TRVI - Earnings call transcript Q2 2022 | Trevi Therapeutics, Inc.

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Operator

Good afternoon, and welcome to the Trevi Therapeutics Second 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 the 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

earnings Good thank quarter joining update. business our for And and afternoon. second you call

or I Haduvio, affect remarks, important exciting at was Trevi's Joining for and the the and out Officer; and end. was Financial have the out nodularis in in the unique trial, believe We Cough conditions This has of or this of me works and PN, believe fibrosis, After Trevi's the Chief significant. exception. diseases. Officer. quarter, and us which these available Delfini, been Development is Chief we will positive quarter read today validation important some in prepared of an opportunity aspects of on IPF, second for most Lisa second this disease have pulmonary first pruritus Lisa these And represent and there prurigo potential statistically cost a targeted. and of of three is the also questions we data year which both the idiopathic underlying an the we and to our PN the was severe conditions. reporting Bill interim then mechanism call peripherally centrally both Forbes, Trevi no in some are be Dr. quarter

X.XXX with least five-point XX% week Activity one-category XX. excoriations subjects of at improvement in on of with to versus at able were XX% For a example, we healing the Scale placebo p-value showing the the Haduvio trial a of on the Prurigo PN show

significant only Haduvio chronic is in forward Beginning me IPF, development indication. you therapy in development positive be in cough the excited and most to In patients as moving patients their reduction plan impact of update IPF to for a the provide with their a bothersome of with on very Let report see programs. represents elements is have this for majority next now study. cough these to one outcomes. are aspects as to cough cough shown unmet the and blinded an both study, lead we we an one if of and results disease. Cough underlying of other the assess the has on health also disease IPF need

first data significant the highly and early enrollment in the was reported full the X, I the the quarter our sites subjects had XX of trial. At set; interim study. interim completed finish treatment and this in the worked trial. in we analysis, As who established, on mentioned, we analysis had subjects close the analysis results to least proof-of-concept both statistically we the period with at crossover full of completed reported periods who XX treatment Since

with For XX trial, ended enrolled. up the we subjects complete

unblinded the data the trial set as announce on full We expect results set are this the in on subjects subjects as results safety for the full all well quarter. and waiting to of

the be for full cough this our and oral Society both in for interim at interim in We will European set where beginning medical data data September, also presentation. presenting data fall, selected the meetings meeting with from Barcelona Respiratory was

cough. preparing study been the for We in next and planning have actively also

FDA discuss with identifying engaged we the intend and our CRO at and protocol We working scheduled sites have partner, this a quarter. meeting to a countries on are that are

you We trial timing on provide and will is keep and informed the you results. when study finalized design to the for guidance

these and severe the of is by on papules the skin and serious as believe a We the due disease debilitating indication target Our other and itching. the incessant nodularis, PN is of nodules prurigo treatment refractory characterized and neuronal to of for be as to mechanism mediated well which neurologically of nature well treatments. eligible like Haduvio. before Most oral already the potentially patients believe is therapy Haduvio for tried with have And an biologics. and turning patients will we disease future aligns failed topical

data, As previously reported on statistical all of we endpoint, have The end positive which in scale. we the out yet data PROMIS the quarter at secondary key we mentioned, the reported primary PRISM not time PN. trial At the trial top was and endpoints. achieved the Phase Xb/X the secondary key out sleep final significance second in did line the the

results scale at PROMIS week also pleased sleep positive that subjects scale p-value PROMIS XX. are versus to placebo experiencing improvements in a X.XXXX overall supported Haduvio the the We with of report the with greater significantly

at The showed the X first also of of was PROMIS trial, made assessment significant improvement. statistically a week which

And is Trevi. with for management cycle patient blinded plan positioned In at year So that we demonstrated been one-year extension September, for will well next Phase and at Haduvio I preparing of the of opportunities. has data Academy attend and request and that the response. end to in all last an data us include the were growth and are Venereology potential positive year important secondary in meeting for open-label FDA. scheduled The the presentation pleased the has been X of Dermatology potential a accepted which the primary European key you complete completing the parallel, has life The for any there. program of in the with along indications endpoints This will PN January data busy we these continue an study. oral one early to be XXXX. other steps trial It if a analyzing two

will the an FDA will we then in review reminder, it and data results to the meeting open will outline for a on for and and later quarter, to questions. strategy full plans. up this As cough now quarter development IPF financial ask the cough going Day IPF, and CANAL forward I have we our and Lisa R&D

