TRVI - Earnings call transcript Q2 2020 | Trevi Therapeutics, Inc.

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Operator

Good afternoon and welcome to the Trevi Therapeutics Second Quarter Earnings Conference Call. At this time all participants are in listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this call may be recorded. Various remarks the management makes during this call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. section materially result indicated including Form of in risk differ statements these both XX-Q may most the a company's file as various factors SEC. which results is from reports with by those forward-looking discussed recent on Actual quarterly the the on of important factors,

views today not be relied In addition, a represents should statements any company's views as and representing as any forward-looking only of subsequent. as of upon

Jennifer statements even may at Financial the of Chris subsequent statements views company While changes. any Good, Jennifer. I'd on upon Officer. to elect our relied the and date any these today's ahead. forward-looking as These be point go CEO; to to like call Seiter, over Participating the future, some the and company obligation to Trevi update Please turn Chief in as to if forward-looking disclaims today. specifically President now not representing do should are call so from this

Jennifer Good

Thank Good earnings inaugural welcome conference and you, to afternoon, call. Grace. our everyone,

continued a the against busy execution is feel second it was giving time and updates. to plan, start quarter has we the our more months. a business summer regular Given good It through

our to adapting to reopen assessing sites our by first were study again. able in were the restarting prurigo lead we in May. We of PN, impacts our beginning pausing situation for quarter clinical the and of COVID with everything, the nodularis and During workforce trials, and enrollment or then screening

about our announced balance which million which I into talk our for Chris of sheet loan, of later. We in XXXX, first more half also July, runway PN sample which the bolsters will and a trial a size pre-specified talk we term in extends the a today, about more comments. And analysis cash his outcome positive $XX announced will re-estimation

the work successful. make team commend for a been and happened, pleased from in well I the hybrid hard back office home the the brought that very to we about model. I've Trevi transition how Finally, to team in July working

However, well in it person. small people get nice to back synergies seeing company the in normalcy of as been a to has some as

MU So, Trevi's cord active parts just potential a spinal for ER antagonist in a strategy skin, of brainstem. and the Nalbuphine are to the as explore moment the the agonist. is everyone in on These neurologically and KAPPA remind two drug a of treatment including many and organs, the growth. developing to mediated for step effect serious Haduvio pharmacologically including receptors also located conditions. The various receptors back including as lung, brain its

in therapeutic conditions role of We activity at medical have important cough of KAPPA movement the focused receptors both on and because play the disorders and an scientific as evidence areas pruritus, MU clinical that of the conditions. interest, these

nodules clinical is there indication. incessant PN, spread and and but skin to no chronic for prurigo and in nodules oral approximately this a indication we severe the and this the in We U.S. itching. because characterized Prurigo by as pruritus chronic have condition. in biologics are that will in to being play disease is well disease drug of patients of important and the oral for development disease. this there the therapeutics nodularis for PN on severe are complimentary and believe in only well the pruritus scratching, debilitating estimate and and skin, both managing roles another XXX,XXX lead and as therapies as development nodularis, are There which the rest XXX,XXX Our We in approved developed world, are currently a serious and papules repeated is continue worsen. papules biologics

patients. option long-term Over an pay oral is important for to role and likely the

were drug the when was which study increase. powering that available so the a July, nodularis, or we that XXX underlying blinded the study. company reduction based which XXX and Phase insights and efficacy at after primary to and that itch and SSRE the maintain increase endpoint. on in re-estimation sample subjects approximately do an in our by on when Based the pre-specified recommended XX% blinded We in sites a based of Monitoring measured Data Europe in a the trial have weeks external assumptions prurigo analysis Phase interim a of patients this was milestone primary subjects the trial. and what We than itch SSRE sample be The designing conducting conditional is was should announced PRISM in power by size this Independent an PRISM conducted currently results, was the The endpoint. activated. falls trial rating trial. analysis, are number the we But achieved company XX important six We power program, a unblinded pre for we endpoint showing In were relevant, trial continue, we trial targeted various range analysis pre-specified more dosing. today clinically we into reminder, recruiting the size outcome intensity completion the primary U.S. The the numerical pleased based drove on initial on scale responder worst subjects as the statistical range the this size specified call the that interim for within point, to the of to with appears statistician not as a by considered to and X were positive should after the the to analysis a have Xb/X the the increase XX the these both results. Committee in is

potential XX% sites, timelines. process we open with randomized Our have consecutive of We subjects enrollment our restrictions. of new of needed. they either a Screening has to ramp were off clinical sites opening our to sites prepared open restrictions the complete or the screening in approximately subjects planned with in have since enrollment of a up study have currently currently be the XXX operations The We being COVID are accordance in in for been team by strong being across been should number believe July paused our strongest and enough sites June in the two trial. May being start, about our and during lifted months and patients sites, this to-date.

