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Trevi Therapeutics (TRVI)

Participants
Jennifer Good President and Chief Executive Officer
Lisa Delfini Chief Financial Officer
Bill Forbes Chief Development Officer
Serge Belanger Needham & Company
Annabel Samimy Stifel
Nathan Weinstein Aegis Capital
Call transcript
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Operator

Good afternoon, and welcome to the Trevi Therapeutics First Quarter 2022 Earnings Conference Call. [Operator Instructions] Please note, this event is being 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. 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.

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

call Good welcome earnings first update. quarter our and business afternoon, XXXX to and

remarks been Chief we end. me then data questions have clinical front and to are the Dr. development Officer; today Chief Trevi’s making Financial already on I us of on of will Joining for three at more and Forbes, this on the On this update is Development we on programs. Trevi’s call, advancing there exciting will Delfini, some an both come. for provide Lisa call prepared of XXXX are Lisa available year progress Trevi, Officer. Bill our be continued the has an and the the

However, at quickly before I do the Trevi. pipeline to on touch that, I want strategy

are opportunity disease believe be where may debilitating that over there on we an aspects of targeting We become also disease-modifying time. the to most focused

patient the For scratch if you heal. then the break is will time and cycle nodules pruritus have PN, and instance, able suppressing to to for urge believed it are the or to scratch, that for by the itch the reducing itch therefore skin and

seen that work We date. in supporting evidence clinical have our to

which decrease of mechanical may lungs, patients benefits upwards cough, and may X,XXX IPF, puts is significantly For IPF cough coughing patients. broader in on trauma there the per in to to times reducing cough result by that potential the day,

in improve critical of are most management parts impactful coming of exciting out providing in on strategy itself. our built mind, in relief may months. of data disease how and it So in very exploring to reading indications underlying was is the this our be Trevi we with disease both programs, the the both

an update on with provide now me both you Let programs.

we be Haduvio we end oral have of patients these to At will reached is and we program of the for and prurigo trial Our Phase visit received biologics. on milestones study. disease keeps severe as believe Haduvio of word on failed portion has by is incessant which future itching. this pruritus treatments, characterized enrolled year. due advanced our several us patients their a skin severe end eligible June. just therapy This and studied last an in serious is drug. to our neurologically clinical XX-week in development nodules in chronic agonist-antagonist being the which debilitating in double-blind PN, PRISM the of patient, last January, and trial. important of of the is completed as in the already well We in most topical our data that refractory trial, final believe tried mixed PN, or a to nodularis like the mediated is within has aligns and track report patient potentially Xb/X and the our mechanism neural nature PN Most before the disease, turning well and by This papules

Our look We the lock. seeing preparing results. clinical data team to for cleaning is forward and database

cough Turning which in clinical to in or program, is IPF. now other chronic pulmonary our idiopathic fibrosis,

cough final therapy that was consistent of with analysis XX% on objective per monitor, for day. an The efficacy in the of were the reduction all with the a the a patient to XX or from baseline only to phase subjects These this measured expect frequency trials this corroborate difference the in well with analysis, reduction or interim patient enrollment be who next the During XX% coughs subjects what up one in Haduvio may one and data. impressive was to found were objective X.XXXX power accelerate deemed P a early, from population. in tolerated cough was Haduvio as interim end placebo were allowing IPF cough study across we X,XXX p-value results evaluated PROs Imagine money the report in Haduvio impactful positive daytime happy of XXX%. development. treatment results the and approximately consistent In in and were save very seen positive XX a frequency other the to have adverse reduction demonstrating PRO indications. have to regardless day at cough result we performed the quarter, XX included be subjects was against from time events cough SAE be a Haduvio not Haduvio in question and pre-specified results assessing showed only at us to and is XX% first separation baseline on this subjects better cough frequency placebo. day analysis, we in starting than less of this cough placebo-treated a interim by interim times than in monitor. in XX one total lead development is outcomes how in to on analysis, reported shown demonstrates antifibrotic cough related, Patient points. conditional in The and use. subjects into

