BTAI - Earnings call transcript Q2 2018 | BioXcel Therapeutics, Inc.

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Operator

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

Lee Roth

Thanks, Anne. again, Second all Quarter once for joining and Therapeutics BioXcel XXXX afternoon, thank for you us Good Earnings Call. from Steinhart, today Officer; me management Mehta, Vimal With Chief and Richard Chief Officer. Financial are Executive Chief our on in are the as Scientific line session. O'Neill, Frank Yocca, Medical Vince the be will Chief and well Q&A Officer and participating Officer;

statements that the we that future asked today's call on begin, matters certain discussed questions risks to I'd Before subject of events to the are like company. may answers and that are to given to forward-looking future remind everyone relating the be or uncertainties performance and/or

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

Vimal Mehta

March. to progress company. in our Good and on the you Thanks, of Therapeutics public real made brief and we is everyone It first to our those have since a welcome new afternoon, as a story everyone, to conference to Lee. to BioXcel tremendous who IPO call Therapeutics also BioXcel pleasure are introduce

unmet of we next the company intelligence of those to in identify immuno-oncology. addressing of and power Therapeutics, wave are clinical-stage a biotech you medical neuroscience harnessing For with unfamiliar artificial the medicines, needs BioXcel

with our through partnership, traditional add have the potential us With thousands regulatory innovative BioXcel we methods. and pipeline enables Moreover, of treatment information, higher on into cost opportunity lives. more therapeutics improve quickly, identify with this to effectively systematically R&D regimens the partnership and we success AI these Our of than to compounds develop truly a leverage data targets. expand and patients' and probability this can to with Corporation clinical

review our I successful sufficient the funds public the the first offering over to generating We advance Before lead million proceeds, emerging would like lead-stage pipeline. of execution I in programs, development programs and initial highlight quarter. our raised $XX of gross to in

and to grateful excited success to everyone our IPO of for us. are of We who the are opportunities ahead contributed the

exposure regulatory We over sedation acute The an agitation. as agitated approved It approved XXX announced patients. of effect path could clinical a case, treatment adrenergic with the In suffering and approval ADASUVE, Dex. In from indication. in our a the condition. treatment started is focus It's selective immuno-oncology. a XXX. strategy neuroscience our results using rapid psychiatric and for regulatory for mechanism characterized. BXCLXXX the let's our treatment blood trial in result the showed evaluating healthy and plan agitation. safety intravenously being XX thin-film provide first action developed pressure acute well-characterized agitated seek Dex, Dex as sublingual is We dose-ranging in in It randomized administration in a agitation. lead safe Phase disorders shown patients. in such in data I of Agitation BXCLXXX The on inhaled position positive X in-human many option single-centered agitation. of has clinical, calming believe development June, elderly which sublingual dementia study neurological meaningful pathway had arousable changes of middle-aged to Now produces a without reimbursable rate. and formulation trial the developing an placebo-controlled established determine and directly BXCLXXX heart provides efficacious and a to moderate ideal million patients and pharmacokinetic as XXX(b)(X) believed and BXCLXXX profile a from for to our drug that drug targets also path aim of acute reference in trials, dosing dexmedetomidine, sizable target or agitation levels be and formation market reference of thin-fin support Dex the schizophrenia/bipolar patients IV acute the in previously mild has provides the for and its most first was our calming a for has is causal been strategy and was the film programs of Dex. the is potential Previous that trial onset antipsychotic agonist healthy on administered BXCLXXX clinical formulation we The agitated in for alphaXA available. and of The of first-in-class effect subjects BXCLXXX as disorder. geriatric to sublingual of represents participants. leverage opportunity ease well clinical studies dosage or have a clinically Dex via

formulation tolerated. the was Importantly, IV well

with the exposure year-end. patients in expected of study schizophrenia of and We I IND the levels probable now formulation second planning evaluate study in and manufacturing XXXX, before GMP a plan of half disease sublingual selected are the this BXCLXXX to thin-film identified approval. completion in the mild bioavailability to Alzheimer's initiate of data we and Also following with dose Phase

