ENTA - Earnings call transcript Q2 2021 | Enanta Pharmaceuticals, Inc.

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Operator

Good afternoon and welcome to Enanta Pharmaceuticals Fiscal Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end of your prepared remarks. Please be advised that this call is being recorded. I would now like to turn the call over to Jennifer Viera, Investor Relations. ahead. go Please

Jennifer Viera

on and afternoon. operator, quarter everyone joining is for results Thank news thanks release this available and afternoon The issued second website. with us was you, this to our our financial fiscal

Luly, On Executive and Financial and Officer; Dr. Enanta's of Chief Chief other our President members the Mellett, senior is call Officer; today Jay Paul management team.

be of expectations recent with include any our our formal call. research these risks pipeline remind to President and to respect and [Technical statements we materially not CEO. Enanta involve that and any will our differ control to our our is Jay remarks, forward-looking you Difficulty] may could certain Form Luly, our which call and reports want with during actual developments making we filed begin and made description and most statements, we other the periodic results SEC. to and with all update Jay? Before undertake does to financial this from assumptions those obligation plans forward-looking A Dr. now XX-Q in of cause beyond that I'd over statements. development risks projections, which

Jay Luly

Thank you, and good afternoon, Jennifer, everyone.

detail of preliminary virology inhibitor, productive another X [ph]. B, X active from which pipeline the in our are clinical diseases, one we upcoming catalysts marks conducting are report studies in liver will year. have currently clinical discuss EDP-XXX, Phase with in the and which quarter we in data We for core Xb more I ongoing work we across the Starting programs second towards [shortly] fiscal X our excited the to company trials. as our hepatitis of quarter to Our continue several remainder portfolio of across

oral middle destabilizer, in Our HBV HBV is this enter to clinic of also EDP-XXX, which the the set RNA year. our includes program

for clinical human discovery viral and treat X Further, or continue L for have our X an for metapneumovirus, respiratory virus, or identify syncytial and RSV, NASH. ongoing EDP-XXX we hMPV. for X or respiratory non-alcoholic Additionally, steatohepatitis initiatives, investigating studies RSV, we candidates progress inhibitor inhibitor an ongoing studies to to

who for on Based critical pharmacokinetic The inhibitor, our we NUC-suppressed Finally, are for tolerated was target that, in we XX announced provide to the and pleased is preliminary the the first patients dose reverse data with safe patients of up cohorts results to I'd with treated positive chronic nucleoside dosing days, an robust where our from refer specifically Part pipeline, study, Part supportive approach With in functional in healthy Phase well protease Phase patients to in profile EDP-XXX Xb was a HBV NUC-suppressed. to be the or inhibitor EDP-XXX X turn particularly able prospects report we enthusiastic to study Xb our to with HBV all-oral data for SARS-CoV-X. as with developing of to oral today today observed ongoing of for of subjects. X cure like designed are an what our once-daily support about beginning and to HBV. program, chronic transcriptase X consistent

There linearly up event ECXX, protein EDP-XXX to grade or trough dosing. mild. exposure and elevations the to X placebo drug One the were once-daily the adjusted arm the serious X dose, discontinuation. EDP-XXX or milligram to Going were X that or adverse of patients, were had milligrams with abnormalities. other were of adverse negative, total XX a grade milligrams whom receive adverse XXX deeper were majority a of events, a no patient with EDP-XXX, the e-antigen XXX There concentrations in data, enzyme events supporting no increased led study the bit of of randomized for into majority weeks. treatment-emergent liver XXX XX-fold laboratory

As already from suppressed patients baseline, because not show these HBV change from did levels DNA DNA their assessment NUC had any expected, the therapy.

results we the highest study placebo, EDP-XXX core final receiving group X.X obtain in future Additionally, data of The with our no Exploratory log group, X.X group at in this reductions consistent RNA the ongoing and results X e-antigen virologic reported data quarter, milligrams, positive in refer X.X study patients the in from after not HBV failure and will X preliminary group. Later Xb patients. were log of placebo evaluated are logs infected we report viral on and reduction are also a patients XXX chronic were of was treatment, scientific is log load, maximum EDP-XXX in study also with who dose reduction a we to versus Phase to viremic other breakthrough high was expecting currently of patients treatment. logs for viral mean weeks inhibitors or a HBV receiving observed. on as in observed endpoints in conference. X.X whom the Further, this negative in maximum observed reduction and compared e-antigen

viral in in a pharmacokinetics. agent As include over safety, when EDP-XXX's and a viremic the NUC-suppressed And patients tolerability used period. of the will importantly, as effects indication study the data study, first kinetics, will give single on XX-day viremic preliminary

including in of and the of the other creating and/or Core as suppress combination developing HBV care NUCs NUCs for affect assembly are as current for EDP-XXX such replication, patients use HBV also inhibitors HBV capsid mechanisms, and DNA, functional import a recycling. HBV HBV virus, infection. with HBV [Technical all-oral nuclear with chronic Difficulty] several of addition, uncoating, DNA. addition, stages an in for we're EDP-XXX, cure such goal other EDP-XXX, In standard compound our newest of