FDA has we To and of to results and the well-controlled quarter an date, requested set of in p-value as team data adequate next the the on strength IPF design similar intend trial, the full as subjects year. protocol reported, set data With the written well this a in to meeting we as a with busy been would which Bill his expect third of the anticipate see final synopsis, preparing study. the design. team the announcing and the have to for discuss cough

our billion. hypothesis have to are global we in And path still all be to chronic We on and months to much This is cough we full determining of of quarter. a We validation with third indication, in us, that interim only a the market third Haduvio forward in data indications. have at also the but cough. quarter into as CANAL It forward, data-rich in data the look this approximately year ahead other the do of start transition chronic been mechanism is has expect during our phase and of to development. then few The of the exciting busy a team, meeting estimated the Trevi, June initial subjects not and PRISM to cough this $XX getting of is data next FDA treating year. but

based we what we grow Haduvio’s of Trevi hand. Lisa? ask We data know financial I at for review it the now strong mechanism to and open results, up are to on will then questions. Lisa well and our cough positioned will

Lisa Delfini

Thank you, and Jennifer, afternoon, good everyone.

as participate. release a XX, to and As with our raised our after I’d April investors March these chose end XXXX, after well-known of The the and at common with advance have was priced to the warrant both found and new of reminder, The biotech investors press market on our no to the thrilled corner prefunded long-time offering new months full the stock $XX begin closed. market update ended be in an the financial filed for ahead the sale events were and million our XX, funds with the this today the who can investor in On call like was any in coverage. results we and we’re of SEC issued to and warrants through them we are Frazier, of investors, quarter. Fairmount, three which Venrock, programs. development XX-Q, also

We of our hand. These completing cash over into operations, also for in next $X.X $XX cash cough open-label will including our cash I’m million trial funds received and private PRISM March, in QX IPF. million ongoing to of million of were us for exercise for April Together of XXXX This of with placement. that trial that planning issued on chronic at in the our balance $XX happy runway now report and of extension related its to we XXXX. proceeds be current and and gives the our have warrants our conducting used investments originally end October

$XX outstanding, to In warrants provide can addition, exercised. we still have approximately up XX which if million, million

quarter to results. first on Now

wrapping first the expenses were to R&D net net $X.X recruitment $X.X up of primarily loss compared first during of trial trial to compared XXXX, XXXX, of this enrollment million million $X.X quarter of quarter to period quarter of loss XXXX, million the a of year. clinical a XXXX. the same in due PN $X.X we cost reported million our For for due decreased same subject to the

as prior the the nonrecurrence $X.X expenses XXXX, period. and hiring of consulting reduction to legal a quarter well recruiting services XXXX fees million fees to in closing, of In prepared company, sheet of for concludes now of strength This recently over the reported our property the cough, about of are and a filings. turn Q&A. in the to our related during as consulting the professional to I period remarks. $X.X certain fees in expenses data the the we timing to due of G&A the use plan. will our to our the primarily intellectual result lower same the declined on due compared professional of strategy and back Our excited balance were continue call in first million IPF operator of executing year

Operator

Serge Belanger & Company. with first go The from [Operator Instructions] Please ahead. question Needham comes

Serge Belanger

the my results? portion taking update for I’ll And readout the off also we the should open-label couple we PN as questions. maybe trial. will more a where of end Or that stands? get trial of the us with thanks on as line? expect When top give safety secondary extension then full June, just specifically and start afternoon, good on Thanks. well the PRISM endpoints a program secondly, the Hi a and we see an just at

Jennifer Good

want to go Yes, take do Bill, you ahead. it?

Bill Forbes

your I’ll Thanks, Yes. Serge, in for jump here. questions.

the as I with as far to what provide information as expect we’ll the think, we that guiding far So as you, line, have. top

to top overview it And expect so I line as secondary well. well with endpoints some safety be as as some

June that of The able out open-label to provide that’s my when continues. hope that So we’ll information. be that come we all is in with

some finishing up that patients have in still that. are We

we’re So information collecting well. one still as that on

take the will through next probably or us that months So six so.

