BTAI - Earnings call transcript Q1 2020 | BioXcel Therapeutics, Inc.

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Operator

Good morning and welcome to BioXcel Therapeutics' First Quarter Earnings Conference Call and Audio Webcast.

Before we start, I would like to inform 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 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 March annual on

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

Vimal Mehta

conference thank Thank the discuss call you, appreciate our good attention. for operator, and first for and We to and Therapeutics highlights you results everyone, XXXX. financial everyone's BioXcel time joining morning business quarter

me Joining Officer; call Scientific and Steinhart, Richard Vincent O'Neill, Chief Officer. are Financial for Chief Frank Chief the Officer; Yocca, Medical today

health time COVID-XX around and times, these Before frontline, we to preventing tirelessly to affected has are us. begin, address care everlasting pandemic, thank created uncertainty crisis who I personally gratitude. spread further the work the that for the I caring has world Their deserves of one the of our each truly all want hard workers some virus. the unprecedented patients on fighting every want the take and to

State for programs. made aimed guidance needed clinical advance U.S. the the while key in we safety our our maintaining employees' Control protecting the of vital activities at to Connecticut, Centers from Prevention and the adjustments Following across company development of have Disease our health and

any and close clinical in of made our order trials, pandemic motivated delays sites. ongoing and contact ongoing monitor on programs. with team remains to in have impact clinical our trials not we our have clinical have milestones. The great track this been with we strides experienced To-date, to BioXcel significant reach XXXX the potential on In our

and updates clinical our highlights, our to to any will needed. the BXCLXXX. would discussion our to I program monitor discuss lead provide as neuroscience corporate Shifting back COVID-XX situation like We continue closely first

formulation thin-film for is for a of acute our treatment treatment As of proprietary the the Dex, dexmedetomidine, BXCLXXX reminder, or agitation. acute

be to effect administered order rapid excessive to of We onset action calming sedition. a easily a have and without have candidate designed in this produce

We of Phase the in of with pivotal for and our acute this studies agitation are disorder. X X, X schizophrenia key made which BXCLXXX in have treatment trials bipolar advances and quarter patient SERENITY

Back in March, been that had one-third in enrolment to in enrolled continues not trials change a than due we to have and treated, announced as progressing the of enrollment more be and rates COVID-XX pandemic. both we observed the planned, patients

report communicate SERENITY to XXXX, data program we data and the readout. to get our mid track line on top from clinical are in we'll We updates as closer

that we who fast-acting with half able first submit of first patients, XXXX, from associated be a of schizophrenia only guided that treatment important is out all by our self-administered has non-invasive pivotal away, few BXCLXXX our the a successfully With neuropsychiatric are within we and will program millions to during months to It hopeful agitation read treatment disorders. the a NDA bringing acute patient enrolled note provider. suffer healthcare for BXCLXXX bipolar

to Since neuroscience and safety the a design, has of versatility trial dose. data continued testing reviewing the program of neuro initiation Xb disorders neuropsychiatric treatment highlights Our tolerability beyond is geriatric for treating conditions. choose we adaptive clinical currently progress This the of in with agitation study acute order are the TRANQUILITY our TRANQUILITY. potential an next of trial the dementia in in Phase

unmet There the off-label in mid need top-line easy-to-administer therapy managing geriatric approved a need with XXXX, warning dementia BXCLXXX and for trial's to fill enrollment and a a this agitation. if trouble be provide struggle We for therapies behavior. try psychological effective is that fast-acting, safe elderly drugs this with data related treatment, have desperate treatment for agitation to is in on a caregivers designed is This the for to expected FDA track approved and patients dementia. having that black-box and to no treat

the as enhance of precautionary the use the the that and this wearable risk COVID-XX, device to parallel, to safety In health illness this agitation. treatment severe preserve hopefully measures such have patient is Watch technology among digital Apple continue prevention to elderly dementia-related with for of we population category of associated the we taken patients. highest our investigate Considering and and

BXCLXXX all long-term facility have and trial, provided TRANQUILITY exposing manufactured the the risk been running of been care to already reducing TRANQUILITY the doses the For the patients. have study,

the investigation our capabilities continuing performed being Yale through at researchers a BXCLXXX's Phase calming are of University. we Additionally, initiation of by X study

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hyperarousal, BXCLXXX and These been an of help to physiological for study chronic time this of to indignation similar only on to this we the trial the potential signals performed bodily agitation. market the will believe deliver would BXCLXXX agitation though use provide episode that has before signals this becomes patients investigate open the expanding caregiver schizophrenia additional into potential sufficient door patients, dangerous. candidate of exhibit Even

