Earnings call transcript Q3 2022

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Operator

Good afternoon, and welcome to the Trevi Therapeutics Q3 2022 Earnings Conference Call. [Operator Instructions] Please note, today's event is being recorded.

Various remarks that management makes during this conference call about the company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of the company's most recent quarterly report on Form 10-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 change. do in do point the even the to forward-looking update at obligation While views its company specifically

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

Jennifer Good

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

I available then this call end call. Chief questions Lisa and Trevi's we the is Financial remarks, prepared be Delfini, on have Lisa today of short me for Joining at will some Officer. the

regard an delivering the This year exception. has been exciting was quarter our for and Trevi plans, with to business no against third

highly As previously frequency cough baseline, and frequency significant in the improvements trial objective and endpoints. key September from secondary the and trial cough in pulmonary reported, patient-reported of on CANAL significant reduction coughs, the in were primary the with were on investigator-reported our several severity, along in and interim positive of showing reported expected, outcomes confirmed included chronic a both This results results coughs. fibrosis, statistically full measures for and idiopathic or cough IPF,

impacting indication, R&D like next to lead provide are disease protocols in results in results patient's indication. serious a we KOLs cough of all we is Chronic Day. our of a major cause is Haduvio along to in for IPF the Day one our and interactions In an end-of-life chronic with therapy preparing information, an I from development IPF in the and positive and emerged phase update since of heard cough review a with you both blinded results have morbidity, with interacting is of cough for the these development hosted the this and our and mid-September, [indiscernible]. FDA to and and R&D Instead in quality rereviewing for PN significantly and European with prominent shown busy lead detail activities authorities. of has IPF the life. is only as regulatory study would on the the developing

from are patient many Although in there to the patient in we there development the unique space, the as can the that related ongoing safety aspects chronic potential relates refractory the not only frail cough it underlying IPF are but is in population effect disease, this population. to also learnings take

for have So In as and the sure step on this for we prepare open we with IND. study initiate the once can we make preparing clinical that development, next are parallel, we regulators. to the aligned in so the are an protocol want teams agreement we agency

and in trial on next guidance to expect the study the as we XXXX the we results and well the begin the timing when initiate We study. for will overall half of the as design provide first

Our data [I-Class]. this Society the late and a has Society breaker presented at at Philip present cough presented Respiratory British Toby month been meeting. as European Thoracic full the also in was IPF Maher, will and at data by the Molyneaux Dr. Dr.

results. trial the IPF from gained pulmonologists attention support publish to the The and manuscript a and data preparing currently globally. also cough are We has KOLs

on the primary of itching. are characterized well XXXX. complete we other to and as and XXXX. of end the the FDA, parallel, on documents have endpoints. patient positive also The In and all expect the treatment PN, reports serious reported and key We the preparing in secondary In or we Phase trial work data II completing significance which The have where we nodules trial nodularis, debilitating last patients PN. and of statistical the skin as request the is is half to in we in June, with the program achieved meeting with X-year to prurigo PRISM in several open-label study various ongoing the still an disease first a which papules all extension IIb/III hold for February incessant in clinical forecasted by severe and Phase

presented and Venerology Dermatology at Our was Dr. the European PN Academy orally data of by

And Sonja as publish Stander at are currently in dermatology working manuscript other several September. we results study a as full on the well to abstracts meetings.

It identifying time the development upcoming across for sites preparing study. Trevi, next busy for the meetings is a our phase and for at protocols designing of regulatory next indications,

more forward studies. look with next as initiate We are ready updating to making get we details good progress the and you to

positive of of As I Haduvio and the by other chronic positioned look extremely lead IPF our financings continue in both trial cough subsequent on The back XXXX, team in to development execution data only have indications. also not conditions. us serious but I cough our chronic proud and the the results well of am trial

For PN, stage next clinical the we potential to that are partners of in discussions advance into program with development.

