TRVI - Earnings call transcript Q3 2020 | Trevi Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Trevi Therapeutics Third Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this call may be recorded. Various remarks that 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 claims Form of in the Risk with differ statements those those XX-Q XX-Q, may most Form subsequent the a company’s file filings file to as various Factors SEC which results is from report company with by those tomorrow. forward-looking discussed recent on Actual quarterly the the on and of the important in factors, included

only subsequent forward-looking as be any represent statements should representing company’s views today addition, not of In relied views the and as date. as upon of any

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

Jennifer Good

to Thank earnings quarter and you. welcome our call. Good everyone, afternoon, third

against the to pandemic. our for continued adapting plans to execute We quarter, challenges the COVID the of business

neurologically to So its the moment Trevi, drug in just an potential to at and step treatment back of conditions. for explore serious strategy Haduvio, various extended-release a mediated oral growth remind everyone we developed effect are

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

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

than XX% the NRS, Xb/X Europe, sites XX with we Itch open-label half on recruiting based currently and our the the to trial, roll subjects call measured in blinded trial XXX. Numerical Phase total the activated. end subjects Encouragingly, after study fixed reached of of of of as the We XX both or Rating analysis U.S. have We the the is by primary the The The we have the end to weeks blinded greater Scale, a opted currently in and approximately prurigo more trial. dosing responder are endpoint into assessed randomized these dosing. XXX first period reduction subjects extension than change of into more have is itch the have date, portion study. that is of conducting nodularis, PRISM intensity and the our in trial than Worst

potential data XX on had well year-long the as to subjects We for database providing approximately with study our have also longer-term therapy. continuing healing skin safety long-term the build as complete

due changing any Our or limiting do or of of sites using conditions adapting not enrollment EU entire this team screening and focused have We is currently U.S. in on enrollment study in our subjects the of completing the are COVID. to for patients beyond including recruitment screen list. additional supporting restrictions COVID find strategies, we for to potential our multiple to enrollment, patient as as social With sites patients to this well platforms own trial. to media regard

We meetings, a We virtually. have XXXX participated Dermatology virtual busy the Clinical site team message Conference in through chat had leads, with live months XXX notes. also visits, albeit with Fall few recently at booth a over medical and had that our video interactions board

the XXXX. with and enrollment the enrollment for expect guidance instructive we participated complete at having effectively European trial. up. promoting how will discussion presented, supported and oral for option a finally, rates, our meeting, an physician fourth world about EADV, report participate a a reaffirm We in also of of XXXX virtual as that tank were PRISM our of in booth upon Dermatology the Based In It the Dermatology that top in practitioners importance Academy we quarter third the our – the this we runner the PRISM has presentation PRISM quarter and we believe October, the the And the month, had We conferences. of nurse adapted style symposium the Clinical competition, shark for trial. e-posters we surprise two were in been the nice data Phase we of to seriousness of assistants line of and and also these virtual in our which in attended to medical well and trial for as this Venereology patients. or a virtual has and X trial Fall pruritus condition

top getting roughly trial to will from continue on year data line this a We delivering and fully now. enrolled focus

fibrosis is tissues. there which or now our in and of progressive program clinical for condition severe scarring the Turning to lung IPF are idiopathic phase second a and cost IPF. pulmonary

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

with by high-risk primary COVID during we from change currently cough treatment The trial since a is the three-week due digital each group The activities the assessment frequency is XX-day paused We crossover arm. period and cough are to This for all versus each monitor. their cough patient placebo conducted individual complications measured a conducting daytime X and lung screening own the in is period for impairment, underlying in a being mean active period. March. washout is Phase enrollment study treatment in double-blind UK, endpoint after percent daytime this patient frequency at their

for our restrictions During a fewer that the time, filed the for on enhance focused visits amending was site amendment trial and ability to paused, environment. as to this sites Regulatory Medicines UK. the safely Since our procedures the resumed amended some well MHRA, COVID Products and enroll steady working screening overall expect study and was and There of lifted to are to had that we reopen we within The We of protocol Agency, trial. or our procedures allow by as recently fewer protocol randomization. approved to start-up sites on then, have our the by screening, actively several year-end. successfully first Healthcare patient