that also not typically slowdown usual in We in are occurs the enrollment development. clinical seeing August

is top subjects of of as enrollment portion the the label out open that the we of encouraging for the Another to data into Based trial, upon over coming fourth rates size in restrictions sign roll can in of increase as of pandemic that XXXX. the of well extension study the chose XX% quarter enrollment of the XX quarter the week reached the XXXX with complete sample third in we line the study. believe

of this encouraged are progress to hard the by continue and trial drive these complete We to will milestones. important

or lung phase in scarring condition a which Turning pulmonary program is our tissues. fibrosis cough for IPF IPF, now severe also of to clinical is idiopathic the second in there

condition. affects chronic One XX% of which approved disease for are no this approximately is patients. this There to of leading symptoms these the XX% therapies debilitating of coughing,

all The change are The is from after washout treatment between assessment conducting daytime paused digital arms. impairment, daytime UK and three-week patient lung with a is a baseline. and cough a is for period double placebo screening their monitor measured enrollment each crossover in cough conducted mean XX-day arm. cough endpoint is We by given blind being to frequency Phase percent this the voluntarily frequency high we in activities. trial treatment primary due study X the risk This that the group COVID and

as have visits population, to a given the we to we to enroll study to have study We that in will implement COVID that used restart they XX this protocol to patient And to indicated our for to on focus resume. position We procedures are fewer of limitations, time sites believe ready already and this are our in study. a amendment four prepares this enhance ability allow the hospital. successfully amending have good plan

later year. patients can screening start we We again expect this

have several that earlier programs other We of in stages development. are

have hand financial we good our a Chief you resources. Chris is Trevi's provide Seiter, However, programs our development execution prioritized to to update. to optimize cost Chris? with a and over to Officer, That priorities this Financial segue company and

Chris Seiter

you, Thank Jennifer.

As found closed. market be a can the with reminder, our the in XXXX of the full for which the financial second quarter XX-Q, filed today after was results SEC

$X.X in G&A and to during with the of For were XXXX million the the a net primarily an chronic net $X.X of treatment X patients activity quarter expenses COVID-XX of in $X.X second of period enrollment was cough increase in expenses increase a in XXXX. primarily the an same patients XXXX. public decrease Phase $X.X to second during the of due same to as reported due pandemic. million quarter quarter period The $X.X result and related the the loss expenses to and same in $X.X expenses company. trial to a for million quarter was of due million second in to XXXX, decreased to stock-based The were compared IPF our compensation of compared of of R&D compared of million of halting XXXX. loss increase million XXXX, a being the we

debt of XXXX. to $XX.X XX, This funding million, our XX, June XXXX, using compared both extend and implemented equivalents runway. and cash equity to our cash of cash strategies As totaled as $XX.X million December

the During of approximately stock the of through quarter, or quarter, second to prospectus. facility. our we the Subsequent we the end $X.X million aftermarket second in ATM sold common filed ATM

loan through anticipated in a into of and are X.XX%. February first position non-dilutive our by per ATM term of the loan which Bank. remarks. loan extend XXXX In payments of $XX initially the the proceeds cash term the term XX, monthly quarter for into monthly from accrues half XXXX. million a results our followed XXXX, loan at fourth addition, requires bolsters the facility will annum That today Valley XXXX. our PRISM payments the only runway term and interest and top The earlier line until rate entered interest X, with expected we principal is trial, prepared Silicon on February pass Interest the from cash all The

Now the for to Q&A. over we'll operator back turn the call

Operator

first of [Operator from line Capital. the from question comes Nachman Instructions] BMO Gary Your

Your line is open.

Gary Nachman

Good Hi. guys. afternoon,

was you that upsizing statistical you if go maintained Jen? want maximum that even is something And predetermined, With XX%, to higher which additional XXX, are power of is the and the comfort at Chris, for to re-estimation to? at quantify allowed you XXX is PRISM

Jennifer Good

thank Yeah, no, you, Gary.