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

Lisa Delfini

afternoon, and Thank you, everyone. good Jennifer,

of the reminder, XX, a be SEC release and X in financial today the after ended filed September full the issued closed. As and can call XX-Q, the press with our for our market this ahead was results months XXXX, in found X which

net quarter were in activities quarter and blinded were portion of In a as for third the purchases the trials, XXXX. to to our during by to expense completion $X.X of primarily the of These compared offset $X.X the our to XXXX of trial for in for million quarter due quarter of in the the timing was trial third XXXX, CANAL including same our This to XXXX. increases quarter of expenses reported million in trial clinical loss decreased R&D increased of II the start-up loss of planned XXXX. of the activity $X.X due activities PRISM trial period expenses of $X.X third to million XXXX. of second related supplies same of the compared Phase the net we a compared million

of was primarily legal third million market XXXX higher million the to the during $X.X XXXX. were same $X.X increase quarter to fees property related compared expenses increased and The of research due to intellectual G&A period costs. in

in results raised $XX the gross a investors from the after existing our through positive quarter, public million approximately data we and full the the for offering. both of proceeds new trial, of announcement CANAL During

We also exercise quarter related previously to issued $X.X the in of million warrants. the proceeds received of

Subsequent September the to quarter related for end, we the $X.X received another option in the to underwriters' proceeds million from [indiscernible] offering.

Jennifer million, approximately today's portfolio and we with So balance high a is and with $XXX.X a in securities end us we invested October have investments quality higher income cash credit marketable of today in and us providing term XXXX of out interest healthy in which to into gives February between This runway plans off accordance our to and pay environment. rate XXXX. interest cash that its loan X, terms execute with the laid now

welcome to team to to for existing phase discipline we supporting for investors I'm investors, In Trevi our new the round. our as closing, development I Trevi, Haduvio. those our agreements who including look funding thankful of latest I'm and with this forward next participated happy negotiate in execute financial and

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

Operator

Instructions] from [Operator Annabel with Stifel. Samimy question comes Today's first

Annabel Samimy

standard regard what incorporating thinking combined usage you asking do of of guess, them the treatment agencies to the looking a of you Do in with patients? on few. at design guess, -- top trial. I with, to I IPF these going be of future you're new are I endpoints of one to has regulatory had any

first thoughts have are the it enrollment think long do have that do what calmed enrolling so to greater about And potential also, that that these your might down? COVID trials And took Phase you now seems you to some given IIa.

maybe So can just I with those. start

Jennifer Good

Yes. Annabel. Thank you,

cough say not study. here and agency. in what we So with we objective trying The Phase on we're been the are of would that's used of supportive our in discussions reinvent FDA this sort to I the has II endpoints. monitor, wheel

So I that. do anticipate we'll

We IPF it will validate need in to population. the

moves patient one We outcome work. need our just statistically a fact same matter But will -- then the of picking think given also some and that I to doing all were the direction. of significant also it's a as secondaries patient-reported well, find the that

take So of drug In too let I'm standard worried that. care. top on of people the we this trial, about not actually

If our X on stable at about half had weeks. to you be just of were patients antifibrotics, remember, for they least

what through overall to going study of inclusion/exclusion be -- making dose. the I of the kind the really we've to working trial say the sure I around design effective would again, criteria, we're minimally that purpose mean next is done, II just sticking finding So Phase

As you saw from early. an impact really our had data, we

And at question. so and we'll really that through need to the get work dosing

the nailed protocol make So down. just trying we've sure got to

would question, though, only that but enemy, far these it's everything, we was in COVID guys, RSV, cold, study difference your running and our say enrollment just as a the U.K. wish the I question, anything As with here, were I good

or XX XX of limited you're to So sort sites.

open U.S. probably We Germany. also will up in the this and

be a lot just to the able move to we'll through So enrollment. have sites more

hopefully, better. that hedges So sort little a of it

Annabel Samimy

can couple if I Sure. just a And of ask follow-ups.

