BTAI - Earnings call transcript Q4 2018 | BioXcel Therapeutics, Inc.

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Operator

Good day, and welcome to the BioXcel Therapeutics Fourth Quarter and Full Year 2018 Results Conference Call and Audio Webcast. Today's conference is being recorded. At this time, I would like to turn the conference over to Carol Ruth of The Ruth Group. Please go ahead.

Carol Ruth

Thank you, operator.

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

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

Vimal Mehta

We IPO conference of everyone, a you completion and achievements. Carol. results Thanks, morning, publicly Good discuss the for call joining traded March. with our BioXcel business for became thank year XXXX. numerous a of our highlights to company and financial Therapeutics in XXXX was

advanced lead BXCLXXX have programs, and BXCLXXX. We development of the our both

first-in-human with individuals for neuroscience be are BXCLXXX. dexmedetomidine company. we made with would built Dex. selective our progress the our a a momentum our and we adrenergic and other the I'm very the agonist to late and or BXCLXXX of XXX and close into by potential since development agitation lead first-in-class into years. profile talented application of that dosed And significantly formulation key agitation. new we in and over clinical established BXCLXXX of and Overall, It we the to cause robust of proprietary well mechanism directs infrastructure indications. that FDA bipolar, a facilitate a our has we We of new accepted of that program cohort thin sublingual the Dex like has for in December. will the film the we type treatment Dex. grow of out alpha of the positioned coming pharmacokinetic year. pharmacokinetic to Alzheimer's This support In development properties crucial announced that and roles report first have partnership dementia IND formulation I been success drug, bioavailability XXXX have patients senile forced a as in safety trials. was Xa our for BXCLXXX is have safety addition proprietary in schizophrenia, carried over the the the start December, initiated which study, pleased These has highlighting BXCLXXX, BXCLXXX is film team

with This in the regulatory a expedited of designation BXCLXXX multiple study in Also in our study that and first the written to announced provides those Study launch that expect to plans, track top including results from more more to Track December, first will FDA data line Designation a remain by the in the XXXX. cohorts potentially the have today, NDA As Registration of half development we file the us healthy frequent XXXX. Phase and FDA. of we number of Phase of review. granted we Fast to respect and frequent half benefits X enable volunteer on With second meetings was the XXXX and communication report in X/X

have completed schizophrenia, in clinical agitation. administered we months, the treatment studies studies the which endpoint high of to BXCLXXX These for have of allowed the Each exposure development. symptoms of the three several in gain rate. primary met valuable development Dex, provided insight with conducted opioid of Over Each intravenously these level support Human studies validation suffering from SDAT, BXCLXXX its response and study withdrawal acute and we into PoC to for last dosage the patients the us respectively.

vast we receiving the as FDAs of agitation which scale and present encouraged is - and XX result for treatment disorder responded include trial. believe a commercial we potential of product which patient its believe no multiple explore well-characterized approved registration subjects Chemistry, schizophrenia experience to patients the and up a dose, for a clinical use for the opioid bipolar formulation placebo reference program work film regulatory a Importantly, we our path is is for This performed symptoms. study, proprietary treatment under a the pathway. planned respect CMC, and both moderate our patient first and we XXXBX produce expansion the and X that U.S., many the reimbursable as agitation, million to Control, approximately we all treatment has non-injectable, antipsychotic the for population to withdrawal as materials as us via responses, our Adasuve, observed X.X treatment have with With Alzheimer's acute to have drug, patients BXCLXXX supply In Manufacturing, are has to with of these for with and disease significantly production mild in preclinical on experience BXCLXXX BXCLXXX. opioid and well million track agitation with of clinical we and early encouraged withdrawal population. With successfully

work with activity to is BXCLXXX system, second established patients. BXCLXXX inhibiting mechanism adaptive an demonstrated XXX by systemic the like subjects activator turn peptidase and profile program single cancer (DPP) directly our innate-immune dipeptidyl dual stimulate Design BXCLXXX. orally-available action. safety has and to in I an It with of clinical Now melanoma healthy to from immune innate agent X/X.