BXCLXXX. We FDA have clinical with development dialogue an active of regarding ongoing

to in of study July, we initiate we to world-class FDA, Marder, bioavailability Dr. Sheldon Professor positive Grossberg trial Board expect outcome Stephen development and global a XXXX. and Professor and neuroscience members Alan Breier. with the neuroscience George include Preskorn, Clinical support established registration BXCLXXX initial Advisory a Assuming programs. In the discussion data Professor The our of ongoing from other

for well study on medical regulatory BXCLXXX and other as We counsel are and programs. these and future neuroscience strategy with working design, receiving affairs looking forward commercialization the to clinicians distinguished as

by profile and BXCLXXX but and in as to and well. Medicine subjects in turn innate neutrophils, protein, immune promising importance inhibiting been FAP second approach solid within systems fibroblast itself activation shown hematologic melanoma program, DPP macrophages be is immunomodulator killer potent cells pancreatic and of by a clinical as single-agent of X/X activating is effector the tumors Nature cancer and solid has tumors. cold potential over-expressed They natural tNEPC, BXCLXXX. differentiates stimulating cells. BXCLXX responsible FAP. its prostate to therapeutic blocking converting cancer. a by established modulating highly both inhibiting in hot. only into cancer, for for provided BXCLXXX acquired several is are has first-in-class immune regulation evasion and malignancies neuroendocrine It further designed X/X published patients. developed and XXX immune types our responses DPP peer-reviewed and by in healthy understanding from being T activity recently stimulate emergent anti-tumor demonstrated journal inhibition to immune X/X the tumors of the the oral safety validates treatment and DPP mechanistic small-molecule A for paper that system Let's not

to the rationale indications. discuss take behind minute Let's these a selecting

blocking cancer and from shielding pancreatic could a exhibit over-expressed FAP First, as system. BXCLXXX tumors immune both by these the and expression, the targets. potential serve levels DPP tNEPC directly of highest X/X treatment

overcome anti-tumor collaboration NKTR-XXX, potential microenvironment. mechanisms produces XXXX the the to agent agents or of memory NKTR-XXX combination combination at pancreatic I-O immune Secondly, blocking Meeting tumor and BXCLXXX, existing multiple effect infiltration an CDXXX-biased tumors encouraging into resulted cell Treatment the and for and entered this therapies. triple in complimentary suppression the BXCLXXX with robust of Chicago to responses, BXCLXXX and our study I-O with Nektar's Annual a cold Nektar and treatment combination from to rechallenge a produce cells. the and the explore with indications. cells. and infiltration. cell anti-PDX help the generation immune-suppressive with microenvironment. increasing tumor-killing data combination anti-tumor NK some agonist, data response also presented mice triple BXCLXXX activity the demonstrated turn an neutrophils by produce the the potential of has tumors overcome cancer the combination unresponsive collaboration to from ASCO durable in June. enhanced the of utilize T two year immunosuppressive alone in and the The I-O into shown of Therapeutics immune of both preclinical last in to inducing was collaboration are this cells making same early of of Preclinical regression research complete and the The this assets immune We in tumor data cells, has hot by cancer that has immune tNEPC to to goal of oncology with that synergistic a We

is our to initiate of associated from strategy throughout development to from cancer XXXX. plan in a further of major the opportunity GMP and XXXX. There other Phase market studies with anticipated pancreatic a released of proof-of-concept pancreatic unmet and completion readout a Both Preliminary competition in both monotherapy second as we significant candidates. need. evaluate data II be manufacturing half are limited indications studies these tNEPC as As tNEPC cancer IND and BXCLXXX as well combination upon therapy approval, part and and both medical are to by therapeutic characterized

as lead our much our emerging about excited holds the are programs, promise. We pipeline just of and potential

noted from disease candidates I the earlier, novel compounds gives of our us expand ability and addition the neuroscience AI our and As in a pool Corporation BioXcel pipeline with of thousands partnership through targets. to immuno-oncology

pharmacology. and In on experts, our addition clinical our team and we robust development, have expanding research business our development continued with pipeline, industry focused include to backgrounds operations, in translational to promising therapeutic experts the of also efforts

the the addition Michael Dr. Vice as in Sharma, of Head the executive Management; and Project and of including operational immuno-oncology in Global President Business bringing with and C-level appointments by leadership During Burg, Clinical neuroscience set play the bridging well three shareholders. Operations we DeVivo, of and company will Neuroscience. role Dr. critical Vice the year, Dr. of of for to accomplishing presidents, President as clinical market Vikas of new vice - creating targets and President these drugs first strengthened and a Development; value of terms Cedric half Vice our Each

the our proceeds a the to of our cash terms In half and from IPO we of build burn, in utilized infrastructure. team the the of portion first year,

We increase to the clinical increase both that, the over our I the second to expect over Richard to year based the XXX With programs. burn results. and in in Richard? activity BXCLXXX financial turn in half of like discuss planned call on to to the trial cash would