You almost Or million back the $XXX chronic to something right any it now. Is thought now? exploring stay is in there indications going additional that's burner? cough to have just

you obviously opportunities? separately it on And that, sounds are to able seeking if then explore sense like are And a all go PN, willing to do it still have those But there are no alone? you you on be to a partnership. bites

Jennifer Good

Yes.

So as a chronic doing study. are Phase cough in II indications, we interested other cough chronic far as refractory

IPF hopefully as primary I agency as way. of of meetings. its wrapping sort our be to do well here sort and through PN focus up on to That's getting roughly coughs that, to we've think I look signaled want get we'll that up initiate midyear. the and going

chronic by anticipate would I cough So we'll be refractory initiating hopefully study. a midyear,

quick enroll be trials, pretty enroll quicker. That should to those much

X So in to we sort done get to X hope of that months.

we million. As that $XXX planned have this not PN, far in on as

At active this the to various in discussions we're final we with think plan study I run ourselves. don't partners. time, in point

hopefully, this a and we'll want this find that to into really be cough as to we portfolio partner do take it think I invest because priority. that to a able money

Operator

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

Serge Belanger

since afternoon. Good be ago? questions. that full the any -- on about month. mentioned set cough it presented later couple the months the A just Maybe X guess, meeting set feedback at this releasing will then you looks the data of first data program. thoracic And I

curious that with that. Just additional . start of of presentation. be if that analyses the I'll there's part will data any

Jennifer Good

Yes. Thank you, Serge.

the interim. full feedback far it, as you've As consistent data seen amazingly with set, it on was I the mean,

it with good I say data, our that endpoint the move because news forward would cough set. XX-hour we it in link So able for were had full to we just strong, that which an to analysis expect the XX-hour was as to -- was us. we

the lot but pulmonologists only meetings also strong. I've a definitely think I feedback has of I whole of been the been through and these community. not attention medical got So just really the cough

feedback I would the has say strong. So been

second was... Your question .

Lisa Delfini

meeting. Thoracic

Jennifer Good

so that the Thanksgiving to -- so British Yes, shared happens be Thoracic We Society. weekend. over

So of we actually because be that. there won't

and the some you're Day. would I things But as data Brits our part so There's I presentation send much purpose. showed do incremental that the in probably there, think Serge, on I if say R&D we can you interested. of

extensive But I think what sharing we've of so in been there. sort

of out when full see of a work on on review a there's thought I sort around data. you'll all the as the lot really the because get the area think manuscript with of manuscript we leaders this going

Serge Belanger

Okay. to just it's look I you partner decision PN, for And then on a made since maybe early know there. the

you've some approval generate for . Dupixent that indication? the maybe recent of to had conversations interest and the additional So whether

Jennifer Good

Yes.

an accepts I the people that people's Everybody need. line this therapy. place mean on in important is So PN sort has of of treatment interested. understand screens, radar an oral definitely they're

Dupixent great these drive about discussion a of a help job I conference patient there numbers. week, presenting just pharma was a identifying at diseases was So numbers. will does how and and patient I driving big of lot think last

to our think sort that's So I like and would helpful. get get of guidance. I FDA all meeting FDA really clear through

partner a clear patient a will of be very So as on sort forward. move forward, the we or path --

yes, I So it think help. does

that it's I part our been helpful for market. of think overall a biologic actually thesis having always the here is

Operator

conference the to are queue. And there session. no remarks. our back . time, further Jennifer the concludes now question-and-answer in like would to this I call this closing turn over for Good questioners At

Jennifer Good

in everybody to today's in in and like . week thank would Francisco We Stifel's you. see San Conference some of for you Thank call and hope participating January. at to Investor next

Operator

now you The disconnect. for has attending concluded. presentation, today's you and may now conference Thank

Trevi Therapeutics (TRVI) 10 Nov 222022 Q3 Earnings call transcript