXCLXXX collaboration for

we combinations remain lives exploring to improve to Additionally, for indications. with indications BXCLXXX multiple patient dedicated synergistic oncology across additional

quarter to many On community. continue XXXX reached the financial financial the others end, year. We we recently XXXX, were several in to and these our Indexes. to remainder in value-creating the in our the XXXX milestones visibility has added achieve to efforts our the we admittance raised Russell the of believe focus second and of Overall, indexes

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

Richard Steinhart

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

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

compared for and second for Research costs, and of and expenses, main $X.X for and in expansion of development million BXCLXXX BXCLXXX XXXX and two same approximately to development an fees with approximately was professional million the quarter both XXXX. by activities products. trial manufacturing research costs clinical expenses period The personnel increase the our totaled associated include $X.X primarily driven increased

million quarter compared stock of support as $X our we expenses the in second compensation. payroll headcount operating quarter quarter was approximately approximately total due increase as additional to to business. equivalents were $XX the to of second We as based million to primarily for and of of include XXXX for continue for The million increase noncash approximately second approximately XXXX. million of expenses expenses to the growing XX, operating General approximately $X.X period in in $X.X compared The approximately XXXX. were $X.X payroll Total expenses June cash million $X.X cash million XXXX. the administrative XXXX results had and and same XXXX of

sufficient and cash well-managed expect believe mid through to cash burn we to progress candidates. leading two forward our will drug as and fund key milestones XXXX. We is increase operations our position going We be

the financial of concludes second That our quarter. review

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

Vimal Mehta

Thanks, Richard.

Once by with you would to the key are wave excited thank Therapeutics XXXX. like positive your results well through to for development coming and the the mid the across discuss I to quarters. quarter Therapeutics we truly believe of results of to provide BXCLXXX neuroscience for BioXcel our in support again, Immuno-oncology. mission call our for We financial you develop That second remarks. are everyone milestones to cash our of and positioned continued BioXcel our prepared achieve joining product hope XXXX. additional next programs thank on conference and concludes medicines updates We

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

Operator

will Please ahead. go you. now of Gould Instructions] question UBS. We [Operator take Carter from first Thank our

Andrea Brettler

Hi, in Andrea guys. This questions Carter. of on A couple for XXX. is

now. for agent, is point post guess treatment spot particularly XXX, which in KOLs, you they’ve it highlighted with upfront everyone here more conversations oral do likely expanding guess, of I in entering you. or are for I’ll of second getting a throw milder follow-on stage use as given target it the think question market then, you you in XXX’s think first, Do those the chronic the are this injection. really is at-home would administration? higher sweet is ER see paradigm? about accomplished? XXX oral for I And so at So where are be -- I a What my as thinking the or some How severity? that much likely to my its patients, gates one Thank use

Vimal Mehta

to I it. start I then will Vimal. Thanks. add This and Frank will have is

is So market risk, been, few, market, and who X has that. of are some point experienced patient about patients are and agitation, there bipolar understanding our million part at million large pretty XX of a it’s schizophrenia major a X.X

pool and is aggressive moderate are that patient targeting could mild moderate, to We also. be a to it

every score to trial saw we mean of our was XX. able in patients, take was film, and patient XXX PEC As

are aggressive you XX, in over the go you if So going situation.

the does treatment This out any agitation, the having is underlying we are not the like this their second for a a to agent strong need they result physicians being treatment that so treat developed. noninvasive, anything. that. in very There excessive can targeting population. reasons it's primary in about, talk find And a and So will can line that that way, not for easy-to-administer or the so that of we that patient be believe sedation, is

some that another that, make targeting of the we comments is So orals Most let the not antipsychotic noninvasive. here. Frank a I it about and are of antipsychotic. drug drug. promise will what stop, It's is that I will are big With

Frank Yocca

So I very Vimal nicely. think said it

first are think in, approach patient verbally patient to has physician to severe. room considered over when they emergency patient. XX, the If is the it's usually try de-escalate score that agitated I take a comes PEC the the a

the XX self-administration. film the we actually take So some and had were actually easy is patients those convinced for very patients and film around to very,

for need XX that a here treatments dominated area. line have the is intramuscular it's bottom been the in of that this the consensus over again, But meetings number by last noninvasive And years, guideline treatments. highlighted there's

So drug it believe we will or shows antipsychotics data our well that works generated, space. really than excessive better good that with this not the as that we IM and sedation, in quite without if the causing compete benzodiazepine which just especially

comment what of do use, home is And promising the I very exposure sense that your patients, is with which and very we're about regard our think profile, this to need good. here film will a to its of safety looks to we and getting first

and safe, the outside argument into That's the closer more formulation to emergency more the make moving get finally, drug we homes drug is the this setting the we given of room plan. drug, the a in our nursing the think into that we homes. I use actually can then convincing then

Andrea Brettler

follow-up are trial the by year-end? do kind you, on and of give or you still Great some expect actually to update safety XXX, tNEPC's on one efficacy

Vimal Mehta

That's right.

