Earnings call transcript Q2 2023

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Operator

Good afternoon and welcome to the Trevi Therapeutics’ Second Quarter 2023 Earnings Conference Call. [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 annual report on Form 10-K which the company filed with the SEC this afternoon.

In addition, any forward-looking statement 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 Good, President Jennifer like over ahead. Please Trevi’s turn conference and the I call now to go CEO. to

Jennifer Good

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

I up we this call Chief questions. Lisa and Trevi’s will is Financial then remarks, it Delfini, on have Lisa today prepared me for Joining open some Officer.

During indications. the to continue advance our Haduvio and clinical for quarter, we development our plans’ chronic cough

Chronic Let on chronic quality patients and socially, beginning cough no programs, life. a options cough serious me in risk coughing IPF in physically, potential there with of tears, psychologically, for outcomes With cough, chronic new to urgent of also lung injury, IPF. Chronic persistent inflammation provide impacts a therapies. for and role disease is of brief each of of worsening a lead currently may worsening IPF for plays micro their and potential a is program decreasing approved end-of-life update our caused need the treatment The lead patients. disease. that constant our and by cough be may IPF. an and progression factor

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

will doses study The first active that is a three trial Xb forearm Haduvio ranging and phase of dose placebo.

in sites in timely total We and to to subjects dosing weeks. and are countries end plan complete able the to manner. XXX approximately study this for planning in enrollment be We for study a a of conduct six multiple

be reported data. development on chronic investigators is for We with the IPF previously you competitive. in patients trial cough a antifibrotics there will and feel positive expect we lot aware, in As that have we study differentiated work enrollment IPF be a going of patients, so as with may only

have in regulatory dose the working study ranging are submissions the We to finalized authorities. of and process various the protocol for through

also through budgets, and this and second We completed qualifying be this finalizing We the our the year, trial. country to are estimate of subject have half selection the in this preparing initiated for of start trial regulatory sites sites, interactions. will working

we parallel, for respiratory is are physiology causing respiratory Currently, generic seen Xb of labeling planning is study. carrying In class not Phase a have nalbufine our something that risk This in depression. we various there studies is ceiling the effect agonist safety a and to falls in, suggests respiration. that on antagonist, literature our data the on impact is across mixed there have class date, which a

the characterize However, Hadubio’s is the IPF of any, patients. on it depression we IPF that given important respiratory population, in if effect, pulmonary function

disease see is varying that of significant will This we Xb label. help and study in define to the clinically Trevi IPF patients levels inpatient to planning if on patient have impacts our any pivotal determine ultimately population a for study program conduct Phase severity depression. the respiratory

sites planned received the finalized and we that finalized, working this year are with half being initiate will Xb are well. preparations have have second on two of as protocol, the in a feedback study preparations through the the to FDA We this IND conduct study. Phase expect study, and

is. provide RCC. study therapy works centrally IPF underlying protocol in X to a the cough, Hadubio chronic both potential because believe the to In Phase cough chronic of a refractory also in peripherally lungs, what in Hadubio addition We the studies has brain indications, a across in range and or have regardless completed for disease the that the we of cough,

with a trial, a the work enroll look been mechanism which we in lot dose-escalating approximately XX There which that in PXXXs, plan lot We success, seen the which RCC mechanistically like lungs. a CANAL subjects. some will to and have has one the was crossover peripherally only of expect this trials trial design,

opportunity still for that also the there’s those cough treat and RCC high a both XX patients most works believe strong level among we efficacy being hour trials. a difficult However, patients, the to currently centrally mechanism used to consistent including in significant enriched of RCC potentially counts, coughs with per and provide but below peripherally in

in leveraging from the are in study. our learning’s RCC as plans We companies own other our design we development

at the IPF both the and with cough mechanism oral data quarter, presentations as lot Thoracic medical Phase the to attention American American Society X during a continued garner Conference. as Cough Our well of at conferences meeting,

the published data Evidence. had results also CANAL from in NEJM trial the We

the this speaks cough difficult think community’s to across program patients I and these our in in medical unmet to the IPF indications. of need the interest medical cough importance treat

other we of is work prurigo PN. or The indication on-going the nodularis, have treatment

upcoming are dermatology was We that conference. with intend study currently analysis the open from an associated at the to data and completing one-year extension label present that data PRISM, we

meeting the to X We the expect this to plan year. later determine with will program. we steps Phase end to next which an for seek we request also After this FDA, meeting,

or conducting is is abuse the potential an this U.S. study. parenteral that the is Note butorphanol, in which of abuse we The unscheduled the agreed which human of study, likability this Schedule DEA. drug. filing. a upon the compare version by active potential oral comparator, are objective is or of the nalbufine NDA a Butorphanol for IV to Finally, study for nalbufine to Drug Enforcement is currently required Agency,

comparison nalbufine. with for study first parts, against The dose the in and various the two to being objective for part characterize is appropriate doses butorphanol oral a conducted the choose