FDA To withdrawal BXCLXXX opioid IND of for we this treatment fourth received candidate. the neuroscience highlights, application indication wrap of for our this a for potential symptoms, up clearance quarter's

XX the in U.S. the majority overdose country is with for number rampant in under age the related. of drug fatalities opioid As one this cause death accidental of of years old the individuals

addicts to to a from continuous disturbing new his to withdrawal Furthermore, efficacious and and treatment desperate these or continue is debilitating for these aid very can options be uncomfortable, many need opioid feeling relapse underserved symptoms. There help take drugs abuse. avoid population

we symptoms, to treating back come action, and Due feel urge abusers of and potency favorable this has offer to to to intrinsic mechanism potential candidate to helping withdrawal BXCLXXX relapse. a method advantages delivery

planning are encouraged initiate patients to shortly. with withdrawal by opioid symptoms promising intravenous a we've RELEASE Xb/X we experiencing of of We trial, alleviating for and the witnessed treatment the in trial are withdrawal drugs the results Phase symptoms,

This clinical strategy, we our hyperarousal the offer on therapy from treating focused quarter, reaching programs, exploring effective indication of to patient lack millions have neuroscience development that believe hopes alternative. in of patients numerous We BXCLXXX past our efforts expanding and extensive suffer population. an differentiated the

on as value well candidates hyperactive potential BXCLXXX, for focused commercial the delirium as plan on agitation are a of and and We for chronic acute as these exploring increasing treatment agitation.

portion systemic tNEPC. BXCLXXX, the a with over action. Phase cancer we our activator available announced neuroendocrine immuno-oncology mechanism designed combination Phase our of that or orderly KEYTRUDA are innate candidates, BXCLXXX trial immunity prostate of Turning the conversation X to for with emerging over dual of Xb/X the in we clinical treatment initiating efficacy Recently,

of twice receive of intravenously men trial, on approximately days Phase days. to milligram X.X XXX day showed dose each administered from totaling an activation KEYTRUDA. X X XX safety target leading XX on that of tNEPC will split then with Xb daily shown has when cycle side milligram a Phase in a is eligible days combination every profile. effects efficacy X.X This Results KEYTRUDA per with the and milligram day BXCLXXX improved X has and the plus consistent XX dose, cytokine on XX safety split dose used recommended with In

making interim approved report to quarter data of expect Currently, fourth there rare X form an are the in of We effective to believe aggressive no be KEYTRUDA. We for potential an has much tNEPC, from tumor the Phase creates highly a to it initial XXXX. trial as treatment immune reactive a treatments response, BXCLXXX and immunotherapy cancer. adaptive more prostate subpopulation the for including aggressive

in also clinical study KEYTRUDA evaluation via trial to advanced This either Xb/X evaluating is patient of combination label Furthermore, Phase tNEPC. the with at Checkpoint for Phase is following schedule refractory of the ongoing basket MD dosing are or BXCLXXX conducted BXCLXXX open using Anderson naive solid the the and Company that study Cancer X cancer therapy the is the Center. advancing to the and

and Bempeg BXCLXXX, of KGaA from and of trial. Nektar and Bempeg following cancer Merck from outcome study and Nektar Avelumab pancreatic that and Phase safety will The trial of Pfizer Pfizer's Avelumab combination start the the completion of in Xb

raised approximately to our we our milestones public fund current provides reserve in enough offering into strengthen which to sheet. operation preclinical million proceeds February, significantly had a $XX BioXcel together runway XXXX. with In cash net cash of balance and regulatory This

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

Richard Steinhart

the and all $XX.X to XXXX joining for $X.X first million you morning reported a this XXXX. BTI to same for us loss again, in of a our compared Vimal. of of for quarter net the shareholders. welcome period Thanks, loss million net Once thank

in $XXX,XXX non-cash The results of first compensation. about XXXX include quarter stock-based

pivotal The Research increase as were primarily for $X.X period with due development in and XXXX. compared costs, The to in the project quarterXXXX, Phase million product BXCLXXX costs trials. research our costs, first related and loss net associated an controls related increase bonus related in million primarily same X manufacturing trial $XX.X and increase to chemical expenses to was for this our and salaries, clinical candidates. to due was costs, professional and BXCLXXX and

$X.X of due matters. were expenses expenses for approximately $X.X $XX $X.X March period and million XXXX. patent of administrative to compared XXXX as for million to approximately increase period were for XXXX, of as fees the XXXX of XXXX. was and the compared professional quarter quarter $XX.X operating General in million for primarily million and first first with total operating the million, same The for same to expenses legal cash equivalents of cash the Total XX,

the review financial quarter. this concludes That first

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

Vimal Mehta

now We call open questions. Richard. for Operator. would the Thanks, like to

Operator

first with Thank we'll session. of Please Instructions] question. Bank today conducting you. [Operator from your Our a of question-and-answer Meacham America. this proceed Geoff be comes At time, question

