TRVI - Earnings call transcript Q4 2023 | Trevi Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, and welcome to the Trevi Therapeutics Fourth Quarter and Year-End 2023 Earnings Conference Call. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. Various remarks that management makes during this conference 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. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent quarterly report on Form 10-K, which the company filed with the SEC this afternoon.

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

if elect the these disclaims future, to so, may some statements any company do in change. point the even the to forward-looking update at obligation While views its company specifically would Trevi's and Good, like to President turn conference CEO. the I over now Jennifer to Please go ahead.

Jennifer Good

and Good thank quarter joining call earnings our for and XXXX and afternoon, fourth you year-end business update.

and I Medical this call then open Delfini, some Financial Officer; Lisa Officer. remarks, are Trevi's Chief Trevi's and colleagues, on Dr. my today we Clark, me it have questions. Joining prepared up Lisa David Chief will for

The of time of productive fourth XXXX quarter the clinical X of and XXXX was initiation with Trevi start a studies. for

the cough and coughers. and frequency. frequency mechanism cough a as in Haduvio peripheral and based IIa Let moderate and cough estimated adult and like greater has more on an peripherally believe up centrally high to distribution, cough underlying hour. to KOLs. brief chronic central which counts you chronic these work to to a to cost the peripheral-only the synergistically into from therapies very for of to and across patients psychologically on RCC having to hour, severe cough frequencies. When showed in XX% refractory for differentiation debilitating our all mechanisms moderate look have coughers very across has a by in be as frequency a all per high the the that I and and at have are the demonstrated mechanism for unmet range the statistical is brain XX in of approved stronger successful than River the cough a patients patients Haduvio in PXXX multiple me of of peripheral point hour to and moderate high, cough and potential low central cough of to condition. high effect mechanism action, drug treatment has both lasting baseline high very significance that coughs XX the clinical reflex believe cough baseline that of affects socially. With only lack patients cough patient of to in We XX% of is potential action The We IPF work is failures cough high trial, very counters results drug across was there urgent have Phase have RCC data to been broader per on XX RCC treatments. cough inhibitors. RCC fourth or refractory the for RCC of population the XX each strong varying the disease and counts of any in to physically, stratified XX% and Refractory frequency not new and estimated the frequency, considered trial significant broadly high The are than caused the whereas significant potential frequency Haduvio's trial drug purposes a patients X have than categories date the per The update XXXX. a that quarter cost and a weeks in a are of PXXX only lungs. initiated shown the XX potentially need effect space works chronic peripheral central U.S., key in will the cost for in provide a continues trials. is which the in greater cough impact by persistent our begin X despite hypersensitivity defined nerves and with

separated in daily period the the the period. of of twice X/X a Phase evaluating to is to be life. close placebo will primary address RCC treatment at market. On approximately double-blind X than trial the those standard our a to randomized, Haduvio for washout weeks compared to have secondary dosing may X-period also baseline IIa X-week cough XXX The the in The whereas relative is the the milligrams hour XX than greater Patients last efficacy trial, up patients RCC Haduvio randomized PXXXs will objective crossover coughs per to in one-to-one period an on across between XX-hour of of Haduvio including to titrated study from frequency those across period. placebo-controlled, study XX XX cost day reduction may The as effective by patients. patient-reported of treatment be the design coughs per will for details explore is X/X hour. Each only measures monitor. the market, quality will cough a milligrams XX change dose cough run potential by trials endpoints, cost outcome and with date. measured with X weekly which stratification less XX there's from So RIVER with These endpoint and several

this We have have sites month. the activated to expect study by excited all end initiated are to this substantially and the of

to half study expect line this second this in the of continue top We year. from data

chronic role physical, approximately The disease. in and urgent on program plays impacts end-of-life tears similar of to update need to such for serious IPF, significant psychological or a factor hospitalizations, or worse new the fibrosis for caused lead as an in therapies. increased respiratory lung no inflammation transplant. With chronic options social approved may patients providers mortality coughing is constant be that and health currently outcomes is have by cough of patients cough pulmonary IPF and potential persistent of need But XX% from may IPF RCC. patients for Chronic also IPF have for treatment injury that suffering a micro and IPF. reported a lead our and cough. Next, idiopathic an by risk progression