BXCLXXX blocking BXCL tNEPC a cells. had in us T neutrophils, cells potential accepted believe other tumors the Thus we therapeutic formation of tumors BXCLXXX as inhibitor. I-O a functional inhibitor infiltration two applications enacts the NK effect evasion multiple IND synergistic several activation produces demonstrated to by other with checkpoint agents to immunological and and with immunosuppressive in Additionally, model anti-cancer memory. encouraging in responsive, while strategy. make protein, combination hot more months. BXCLXXX cells, in agents elevating turn tumors activity target combination agents BXCLXXX with a cold The The program can of and anti-tumor offering tumor immuno-oncology combination has and fibroblast robust of pancreatic into an I-O immune tumor-killing FAP, last

The November BXCLXXX the as the study, in known which announced prostate combination we Keytruda neuroendocrine for first of cancer. also is with of treatment pembrolizumab

and has been is open patient and labeled recruitment is site an Our ongoing study. it first clinical activated

We expect data year. to report throughout the

pancreatic is a us The BXCLXXX for infiltration study second [indiscernible] XX BXCLXXX MoA, and IND examine cell metastatic immune to study cancer. for into This to which as treatment to patients insight allow circulated of enroll is designed expected a and mechanistic provide further activation.

the from NKTR-XXX of We results BXCLXXX, expect combination pancreatic value support the in a study triple development of the and further cancer. map the will

and development agreement, checkpoint Pfizer inhibitor provide clinical include as this map will and NKTR-XXX. provide of use Germany triple Under a announced Merck this the Pfizer Merck of the a of Nektar Speaking with in study. KGaA, the week, earlier a we and Therapeutics partnership Nektar Darmstadt, our value will KGaA combination, expansion value the to map and

proposed combination on and the their clinical regulatory positive the received Working recently in with as We feedback with initiate anticipate will broad BioXcel such the our clinical cost and opportunity FDA near pre-IND for expertise between advance development manage will study and from equally program. and be Merck validation triple We IND a invaluable submitting leverage Therapeutics industry leaders style this the program KGaA provides shared as tremendous Nektar. and we for the We design. to Nektar program BXCLXXX future. Pfizer,

We to types continuing cancer, explore treatment other combination potential and as pancreatic therapy are as a that has cancers. for approaches of beyond believe tNEPC significant BXCLXXX we additional

breaking support broader completed Association opportunity. at as fact, preclinical These belief In of data abstract the of OXXX-Agonist and our are Meeting. Research American XXX accepted the Cancer was encouraging a an recently a Annual and BXCLXXX in highly late study

progress out across of key number our neuroscience invested have program In also in have lead, and we XX made class in significant of and XX a our we advancing team clinical strong building disciplines and a addition to a have we of made the hires, infrastructure. advisor. significantly immuno-oncology, to and grown world XXXX, Throughout team variety

year. and we of highly board. IPO to who number in bring a board member candidates, Overall, accomplished of our last completing appointing board that with qualified near all future, discussion in a in our proud added value the have will we new anticipate believe are currently we are We

drug advance AI-based as years BTI to I mature over to With lead of turn important to validation are would the We that an programs, in development and organization, clinical call growth Richard. like for our our come. position achieved to the and success approach

Richard Steinhart

Once The XXXX, capital BXCLXXX. clinical our March shareholders. necessary and Offering gave BXCLXXX the proceeds again, of from Public development Vimal. for our the all thank us Thanks, to joining and this welcome you to from morning Initial us advance

administrative XX, reported as year the full XXXX turn for compared the development in as full period program $X.X period XXXX same a compared Research company. as our cash of full regard the concludes and quarter additional in BTI operating from for to trials compared With $X.X were to million quarter and we period the I'd of totaled The That a and million back increase BXCLXXX the $X.X General XXXX, XXXX. the expenses, this for Vimal financial to million as million to year administrative loss million the any and for million IPO. of XXXX. and it a and compared loss approximately The fourth for net increase For including the fourth and activities increased $X.X research XXXX, a fees, quarter XXXX. expenses expenses to related manufacturing $X.X primarily approximately fees $X.X to costs of XXXX. for same proceeds public in development to year in loss of $XX.X to December $X.X lot and $X.X XXXX payroll professional $XX.X recorded professional associated over costs, due of were for $XX.X development fourth review, We reflects XXXX. for from comments. expenses XXXX compared was BXCLXXX in Research equivalents million of the and the reflects the development XXXX. net a million, costs. to both year of compared clinical fourth for and quarter increased cash payroll $X.X of our and million same about like to closing million expenses the million, the with for the were had million of personnel in General $X million, expense quarter,

Vimal Mehta

for you us today. Thank all joining

We now. will questions for open call the any

Operator

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

Scott Puckhaber

Hey, Scott for is taking Thanks this questions. on Jeff. our for

For Bavencio you exploring? versus the choosing with as additional combo, Thanks. was XXX, therapies the us and other can both then to checkpoint you give combo wondering, or for for for expanded XXX, XXX to I the here And what are rationale regards triple inhibitors? indications

Vimal Mehta

to will I question this Medical our Vincent O'Neill, Chief So, who Officer. is pass

Vincent O'Neill

Sure. Thanks.