So you're original the powered power. study at right, XX% we

actual calculations. But see study the don't of that's what we So the was. the premise

of the size going As like any trial. sort far as above, is sample

finish. people sample them of experiment technically, have in a you're off size. let the But certain running you If can an pipeline, sort you based

tend they in oftentimes So, that's I again, what because just target patients run bit people think over the are we'll a to queue. But for. on

Gary Nachman

Okay. you the then to And you upsizing pandemic, about the discontinuation, have a is that's past? you behind think challenging And more has how maximum or the up maybe been patient too And in hard something through been do it factor was the it amount, to education? appropriate the the that providing talked that managing tell?

Jennifer Good

I'll start the so last forget I just So it. point, don't with

one it. dial have what count because might it's certainly We That's to and say in no hard essentially discontinuations, we treatment be. drove if as have visibility on failures what exactly those factor,

site have been that part lot of calculation. that also be variability. can could into it. a things play that It So There's of

have actually I a what So, can be. sense don't of that good

lot managing of study, follow this make patient we're to sites, how But handling into attention have do good XX that with We've we paying it. just as and sure up our patients. facing only a the not we put sites it far effort to with they're training appropriately materials. As this often

anything and usual. raised we're what worried So the pandemic, disturbing. also I did though, seeing sort business say not of alarming of higher. That's that was what sort I would about, or discontinuations contrary there during as go not you

As they I of were a bit a think fact, home. dipped matter actually because people

focused run work good people. I think trying to and there was around, they're not

to blinded portion I one visit think didn't anybody the We study in lose COVID. the of had the during we missed time. only

and and mentioned, all those place patients. together things visits, in people was to situation, So, as in of up PN, and different of that in actually did everybody held didn't a well. we IPF the drug paused days, waving put needing of the I things end But about early worrying because little really nature that sort sites around, IPF. the getting and

Gary Nachman

makes XX last you're one said study. the I sites just Then, there? it difficult pandemic, be think terms But amending like the a IPF Okay. going geography hospital are maybe that playing out visits. just have protocol on U.K., quick do go. sounds that's in cases just the to minimize ready the are to you And the of one, sense given the to you think of how expand to It beyond Thanks. four yet, if you

Jennifer Good

you Gary, should development a little question, Good company. run drug Yeah. go

exploring for more whatever's So, sort we're so because trials we going we at another a just that possibly the not about say, one for it's country doing tied the do Germany, pandemic. place making to we're you mitigation. instance, sure to great exactly reasons is on Austria, time in adding looking are country France, during this on of And are already of actually which in this. risk

exploring. So, those we're are all options

Gary Nachman

Okay, great. Thanks.

Operator

from your Ami question next And with you. comes Thank Fabia Leerink. SVB

Your line open. is

Ami Fabia

my taking thank Hi, for questions. you

of talk bolus about whether pandemic? the you you PN of on channel any And can how pretty that months? sites a opening continue of we you study, coming the run in of to have into Can just patients that enroll do strong think Firstly, in July. patients Are might kind there up been enrolment because the can rate the you had patients trial? new to new of sort June,

Jennifer Good

a during memo. we that thing advantage competitor are encouraging transaction think Amy. I up to COVID reported in you? anyway, to about June, question on very they same long get seeing - the got think bolus some were that's productive productive they we're through I and through to August. is nice sites whole essentially I it's a Hi, think How do things. took would think - function of this And were but pause, sure. question. they during me queued the One, ended now The enrolling out a negative eventually I I good place, Yeah, had what So, continued trial being reaching of that have transition up. patients, which into time of that but think not people more July, out a in really two the the is

and of actually same because up so get of bringing and about you exactly I to been thing recruiting during do for said, them we which window virtual new SIV's patients. helpful is quite that's think very out this other have successful is how running. people And you've got And the what creative on sites, people the and were

of there. I of patients the But continue bringing we fresh thing. to is to think think just new a will as So, sites as some we about add we're sites I good into mix because enroll some far in these there number the need

little of So, strong I month nice but continued there a August. July June. do think was and a in a was through bolus bit June

we're number the think of rate So, we at, we're sites a I the run in it's position with have. good

Ami Fabia

Got it.

part sort on And give look color have can of you to be on many they extension it? the Just how after been patients the followed? how open chose me to long trial, some of

Jennifer Good

Yep.