Additionally, with Trevi study a pandemic. country sites which Germany, enrollment single in accelerate the potential the recruitment could COVID risk is setting during inherent and reduce

have a interest in in and have several assessment We feasibility Germany the had completed study. sites expressed

well scheduling to through this qualification the for year-end as on regulatory as bring visits through We working study. of Germany potential requirements the sites are

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

Chris development to However, the you resources. to now programs Seiter, us Chief allows with will Chris? our a prioritization both and provide over Officer, of and Trevi’s optimize hand I update. execution financial company pruritus to Financial cough our it

Chris Seiter

Jennifer. you, Thank

full As third our for we a XXXX XX-Q, plan with the reminder, the be which, can tomorrow. noted, financial to found of results SEC file quarter as in will the

to The of pausing million of Phase increase treatment in was compared disease. in as of of due of million our completion we million quarter of The the the chronic – a XXXX, Phase the X chronic decreased in an million $X.X R&D to XXXX. $X.X increase in with our activity third $X.X same as quarter activity due an and enrollment in of the with result in the to quarter G&A the third in period loss to loss was quarter fees. of patients same of were patients reported For stock-based quarter expenses during million compared of increase the XXXX compared XXXX. cough patients net expenses million a primarily $X.X expenses net to the third IPF in the consulting decrease $X pandemic XXXX. primarily to of during for same trial due liver XXXX decreased period Xb $X.X as were well COVID-XX of a and with compensation trial

totaled December XX, of As million our to million XXXX. September and XX, of compared as cash cash $XX.X XXXX, equivalents $XX.X

implemented cash runway. During funding extend to quarter, debt our we the strategies equity and both third using

quarter, third facility. of the ATM through common $X.X our our million approximately stock sold During we

the runway and with position, PRISM expect file, facility cash first the is the in the non-dilutive into a Bank. past our the which third The in bolsters proceeds we from quarter loan loan addition, the prepared million expected and half received from XXXX, ATM In the fourth remarks. $XX Silicon Valley our from all term are anticipated extend we will That cash of line XXXX. for quarter, of term results our top

back over turn operator the for I’ll to Now the call Q&A.

Operator

[Operator Gary question Thank Our from first Instructions] BMO of Capital with you. Nachman Markets. comes line the

Gary Nachman

afternoon. Good guys. Hey,

that be of If sounds well? with enrollment some resurgence? in you curious, about absolute study. some there, that you max? up picked for go more the have is highlighted. XXX And wanted than a Has Is like initiatives PRISM. place it the even definitely how now target follow-up been certain, a has since enrollment momentum? can higher a the good Jennifer. slowing I’m accelerating? Any to when with Or is in statistical made I if bunch enrollment pace you guess, building where progress just then you guys of COVID You were the summer scenario much significance you the going It it the

Jennifer Good

questions. you. good to Nice Gary. Two Yes. hear from Hi,

bolus the then lighter, was good August of first a say coming So was bit couple a of is months. not enrollment the And good. would fall unexpected. strong, the I pace which out definitely been COVID has of

an going for good we’ve clipping interesting months-ish. we of I time But but month. along sort of at keep in been think I developers. this window that, we average, so we patients are it screening, XX say, heading a the of direct if X.X And be on would on people this screenings and shape. holiday have should We always I don’t – into in to interesting XX sort will an is be season, good hitting

good. So that’s

have them question as you the for have this people the max. their typically, work way you I to think time, tend you when your long XXX, let doing a queue, from being When XXX around through. you the know, approximately in

I our and number FFRE just staff So in results, finish. many depending tease we’ll But should out statistical the to think of significance. a them based how let our that sort good are people queue, on be on

at it let people upsize end. or this overshoot queue, the But in to try we’ll if the them obviously to looking not finish. we’re So are

Gary Nachman

Okay. could then And more. I if in one just squeeze

patients the long coughs, do sounds For running getting potentially are XX Or take started. how really that’s Germany? that, chronic this it that UK like think will target Is and and depend run on does this the completers? And to knowing point how XX many it it study up might both just you and in sites still at change?