initiated are we patients, in initiated lot the end IIb a chronic programs for this a of IPS, complete top CORAL multiple in cough, the doses chronic of is sites data elevating Phase and early trial of X X-arm timely the line need. At trial and along the our reconfirm in-development development Site in are of IPF, and a manner. CORAL an have unmet on study or there therapies year. activations is for study second current this in assuming in primary the countries study and a oral of is ongoing these moving be crossover HAP in nalbuphine of half to study. XXXX, year. we placebo. The in guidance primary study relative XXX selected placebo double-dummy butorphanol, first shown both that of IV enrollment not no butorphanol stages. We enrollment impact our the of and study complaints is as plan primary The We is we a final one HAP IIb DEA. the active cough endpoint of a reestimation in changes of dose-ranging final human will is the is multiple And able X-week of of in Haduvio X-way double-blind, The This in January placebo. conduct Phase objective compared study a XXXX, patients. study countries this to of While enrollment in to approximately passed from moving part sample X parenteral the the design lastly, half randomized, the along which Recall the the of scale. abuse determine doses likability to by and that nalbuphine drug-liking the portion of potential nicely, are to to and is this and the have unscheduled potential study size mark. XX% evaluate to nalbuphine vast expected dosing results, abuse dose

expect data half from year the in top as to continue well. line We study this this of second

the As and you clinically development is Haduvio important from cough trials and it Trevi, forward be the see, will believe to time busy chronic inform data these for path conditions. for a can we

to turn review then these costs. and motivated Lisa results, any our treatment with will serious effective over will questions patients to to have. offer to the up potential are for we may it We financial it now you conditions an open chronic I by

Lisa Delfini

results December found our market our ahead XX-K, ended today in good after Thank which full and you, call financial the was filed X the this Jennifer, closed. the and issued of afternoon, XXXX, be months can for release SEC press XX, The everyone. with

XXXX. of $X.X compared to For XXXX. fourth $X.X and the quarter in XXXX any net clinical loss our starting a of fourth during a net loan fourth net million cash are income fourth RIVER reported the essentially a increase clinical interest in in as of result, remained to in and May XXXX. G&A XXXX. due period loss interest increased disciplined of have the a trial fourth the the were in our as take balances, of same XXXX, XXXX, expenses million expense. We R&D off million which by cash our the quarter up for compared fourth million quarter XXXX. we XXXX income was $X.X minimis initiated $X.X the quarter of million IIb XXXX so compared consists same We CORAL on during while management expenses $X.X term XXXX Phase the trials. we and of R&D to quarter million million both consistent. Other quarter quarter of was our same was paid in primarily and the in flat of quarter $X.X of costs in The increased of approach were of have at to IIa interest very to trial, both trial expense X G&A de expenses offset Phase remained expenses of primarily $X.X

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

Jennifer and is to will discussed gives runway readout. In million. us diluted is equivalents quarter last cash shares have cash outstanding guidance the believe about at cash after securities $X we that Our the remains all burn and $XXX.X X, of per fully unchanged, and million our and we good fund $XX we into cash, of XXXX just trials XXXX marketable to expect average XXXX, million December runway enough cash

Operator

first Instructions] Oppenheimer. Leland with [Operator question from Gershell comes Our

Leland Gershell

from Two us.

CORAL First, with respect to [indiscernible] the design.

wanted Just primary endpoints. clarity have the to on

levels You're then and placebo. testing have dose you X

would it in primary level dose all endpoint versus call of versus the be frequency on basis to placebo? an doses that terms Or XX-hour frequency each aggregate with cough analyze across placebo? be individual X will So

Jennifer Good

ahead, David. Go

David Clark

for thank you Leland, much very question. the

per will analysis be dose level. the So

analysis placebo. So get us help compared dose, that all It's for feel dose, low us to response and with to allows important for dose mid good independently that. dose, do a

Leland Gershell

could trial in short-term IPF But trial of Jennifer, placebo. a which data very low-dose my just context comment fact of That's from morphine offsetting, on to only nalbuphine? the And XX% the in if you a maybe cost question, has course, a reduction other controlled in was Okay. the and X-week then it wondering, recently of published shown used then, versus the relate that morphine helpful.