Ami Fabia

of sort any And feedback? anecdotal

Jennifer Good

Sure.

of time. XX% into open That's an the have additional of label extension. comments, XX in opted my mentioned over weeks I patients roll So, to

that you the you've window. XX-weeks, the to a stopped low number itch patients all People we've end year make way if a to different on been at their life for fair had although of different be the the can way So, way therapy. gets the happens, Their of points study reasons. up or discontinued on that down, along first

And that so still we on have a study. lot of patients

like sign about trials. lots when probably the course, hear are way extension. same several So, a I people to of things. lots encouraging the stuff said, so, I the make all find patients continue good skin or always it of almost things with are that's forward good always an We're of encouraging itch label the pictures had Like we've We year, Anecdotal, open all taking hearing XX into healing, it's in that. feedback actually and to some choosing you sites. of

able the of when started We here open real of up the the is those ring information yet skin heal but lots sort you encouraging because have not looking are golden out hearing at label study. of that's to

Ami Fabia

rate of you the - were you just trial? could overall the were And to discontinuation confirm blinded you

Jennifer Good

discontinuation blinded drug just know We they're No. really into whether or to, don't we on overall the it I'm because but get placebo. rate,

the discontinuation anything rate overall were of not that's assuming. what is And outside so, we

hard very you all to on because no out, sort people parse placebo. XX-weeks way, along it of it's out, itchy. discontinuing they're because Just I have have if the drug or they're idea

perspective. doing think So, nice It it's is the just a and really drug from I parse hard what team's that a of job managing. means something to

Ami Fabia

Got it.

when Just I but be rough able in kind be last you process, early would the what it's give? rough might on question readout? timeline study is the of the IPF. to for timeline know What would the

Jennifer Good

Yeah.

as by until year we end, - we COVID, have you back. pulled need think XX but Ami guidance we completers. know, So, that I And with out we there

with date I and UK Gary's other I this think we about are get out hesitated there. open a put any until rolling we've territories, the to going our think up to question we and to sites in

quarter, have as and think the I up sites So, hopefully we'll visibility on get by next that actually rolling. more

don't confident So, make want I to it's to out can any we're do hit. that, lay just when want dates I yet, we we sure something because

Ami Fabia

it. Got

so thank Okay, you much.

Jennifer Good

Thank you. Yeah.

Operator

Thank you.

comes Sami from of Your Stifel. the line next question Annabel from

open. is line Your

Annabel Sami

I for any do. Hi, I'll wonder question. left. But I if even taking my of thanks have course

So, go you to want a that the I want something to to upsizing clarify back said. I for moment.

maximum at for So, upsizing. you're allowable level the

in the when enrolling want to the of understand it you we I more down suggesting maintained So, you that you're some you max what room within seems given terms that? by exactly was patients wiggle have some, your I want is, - meant into And to drill read that allowed? lose in but how power, on case still guess then say just you I second should you to number that that one, point

Jennifer Good

No.

So yeah, okay.

Annabel Sami

ahead. go No

Jennifer Good

And the if As room trial just have, your a in than our typically that don't to say, XX have up, matter, that let patients normal clear the maintain you when hit does it wiggle you you XXX we finish. queue, power. other them really say,

create sort why try any of anticipating at. never room better not the efficacy trials were end we're So, that's little on spot up needing to But wiggle to no, to number read. they a

XXXs that's in targeting. there. what So, end we're are around up that And and we'll

to... question first read upper limit? Your for around, me hard was to the what into It's

Annabel Sami

it's like way just Yes. I yeah, the to This about so upsize or mean all max, size up this I is - sometimes XX%. the XX% have sometimes like that? curious you was

Jennifer Good

it these Yeah. magic any Annabel of would understand because of picked ranges I drop on. of in curtain, like. look number, results The end I is as when There's similar of only bit sort is it sort behind you into the into And end don't that you the of going have the the a the get ranges, to up specific why of numbers. X you can a That's not calculations think these that there's I see what Phase our to number. at upper XXX, looked read that. thing we

had we and of end try up we the we essentially of made we sort that's had going phase in it where could this our range of sort on we what recheck so, lower the if fashion then happened. results, And go to the two had to that stepwise middle, do that, to and were decision enroll in to that

Annabel Sami

and burden of COVID patients, of during talk enrolment COVID on these and for point? then these started. managing Northeast to how of talk patients, how the in want this it's everything do so And Okay. Can in they're - of kind patients period the conducting at Are are the have I just so about more great been have as about come much more how monitoring wreaks just region? how So, you that around and they visits? monitoring these you monitored spreads has country being you havoc, virtually than you the this to

Jennifer Good

have these that to studies office gone conditions. on have particular patients, for somewhat a don't surprise, medical ongoing in lot mean, the my PN actually typically underlying into on visits other I coming were all patients No, the

through continue And their visits. so they were able to

a so that up didn't problem. And end being

monitoring as remote to monitoring they're far open that As was in that and was the They visits, person. also are paused know I in monitoring doing something started Germany, I has countries. up know. that in

monitor, remotely are is site a to little some and So go then monitors, in they in-house. are of they ahead verify on in each they'll can sites doing other some have the are data letting different, sites what go patient-based and to and site when