Serge Belanger

given be? And know trial And Okay. PN. be be X the a conducted the us than ballpark trial could an Can in a to X you’ll have Phase second those. Thanks. improved. this how second the to would assuming of that trial lines? maybe should just give you conduct maybe one, what it’s cost in environment maybe the we Phase previous COVID I the in positive, difficult – time then to of be lines is just But time better provide is idea

Bill Forbes

Sure.

Lisa, response probably for indication. need we’ve to pass budget guiding a been but on in the second So study probable the yes, towards I’ll this

rollout PRISM. entire XX depend large next the that that do can that we years. a Obviously, on feel we lot over of that But it the we centers is is. participated over of in study have will hope my so And couple confident how that

We as well. we more – add as excuse more will don’t second many And the patients study patients hopefully, of in have have to course, or me. centers,

of So the depending don’t about phase know on for the to I Lisa, a in study. years to handle two the that completed. if in-clinic lot will hypotheticals, cost hopefully, of be take it want you

Lisa Delfini

Yes.

On and side, we all I to RFP the that. the cost of do have study still mean, formal

have So it $XX the that million exact in are to we million we estimating be $XX but an don’t range. number, will

Serge Belanger

you. thank Okay,

Operator

comes go ahead. The Please Stifel. Annabel next from Samimy with question

Annabel Samimy

taking my thanks question. Hi, for

each think trial how in you So I like just two thinking position cough you guess What Do different IPF. prioritize them size to asking programs. could about feel would you have that you because chronic And might the the like I’m based and a do the of in another of large? programs on value that of need simultaneously? large potentially look late-stage you’re

chronic So large running think have simultaneously? how trial like? look any how you And sense next will programs two cough do do of you about that

Bill Forbes

Sure.

study, we I’ll be maybe, vocal months, But that We might months enrollment to of then But will that if Right you about months start, step we’ve to treatment be to we’ll XX enrollment, couple would patients possible. everything pretty So on XXX on do about want period in go and now, XXX that anticipate estimate can for going patients what next and and XX these. it group. the XX to to we we months, we’re to follow-up. per this. been Jennifer, in have if we’re a keep to the try at, six XX it looking

years But be on it So the efficacy be obviously, cough would would a that couple again. count. just of

very one Phase show look counts. So a about and of vocal patients very patients statistical X we experience the But I’ve that don’t I’ll difference. Annabel. based more need lot know color to to efficacy, cough things add that upon drive to required a our few of here been this, But a we is little are we’ll at that

following patients interested We’re these in for months. six

these can we disease whether the unburden we impact from them patients itself. hospitalizations respiratory amount start and or anticipate that kind that that have So they an cough think they from into We exacerbations. respiratory and will not an well this of see the on I and have, a very that to play in cough, of distress improvement we will perspective, respiratory have do when that their that

have discussion for QX. And FDA. have part, now. right we’ll a as I mentioned most So follow we’ll them get for the the And We six her to months. them in think, them with we’ll follow Jennifer talk, predict in we to

if anything. missed Jennifer, know, I don’t I So

Jennifer Good

resourcing, No. asking. Annabel, I add the on you’re would just

of I We’ve got these of what spaces. couple adds sort in running development strong may under off a trials. comfortable, new with, of completely and are think our indications There and comfortable plays a or into I it got of clin-ops other we wearing place. some we’ve team both hires. be a Bill, feel and good as I’m capable of decisions less probably into But

you has drug, we utility. As broad know, this think,

we I ability I home pruritus sort and in feel long two cough, comfortable as our stay about think trials to as of parallel. run in

Annabel Samimy

if actually. just up And follow on Okay. topics both could the I

So disease about when you’re potential assessing talking for modification.

measure PN, it’s think healing. I easy sort to of So pretty

think are modification chronic you FVC? modification, things about like how for to to going you So you disease exactly? going are cough, measuring when chronic be measure for Or disease cough

Bill Forbes

to of this. have out I trying a think stick Well, Yes. the done antifibrotics good pretty some of job

see think I hospitalizations a that hospitalization, around in to look I hone bit as is a take closer to to there’s things other take like think to specifically I that. result But little think anything few respiratory of probably at. be although in able a like things changes months short a we’ll like at a respiratory try we’ll FVC, look illness. And we’d six