We nalbufine second have the the of the and the part have selected and study. for I doses study completed butorphanol of Part

to FDA this get comments. to data We have the their submitted

is relative three of doses of the portion and crossover study butorphanol five-way placebo. the and of determine placebo-controlled dose to The oral randomized, the double-blind, second a abuse selected nalbufine to of potential active, design

work to of the single-source IV a butorphanol, the was secure is due shortage working However, as nationwide the the study U.S., study. this the from there in in plant the portion of delayed comparator supply bit, a but damaged supplier then drug We were recently the now is that IV of commence resuming are the and FDA will company final the the tornado, on will conversations. study. to portion recommended a butorphanol secure before need from we through to to we doses, have Once able the input and let matter we supply

opening Importantly, studies this support study cough critical our for any sites is of strong and trials. we path planned closing, three enrollment. running getting not these focused on to In the on chronic clinical and good up are

initiated timelines. studies are We and will expected and study announce design provide details as the they on more

then questions you may to review up it any we turn now will to Lisa for open it I over will have. financial our results,

Lisa Delfini

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

net same million start were second well expenses. consulting fees related reported we three trials, of personnel quarter to compared quarter in chronic $X.X the with a R&D increased a the activities of as in XXXX. increase quarter XXXX. million to For XXXX, to $X.X compared of of as up due million the was during primarily The cough planned same for expenses related and increase for professional loss quarter an in second in loss the net $X.X million the $X.X XXXX

of of the interest same in higher during G&A XXXX period compared expenses the a Other million the due period other to cash same million income income The due market of compared expense decrease quarter to second $X.X the net of were reduction million $X.X research to and to in net second change The was rates. million of XXXX XXXX. in due $X.X costs. increase $X.X was interest in quarter higher in was balances to primarily an XXXX.

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

the the during I Citizens imposed now to First loan our last it $X.X discussed pay and payoff million. Bank, full. was free elected Valley loan paid to ourselves off by on division with in term As Silicon off Bank, was restrictions lender. a of quarter we of quarter’s we amount The The call,

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

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

Operator

you. Thank

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

Annabel Samimy

Thanks the other for taking you really RCC. question. Hi, in go trials everyone. just quickly from to learnings wanted the over got my that I

went pretty wanted you’re I around that going that. from this to quickly. so have trial You population IPF? differently same just specifics You Thanks. behave design, to mentioned the the How understand might

Jennifer Good

Annabel. question, good a it’s Yes,

I sort is was how to internally. the the think That’s not pretty and counting around, learnings would I we’ve biggest of and debate objective all that monitor and what nailed debate validation obviously or say endpoint. the a around enrich enrich, comes healthy been had where that. the cough down have much the of

strategy you the XX three coughers. had greater As enrichment a, Bellus around know, one I [Ph] to than think, study

works boards, did as data, see portion having any own difference In heard our meetings and some XX the even for Merck there severe coughs what big a I’ve data to XX really of not cough, coughers on unmet of disease, per physicians level market. these and cough, medical not advisory only hour. the view IPF counters, cough need view attending sort a and the on in of higher though, which our in this these we of that They data, are that [Ph] as based severe Bellus is big after and is

trial that cough feel come of and stratify saw IPF and per So on what hour greater half in XX than in to it confident our XX we from this coughs the coughs hour, to cough sort per XX we we’re and various how the levels. going have doing and based responded actually subjects

similar sort would inclusion biggest debate. say protocol, of than So similar I exclusion Other that sort that, of criteria. was the

Annabel Samimy

want correct? confirm or of just Okay, then great, and not you a RCC, is trials, rate-limiting said not for IPF any to the step butorphanol

Jennifer Good

to to impact on abuse the but only rate-limiting clinical a It’s step data, Correct. final human getting our no studies. potential

Annabel Samimy

you great. much. Thank Okay, very

Jennifer Good

Annabel. Thank you,

Operator

question from next Belanger Please from The go Serge ahead. Company. and comes Needham

Serge Belanger

Hi, good afternoon.

past process XXX quick couple dose Xb questions you’re a for trial. enrollment first I about the for XX mentioned Just sites guess in be think that number trial, that I the Phase of patients, one, targeting the maybe months. about screening this would for And you us. the

given this could Just Thanks. enrollment. curious that in that you’re comment competitive a same still if ballpark, be your