Operator

Markets. comes question Capital next Kim from Our of Do BMO

Unidentified Analyst

effects given you. offer in combination, these color synergistic indications dialing but know you press the congrats interested on Jamison promising your options? approach progress [ph] your in and some and is more call, other program. and preclinical Do you on can Thank on and data briefly this quarter, XXX release in modalities for This the I you're or good mentioned immunotherapy and in exploring question the the the in

Vimal Mehta

That’s a good question. very

come initially, target data said, very you cancer which back. the complete And So of cold as and tumors, And tumor. we pancreatic triple eradication the combination. chose it results were to two didn’t tumors with it in convincing was

immunotherapy melanoma. guidance we activity single currently combinations synergistic lukewarm called a what provide opportunities our of And tumors those forward, believe can we combinations. segment, T the that be or opinion was to will more we and exploring our where a those there we is in leaders. other And refractory cells. continue find other we working related there patient be as move those other And we specific with XXX to could had as key are combinations. plan working. that, memory formulation So not agent test already And Besides is opportunities

Unidentified Analyst

Thank you.

Operator

[Operator Please from Wainwright. comes Instructions] of ahead. H.C. Our Raghuram next question go Selvaraju

Edward White

on taking Good for Ram. morning. Thanks for is Edward This my questions.

few from me. Just a

Just that wondering about if little you And bit, to start the the setting but do setting know XXXX go you’re this hospital mentioned move in into patients? in was similarly story? looking whether then acute for the you're a still in press going I you will or whether these is I first XXX XXXX delirium. story wondering just to nursing a you’re into perhaps this a a home or release going to agitation,

Vimal Mehta

because is we’ve a XXXX a certainly working while. deliriums story So, for been it on

patients. there XX Dex was had, the XXX% with know, IV demonstrated in know, we response was like you all you almost that it As previously

that big Maurizio May MGH is Fava medical with kind need. -- in our know what Day is a unmet is the XX, showed And from delirium. of it a Conference problem Investor we on So how there

continue and we year to those explore provide for our we hyperactive that this able So believe launch study what going to and will we’re to guidance delirium. when avenues, we more be

Edward White

XXX, A questions Okay. on you. XXX, I’m of sorry. I mean, Thank couple

You the there’s combination a mentioned the in readout data for half XXXX. of that triple first

or for So like for any if was there's I be going just well to going you're many this ACR enrollment way seems thinking all that an how patients? But it’s like currently in be, perhaps, And trial. ASCO the the to whether wondering going going be interim whether whether until to wait And about data? would final presentations? it is

Vimal Mehta

XX know, a we able pancreatic be are combination, our the XX great of are trial. phases. a phase. you question. finished will the it’s One these triple into two And that it's dose is escalating as label the agents. Simon In stage trials, plus That’s cancer, soon have we as we phase phase is move open doses patients And a in efficacy so these escalation to three as escalation and two efficacy and

we matured As and data data mature depending and where how the compelling to a are is, we the we a in would discuss. level once data, know nature discuss position get data how we the it that like has of to is on to the it

the data CMO our readout give will So more guidance as what in line, I we months, be, Vince. that next and can XX plan know the is on

have will about to embellish data anything the him Vince? likes I more he rollout. So

Vincent O'Neill

you've Sure. are we'd studies to. Thanks, I've very designs said, Vimal. PoC little to add the these Maybe X-stage. just say Simon that, as of

we your where, So up the interesting the if able and to so see ASCO. strictly signals to we want be report a to it's how stage of data. likely entirely get more by present to question, very-very end probably we back data But and book, would would et to out cetera to us the earlier, original

Edward White

these population therapies? line, all. patients And like maybe that's makes about whether the could since enrollment I ask that is, any the Okay, first a have so target that's if And what sense. second line, call, you're then just on prior

Vincent O'Neill

Sure.

this So trial. line for the is pancreatic a indication, second

therapy So have patients received will metastatic essentially. of one for line disease

the no Taxotere tNEPC studies, point there. during interesting, of treatment is agents, really a For deprivation Patients the had standard clearly have more their androgen Xtandi, had at they there either journey. much will Zytiga who some or care

had disease. have anything not will we they tNEPC, of terms in But for that

nothing. really Just is

platinum-based but effective don't are as And investigators see, patients many have We to use generally we viewed allowing, chemotherapy, that. you'd active. to received therefore, and as expect not it's

Edward White

a the appreciate previous detail follow-up the of final I one just right, from All questions. and

pretty AACR year you was that XXX, - data presented this at compelling. at earlier some Looking

targets this just whether of going you're that one to Or go was to of different still a that your that of lot first? very And you're specific XXX options? wondering as sort with therapy? Just proof-of-concept a couple was if of investigating

Vincent O'Neill

maybe you I'll more progresses. see answer Yes. because the data that generally, preclinical think year I as more question will some

a think co-stimulator. disappointing. activity. bit any you know, they a I they as example, significant say, to agent, fair as good it's combination, single a probably have And have in a little don't is OXXX it's So maybe Co-stimulates been,

we because very more area. and you'll deliberately later. this about area. we so think that being with again And I'm one OXXX, one learn I That's know strong that's level agents like synergy have So genuine high

one the So co-stimulators think is I bucket.

the just other XXX I adaptive argument, on it sense. immune think combining with approaches, synergy based makes again, huge

hear probably You more about that.

macro And tumor. that solid we and in then And it of agent because of course, we with a right, CAR-T, we like the said publicly property makes have lot XXX inflamed the of especially have a altering sense, combining environment tumor XXX.

later may So in you I the hear about those potentially, testers just more to guess, are year.

Operator

no There time. this at the Instructions] telephone over are [Operator further questions

Vimal Mehta

again you look for with forward and to Thanks. today’s participating future Thank call, we updates. you in providing

Operator

today’s call. concludes you This Thank your participation. for

You may now disconnect.

BioXcel Therapeutics (BTAI) 10 Aug 192019 Q2 Earnings call transcript