Scott Puckhaber

dementia, questions. XX, sees Hey, guys, study Thanks X/X the population. ask to Scott I the Phase patient Jeff. this for doses are our XX, as to for XXX XX elderly lower wanted taking is the it for due about micrograms on

microgram significant. Xb Phase in not the However, schizophrenia, was trial in the statistically XX

with and for can certainly be noted concerns the for improved safety wondering, X.X splitting these milligram prior the a XXX, recently There patients? And drugs profile. need the efficacy you dose the is then history. the So, I recommended the associated and in balance tighter was follow-up to if should for XXX anticipate window as given given around dose we dosing a success safety

So, any and into impact the dosing around the you're can insight Thanks. splitting concerns daily? once a as any seeing whether dose it potential efficacy might you give us reason for

Vimal Mehta

will is Scott, BXCLXXX. our and this this then question the question of Vimal. to pass XXX be question the to is Vince answer Rob? who VP Clinical to related Rob Risinger, pick-up I'm going Neuroscience, to

Rob Risinger

tend they we're in identical range be if they older, you on banking, will more dementia, out, frail. dose as not thing pointed in schizophrenia, to The you are a

we so, simply different may a range And determine also safe, are the to that effective. doses be dose testing slightly but

Vimal Mehta

Vince.

Vincent O'Neill

for question. Thanks Scott the

versus So, that around splitting believe. on XXX, doors no was really I

the is at But on splitting thing GU know that on is target milligrams daily cohort that certainly of a couple What micrograms event do. the and saw longer tolerated poster or all. to you types necessarily months we of We doing, dose X.X we're but dosing present. the the essentially saw toxicity. what as dose, So, syncope, we of those in non-split still we is drug a better expected that a bad It identify speaks was no And this no event once or that's schedule. an to some of not ago. longer was at simply expand found to presented dose syncope, just at the XXX it's ASCO the required otherwise, by oncology, And saw events. and

we the believe your dose. the splitting by So, that's we fix that answers question. Hopefully, tolerability that --

Operator

Humphrey. with question is The next Robinson SunTrust Karnauskas Please of from question. your Robyn proceed

Robyn Karnauskas

you've XXX, need then, first think in can data us you what can withdrawal all, completed on do the thoughts order opioid on early that X data? the so working we be rate -- still steps? safety what limiting can to the you of sort learned you. then And learn when still it steps are hints So, some drug the way about learned of is you've about you the the anything Just some give year? start see do on of you Did the points in this think give should Thank is so the data if trail? efficacy working? on And be far And from drugs? we profile, around what what what you to the think Phase

Vimal Mehta

This is Vimal.

right pivotal trials like, Regarding in COVID we made the for our our trial Phase press withdrawal the we you withdrawal choice of bigger safety, the X, X have opioid as employees, opioid three a In COVID-XX. and a employees go trial, the the of as the to pieces not which arose. a SERENITY start opioid conscious middle of crisis, all the partners, is in as to company patient and had integrative to, COVID-XX ready noticed our this running X our that the trial, interest interest over were the might place. initiate situation We all and creating well as is in TRANQUILITY even

we that The there number initiate had we will and don't CRO of been and indicated to any the site. initiate are the what about We that's are provide that limiting have think site to at plenty and anytime clinical I keep coming time. guidance the as this they we we step, our could advised rate study patients by is shortly and

a task. in to position we withdrawal opioid initiate So, are that good

Vince Regarding been aspect. what from to signal the Vince? in able will have weigh we the observe XXX safety, question, the ask besides to any I efficacy

Vincent O'Neill

Thanks morning, Sure. good and Vimal, Robyn.

going I'm the pivot again, we at presented So, GU. to the back data ASCO that to

In to system. be immunity that's innate I strong many seems of important innate a that, thus weak. of the other And the an this approaches far, been I important because think potential learnings, think activating of one drug have terms to and is immune activator

What like actually of fever first chills, transient. second see, episode still which the the have mentioned puffy previous of down seem one The substantially. the those things see see ankles, settle target see to after did tend hypotension are as to do toxicity. all we splitting yet, or we myalgia They by dose. I So, and and of we the cycle. And was events syncope hypotension question, -- from on mitigated we remainder

large safe know, So, is strong time you'll have we database our already of at same course, drug we at a behind that innate belief is point. safety the activator the a that and have this

we from efficacy, GU presentation. I on at and were learning safety a GU important Xb haven't this released patients the data of The the or one any disease point simply new This fundamentally ASCO and stable of time study would that, I that presentation. that's So, since study. the mean, portion. ASCO remained But on majority the is is out on

Robyn Karnauskas

and issues, dataset Can if when latest from to you. with update COVID. on they're see also update an you And just other the can proceeding with going any XXX? the and give we trial on next Thank due XXX, just the there

Vincent O'Neill

Sure.