So Bavencio. I two chose why three or we reasons think

an it's approved First, checkpoint.

I and large date. supported. were to fairly preclinical think it a three, useful And has large, behind the Two, actually that's models important. database

going So for reason we in direction. have that good three

Scott Puckhaber

expanded or both the therapies exploring? then are combo you And for and indications XXX XXX, additional

Vimal Mehta

indicated we hyperactive well incoming of in a result we is symptoms, patient. the bipolar in besides, works indication. delirium that that's as so equally mechanism the XXX, another already withdrawal validation it's So Dex this there that opioid Alzheimer's, that and demonstrated And schizophrenia,

So multiple there are opportunities.

Beyond I it pass Yocca, expand to on it. Frank that will on

Frank Yocca

thanks, Vimal. So,

basis As Vimal its indications hyper-arousal. the mechanism from to XXX in which use for mentioned, stands is different expanding

role, that different This with in know problem a the drug was with take who significant is then removing patients giving activity role we upsides opportunity believe But that So and area fashion major to hyperactive advantage an that the we opioid other than has withdrawal in that the really in playing the a a delirium. hyper-arousal locus increase key coeruleus. of and the is of. an give from IV formulation anesthesia mentioned that them ICU Vimal we undergo can

Scott Puckhaber

Great. Thank much. very you

Vimal Mehta

combination we what kind other will process complete thought Vince are. of

Vincent O'Neill

Sure.

It's it's said because we because so and only sort essentially before activator think immunization. I action, it's innate-immune inhibits and of XXX an available combinable. it's also highly

we're it's discussions so with currently combining And modalities. other I-O in like now

I think alluded sense. questions. that also as indications other in clear makes And potentially you your to

tumor. cold sponsored in classic So obviously the companies efforts two are and

potentially indications are look there I sense sensitive. or may think at immune it to make other mild moderately

those now. those So are we due right but ongoing in will announce course, discussions

behind what process that's the thought think we're doing. I that's

Scott Puckhaber

Thanks. Alright.

Operator

Gould from UBS. Our next question come with Carter will

Unidentified Analyst

Thanks impact all? Carter. a in tandem? [indiscernible] way, XXX, questions. you for if there dementia Does the Hi, pivotal disorder the opioid a filing our at prioritizing data run or for withdrawal is strategy for your filing, opioid still for schizophrenia in another and use pivotal taking are Put in possibility you'll XXXX

Vimal Mehta

That's a great question.

But very make and clinical, bioavailability the and analysis bipolar the our what seen will well what we currently we full then are decision path data dose are our from know levels from the trial. have We Dex for Once data done indications and PK prioritize. we understand in is which established. waiting company that schizophrenia of which investigation we our to exposure possibility IV is our laboratory have and

may required get the are established. the to indication get NDA all because that priority the to pieces are So well that

Unidentified Analyst

follow-up. And you just population, defining end, treatment, in about that commercial in a treatment where How Thanks. could addressable use the opioid the are paradigm? disorder? thinking the get you how as spotted Great. duration BXCLXXX In opportunity are of

Vimal Mehta

think pretty molecule treat commercial a and like irrelevant a was large but obviously a is I factored in, what which potent drug patients. recently approved ease to we low have has of we there year know And mechanism and Dex, our this these delivery symptoms withdrawal similar molecule properties in our more opioid opportunity.

and and opportunity that through currently broadly, factored the We process will into second big our is, - what indication. of become a the be a kind market third commercial decision, of are will in how in working our more

Unidentified Analyst

you. thank Right,

Operator

And BMO Kim with Do next we'll hear from Capital Markets.