And to about it. look count improvement these have will we take this, And on of of want on discussion at IPF, those, try the things. want talking far to same patients get the as that a to study my so I an done some I skis as But so have some these types we’re longer, a over things antifibrotics if with those of exacerbation and look of and we’ll think have just of to FDA some be follow the open-label too. measure in things, we’ll that able to you

months and will rate The placebo allow flow study six population. patients longer. of will an these event follow the run can us that, open-label So into our give inside we that we them to even on

that these or see function So over if into translates I patients over time. half we’ll in of not their about think respiratory daytime we’ll by whether see cough, time to reducing XX% reduction up cough, in better

Annabel Samimy

side monetize the the it. mean, other question Are there I Okay. warrants, lift it. have just to what ex-U.S. on really any of that right additional last And give are programs of had some these now? you maximize yourself sourcing you one with there, you mentioned do opportunity can ways potential but you to to Got

Jennifer Good

Yes.

readouts. for been year, of we’ve the last sort data that busy preparing So these at over

the going not Asian in are market any We to countries. to Europe obviously this or try of

lots So we’ve data. They’re been waiting the in of on active discussions with partners.

and got these your to on And bring feel territories. a decisions in the there. some I I way point, think lot development some through expertise approvals, of of I there monetize it. been strategy jurisdictions I experience those to comfortable getting in and the also, sort think some of Bill has we’ve helpful. Europe. about to and But make in is U.S. We’ve think, do all bringing knowledge pricing a the is but got their around stuff

readouts all here. So get try the we through data to to will do that we once look

Annabel Samimy

Okay, great. Thank you.

Jennifer Good

you, Thank Annabel.

Operator

from The question go Please ahead. comes Aegis with Nathan Capital. next Weinstein

Nathan Weinstein

two share maybe thank And the afternoon palliative Haduvio. mean were my taking Jennifer, was for thoughts questions. market the could what a characteristics could and of that drug’s you it if for good regarding Bill about disease-modifying Lisa, versus questions. I viewed option? profile Hi high-level you just some as One potential had

Jennifer Good

start I some if think on But I’ll year. hit Annabel about with end you of up at that. Yes. priced FVCs obviously, I mean longer. that’s are antifibrotics a disease-modifying, the the annually $XXX,XXX

still severe If cough, treating it’s quite aspect disease of disease you of meaningful, modification which up sort is end not in of to I the going category. just be think that the

are some about of thought around the Biologics priced always we’ve type pricing XX,XXX. pruritus at with somewhere discount. biologics roughly So

of sort level to that between of disease-modifying of pricing would I a So somewhere range sort give probably up aspects.

will on data. I depend think just the it

range out just lot So what come sort to there but Bill to in is going down trial. is able it difference, huge and to a of read of this

Nathan Weinstein

then indications. Understood. And regarding the it. Got one just adjacent follow-up

You speak there paths the have some strategically, been about vocal embedded markets you to Maybe of lead guys that you into are outside of might just how And you are indications. it? potential could large pretty what that then the to take think tap optionality.

Jennifer Good

Yes.

So on both read we’re the trials we these for we’ll data of PN. out wait sure and that. both does, Clearly, their supports get way, make cough going programs of assuming these to

indications we’ve So going our already be forward to first priority is committed moving the to.

sort internally we think that, what are I we doing lot to strategy, markets, other resourcing, preparing the Beyond pricing for can a about of of work question handle.

along I company. make think, potentially really the one help sense, maybe fight could the we’ll indications grow to So out two other or some off way that

around hand give in and some that. be So get and path are the expect, on I able work, doing that guidance would we we’ll to data course to forward, we the all are able once

Nathan Weinstein

taking for thanks Okay, that sounds and great questions. the again

Jennifer Good

Nathan. you, Thank

Operator

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

Jennifer Good

call. would team, clinical thank to to you. Thank the subjects the our Trevi everybody thank trials. We like study also participating in who today’s participated like for all have and our in I’d investigators

Operator

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

disconnect. now may You