TRVI - Earnings call 3 2023 | Trevi Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Trevi Therapeutics Q3 2023 Earnings Conference Call. [Operator Instructions] 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-Q, 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 any subsequent date.

While the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so even if its views change.

to CEO. conference like Good, to now and President would turn over the Jennifer I ahead. go Please

Jennifer Good

Good afternoon, you and and thank business earnings third update. call quarter for joining our

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

pulmonary to study. cough human Haduvio continued have idiopathic and in indications, advance chronic of our abuse development cough for We chronic our plans both the including as fibrosis refractory as clinical well potential

Let on IIa I refractory programs. a recently me Phase study will cough provide was that brief each of chronic our initiated. update begin with these

affects is We adult X associated of underlying have be or named as the defined weeks study. an condition this lasting no RCC, to when population despite up the RIVER greater and Refractory persistent or a identified. cost cough XX% for than can treatment cough, conditions chronic

cost and ] brain and stronger chronic patients the [ has RCC in is mechanism XX% more is the socially. the provide mechanisms nerves uncontrolled. currently or on in and reduction. therapies peripherally and hypersensitivity psychologically cough central like and which work caused report Haduvio's moderate patients The physically, peripheral their of potentially EU RCC significant a in the no to the reflex has point cough coughers centrally are a and for in differentiation central Haduvio being by high impact the and We works peripheral-only cough for mechanism of of PXXX U.S., There and peripheral U.K. approved the in response key both action, than in lungs. potential believe

FDA results, being been at look in therapies there a X mechanisms the reviewed inhibitors in Phase late the success. X other the the PXXX of III have other with we and in little stages, Even competitive have by trials. but RCC, studied are mixed When number PXXX landscape

nonstatistically believe significant cost XX drug's the that importantly, compounds However, in both trial We of cough moderate the RCC action moderate mechanism these to IPF work both in of per that of effects shown to Haduvio our and XX hour. and cough based on the patients have from data cough with have may high been frequencies. frequencies

you the patients estimated to When distribution, whereas of moderate XX% RCC have frequency. cough the look at high have XX% patient only cough frequency, are

evaluating crossover X:X randomized will between to coughers those the with randomized, hour, with the the in cough close PXXXs the X/X there's X/X than and a market, of greater a study, coughers. may been cough run XX address less XX RCC The in those the So potential market. XX of with reduction that IIa approximately or subjects. be only RIVER to be The XX is a trial all objects Haduvio cough of high-frequency hour, double-blind, effective equal placebo-controlled, to whereas in crossover may is X-period per design cough It has per stratification Phase trials. frequency than moderate standard

as Haduvio in the monitor. treatment for across baseline the milligrams XX last to frequency cough the will dosing compared objective Subjects period by endpoint primary period period. washout dose The Haduvio the twice-a-day separated efficacy is XX-day days period. change measured from day treatment weekly relative up XXX XX on placebo will Each XX milligrams the XX-hour from at a by titrated an cough have to

patient-reported cough including measures outcome will explore for quality life. secondary endpoints, of and also This study

second half of We top are in initiated to excited report year. study this line data and have expect to next the

IPF approximately or may also but in and XX% lead respiratory end-of-life plays has idiopathic constant is IPF disease. to lung suffering outcomes physical, IPF. Chronic role for our a patients, is update IPF, brief on worse a hospitalizations, as cough by and RCC lead pencil health from of need social serious chronic a that impacts injury, a transplant. to The program similar pulmonary reported Next, fibrosis, of may progression psychological micro such cough. by of the in inflammation mortality risk that increased for coughing caused factor or persistent be tears and patients

and With providers therapies. no an options chronic need IPF, urgent treatment for approved for currently and have new cough patients

in our conduct We this cough in studies program. phase of X to are during IPF planning next parallel chronic development

a IIb is dose-ranging active trial first doses will X-arm of X Phase study placebo. that The and Haduvio

to to trial complete plan conduct in subjects. this a enrollment approximately are sites XXX multiple for to X-week in and timely in We study We countries a planning able be manner.

received schedule on countries. approvals have our proceed regulatory to planned our are of some with and interactions in We

We will trial in top announced expect to the this fourth quarter XXXX provide of be when initiated trial. guidance line the and we

planning severity. will The we for varying determine define patients is in study to patient population this are Phase label. depression study help of see This ultimately subgroups. significant a levels disease the clinically parallel, our if of purpose for and impacts In physiology respiratory program that the have we in any Ib on study respiratory IPF pivotal

initiate We expect the XXXX. study this first to of in quarter

required to able we're Recall that hurdles make X clear. had on human had abuse for we reinitiating potential the progress NDA Finally, study, the we is to which filing.