Richard Steinhart

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

with forward March offering in move in XXX, of will give $XX our and the in clinical through year. of proceeds in million public developments These planned BXCLXXX initiation capital of this initial program second essential including proceeds. multiple the Our brought both studies gross each us half to

same $XXX,XXX period XXXX, reported second was million total from concludes expenses, position $XX.X That million professional and BXCLXXX XXXX. company. of for XX in approximately second a our both the I'd reflects needs for concluding quarter the our programs, compared of For General to net the review, year research approximately turn next The approximately to believe expenses XXXX. XXXX had at current second million payroll, personnel the operating remarks. the to cash generally increased our We to XXXX. and million the increased for least development and meet quarter in the that $X.X reflects associating of of expenses for increase totaled $XXX,XXX approximately were costs and financial of payroll-related that quarter $X Vimal additional cost. development is a as $X.XX of net sufficient compared professional approximately with administrative trial and loss like including in and fees, in manufacturing clinical public proceeds BXCLXXX loss to the cost, and We quarter to IPO. our equivalents his second expenses of cash for cash and to as back activity it months. of this June and due development Vimal? $XXX,XXX fees Research XXXX compared we a increase the The the quarter second XX, primarily BioXcel for of

Vimal Mehta

story. BioXcel Thanks, like our That open to everyone I for like in Operator? participating thank concludes to the questions. We call remarks. the Therapeutics would Richard. would prepared to

Operator

Barclays. question take [Operator Instructions]. We'll first with our Meacham Geoffrey from

Jason Zemansky

just sense Jason the discussions Real do is given This if quickly, a market, start Zemansky for of complexities? Geoff. kind and, XXX potentially, to of and for have for on when to bringing you'd partnerships both XXX engage you

Vimal Mehta

question. great a That's

recently was have growth we that of hired a Development, company. noticed Dr. and for plan you Vikas part part President that As Vice Business the strategic Sharma that of - as

will are first it XXX - I progressing I go we and As will BXCLXXX. about talk to then

a on And company, have immunotherapies there can We the ADCCs are modalities that we as and is vaccines, as selected. types some like well types, therapies potential execute with we are of other marketed. other large tumor as XXX a realizing that two currently rare other for tumor being the RT, combining

just for And are that is ourselves. partners the So inbound some XXXX. for XXX, And person registration we - a could help for in those we plan request. getting that will we which we who focusing initiate partners. trial be look having And areas development our will board regional around time, opportunities strategic therapeutic XXX business and evaluate will some were us program outside seek on partnership

XXX, We XXX. in develop have Could for other regional partner to U.S. be we strategy or look in whole but around Japan not commercialization for be areas. will and will our strategy for strategy embellished a Europe. And territory the

Jason Zemansky

Great. a And then quick follow-up. just

want kind that kind which of portfolio, fruit or In of immuno-oncology? experiences as bit versus you to return something of with not a terms much the program, that's like but there little where maybe you straightforward in but next potential is selecting anything upside, development like bit little balancing complex you regarding search bit can terms something of maybe more immuno-oncology more us greater something agitation little tell potentially for a with to your a is lower-hanging would go the

Vimal Mehta

regarding will strategy, first I So the neuroscience. tackle the

like be is strategy. team develop very as our will our are dual to who Michael to And the continues of VP pursuing our in Continue CSO strong. strategy hiring treatment Our with Yocca, of DeVivo a Neuroscience, we symptoms-based complement so neuroscience agitation. Frank

resulting be That Then you So to that pretty finish acute will XXX(b)(X) to treatments, indications. are franchise are agitation that there are but development there expanding from in those first as path. our And path to in continue the line. diseases addition, we'll the and agitation, large for symptoms no focus. in rapid normally so neuropsychiatric multiple other are going explore indicated,

could the success neuro the past, developed that align in and And had was drug In which had we addition, we we marketed have we of that that is gave that there In a into and a NFX, defined. rare drug. ultra-rare neurofibromatosis diseases. then is opportunity huge compound which neuro treatment in developing And diseases platform and X. us validated our is well a us the for ahead ultra-rare lies confidence rare saw population where

to So neuroscience. we'll continue that in the explore

XXX. So those mechanism all and a immuno-oncology, coming And neuroscience strategy potential we currently, with out looking - the is that seeing in will promising. such data program. be for Its validated the vast are quite is getting the

a we artificial immuno-oncology will and our space, can what combination identify intelligence have exhausted regimens once we we which are to impact transformative And will the XXX. that other So can platform. continue will we using have explore potential then then determine what for we agents - in

Operator

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

Unidentified Analyst

Deveron is for just the [ph] IPO. successful Keith question. had I a on Congratulations This quick Do.