Lisa Delfini

Thank you, Jennifer. And good afternoon, everyone.

during ended was filed quarter of the reduced of months can flat with found trials for costs, six in full XXXX, ahead today our and XXXX, be the which reminder, were XX-Q, SEC of and financial June to release call recruiting a As in second this our to in after our the XXXX. of same a of supplies press of XX, the compared net loss million same issued consulting the to same R&D subject primarily a the nonrecurrence three trial due and in The quarter which the second related fees hiring period results a of period. XXXX. $X.X were of we million to to decrease for of during prior XXXX, closed. quarter the the to $X.X In clinical of net $X.X services $X.X reported quarter recruitment the XXXX expenses the loss million million second compared was compared was clinical million $X.X and reduction professional year XXXX. of purchases use in G&A the of expenses period market

As marketable market income. interest are early the With April I $XX cash provide coverage. warrants. investing sale in the quality and on raised high to securities with through hand last rates discussed more in priced prefunded stock of we quarter's no The interest our now rising, portfolio of and credit call, common on million we at the warrant cash was approximately offering

in to We exercise the quarter our were also proceeds private $X.X issued placement. XXXX of of in originally warrants October received million the related that second

the the balance July. our marketable was another private June and in in received from XXXX placement were proceeds equivalents cash million. securities $X.X in cash, of of warrants We Our at October that end million $XX.X also exercise issued

cash Phase with conducting for into FDA cash, million. with next July IPF. planning the equivalents securities of cash end the Jennifer including like of of meeting fund for our the to, we trial, of ongoing end runway operations, QX to XXXX balance approximately for X and trial PRISM our $XX.X completing cough extension So and and preparing chronic us gives marketable open-label and This in referred the

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

more you. our it a table so $XX I With has in wanted cap raise million April, lay gotten for the out to little complicated

million outstanding. paid time substantially called issued. warrants are we In April XX.X today, we They the of have XX.X prefunded the they also prices placement, of As are the issued all shares million warrants. at prefunded strike private because

of as and from I Also, So legally required be in calculation we to our share. outstanding included stock before, they're our shares average placement and per options approximately while weighted outstanding, warrants they're mentioned XXXX XX not outstanding private million outstanding. X.X loss diluted in have and basic million October

shares diluted is over million. fully outstanding XX So little a our

concludes our sheet data executing Q&A. to turn We over continue recently under $XX now remarks. the strength will the the and of on I In the balance to excited call loan our term principal in we're balance down continue PN and This the for about plan. million. our operator is to reported closing, now our prepared pay back

Operator

Thank you.

[Operator We Instructions] first from ahead. question will Samimy Annabel go now from Stifel. Our session. Please being the question-and-answer comes

Annabel Samimy

Thanks my questions. for taking

So it's you realize ideas, too just little I I curious had a if any was early. bit

And I trial. second filed about you're starting landscape shape forgotten of of or realize idiopathic You might in And final guess chronic a in, no in space. suddenly landscape and PROMIS for has targeted Galderma sorry, cough. might to then Dupixent Could like, done Phase But in chronic that it and to for the to your just then then competitive development additional the it could X out. be? the and for there's the now a read might look of to it's scale this hinder antibodies or data do a might report how ahead. cough in regard as the PDUFA what's for any so sense opportunity PN? others come refractory But So their a oral I've you're PROMIS heat how have name I remind us to awareness I you a have to can is of get but Phase what still large that the have have raise just have sense what you just program Or to with out it – has what's endpoint? suspicion based – you say, idea have PN, thinking scale, as Obviously, finally up get been they're X how meaningfulness your Thanks. that awaiting it on the And PN? And of want out? that couple in PN.

Jennifer Good

the trial design Thank competitive and can scale I you want you, on landscape? do two PROMIS the the then talk about to Annabel. Bill, take and first

Bill Forbes

key let [indiscernible], Yes. little description is in secondary And obviously, Sure. little the IPF. the in kind of with study our bit, noted. out you just PROMIS with Activity with you scale. although were a next Prurigo PRISM. just a we back for going I'm But three bit And started endpoints the of a Hi, and start to of question. Scale Annabel. up Jennifer to me [indiscernible] had Thanks ItchyQoL as as know, the which give read previously kind

so we've That disturbance. that And the now which we here use. PROMIS, is the form short the got sleep was

a was So questionnaire this questions for in clinical really controlled And developed sleep there's trials. eight in it. as tool assessing general

so statements very it eight at much. with as not range options. really to five to all utilize poor from open-ended said, And very we here. options Essentially, I good or the very And

so sleep around quality. And questions really and are the sleep

a And that you PROMIS I bit so side. little hopefully, the on helps think

statistically was of fixed at I'm months Of – six and one, three course, it dose. two sorry, significant at

right, have, coming expecting strength we're you're very those obviously data still. difference. the we to some data given CANAL, got that much the So were see to not we we've happy out of read But out.