So I'll triple them take take I'll off. I the mean, combination study first.

has we've So avelumab doublet NKTR-XXX of mentioned, I think, the before as Bempeg from we be combined XXX. to in add plus

a And so ago all reopening trials. weeks maybe did that announced they of ago approximately studies Pfizer pausing is six in all announce the Pfizer. week they're trials. They were that hands

accrual. it's So patients was and now that study as reopen to were again underway enrolled

we So the our anticipation safety is doublet, year. in that previously have we to that, later we once will as guided, data on this add portion XXX

that's an Anderson And triple and study, that's important the MD development plan. So, part combination. the the then of

KEYTRUDA KEYTRUDA year. that and the aware, tumors, who also opened. that's And it. is guidance, at hot be we're And just -- progress the end with through turn again from both the opens are in at of anticipating patients consistent feel It data who able naive year you're present of our that's to patients in trials. As the progressing study

Operator

proceed Please BMO is Kim Markets. question next with from of The Capital Guyn question. your

Guyn Kim

versus within is expect? for slightly that benefit just it for studies, could -- look Is normal you meaningful Or hoping review you than bipolar was be you variability trials. ADASUVE when a terms could of you agitation reduction patients be at something placebo for SERENITY in the considered studies? also And the what us or schizophrenia. would in saw clinically in I what you

Vimal Mehta

answer I will Rob? the schizophrenia versus question ask Rob bipolar. about to

Rob Risinger

Yes.

realized that So, points. to the X a benefit trial dose around antipsychotics effect in patients acidotic by data, to score difference or Component X on bipolar tends seeing improvement ADASUVE to between the the efficacy a effect be X did. or schizophrenia We're and equated saw than the I relatively X of an X for We bipolar There point of slightly had CGI PAN's X from minimal. better Phase Excitatory that the on we clinical improvement schizophrenia.

to schizophrenia. expect as with patients see bipolar it'll we If So, for be possible effect greater. a that similar

manic that the bipolar we -- actual are could and potential hypomanic, patients remains agitated we'll the I related seen. might the on to system more a it or know activation reasons be be we efficacious than about example more in But schizophrenia in have but of having wax for why once autonomic data. nervous bipolar relationship who lot to, and

be will counting of a not don't answer, terms powering would it trial. in but there difference, the if be short of So, the we're that interesting, on know

Guyn Kim

do as population? in still in reduction point see the either score bar you And a PEC meaningful X clinically patient for negative

Rob Risinger

that yes. would able of that, clinically We study expect about, improvement. the and it's change to Yes, smaller in were demonstrate meaningful represent really that a degree

Guyn Kim

And could to you setting later? should whether settings XXX you COVID-XX? due actually the speak And rising a start at cases ER in versus delirium to hospital in in now also looking that study

Vimal Mehta

So, is this Guyn, Vimal.

are is vendors of they around as patients pre-intubation reasons getting well tons of a of they getting are like delirium. And lot due press it, why are to are but lot there are these as there a As COVID-XX that. getting elderly mechanical use, or post-intubation of who patients

So, we leaders continuously opportunities. we opinion how talked those to key these we and can and explore help evaluate patients

COVID-XX for reason. up the this strategic we own a tremendous treating as patients trying for In program, so strategic resulting the as in are to a delirium terms -- of of for agitation need of from part our speed settings that that, the our hospital is we it's development, already benefit well delirium considering

add on that? anything Rob, So, to you would like

Rob Risinger

come ICU say the use in is API the to just for treat BXCLXXX already setting. that, the would delirium dexmedetomidine in I

that And in of so, we development a potential do hanging low we're fruit that see area. as and sort options exploring

Operator

of with question. The next Sumant question Please Kulkarni your is from proceed Canaccord.

Sumant Kulkarni

and have on XXX, I on one then XXX. First a follow-up

seen terms on acute management on specifically the your progress we've How do side potentially some XXX developments encouraged And Phase patients. to the bridge trial you you from to single-agent if we of activity what part on agitation KEYTRUDA, out parse were potentially might with the into XXX you but of of bar XXX, and possible? for management in in to the the tNEPC could efficacy treatment activity Alzheimer's efficacy of So a of competitive side, in that's the to to II how expect to give chronic need us hit combo? of combination in chronic expect sense of see versus

Vimal Mehta

Sumant. Thanks

please Regarding the you we can the it question -- to question? XXX right. want related Since make I sure repeat to answer

Sumant Kulkarni

Sure.