Jennifer Good

question. The Yes. It's the PAC IPI a was trial, good run which U.K. in

the was think that's or works. pathway I opioid the of takeaway you why working think, see drug surprising a a Leland, of But we XX% morphine synergistic both that We it our at nalbuphine. from is reduction mechanism. on the reduction XX% our important. CAP effect We think worked. at reduction believe [indiscernible] XX% I believe wasn't and in also And

it likely drug thought we would better. thought we would always our work So and work

[indiscernible] the at the respiratory they are morphine just has very is practically because of doses. have limited. I dose challenge depression, low think They other

sort to can hinder with going that. always that's where So of go they

Operator

Next Smith question Thomas Leerink from Partners. with comes

Unknown Analyst

on Congrats Tom. progress on in made you XXXX. for the is This [indiscernible]

couple a have of We questions.

the last the CORAL process behind in So the Can the for side mentioned? the now U.S. conduct plan walk ex And sample first and to you again the through trial. between us also sites number targeted you U.S. and clinical sample us remind the on as side one, of sites? a estimation you can split

Jennifer Good

Yes. I'm David do let to this. going

David Clark

much Yes. the No, thank you very question. for

to rationale the relevant as study. Phase seen the in effect, the protect very So really IIa study. is described a clinically we've We we've believe

for effect into have be believe effect size effect XX% the the compared be Phase the effect we situation we where to to to CORAL because, where to placebo that the wanted you a the appropriately size. study conservative as in from assumed So than from cough be XX% want size the estimates been protected we've saw effect clinically is the we -- this size going we've relevant on still we corrected that experts from of could field, from relevant. the situation know, We study. But ourselves protect clinically objective to XX% XX% size IIa more believed

powering with saw the but and we've we So IIa, Yes. and for SSRE we done size the which we if not that supports clinically detect sample an large relevant, if increased it's is as an in the what is still have as have we XX%, Phase with this, can size. example, effect

Jennifer Good

I this would of ] good-sized work study in hasn't area, study. David, done was small There add, been else right? too a too, our or Everything just lot has there failed canal [ little. other one been in

of not So lot a information. you're powering with

So a sites question and it to take want to of this made sense, I targeted ask you think. do number you [indiscernible]? Do

David Clark

Yes.

we'll approximately And ex the or those XX of sites, So right for sites majority they're be U.S. study. now, our plan the so CORAL

So and they're EU primarily U.K. the in

planning. main Australia and and We Australia countries also regions, in regions the Those time and at and have other in sites starting in so are up we're Chile the Canada. present

Unknown Analyst

of question. for meeting and feedback partnership with discussion? And it. the on one And [indiscernible] end progress in Got the helpful. HBO meeting what's [indiscernible]? an Do the you FDA have the from Very last

Jennifer Good

yes. No, question. it's good a No,

We II We've up and to. request of have running. It want file running. we down David these sort the what just we'll an not one for yet a II writing an sort and team reports got need as the been studies of can were meeting all from share, end of more, get hasn't filed flat late buttoning you getting and Phase year, out meeting. tell end his a And sometime priority. we're for Phase a of we to in But

So eventually, we'll there. get

yet. so done not have We

Operator

& The with next Needham Serge Belanger question Company. comes from

Serge Belanger

just of second takeaways the kind gotten curious following adcom CRL. candidate KOL MertzPXXX] David, I [ what or for Jennifer you've and for feedback and guess FDA the

market chronic costs? there's for regarding if curious Just the or opportunity clinical been approach any the they development change to refractory view how

Jennifer Good

let David looking not of also of at book I end, a this. endpoint sure [ at are meeting, briefing then and mean, fundamentally, pros, the fundamentally, Think give the and up think didn't David to just saw have listening the comments can because only and missing cetera. Board make I'll but we Merck comment. I got good KLL in with efficacy to something. other primary answer followed up hurdle couple the I the what own each correlate enough et everybody at hung clear our we to and the advisory in sort both weren't we ] drug didn't the with

then I David the at let it, end comment. think day, the was I So of that would and say, I'll

disruptive heard made when watched recognize had -- from from that last a you sort a listening other the lives. how over to is The was patient the that the from I huge that to me. was journey stories they takeaway some condition. That and I just Having was you say years it's real certainly it the panel, AdCom X that is FDA a that, there serious impact disease. debate the compelling this about of RCC were heard a And on about their how think it

I good sailed. has of clearly the and that job patients really bought in the the did ships FDA left that case. that a think I making call feeling

from David, what you developer, do drug So the hear?