IV as If to about tolerance? a duration you you variability expect sedation - PK in should based and of or factors the talk state? For contribute for from to bit - to change of patients to on and could go Dex or see patient's we PD an what individual you a example, disease the individual's little transform sublingual

Vimal Mehta

on Yocca. So I will to question pass this Frank

Frank Yocca

IV to that. in on looking your that's why to get studies to at reference we're now reason right question, the So the handle

dosing level bipolar. dexmedetomidine there of patient different a is be dementia a treating Our to patient that several or for than is the schizophrenia possibility because the with may with example, treating plan strengths say, really develop

its the index So will are pretty is we there is yet, been is So PK/PD understand beginning this really that into very drug Whether subjects the okay? translate dealt the that with know that a possibility to we've predictive there. far, therapeutic difference has not or the just actions. - drug, with, consistent. in of a that don't We is of what

we the about to we'll like different it for there's if see dosing we what film, And continue we it. that it way. them. that's regimen different populations that a into over So should But believe once at translate the look

Unidentified Analyst

therapy Okay, if follow different could just but what that redundant, that might than any would how with there challenges be that makes to take be a you not a some inhaled are agitation sense. like and ADASUVE, up And to color the to XXX? to think you consolidate it that, see for standard add market general XXX, you

Frank Yocca

really it's psychiatric affected, both a is it's - disorders. out because but market being agitation Well, of neurological coming and big

have apply in a that remember, XXX to. Right very nicely. our broad is a a is you a acute is now, lot can an actually the you're drug we're And drug chronic what what dealing well them can quite think I work with here believe treatments. you We market So treatment. drug that and seeing with marketplace of like

So a you're line part that, I that situation caregiver. and bottom that number of I a think with situation the the different is situation become think to patient the because controlled dangerous the a for of both that's which be of agitation with is here with and occurs diseases dealing needs

there's a treatment think on big that actually fits well. big focus a I XXX clearly market and and But So acute a quite need.

Operator

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

Sumant Kulkarni

one. quick a Just

your portfolio? hiring neuroscience on some hires the that on you part made are and oncology the side, in plans the the what side. Are You've significant done with of

Vimal Mehta

saw we the have have public, been And since space aggressive and have and currently becoming talent. strong that the of we depth - of it. I urgency, talent broaden just what build to kind started where placed recruitment in think And very also. found on talent we we we place. will to a we continue in team the continue feel immuno-oncology We'll our we that have

Sumant Kulkarni

XXX specific population other a specific same of time? the at trying because And XXX. non-contraindications using any drugs there the patients one on in they that be for then be might may several on Are you

Vincent O'Neill

M Vince. the on interaction. lethal clear doesn't contraindications is will seem to a based seem for concerns at, us. this be we drug-drug I obvious. that have but Yes, meds would something or con currently looking any there [ph] I based on say, anything currently, Dex That's be doesn't be to

Operator

Wainwright. H.C. Ram We'll with go next to Selvaraju

Raghuram Selvaraju

by for BXCLXXX anticipate I just start the XXX CRO you over And to if of announcement wanted both programs. of just and anticipate or clinical if that the of selection all, announce to, of itself? announcing first the formally the of the timing weeks, you about asking continue or the selection coming focus initiation on wouldn't course per se trial the CRO clinical actual the and you

Vimal Mehta

down So a our CROs. CROs. very been and selecting choosing. of for constant evaluation the the for process long-term process we the started in have have have we commitment a And so selecting It's to both narrow like programs, we

to to have product any And want both site as initiation the you we and be as made ready with IRB and directly site. and approvals trial currently as process. a made CROs we the XXXX, not in will choice it have of that initiate We initiate will the would constant the trial. imagine, manufacturing open be the GMP we the the a done all in well announce of very the completely to decision you can or is we - will That way in the decision announce this future. But

Raghuram Selvaraju

previously, to feel focus strategies? Dex Dex. it. on have my based How And assessing doses with on healthy the to you Dex the narrow Phase likely more that I many But now dose. sublingual you whether information, how likely then, identification of was Which wondering an on design to got starting some question of the you benchmarking a was are in be? benchmarking handle good appeared in arms the is studies are be to success could study optimal Because Okay, the you provide demonstrated spectrum IV do volunteer IV against Ib of these going terms most granularity on?