Keith Tapper

opioid guys, to in thinking there floor or sense I be expand you're defined for how and disease guys. Keith you less our is terms expanding to Do a for severe a just of one as something to common, questions. as about trying agitation this going get severity, withdrawal, it arousable just Hey And on is Tapper like you're something Kim. Thanks, person to person? that like XXX specific Thanks sedation. have is to more but the would taking about of anxiety? I'm

Frank Yocca

Hi, this is Frank.

look its of chance drug try chance - also targeting agitation approach we extensive way non-invasiveness de-escalate that of where is know, way really at in the verbally. psychiatrists There's but it the is we're because a because used you could agitation. they the the to it it, that the there So good moderate, the be more of situation a

patient, So your really - think to answer will. if your opioid question, I you it with question? goes from patient second to And

Keith Tapper

Sure.

it's Second you something anxiety, more Bavencio question like expanding you're a less consider common, expanding you indication to just, to or would replacing like was know, great opioid severe withdrawal, that?

Frank Yocca

an the that's way moment But positioning at we're Well, interesting as XXX is question. the acute treatment. an

coverage of very we that that or the anxiety to necessarily different very, drug setting. treat So chronic takes treatment. nature development would the tox acute have where of kind a don't into for we things that And require plan the have

Keith Tapper

you. Very good. Thank

Operator

[Operator Ram Wainwright. with H.C. will Instructions] now Selvaraju to go We

Ram Selvaraju

and very questions taking progress so thanks the for much on congratulations Hi, all far. my

for as or to you you year. it First scope line provide you in timing I year that would design if at BXCLXXX, the the to Thank additional take study this of second bit you get data to see this question longer? be any what Frank. a for Could And expect from end the a before point? and half of trial sense on think reaching maybe the what envisaged that expect from data you that details you. X/X expect could just we top likely started that wanted of gets Phase would the program be with assuming the is of

Frank Yocca

the have expect And trials to we in an of Ram, read will look we idea like. out the XXXX. what data

need there the As schizophrenia, trial we well-trodden reason pre-IND Vimal in get And one one in X/X X really agreed the say bipolar that schizophrenia and also that mentioned, is development. bipolar the for in FDA schizophrenia, with drug a of area with trial meeting going for path Phase the well-played, one approved. in example to towards Phase trial is our

and be we those we time age we of as use coming that have XXXX where film now the when the And a studies. with very studies quick to our They're announce when timeframe those that planned, very can So believe see in we we completed. And it will fast these studies when deliver. remember we with would data are in really do. can

Vimal Mehta

the They In the are companies. normally seeing experience, around These Vimal. - we this months. studies have six to take eight is previous

it So that it nine to the by end begin able file even half finish be we'll NDA of in second will period, of feel very take year these month to our we this in time if and trials XXXX. XXXX still comfortable

Ram Selvaraju

then expect of asked I these Naloxone over opioid XXX question of great. builds of administration? withdrawal? you Frank, other couple earlier a XXX and the withdrawal Lofexidine? you overall Again I to replace on Okay, that Is that aim might this for opioid advantage And with do was of quick then and could another specific of because combined was to the the treatment be follow-ups. think route existing comment modalities treatment some also the have formulation And hoping on

Frank Yocca

one. question really first is your good So a

mean, combo they're with cannot to try the enter You opioid opioid the could to here antagonist withdrawal antagonist rehab bottom line precipitate envision, of drugs. for to that or some example, either week type get off say, unless is a paid. faster patients I

do second Again, idea as am quickly question? for So get possible. Ram. them to combination I would potential a point sorry the that that. second your could question, your the as be And to And

Ram Selvaraju

complimentary know, to a, to do considered, Lofexidine? replace is Lofexidine to expect you or was you This be likely this

Frank Yocca

the of most with its and fullest when probably dexmedetomidine, agonist. terms potent really the interaction most the in the of the Well, properties you it's receptor, at look

properties things so vomiting this very believe of those look best-in-class drug are go when given our can lot that we the and rapidly. powerful properties. way actually are you of area. a symptoms, that really has sublingually at a get administer be is these and for this important that withdrawal drug We a it absorbed phenomena. And it it withdraw. drug, are when for fact at lot on withdrawal drug the making look developing The the there's ones when patients that gastric, the given We So,