IV We with first likability FDA's quarter. the to butorphanol The agreement the during the proposed that in FDA was received the plan We from dose the dose. agreement of portion getting study.

single to of which secure supply do. were source to were we we in Second, the IV supplier also able U.S., the from butorphanol working

and objective potential placebo-controlled X as relative to design oral randomized, nalbuphine is of a and primary of vast is and placebo. The endpoint crossover The the doses of scale. final of the placebo portion compared butorphanol drug-liking selected the and dose of double-blind, primary the both study evaluate abuse a the likability to determine to butorphanol, X-way HAP to active nalbuphine is

the second expect half of in in expected this of study We to dosing data first XXXX XXXX. quarter begin the with

over bringing a conducting the you turn we may and we our to As to clinically forward I for studies open to review X it results, it up trials. you is can Lisa of have. all questions it on see, reporting busy will any results these then will company, and up look for time financial now these

Lisa Delfini

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

third well to we to $X.X trial R&D to Phase of $X.X start-up $X.X expenses were PRISM as our in increase XXXX, and to expenses. expenses in costs of our million compared chronic XXXX was trials of the These quarter increases XXXX. a as IIb/III third supplies. Phase net the The net programs decreased same the $X.X million in for the due an in XXXX. cough as with of For million and loss a same were offset quarter loss consultant as in completed reported II of compared well quarter primarily partially million increase development quarter by CANAL related a personnel-related services associated clinical clinical decline purchases during

interest to increase of in $X.X in XXXX which period quarter the of $X.X flat This XXXX. payoff XXXX. these quarter expenses due increase in G&A million net, due increases May of was to was to of income and compared during essentially of million other in an of reduced income third same change to same term an was in million the SVB expense $X.X the XXXX, interest compared the period third $XXX,XXX loan primarily the XXXX. in the expenses Offsetting were in

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

cash conduct over trial expect the ramp burn as Jennifer quarters We the today. several discussed a to bit next we

cash marketable into believe guidance XXXX is all cash remains readout. equivalents have just to after last runway discussed the and the and that trials Our securities enough we unchanged cash will us runway gives Jennifer fund cash, we and good

our and prepared to will I now remarks, turn back the concludes Q&A. over the for call operator This

Operator

[Operator Stifel. Samimy from Annabel from question Instructions] The first comes

Annabel Samimy

for the on landscape the -- enrollment trial, for you just competitive your any from RCC mentioned. you outside And away RCC? take a as development slow just is the in you typical on trials ramp-up trials here -- that might the what that IPF, first then Are start How patients trials. time the goes guess you and these the I that do enrollment? seeing same to of development So competitive just see waiting

Jennifer Good

you, David I'm to Annabel. go this since Thank leading he's let going ahead answer charge. that and

David Clark

Thank you very much, Jennifer. Important question.

the are heard early now, sites first have certainly the It's patients. of targeting on Phase and be involved would the small online quarter. of in whom of studies. a we So studies lot having RCC number in the a be substantial RIVER from of patients who also are competition And other the XX they challenges. not of we -- PIs with all study. of planned study RCC at III And actually, many It's work up in terms a these for to issues running right RCC end -- XX ramp-up targeted ongoing anticipate are fourth other in do quarter for

the have publicly is, a One the there disclosed, X:X factors of as enrollment we strategy. enrichment will be

them hour in per half category. and subjects, to So of least half at the frequency cough XX the XX XX

is think this that help factor that with that us I X for study. So recruitment -- will

CORAL before on question anticipating on to CORAL answer there. move any problems So your I reiterate for mean the on, the... can study, you on we're not moving study? So does RCC that the I

Jennifer Good

question, The Yes. same basically.

David Clark

Yes.

of So up the we're of the is the majority subjects running what far Phase for the we've and study studies to by is II centers the IPF being planning the quarter. heard -- end there cough for first CORAL what have so

that QX. as been near again, will QX we've heard majority discussion be the centers but with in lot So in a of announced, of start active the with we've recruitment what And initiating anticipate we -- the in what from and a been for study. that in -- in reflected heard individual investigators study, would future, scenario has we've we've the cough would What it what be investigators usually an better this study. for usually recruiting for And is disease-modifying IPF investigators that's study. a program than the study

be So -- programs. disease-modifying to back are not we're to enrollment disease-modifying other right those programs. to your not anything, come question, issues than higher to significant compared now, is expectation expecting for If we