new out reported we the at Although will data look as a can XX-hour take read able we've expect data. out new a the of some the be XX% in data we'll data that have earlier. in increase to amount you And as that that well We'll about readout.

what into would a of meeting FDA conveyed up six-month treatment anticipation is in we've the to coming Going like we study that to [indiscernible] three do groups. forward a with

study that now endpoint at using over and the primary one be But cost look, the early We'll at for very as well we're question of six in And Well, the as getting using why primary four – months. obviously, a of think monthly weeks doesn't I six-month is at put we because get we'll is do as the endpoint long often two, the very after onset. take probably subsequent digital month. then we'll months, it course, additional data information durability. we'll effect nalbuphine onset monitor since the have So that right looking take that far rapid.

nalbuphine believe imagine we lines information goal collect along of six the may is you the So can how the understanding that on affect these to will And important of the months benefit safety XXX hospitalization out months that but in allowed are FVC to causes That exposure go about twoactive like will things years. for us interested we're doses. respiratory It give patient things in. also six us patients.

be the efficacy to able really enough this firm of course, of understanding in have safety we'll So data a and, accumulate the in to population safety it.

Annabel. hopefully, So you, that helps

Annabel Samimy

was Yes. very That Thank helpful. you.

Bill Forbes

Do to the… want handle you

Jennifer Good

Yes. No, to do that, landscape. happy competitive the

enough Annabel, we sort UP road the and fork actually around the at to think, would state. be So I we market. would pricing because they to the to what been PN. develop know in of you've level, us space following the And be long to we felt in chose of the Also, biologics the a a or reflect set help able disease largely came good

be they there. known always we've so And would

sort treatment biologics. follow, there's you I think to dermatologists, is also which to oral topical a of to they ever if paradigm talk

follow So is whole think, piece big systemic in equation. I a to there but, that not unmet everybody that is of always need that oral going this

I obviously knew one and positive. So nemolizumab, it's you the dupi overall, they were think forgetting. there, is We were which both

So hard the And No, to it's in not think we can we market. know overall one a no, – remember. actually helps compete. think it it's I I

sort If a in reported sort lot sort lane this you dupi delta. think hallmark of we where which gets of weak trial, the of And look disease. the then out on swim sort data They that's a at of bigger. same months, out, of read three which we're I six-month is the the

break over cycle. And And to effect. nodules really scratch there's that overall in an it's you're already really itch three time, seeing which trying months. – heal, You're exponential

up be to more of of as Bill share hopefully, So extension to term. able sort we'll longer is able open impact the of open-label the data, that

Annabel Samimy

you. thank Perfect,

Lisa Delfini

you. thank Yes,

Operator

go comes Our ahead. Please from next from & Belanger Serge Company. question Needham

Serge Belanger

Hi, good afternoon.

that's just cough current think, a indication. IPF and I indication, meeting agency the cost for another guess then about with on discussing of something couple have what I on curious PN, that meeting. us. upcoming questions plan is the Just if first beyond the your thinking for FDA at you on indications exploring And you

the curious specific will meeting. goal be that Thanks agency Just what for

Jennifer Good

Yes.

of each those points. So

program not looking we get something with lock and as far going there. discuss our down at in beyond stay are that As We're indications we'll on cough, meeting. and the agreement other really That's IPF. to agency focused

will development are And of some – summer. We in cetera. my discussions Day an are trial R&D the having internally we sort around time have lines, over probably clearly I mentioned guidance, it's et out of latter why in we comments, the indications, the can we strategy and the and half September, where lay

IPF any So up that other opportunities. Serge, we're cycle of clear life going if be to we'll beyond sort to pick where management look

still of we ahead As end for actually right, our meeting PN, you're us. Phase of have X

pivotal the we our data, to last trial of So about that. approval. is take we'll it talk able in to them, get with We'll what advantage major take go That's hope a meeting. over be

in the the that's do program. the I in around a agency of lot other gelled think a since But So checked with that competitors it's been we've with while space.