David Clark

I said. you've pieces I agree what would add points. The only with X

IIa side, be the effect think when and saw a excise see differentiating effect for a we in we'll studies. hope translation is we population factor in subsequent from Phase If cough what our will we RCC the program the get the in side. ] population [ I hopefully,

which from our run, the lot be were that Bellas and into really a to learnings So that program, of in are lot us. we protecting now reflecting GSK There's other RIVER to think, learnings many add, think were larger from you multiple a said, programs been Phase of -- Jennifer. The the are happened so field. successful to lessons as it we're we A learned us have will I KOLs the as Merck these there Hopefully, lot we're ] program place, good I'd being which in be a -- piece differentiator aware to that into A the also and of utilize. [ only you expanding what studies. of and advantage. are IIa

Jennifer Good

easy guy the the be never a Yes. It's wall new condition. in first to over

for it job -- easier makes So sure. but our

Operator

Mayank [Operator Securities. from question Our next Mamtani Instructions] comes Riley B. with

Unknown Analyst

some for Congratulations your IIa RIVER and announcing Phase is refinement full give actually the I quarter. plan enrollment do couple Mayank. enrollment? as trials, readouts? already the on On nice William to or the dose should HAP given to on that last over This year-end first, a have it's read on follow-ups. of you time frame And expectations HAP out surrounding patient we XX% these expect trial

Jennifer Good

Yes. Thank for William. question, you the

when is we'll the the guidance should give think line study is. people we I let top expect what we'll data you know readout think around what initiates,

think mark patient we're on will enrollment. also back sort the hit we let so know the front enrollment a that That's enrollment last we'll We of I the in. end people big XX% pretty analysts when of milestone. of and announce whether would investors know or end

of going just what of in everybody. gets doing for where we So that around avoid by to is sort all update are we're enrollment, update painful

that's So current thinking. our

Unknown Analyst

a That's follow-up on And that. quick helpful.

potentially -- to put trials do be be possibly would each looking of or into should on both are some and you And sort plans And trial, at missing with falling incorporated place will close of next I'm HAP readout other, here, specifically meeting? how for of one REMS be 'XX, with to the discussion next And and having what steps? on given so going forward? that? the second the into that those regulatory your the [ sort With readouts, the we then the some half FDA discuss the meeting ] in

David Clark

Correct.

abuse right that, then it data expert right, that the decisions, comes the steps then really quite preparations opinion. next their the with so with we are you're for now to doing we're liability to is okay, in in thinking And that we get with with and expect think is further interrogate what field regulators. current the our do ready So any make discussion our logical them experts

So planning. that's what we're currently

Jennifer Good

And of will Because that minimum discussion Phase be into, probably, right? end goes the at defined II a IPF, around David, meeting. a

whether that, think relevant something flag. we in there's I from something only we do if to the really to data it's probably want separate choose

By remember II your would So bundle right. would up the that of discuss you're asked didn't William, which way, for thought the at I come And first. I all we'll we then. I question. Phase IPF, had end and probably expect, it meeting that you answer

I think enrolled. the I more study we're out subjects report first. that HAP XX with only will than needing XX% trial and imagine

Unknown Analyst

Okay. the that. at said, it's then cost. breakdown readout maybe And Should reduction time obviously, the I just to that primary efficacy RIVER better expecting a stratified, guess the top be appreciate just the of last, on when better line expecting with endpoint top you I that as we these trial of the what in should that subpopulations? Or understand occurs? color be some line on at we

David Clark

that Yes. X and analyzing these we overall No, line that you the will be and also are plan -- doing plan correct what announce readout. subpopulations data that's would population be We assumption. top would with we're results those -- would -- the in to

Operator

to not further This the any to like am session. our would turn back closing I question-and-answer remarks. over questions. concludes I showing any Good for Jennifer conference

Jennifer Good

you. Thank

to look exciting We for focusing see call on and after these and important today's you any for get with Thank may data road you. Trevi year. the milestone Haduvio. call for for thank to are trials of regards participating clinical in in like beginning We indications our second expecting forward this a questions clinical to the an to everybody our half would available follow-up We execution have. trials to are year in of ahead data

Operator

now presentation. has The you for Thank concluded. attending today's conference

disconnect. You may now

Trevi Therapeutics (TRVI) 20 Mar 242023 Q4 Earnings call transcript