Jennifer Good

past with conditions I of the we've I Annabel, been to really difficult having struggled of add, recruit in plenty just thoughtful sites. Yes. would having think

sites sort XX about have patients countries. for of to enroll XX IPF spread We across XXX

done got some able behind strength I enrollment good manner. to get be it hope So to we've that of in a timely sort

Annabel Samimy

And Okay. Great. a if just ask follow-up. I could

that data On magnitude you that we the can the the OLE the saw and the WI-NRS benefit the patient there see comment share continued [ PN any that on from to safety Is program, ] score. if And X cross over whether was remember do you with this us? any any can the components. I to chance is trial? share have there healing placebos of the evidence? in can't And

Jennifer Good

little So that a comment. teaser, was efficacy that

yes, to end blind, -- double the what rolled finish the when So drug. the happened of everybody you on at

the chance you put -- will meeting. which have So did that tend placebos got have consistently data didn't have we a to go efficacy pictures. that to a double-blind at And of But data. healing be We've your this in we do are a got future on because out at this, future we into it sort at able as quality out to and put We've down measures, meeting life to skin data. want you people the going over as might to other some a want when you around to a itch of study come the year stay saw year, meeting for our imagine, follow.

Annabel Samimy

Okay. close of to And with an meeting FDA? now II you end Phase are

Jennifer Good

So as we've you heard, very busy. been

slipped we a in of meeting also say that II will the request underlying quarter, to because briefing that do is to to may want questions end we the drop on to our sure would actually ready We full even first we when we cough the program molecule have document I go related a but So request, which make same. Phase plan bit. the have

there. to get we and requesting anticipate days meeting first from takes in meeting a a it quarter the So roughly

Operator

The Rohan from Oppenheimer. question comes ] next from Mather [

Unknown Analyst

me. questions for X Just

more see also, where chronic Haduvio will cough, fit advance between As trial? remind regimen? you Haduvio or in think you And if cough in refractory any are in how versus did maybe the should us data in cough so, differences CANAL points in moderate in moderate results And these benefit our observed IPF if the we IPF could about treatment there likely the patient cough?

Jennifer Good

Yes.

the So part, I'll you the want take sounds comment It good. first David, to second on part?

with did lot payers We exact of So antifibrotics, last around And a of thing can't of they're mean patients through it's early the not treaters for fact a of GI I treatment they're is challenging and summer patient, regimen, still research shown calls. side only patients. patients, sat A effects. a discontinue I do a the also do question. this interesting. also lot lot the they slower. other but because the they heard lot we life, And progressing they it's the been of that detect decline. extend but

they them patient hard rate they're to then probably antifibrotic. one response win this have things patients these declining really so success start get with aspect because slower keeping treaters they're really -- difficult from might on and was the better, these they less. of the move than of lot thought a feeling would. And patients they lot the with of a for is a a better So fact would it's dramatic so of that we drug, actually trial our disease, the on detect heard a a investigators from prescribing coughing our And of the

So is basically, heard in what cough disease through we there from all way beginning the the end. this the stays present is

a would And in and counts disease. used the think it on that and I'll let be David moderate of treatment early severe. So continued work speak could really seen the was cough we throughout it on the why and both course as

David Clark

Happy do to that.

not So the looked there relationship. affect CANAL IPF in cough at cough efficacy at the analysis post-hoc looking the baseline what we in basically signal, was frequency, and study, subjects, a

disclosed was RCC equally. high cough the frequency look. who that think, get really RIVER the good fell the lack approach. moderate cough to higher frequencies are assess we lower when That to of of effect of signal frequency that baseline that So And so were frequency can, the cough focused the we've supportive had we in the efficacy strategy, enrichment programs CANAL, in study, We of both the on same want population baseline into just subjects. with the to we're subjects why the for X:X as XX enrichment being XX essence, cough that and at one those PXXX looking rationales cost we baseline frequency a efficacy going the even that is for

Jennifer Good

as should as think minimum mediates works much we so level it centrally at variance. cough across And and the not get there's the which you that work because brainstem, really some coughing counts drug breathing long to where

Operator

Thomas of Smith Partners. The Leerink next from question comes

The Sean next question Jones comes of Kim from Trading.