Annabel Sami

Okay.

is, that guess you of by guess the question given I last you can faster? last it The could had competitor you months. Okay. some that's the 'XX of Do completion you very few think quarter out through I most conservative I and little timing that think third the on is do I'm rapid expect this get enrolment that surprised enrolment a you way, speed and the or up had that

Jennifer Good

to Well, can. we do we better try if always

severe I to that be the think PN But try guidance. we challenging out It's patients. to of It's not biologics. mindful aggressive think able some are with competitive most that's are to love the I'd these beat There we're studies there other guidance. patients. of realistic that.

on months Hopefully I So move timeline realistic through see little COVID it's a the challenge few have that. as studies. better lens we'll and to continues next think much how we a

Annabel Sami

more Okay, - it up up and actually treating is other underlying one PN disease nodularis? happening Or point. sorry prurigo that on that follow-up biologics targeting those as are - manifesting Are ends ends the specifically?

Jennifer Good

Dupixent's in Galderma nodularis, no, running are. they're start just they're done here. going trials. And two going Kenexa prurigo some pruritis not quite but Yeah, trials. work is announced like up they've we to has then targeting And

similar what a but do. of my So biologics view it's of more doing sort biologics the space,

of. for run stay I these it's need aware clinical but sites, much here, an of the big but there we at oral across not have think I is a something

Annabel Sami

you. great. Thank Okay,

Jennifer Good

thank you. Yeah,

Operator

Co. question of Belanger [Operator Needham Instructions] line from the from & your next comes And Serge

Your line is open.

Serge Belanger

Hey, good for afternoon. Thanks taking questions. the

treated? U.S. patients react the expect difference how are a guess are and whether in to in first any differences European one the trial? Just me, they'll nalbuphine And between a for how I is, you couple PN there

Jennifer Good

U.S. KOL I Phase sort those good Serge, across reported was No, think, European U.S. Western a from that some is so patients had and United similar similarly just are not I X a defined see our only we've effects of European didn't Placebo community of think trial and that evidence the territories. out also similar results where Memo effect very in both. difference, very drug and we a trial. but were And

we populations each So see about were their XXX about differences studies patient didn't two between the in patients. both XXX - which

So we seeing any further two we're evidence not the to across that differences and I think run territories. that that able be was should

Serge Belanger

And willing initially I were that and still Okay. IPF then out little or quicker? trial, responders. able these to have the set the be a results XX Is on think be numbers target you recruit XX-ish smaller to to to have you'd report patients

Jennifer Good

Yeah, it's question. good a

as are of we do. guys You all thinking sort

goal to the XX with XX still Our is do completers.

mention. a rolling IPF patients had lot We on here, drop There's and In wanted had going their substantially A could trials, are exploring them up a of out various many avenues. of that's those it were of to doing kind UK lot nice sites I and when? of we get some and to One, enrolled. didn't we studies. our that, that how dynamic see hurt people that

of they're so the out space. And

in IPF IPF had So competitive it space has was one we cleared out. a both and company cough now in very

actually to get So the quite sites ticket some hungry again. studies are new going

We're study. X country, this over to on of prioritize is all that, another COVID the see read a proof-of-concept really Phase sort said Having out. would which study. that, pursue So plays doing how to a want going a get little thing smaller I

take if is So working. at a time. appears draw made that We going of point like looks much and drug some see it's sort drag line and too to the on

So point, those we can all the interpretable think we But this sort original of favors on data do of at out this to because it. sample get the being size table. are more options team the able

Serge Belanger

That's Great. for Okay. all me.

Jennifer Good

you, Thank Serge.

Operator

Jennifer back for and further questions the would Thank you, turn Ms. to showing like any conference Good time. I'm remarks. at no closing to I this

Jennifer Good

would participate I the our you. call. soon. in and the continued like during team, Enjoy healthy. clinical continue investigators our thank and rest stay all progress We and everybody and for you trials updating very Chris like to look to participating summer forward I'd this the thank today's who Thank of to also Trevi to your patients study of challenging time. in

Operator

Ladies joining. all and this Thank concludes for conference. gentlemen, today's you

now all disconnect. may You

Trevi Therapeutics (TRVI) 13 Aug 202020 Q2 Earnings call transcript