Ram Selvaraju

of could you expecting potentially of versus IL-X comment possibility Thank for that nature XXX in blockade pancreatic you're developments And pancreatic if implications endpoints XXX. and do on potential broader combination the maybe about talking likely future cancer critical strategy of pancreatic do of on that's whether of items. in just an in in know, have consider establishing regulators what tNEPC tNEPC? context very I of then this wanted about or And earlier this when consider metastasis run appropriate think to you published then in we've on question and therapeutic I-X the might population a the prostate cancer maybe role you the being a you What within ramifications for a you informally. combination Applicability recently and cancer proof very, or Okay, setting think most these paper example potentially And talked look little could specifically? helpful. think to also bit before in that study points couple at the XXX the comment I that of of the stage you light is to Vince regiment you. concept? was are maybe cancer,

Vincent O'Neill

all. But Okay. the can't I'll remember last take Thanks, ask I you repeat absolutely other actually right. in because your Ram. second. two morning. you're a question first to I'll Good

been direction. pointing in-house. alluded going combination And high publication we actively has So quality anti-IL-X you've a strategy forward that strategy, are clearly has in something to, a as just discussing potential

want So that now, something I and - looking much we're to say actively but here at. don't I too is that

and and think it the your you I question? rationale thanks for possibly up. very bringing second first is that strong Could repeat for

Ram Selvaraju

Yeah.

to the others in applicability XXX's specifically were relating setting. prostate The cancer

in should Firstly, applicability comment tNEPC? assessment of of could in endpoint what if of then tNEPC? briefly on prostate XXX you beyond And maybe XXX cancer if critical looking as be the potential we could for on you concept the comment in proof

Vincent O'Neill

Right.

highly So I prostate. And study adenocarcinoma endpoint - so - you'll of think first because we in objective PoC the rate. the is the primary it's tNEPC A can metastatic unlike overall so use response of of Class as know them

an I think acceptable that's surrogate.

translate between a example, cell into if for and which have agencies rate other survival. very in is good overall often, objective think I comparison tNEPC agents impact, make always, not the you response often small interested the that but

a a perfectly on with think probably is so this as is later discussion agency. acceptable. surrogate a the point So as to think table the going OX stage But is be I I overall disease,

So I point. that addresses your hope

including moving our into of just active therapy, In point. terms actually that very who a of earlier again with of raised lines PI topic know discussion

people are right of you that point. that And to you now. active discussion and of UCSF on so, these So Eric as course a know, again, at on back Small topic get we'll

Ram Selvaraju

you a an for And And you Richard. Thank of very like give compensation XXXX stock idea an expect appropriate for one frame Great. Okay. we as that? be just if should of what you. XXXX? look then comparable considering sort quickly to for Can based us

Richard Steinhart

Ram. That's a good question,

pretty I think is probably surrogate. a 'XX good

the compensation good will we're be. of steady probably a non-cash state expense what I in terms that got in think pretty

I it think slightly higher. maybe So you 'XX could using model

Ram Selvaraju

Thank very you much.

Richard Steinhart

Sure.

Operator

from next Canaccord. with question will come Kulkarni And our Sumant

Sumant Kulkarni

And differently? earliest data Good would already the forward? Thanks in indications, going will This But built, cash your a my do at use go seems given for in you can mean because withdrawal that what to you some mean which market a those. like entail for infrastructure of be the you terms there time, different given opioid that might morning. that might announced that in think what approached taking XXX, of is it on pick pathway case with question. just is

Vimal Mehta

many one an to that's a have followed you've are know, for you another. we what phase management from that that within rapid two a parallel study we programs are XXX human and internally build. we PoC indication another a have we in Currently, conducting we asked can XXX think the good pace studies as pivotal currently XXX. the very moving question on debating then as for very prosecute and one to company the And how Sumant, conduct as board team and organization, that by at designed and we two the with organizations

So that's afford. how our capital to what evolve strategy see current and and going results we infrastructure And can will come out the continue forward. our

Sumant Kulkarni

you. Thank

Operator

And like over turn with I'd no further Mehta the call back Dr. any for to to questions, additional or remarks. closing

Vimal Mehta

like a the I and to exciting who to And the all. joined would everyone everyone. from questions thank and Thank quarterly call look providing next we XXXX our all very call. forward you updating

Operator

for conclude again, you once And your does Thank for call our participation. that today.

may You disconnect. now

BioXcel Therapeutics (BTAI) 7 Mar 192018 Q4 Earnings call transcript