So some Alzheimer's agitation seen patients. on of the the chronic management side competitive was we've specifically question in on developments

You be management a acute -- now is product in agitation. to have How agitation potentially the run? longer could translated right development that also in maybe that for has chronic of

Vimal Mehta

Great question.

I see treating spectrum any these circumstances, we or think in conditions episode you patients. Currently, all as treat progress. a that those know, to no progress, big dementia/ there Under as they we agitation Alzheimer's to available treatments agitation success are is related the know neurological searching.

you sub be a a agitation. state pre-agitation may and chronic chronic in agitation sporadic go You agitation and to then

there that's a that chronic as sporadic you of agitation agitation can acute beginning, as is be you agitation agitation have in something And about So can with the when a treated a episodes, help still, is but still that any in in no think treatment to these use sub-chronic. kind happening patients. well happening if acute and need agitation number good a the will agitation chronic be of that's that because can treat reduce treatment

two this a be will become and So really a week of could to need in is, episodes fit do there month and In patient. a -- sub-chronic does the two breakout number agitation need to way become to you but some be about drugs we will sporadic be a they episodes, reducing quite well X episodes chronic agitation it were can want have of you the a the is or XXX in the take time, effective still effective, episodes think treatment sufficient. ones as still that it chronic long to so be as we and treatment the weeks chronic X manage that can

in will both of is chronic we in build will if fit fact So, kinds available treatment for market, both acute treatment and agitation very support any for that the think XXX situations. agitation. with well of It help

So, more did or it answer on question I'm happy to your embellish it.

Sumant Kulkarni

No, that's great. Thanks.

Vimal Mehta

question, I what XXX what neuroendocrine trial? our to on bar will from regarding to So, prostate it the pass cancer to and is describe expect the Vince

Vincent O'Neill

the twofold. really question So, was I think

first agent one what individual how the the and study KEYTRUDA. is I latter be contribution, has or So, was been So, we this arm, of a an really will why the we the question think made cancer-resistant prostate population. contribution but with bar a similar, know ADT or right? didn't there androgen patients not that blockers. treatment KEYTRUDA This XXX single and not a of with internal identical, control in alone include was And had in group setting, who similar cancer

in X% response between X%. setting, indeed, And low is that it's very and the

And a KEYTRUDA so, have in can tumor. think what we this on handle do reasonable cold classic I

that's immuno here agents. response the standard there is of durable, obviously, Given that okay the and care and provided feature rate -- we a believe of fact it's no

on substantially. XX% would response or field, and above, of would move and the Our actually team's be field typically to rate interest the quite

Operator

question next proceed from your is question. Samir Devani RX Securities. Please with with The

Samir Devani

dosing. like My Looks question that micrograms XX like the on planning, XX study. actually is you're you're to coming looks and again, delirium back exploring study in

year? also perhaps very could to guess, you and that that the compares any currently, product Thanks there costs are I used intravenous extra what's program how with being associated this R&D on currently whether much. So, with just elaborate

Vimal Mehta

not patients in such in on speeding and big development. are stage. the is, is with and are still out plan need, because of it's will the situation a what Regarding stage. obviously planning COVID-XX a what Dementia, clinicaltrial.gov in up have we is doses the using, these we kind delirium there planning pandemic that be the we delirium, spelled that's Considering

As our Xb/X. a strategy, we Phase always overall do of part

that on our of have these be you capital to tend don't an and finished to And number trials much fast. dementia. as intensive and be we do enrolled like and tend short patients, schizophrenia These it trails seen rapidly with

don't are the reasons, impact all we clinical stage. of some. in And those because be our still much So see planning spend, there we trials but on will

We will once guidance we provide will the when all on come data delivery. have we together when provide can and start pieces readout the trial this

Operator

There additional call time. questions I'd like are no Vimal at to to the for Mehta turn back this closing remarks.

Vimal Mehta

Thank you again for joining our call today.

first focused data quarter occurring we our of the the BXCLXXX programs development with During XXXX, XXX clinical remain two on in months. of advancing coming and readouts key the

any Have great if you us, questions. you. please Thank a reach out day. additional And to have

Operator

conference. today's concludes This

lines may You Thank disconnect participation. your for your time. you this at

BioXcel Therapeutics (BTAI) 12 May 202020 Q1 Earnings call transcript