Jennifer Good

number still questions. Xb, Yes, of two sites we’re The for good the finalizing that.

a be XX lot the to going approximately XX qualifications, site but of sites. doing to it’s We’re

this on So to move lot we’re to through be quickly. of a sort sites of able bringing

So is that underway.

end’s going we I when But we XX-month statistical enrollment, as adjustment, think be it’d thought our the initially to as one the XXX. fine-tuned far approximately started, be XXX. assumptions, we as

helpful. So a think that’s still And enrollment. we XX-month it’s yes, do

Serge Belanger

Great. Thanks.

Jennifer Good

you, Serge. Thank

Operator

next Leland The comes Oppenheimer. from question from Gershell go ahead. Please

Leland Gershell

I study, RCC. good thanks than the chronic update on ask, to work cough, afternoon, abuse in those for testing much you’re and and Hi, doing obviously doses IPF, our the that just higher you’re the taking questions. are in human wanted both potential and

Just Thanks. an scenarios impact DEA on liability from potential wondering, to would the that if are we would you the for doses should that do beyond indications, labeling some contemplated or higher what potential How those have at start would about restrictions? data? be those think see be what potentially

Jennifer Good

look DEA a lot good sort the totality. question of because bullet, here. is of a a silver going what’s get sort this things success you no And it’s as there’s to Leland. lot know, of in Yes, I at question, about

generally, Our then that. It’s Xx the clinical a high going sort dose going all a marketed to we’re I marketed done of think But dose, work to sort nalbufine, nalbufine, of be dose. dose which have the of around etcetera. and low databases, of the we’ve

any already as do likability done interestingly, receptor. interesting. It not not that is doses. high tolerated, get up swamped you we’ve in sort doses. shockingly, of an kind increase to characterizing all getting those But ends is around And And the those kappa which see work of you [Ph]

those you when get of those of dysphoric a up sort you to effects so high come really in doses. And side get hard lot that

So see expecting we’re that. not to

mean, you factor I did, IV made definitely I somewhat that’s drug. schedule that’ll And I think what’s butorphanol think a if in.

you conditions. looked high what So to in saw doses would I likability compare dose think increase be opioids about be around nalbufine on in, drug, type higher, patients would if similar, could the are anyway. the schedule you real got an butorphanol. serious which, conditions talking like that they’re of and IV you If these we’re then as lot a these answer A are

the don’t So we market. that see as impacting

Leland Gershell

Got it.

Do year-end. Or you. sounds you like butorphanol And can if go have when you we to to Okay. XXXX? see going data, share. be shortage, first this these half it I’m just the is presumably might a given past wondering of sense able Thank

Jennifer Good

needed Yes, no, can plan dosing in question. It sort that be it’s working call. is sort which get year-end definitely won’t problem Pfizer’s last a we play we through. to We July, to because of good just This and is were June, when that depends. of

We conversations them. with quite are been in receptive actually helpful. and They’ve

this of hoping maybe and people sort we when can that I’m keep get settled that So out we’ll updated. gets in-house

For now, you we can just put guidance our of control, very out new that’s haven’t because as imagine. any out

Leland Gershell

Yes, understood.

for questions. the taking Sorry. Thanks very much

Jennifer Good

Yes. Leland. Thank you,

Operator

comes The Partners. Inc. Smith Thomas question from Please Lear, next ahead. from go

Unidentified Analyst

Smith. Sharon is on Thomas for [Ph] Hi, this Nat

I first? these chronic So are health the first which trials a three follow-up. question And is initiated gating will to factors initiate and trial what be have likely the

Jennifer Good

Yes, sure.

primarily are regulatory around getting really factors gating the just clearance. So

Protocols We’re to pretty go. written. ready are much

contracted, of getting first My a guesstimate is It’s sign-off the to study them in We’re ready RCC and getting to ready matter from probably everything sites just the trial. of all go final regulators getting go. place. the actually

Unidentified Analyst

do in health chronic it. IPS? implement And to what you Got to compete competitor plan other with programs strategy

Jennifer Good

Yes.

drug there’s chronic RCC. drug. [Ph] in that program NERI only cough. a did So It’s X program a in It’s other success competitor Phase not IPF have one that

as So big view them a we don’t competitor.

is to XX enroll think their study looking so. overall patients only or I about

work more I patients So for and we lot antifibrotics them don’t competing a view landscape going view IPF on IPF. there big is is as a competitor. in the of because the competitive

competitive our one in we’re what cough. the be, So of will I trials advantage only think

that’s people that I think for be cough, them. So to severe intriguing going have to

a We commitments. short running The one-year are six lot trials, also study weeks. are a at of antifibrotic them

sites And to could think able done bringing coughers, trial, can get be them. an for frankly, quite six-week out up we’re proposition spread time. rapid this patient in for intriguing be we just So and a that into enough they’re I to a this this a get severe

Unidentified Analyst

change phase question Makes recently a submitted sense. RCC partner advance Xb? still you last it for one NDA thought to to how Merck, on all RCC your in And Do the we us. With from maybe beyond plan we plan Does the do RCC? find drug.