Sean Kim

I first I trial. guess the question RCC that have is on the

you given that are So versus stratifying moderate for severe.

the to will significance hear the severe X group? significance be moderate to also and reduction, think curious Just combined. and whether going meaningful what And plan the statistical for for of also you're you moderate groups, statistical individually statistical beyond especially seeking those clinically potential be

David Clark

question. that for you Thank

we with study. -- with we've that powered effect, assumed So XX% which end okay? the treatment to placebo greater have to expect XX% we're than nalbuphine, that our a be of a in in effect RIVER, XX studying So XX% effect we for anticipated it be

think placebo. the for We Clearly, a CANAL that's much we conservative. population XX in IPF of saw double the is XX% than that We total that know, the separation greater you study, So population. a as appropriately saw in from subjects.

So we conservative. think we've been

subgroups. means in have placebo, is that effect larger actually than XX% power size, which would both we an versus What we get XX% is if

be each. address than effect the versus question? in that our more we increase XX of placebo we of if size, powered your So conservative and approximately Does would XX% groups both subjects

Jennifer Good

as clinical what And also clinical David, meaningfulness, about meaningfulness. was he asked defined

David Clark

one the size experts was reasons set significant XX% you're clinically by a to effect is that the about if majority Yes. of that And by subjects relevant to -- that this XX is reductions to believed looking that these -- patients to of of frequency. the you field. is with we've detect the in ability or cost be in power clinically XX% the believed range know, experts because be to a And is sort at the sits as that really XX%

Operator

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

Serge Belanger

between the I think differences be the chronic action to cough cough pathology whether of X. maybe cough and guess and Haduvio's about talk program. have I you mechanism IPF Can you first, PN on of effective partnering And any curious the for discussions the then in program. that on how more describe if one another? and program, interest had you refractory would or about disease you've just level

Jennifer Good

don't why David, take the one? one. you take I'll the first second

David Clark

Yes. No, a really it's important question.

degree So you terms initiation the is underlying as a from driver leads Jennifer of our these mean as sensitivity there's though us so about is that cough presentation key X both factor, different in the similarity of But talked to and differentiation I cough, refractory key during you've chronic IPF conditions, a same of is the what driving in before, of is sort pathophysiological her it in here. these even both key know, conditions. hypersensitivity. heard

we've good. is So got peripheral activity, which

central so essence, and key that, independent and these of mechanism the have and going of us. cough severable activity the control And to also in that brain center effects it. essence, the We indications. what level reflex differentiation be central the its that other triggering modeler, we That suppressing both ability of higher is, indications to cough believe which in drive so basal activity activity, in differentiates is is

Jennifer Good

with Thank parties partnering you, for interested. question. we PN the to continue in Serge, Yes, be touch

Our Farrell those continuing Europe off colleague [ was at ] discussions. week, Bio this

the we're who's So interest lies interested. on where here, clear

left, make whether the the that forward drug the As we've FDA about at or about said, path and at would we and get not time always that meeting and license we'll what's decisions we be like clear through to time. then

you. good So yes, Thank interest.

Operator

B. from Securities. Mamtani Mayank The next question Riley comes from

Mayank Mamtani

of of inhibitors -- or might sort closer coming looking second the appreciate end just one the year FDA process. if be what filing, the PXXX to up at remind that where we for the us was the on outcome you I are could mentioned? the then of And the you curious the that IND question you on comments helpful with

Jennifer Good

Yes.

outcome is watch great And to the a the going whole David, any should add I'm So question. color. you day.

telling FDA think on what -- the gefapixant. they I will be it really how focus or with

know, it some have go a change, and sort you they of statistical required were they -- small but back do was work. significance to placebo-adjusted As did

But are the people I know, anything certainly ready learn how a is, position watching if I be my putting resources Merck we'll of is likely launch for? expectations gets sort view So getting looking approved. have you're it. think the of what lot behind just it it. to you drug David, to else regulatory-wise don't

David Clark

Similar what lot get own this a said, certainly they you've personal share field. the comment of shortly, medical just to approved No. of I this need in field. from view. to I mean, I in experts because listening hope would my I your

Jennifer Good

IND, take want we open. you that an one? to IND getting are Where with

David Clark

study. So the for IND physiology the is progressing respiratory

to having future. expect timing would make we the for on on announcement track future. we But near an that So in and that submitted the near are that in for

Mayank Mamtani

maybe question. runway Got quick it. just one And

If from inflow have cash clarify you spend prudential a you or may any CN that any incremental assumes could if on partnership discussion?

Lisa Delfini

No. cash The cash. includes our existing runway

cash additional no So inflow. assumed and influx

Operator

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

Jennifer Good

for today's call. We participating thank would like to in everybody

you. We some there. next Stifel of will attending hope week, be the Thank we you to and conference see

Operator

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

You now may disconnect.

Trevi Therapeutics (TRVI) 9 Nov 232023 Q3 Earnings call transcript