Jennifer Good

with of our shut we So with when people COVID. XX, to potential the we that couple do that amendment a it trial the from MHRA, had when we and end of to patients discontinue for had we to upped down filed

completers. So to our give get to XX to wanted just ourselves room we

room what? you Timing. And I’m some So same. left people screen study. number many question, the just how Gary, second still the completer sorry. was of is could your the into We

Gary Nachman

Yes.

– mean, point. this call Just to time completing this for it’s study. I know tough frame at I And

if a had how on But many you this you up at get take point? ballpark depends sites much to and So guess running.

Jennifer Good

to up No. them It we’re to up our because and UK, get sites we’re Chris, I know Yes. from hard said running. we’re question. this going the to bringing is getting

the we are try at I good try just finish to on to the enrollment I’m to don’t accelerate definitely Germany mean within visibility timing looking have We next think to pushing, year. want I I this. year.

on going just that I also first people investing, paycheck I would cough we’re the there’s COVID. just have – of helpful. Europe of from sort and of make. of not enrolled sense that IPF in randomized positive way, There were it. to one in the cough. lot had lot But our trials on And, back. got shut ground, of to tension had back a proper players fully down, And good us did So is have is not there so those come this more walked We’ve that occurred for resources the away just of We a which don’t from here, was a Respivant, runway by yet. have us. the we’ve through and dicey UK. it’s against drug COVID one in say have thing out whole failed, competitor front base, tough whose activity leaving IPF’s particularly general, sort a in call

a we when seen people on real we’ve went willingness, So we to again. eager to going at trials clinical that Germany and heard get

that with of it. us. helps the backdrop COVID So I’m hoping it’s But got

not just of sort we’re around a good So in yet to position guidance that. give

Gary Nachman

Okay. That’s Thanks a fair. lot.

Jennifer Good

Yes.

Operator

you. Thank

Your of comes next line Ami Leerink. question from the with Fadia

Ami Fadia

good have Hi, Can an of evening. you any seen on progress the good as patients enrollment. on? dropout event Jennifer, give rate color or more come for on Thanks the the question. profile you adverse us sort

Jennifer Good

Yes. Yes. Nice Hi, Ami. voice. hear your to

all because always resist of know, you into percentages it’s getting as blinded. dropouts, So sort we

to as reestimation. I was range. in our they’re that sort validated said difficult of see. say, we’ve in an sample size would think expected before, it’s So I And

As our the up unexpected is and far in other has of like as something adverse we trials. typical trial. And come – sort obligation. looks dizziness, events, somnolence, very I nothing our nausea, it monitor The that as much

They’ve independent and trial, now expected. have this met in monitoring we were proceed to an data We able committee. twice as

of sort like it say events adverse we’ve our would trials I the other very So looks seen. typical and

Ami Fadia

IPF then or do program. completing cough on PN it. your while it to the Got forward next you just you’re over plan And the move so year study? How

Jennifer Good

Yes.

So have two we different teams.

of of to assigned ops a them assigned physician them. clinical team one a have each one to We each and

I we’re separated. mean, company. a small they’re So

So bit. I don’t resources. we the crisscross all But about a worry

challenges behind we backdrop the it the certainly, those a to as These and both through even enrollment. I are recruitment some and of move think and in both time. patient small cough trials in extent, populations PN, winter are has COVID IPF

resources trials really getting the is to enrolled focus what them our and there’s we adequate think from can I the a team we – perspective. support because do So around both have

saw, doing hiring also some COVID the probably window. You Ami, during we’ve been

more a So in point. added is another around. good I strength we’ve commercial strong built would this person, person, clinical our just actually at There’s say out pharmacology team another completely regulatory coming company all person. And the

getting we’re constrained. them don’t just resource So feel I of enrolled. It’s a matter

Ami Fadia

it. Got

possibility wondering how one as one And like it resources there we trial second in be Okay. the the a Maybe to second was if sort about answer you’ve think time the we about feel of one? is I’m do of Would just last for question. given I PN? trial first but any just this, of If successful. that sort the similar-sized the and might be required think

Jennifer Good

Yes.