Jennifer Good

It’s question, a good Matt.

RCC do right I think think here is the create that of marketing our value to development understand a asset work the plan here. is and you’re and do optionality the I and later. are like marketing all condition of sort be can different in people plenty of than specialty cough animal There’s in a things that IPF. But interested out space. sorted those this

data, able broadly I really we’re think if we think if can coughers be put up population intriguing work more to I have enriched. doesn’t patient in so especially, severe that to good this it’s of

in think a makes all I class. this of asset best that sudden

out work sort later. through we’ll work it So how we and the commercialize best development

Unidentified Analyst

much. Got it. so Thank you

Jennifer Good

Matt. you, Thank Yes.

Operator

B. Next Riley question comes Mamtani from from ahead. Securities. go Mayank Please

William Wood

for thinking other one, of for the there part are Good a timeline you proceed, actual the afternoon, are about considering, William scenario options questions. on FDA When Mayank. feedback our team. worst is and where This or the on redo is for scenario? Wood there shortage, you Thanks sort maybe following case the butorphanol depending taking shortage,

Jennifer Good

scenario. I think case worst

validated a want wanted is small would think sound. dose, we run study. data. whole reason So us look don’t at I doses they the we’d to do to did we before If we us to cohort guess dose. chance I there. the that together think look that way put a agency one. for the at I says a But some have scientifically a redo only I at look But just We a part they that there’s have to different generate we different multiple structure want think, dose likability and

there’s short your to other likely don’t to we’d you old All the butorphanol. of worst have drugs, a would pick out that these problem sort comparator was I they’re get probably supply case And is really we’d think another issues. have in scenario of Pentazocine to wasn’t all that agency be because agreement is that manufacturer. The these the point, good, one. one IV basically with get

we’d probably coin hoping do, butorphanol time. that like toss to when Pentazocine and the but we sort be likely comparator, it the with was of about which it at did I between I’m talking be we what point, said, So would we agency then a another don’t if get

So have would of would I we fine then And to those us. think the be either dose work. for repeat

William Wood

that No, morphine nalbuphine will dose the pacify I Right. makes early terms read quickly know we to your there. ER? How expect readout September, study approaching of through data presented be sense. then about when additionally, how where to see ERS And that we in is it think low might should in

Jennifer Good

team Yes. And at whole we’ll a ER. have

So there, happy to group you to our there. connect if anyone’s Yes.

mean, this Morphines before. used I U.K., now and going I less work. be William, here It’s to Molyneux study be cough trial. low mean, it more I because have and dose going the I’m investigator. you well. of So surprised. is morphine a morphine was I’m Dr. talked our as to the The about who [Ph] investigator in on whole opioid that lead Great surprised restrictions. if in doesn’t

the going to, work That through the think I’m read So in is mechanisms, cough. I right? opioids

I two going think It always It’s have is is a to schedule morphine low generic. opioid. challenges. dose

probably to to IP that going around be at not You’re all. able get

with the think actually and commercially I compete doing. mechanism doesn’t it what So validates we’re

William Wood

It Should Understood. now that quarter, we or for half. XQ And one as pushback looked past RCC ER like that just a or then just read in as more third slated a one. quick was very listed last that, from your generalization? second

Jennifer Good

verbiage. It’s more just

[Ph], we third quarter. say still in you’ll think see, I XQ

some say year, just casual my I it’s but this later of in might think comment. I a remarks, more of

William Wood

questions. our taking for you Thank it. Appreciate Yes.

Jennifer Good

William. you, Thank Yes.

Operator

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

Jennifer Good

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

starting at are in week are issue Thank hope that several you. with We which meetings. participating upcoming to detailed our in have earnings release some you conferences We see Stifel next these today. of we

Operator

Thank now attending has for concluded. call you Conference today’s presentation.

may You disconnect. now

Trevi Therapeutics (TRVI) 10 Aug 232023 Q2 Earnings call transcript