Vincent O'Neill

Ram, Hi. Vince. This is

sublingual have question? to an have conducted planning with feel be film, we to a study. the some study will versus forward then forward. dose the run comfort that arms - we we're Does not sublingual and to that the IV define IV to clear, sublingual just We So answer dose will multiple take which and around run clearly your take we

Raghuram Selvaraju

doses? got Or I X? you based basically, that asking was what knowledge focus so, the do of X can studying Ib feel Phase So sense you you that there? might going be? any is arms be to you confident on of it if Is small And a reference the on number study, give what or of can from number

Vincent O'Neill

Yes.

that of answer So is confident small a number short I the we can we think test are doses.

decided likely or We be to arms the number five. than haven't It's less to really on of doses test.

fair want I to you anything? add Frank, to think did like say. to that's

Frank Yocca

understand We've range. dose extensive and No, with comfortable very to some I I fully, think that how agree. that modeling, a The Ram, question get to gone around through is to range. getting are try dose we fine

Vince. with be would It's agree definitely is less than five. going I to So

Raghuram Selvaraju

very helpful. this example, effectively many if the it, is, are of a setting likely wanted mild what to being for we frame hours you How would is address of respect reference frame with context, Just regarding then this could of in aspect within how real-world be? be given let's ask application real-world drug mildly which time sedated? what's talking agitation that's the the a I Okay, patients, the provide call about? - effectively to this, sedation to to just And

Vincent O'Neill

Vince this is Ram, So again.

IM, intramuscular time, around If beyond in to it would to you're XX And on be XX-minutes. really injection. an clinic, the to that time say I be talking because for would have that likely about

be So time. on target XX minutes the would

Raghuram Selvaraju

Okay, great.

indicative that first steady-state we there? ask, second reference second I quarter's quick frame and just the of using more if significant going first Richard, is was difference noticed of a or very I be kind two of the to the quarter number the is wanted things. comp. between quarter there should Just as forward, quarter

Richard Steinhart

the second Ram. No, quarter. Use

in so script we're said discussion that the coming are in people, this we we've people hiring on. had As

up, the comp will on So the as number obviously, go cost well. of will people up board and go

Operator

from We Ram with a will follow-up Wainwright. Selvaraju take H.C.

Raghuram Selvaraju

just space, prioritize So other into of to juncture, at more a likely looking if sense, neurodegenerative really opportunities the Or And or this indications? one say is reasons very it broadening this to if things. areas are impossible to of the neuropsychiatric in in what some would other, out be two at at point? might general versus were quick prioritize the In you neurology why? you be you

Frank Yocca

So out. engine Ram, because using okay. de-risk here is, we're had do programs trying right now, what that speculate with I if I But wouldn't - we're trying have the to that to easy up to readouts, again, figure we're come to

example, we Or go where example, for or away, things for example, - disorders that. But or stay as example, another related the orphan So into neurology, like we movement diseases of are things movement might from cognition. for readouts nature. in that would say, diseases,

things we it's And not prosecute. is. or really whether driver to viable There are that couple a entire or in add that our the something is neurological it's equation tells of whether us psychiatric. what really need not a that's So candidate to up

Raghuram Selvaraju

Okay, you you're to a a definitive going And decision pancreatic? therapy? confirm first of then the if with in triple you one go question or in be if pancreatic. the conducting time a whether study will at case, definitely this can design you regarding therapy dual pursue quick that's development studies path would made And XXX fair that the enough. regarding Has or the proof-of-concept been just

Vimal Mehta

- like being worked So plan key is on it to Ram, going data in what opinion very Vince? are combination. like pursue up to I they Vince be will And leaders who the to trials, upon. general, doing these and like pass will exact is compelling. look look triple

Vincent O'Neill

Yes.

So around just possible. a as - as soon clearly to so triplet into compelling clinic that, those move the the up to on case pick those, there's

I discussion. Now is like advisers that. It's most here - us do you actively that, certainly can the would under tell our to clinical that's

Operator

would back Mehta additional the remarks. the like call I any questions no And over turn with queue, Vimal further to to or in with closing

Vimal Mehta

we I'd management Q&A support like really the to for you Thank everyone the and have of team evening. on again BioXcel in provided the all of and help thank everyone. participating a by good session, behalf Therapeutics, and appreciate

Operator

This participation. We today's does thank you conference. for your conclude

may You now disconnect.

BioXcel Therapeutics (BTAI) 12 Aug 182018 Q2 Earnings call transcript