So of that. think I be ready next discussions. have ability stick position good team to a We do to transition we that to has already same into started want lot quick to a a the with of those team have We’ll We’ve And got some go. probably trial. a the in CRO.

options, a purposes, a mean, the probably about the but we the here for change bit. roughly number same a a that’s I assumption. different some is the as think sitting think good design, today, think I obviously, as end. assumption bit see assuming I we I when talking we are good far study But may probably data, little powering planning

Ami Fadia

Got it.

you. Thank Okay.

Jennifer Good

Yes. Thank you, Ami.

Operator

you. & question Serge of Thank Needham the Company. comes next And Belanger from line our with

Serge Belanger

the folds that missed in that on for of still guess level a range are they afternoon. end full I I the you good many mid-XX% you on that of staying first getting point, of guess, are – you PRISM. And rollover an open-label they think completed I patients of have healing? XX trial. mentioned what patients trial And the weeks. but it, or into lesion – have this may of couple Do questions also to percentage even are reach trial? how XX the once had additional at patients idea Hi, I the

Jennifer Good

Yes.

So Serge, question. a that’s good

we yes, did opting it’s open-label extension. that into than mention greater to So are the XX% roll

I open-label haven’t people done are where leaving we the end. of you, the analyzing to people haven’t with honest their and second I’m at getting data, of all the success that. if sort a skin question, lot and is and your good looks having What We’re part looked how of

dicey too it’s can’t data in people that are And durability the doing really always be comment suppression. on it. anyway. on effect well itch their abstract But to And So on I of blinded little from drug. that much. They the a staying clearly, good there’s do of

down So of leave is I to we’ll don’t is analysis because know, gone of I level, sort their haven’t of of people as certain a part through the do itch thought about and our data. that when sort it

Serge Belanger

extension patients have the Do to to open-label for of that data for complete FDA? you need number set – safety study required a

Jennifer Good

Yes.

I I already one We XXX from year know I you are XX, mean, – with already probably patients our one XX the we or So our had last have XX XXX ICH from data. think, study guidelines, here. XX to study, prior of year have maybe think,

So to we’re a a lot stages trial. people that. We various there’s go, significant dent in to of long this ways and have of still from going make a of sort

shape, to going think, this we’re be So I good after study. in

Although open-label we people I always are another study, some least think assured because at it’s with – to run to they’ll second point. advantageous offer then a at drug get that extension have assuming

a So while, safety it. I’m worried as database FDA so know And lot our about drug this been it. not you here. has around recognizes about a know,

helpful. all that’s So

all So we track hit to those numbers. seem on

Serge Belanger

anything trials response months talk I of activity terms cough if differences glean to seen main in then of between cough the those can And last or know Okay. a the there’s We’ve cough IPF placebo? you IPF and few in the cough. in and program. about don’t just one lot on if from chronic chronic

Jennifer Good

think a atopic been PXXX are pain all, being fascinating drugs. chased as here. It’s drugs of of I’ve variants as a like those, as their first sort I derm sort all know, to of the of is cough started well. gorilla would world. is chronic it which different the big following PN. sort lives I say, It’s Yes. primary you of

that interesting. I its be nalbuphine So as where of an find sort also of sort to life. mechanism, is mean, seems started that I interesting know, which, you

find compelling. So I that

because of had sort we the the triggering neurological lungs IPF the and signal the opioid chosen receptors. of these where of cost mechanism rich think fibrosis was in body I the of

the was somewhat world progressive in So drug. right dose frequently, had we studying us back these to in reach the our is We’ve a Low the place. It that’s experts interested it by felt challenging. now patients. cough disease morphine way, used in

this mechanism in opioid So known is mechanism interest and it. a that’s there’s

that primary we to ourselves think big areas think we U.S., area wouldn’t not in a be market we to think care we into Chronic I with cough figure very interesting of to. that if doing are trial a biologically data becomes would to cell, could But that springboard try interested. out chronic and makes into wanted here also eventually sense an I we we how sort cough. stay that the

So following all certain screen isn’t a to and in PN. to trying about literature severity I of mean have I’m the dissimilar cough, which

think all I are areas. see There’s cough start our it these in to it at a means. through with data in and get totality to have we to going learn what analyze then the to still just lot looking trial, chronic

Serge Belanger

you. Thank Okay.