Serge Belanger

PN point, you for And expect one would correct? still at X do only needed, the additional Phase trial this be program,

Jennifer Good

Yes. I Bill, do that? to you mean want answer

Bill Forbes

here. Yes. guiding No, the do most to to We expectation. like think more everybody one be appropriate the thing opportunistic. But to that's trial is always I

There's has data the – a I sense. in had makes look that everybody certainly at But this think lot I think study indication, data. there. a quality another for to doing It's chance for strong. of

Serge Belanger

Okay, thank you.

Jennifer Good

Serge. Thank you,

Operator

question next from Please Our Oppenheimer. from Leland Gershell Instructions] comes ahead. [Operator go

Leland Gershell

Thanks afternoon. my questions. taking Hi, good for

timing be any for ask into patient September But in studies as latter and early, Day. know timing indications in of of we'll expectations. a R&D I to of it's get terms both Just kind the the try bit on Thanks. XXXX? of sense wanted to start we next

Jennifer Good

Yes.

first all year. in FDA that accumulating we're parallel. So to all half on our in of the and on been start getting IPF-cough, sort Leland, meeting of request try that PN, and the looking which data sort doing next still we're hustling we're to more to have done, of we've and things

have half we to guidance. So enough towards we on don't moving start are in good give the of year next trying that yet probably IPF-cough, first earlier. or But one to that visibility

Leland Gershell

then And one more question. Great. Okay.

sort of you evolution as two the really you these see that alongside kind prioritization with as approval? to respect do with have marching your – two Just about indications steps other Or strategically of we you you each in the as head forward for over for Thanks. one into think other? problem of the anything of Haduvio, share can high-class available you terms thought

Jennifer Good

question, good I of. kind But We've is be protocols in place. to I out. a doing little cadence that have know a in for always space of partners our a mindful say We've on. something this Yes, got go will it's bit PN, instance trials mean There to of CRO well. a we you be will mapped has been here,

along. should move that So

IPF-cough of because Our over of got Clin it the bit a kind jump data. team Ops that. on is all a interim of

sort we'll out too. it, way. I'll find I But on think largely, and things and would let of So schedule you comment naturally our Bill,

should I along they think able parallel. move largely in to roughly be

Bill Forbes

Yes.

going that's in trick, trying parallel. keep to to be things I think going the it’s

Leland Gershell

very the for questions. taking Great. much Thanks

Lisa Delfini

Leland. thank you, Yes,

Operator

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

Nathan Weinstein

and have sleep? trouble first this do in sleep they PN That's feedback indication? heard from help manage Bill and taking a was with you PROMIS us can questions. about think I had And on thank to sleep. two of you've just How the question. regards Hi Jennifer, Lisa the with patients follow-up One for doctors? my perspective from Do the the questions. you patients

Jennifer Good

take take you Hey it? me you do to Bill, or that want want to

Bill Forbes

imagine one. that is some has on on sleep of the to with itch investigators had of the able it, with can a as extremely handle. high this you that I've something No, they to severe Yes. And want things be list conversations with some disturbance

poor are, then, imagine these be long having of able how to ridden day to You patients sleep. anxiety can and course, to itch all not

sleep of about So we're it. excited component the

the scales the with this to think We're it and investigators I of clinically to believe, PROMIS. we're the happy that able a it. it's some in but way improvement, meaningful around kind still to that been point shopping be move we the at to leaders we've shows with able thought of the do

Nathan Weinstein

just on then And sense. that's for next makes the It engaged trial. you. thank one CRO cough and follow-up partner Great, the

don't Is working the then you've it Just And CRO me overlap a you trial you've if the mind. for be will where same on significant reminder with enrolled historically? been with? there sets,

Jennifer Good

Yes.

So so I partner a CDA is it CRO but last we partnering, we're the of disclose worked within round can't under it trial.

So they terrific. been have

start. to good, of So have And we'll the we recall, But as be as in of an sites ran go only countries. definitely of our with sites overlapped the PN, we will ran In that's kind in back cough, one UK. sort the before. UK easy we'll for – that

broaden So the we're we're and looking as U.S., out going country have at . to other opportunities into well. now to

Nathan Weinstein

half on first And very the year. the Got congrats Thanks. looking back to a it. to strong And forward half. we're

Jennifer Good

Thank you, Nathan.

Operator

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

Jennifer Good

you for I everybody your of today's thank summer. to Thank the rest hope you. like all would enjoy participating We call. in

Operator

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

disconnect. now may You

Trevi Therapeutics (TRVI) 14 Aug 222022 Q2 Earnings call transcript