Operator

the Stifel. [Operator of question with Samimy line Instructions] comes from next Annabel Our

Annabel Samimy

study just in terms been my Obviously, study? able have Most ask the starting resources of any of studies trying there about second go runway at be first them if Is more trial risk I seeing a you, have studies conduct same the it the before completion taking question. the for merely of a start to there? before – to is of Is to Or to Thanks those for it lack But to modify this any PN. getting programs. at thought second the risk could results answered these we quite time? of point.

Jennifer Good

I at cash the it question, table. we’ve Chris pivotal good and don’t to talked one it’s feeling not lot, I talk – and we level. off is the starting – parallel But on all Now, that, about not obviously, talked get My and mean, way we’ve that’s about a is us another the Annabel, the have through study. Board a in

sort of somewhat actually more strongly long a Although, is between us data I study, need and be relationships you really competitive on the time. from study kind the of factors comfortable second up make XX all, many any the first lot seeing that board. also, understood now the the will trial, running We’ve size will run, feel help got the of helpful. way, think, the how protocol We’ve we some feel nuances. optimize of I Europe. of sites of sites U.S. we’ll in that I this dealt with I out And with from over for good think which

worked our protocol, kinks. out of sort any So we

So of be the to and starting that do is it’s out I I quickly in there’s particularly a light good fairly make to Trevi up about trial. now only the nervous the biologics in shake how could the it, data the before from would time. landscape ability we opportunity, competitive this and oral. think transition label optimizing about I going locked and see and being clear trial with Because think

and the jump I being optimize of product, in how I to don’t that thoughtful think, – something about of the you sort optimize space of play in of ability value final and want thinking important. to that the trial. And ahead So lose sort is the

Annabel Samimy

that’s comfort kind any giving you of it. programs. Got somewhat the your anything that And Cara mixed there kappa heard is targeting, product although, realize of it. opioid terms Got has I agonism. competitive in your Okay. of

you greater So trials? is going there you could your indications around to can their from comfort in conduct any activity you’re that comfort how give that take various

Jennifer Good

both is us I best agonist. and we’ve talked think being hit you to the about pure comp mean, Cara a I always know – think We I Yes. this. receptors. kappa

some away do I sort I us itch. mechanisms of the there. think out both are most of stepped important had from think like types But of and other they’re always in different

It’s from year. for a are We it using get encouraging We the investigators encouraging stuff. anecdotal on see I that patients feedback stuff. lot quite a of when kinds also drug, staying me of get all

excited are interested about to to the people data. mechanism. get So I’m

I Cara’s think yes, mechanism our trial. data supportive good But do getting and is all about the overall. right hopefully, of I of conducting of it’s end a think sort

Annabel Samimy

then enrollment, you’re the both that last We regarding just here reduce that’s lockdown question Okay. the IPF. and slightly the are program they’re moving keep of Germany. doing whole derail Obviously, going number on the this possibly in somewhat not even the UK is the have to in And and doing lockdown. your the peaks amendments know pandemic and study of forward a that to in you’ve made different opening sufficient to scenario lockdowns? And visits

Jennifer Good

a Yes. That’s question. good

So last when everything, shielding pause to environment. what’s we were in they called the had time

bars like their patients They house. told certain They that. were here restaurants kind we’re patients and there to and are things were seeing to in leave with what that IPF are that So not around similar not basically like of lockdown.

And their doesn’t to procedures we’ve visits. have So patients, been by right in that set can miss to it able the the see up told visits, we place. they all to have protocols sites impact be some ability to They dropped we see patients. these

So patient and so, get is if things population. this but hope a I Annabel, worse tough

current the the which attention shielding, created to back go have procedures So to not to it. before. the pay to do we’re is pause But going lockdown what

Annabel Samimy

you. Okay, great. Thank

Operator

like remarks. any now call Good would back to turn I questions. the further further any showing to Jennifer not for I’m

Jennifer Good

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

Operator

This you today’s today’s Thank conference. for in program. concludes participating

day. may great Everyone, have disconnect. You all a

Trevi Therapeutics (TRVI) 11 Nov 202020 Q3 Earnings call transcript