agent levels high However, reduction viral patients. cure. RNA, HBV as destabilizes in leading viral proteins well S-antigen antigen HBV achieving the of EDP-XXX to to remains a that challenge potentially functional oral S is an other in as a HBV a

discovery forward model, or superior based We data, compelling the X siRNA to with and in presentation to we Congress of X a log look showing in and which reduction a levels equal poster the International sponsored by presenting S-antigen EDP-XXX with agents eager agents this results and encouraged June, our are expected XXXX. at of data trial by EDP-XXX of Liver in tested on demonstrated initial in to same year's the efficacy Phase half mid-year, antisense oligo-based in are EASL start a in We first mouse model. in EDP-XXX characteristics

there and infants, to X currently and replication and morbidity associated ongoing Moving respiratory which N-inhibitor safe severe candidate and the clinical blocking with N-protein condition in is effective evaluated elderly RSV significant than designed and of a is development virus lead is infection in our being rather a EDP-XXX, in currently only today, RSV, uniquely product block for the the we expertise mortality to no Leveraging viral therapy. entry. in and the machinery studies. the adults, EDP-XXX target our immune-compromised virology,

As not season like flu, year Northern in mentioned continuing we and the usual due winter the have to previously, Hemisphere the emerge the past RSV RSV, during in COVID-XX did measures. late fall mitigation

X pharmacokinetics the evaluate with of RSV which efforts trial is the in randomized, RSV social recipients when been in symptoms of ready However, transplant second multiple of the upper once that acute mind, measures EDP-XXX pediatric Once establishing With ascending to distancing observed will infection; globally, the reemerges as our infection these we studies. in March, doses, has of EDP-XXX antiviral this reemerge Phase evaluating the trial spike These placebo-controlled, a preparedness double-blind, dose-ranging and cases Europe, will in provide efforts recent study ongoing North including study program, RSVP, we evaluating EDP-XXX. continue in we objective tract guidance of primary to Phase Australia. our of RSV initiated sites RSV already America, ensure RSVP, cell while X RSV will clinical study adults in our in The includes becomes evaluate safety subside, activity again, respiratory in Southern of key pediatric Asia-Pacific will RSVPEDs, we infection; to of the for clinical community-acquired and in adult to part Phase in patients. Xb part with which prevalent of the the Hemisphere. first hematopoietic region, RSVTx, and updated the recruitment EDP-XXX study are a primary objective and EDP-XXX likely be

EDP-XXX, RSV other broaden and lead our another inhibitor inhibitors L block RSV treatment class human progress. efforts addressable as patient the population. to alone to continue optimization with replication possibly used L-protein EDP-XXX, Beyond are potentially that in window in initiatives be metapneumovirus our agents, such combination can inhibitor drug or discovery and or

EDP-XXX, data to development. anticipate Phase analysis EDP-XXX lead that analysis protein this differentiated have is if liver cells virus oral efforts early are of X disease EDP-XXX. summary and studies COVID-XX approach NASH, Phase in third potential of medical and patients weeks our potent data, will we characteristics could potency on interim than spike Phase to of later quarter. on be hepatitis steps as for enable positively, advanced are for in will FXR ongoing candidate, in of in success to a internal biopsy-proven targeting is replication our protease in expect variants. progresses XXXX. FXR And IND-enabling emerging studies XXX in antiviral lead SARS-CoV-X approximately We to and agonists oral we hMPV, XX inhibitor with most plan with Recruitment in optimization our and clinical be X dosing our expertise such treatment against designing making EDP-XXX, an viruses versus clinical are preclinical study to we of follow-on virology protease initiate all entry. compelling our candidate discovery EDP-XXX upon NASH study in and report of progress our Due us conducting our combination that ARGON-X, in in now subset on focused and the inhibitors we our Europe mid-year we pipeline ongoing. In in South For from we interim and on the significant are Xb direct-acting data initiative next will need, with where our study of current a quarter where FXR that and we And some other mid-year. end and on Building internal human of Recruitment our review the I'll with patients sites, to and on with build with compounds work the agonist, our tissue suggesting a respiratory also impact resurgence develop rather NASH a dosing calendar study determine blocking EDP-XXX of our my XXXX, a clinical aggregate, expect based high program. prevent inhibitors. compared global polymerase viral rates and C, are in fibrosis effective in America molecules to approaches of unmet first-in-human

like we Before moving HBV I'd expect milestones. results later upcoming of this EDP-XXX of preliminary viremic patients and a trial our the initiation to the look In financials, EDP-XXX, study HBV, in reiterate to we quarter, toward of oral HBV the in destabilizer mid-year. Xb our RNA clinical for Phase

for expect quarter specifically protease to For this IND-enabling begin our later to lead COVID-XX, oral SARS-CoV-X. we studies target inhibitor, designed

we of look preliminary our NASH, by analysis the EDP-XXX, FXR agonist, and data an ARGON-X study reporting to X forward of For for this of followed Phase next from steps program. internal mid-year, determination interim in

turn I'll for are X RSV Paul that, discovery candidates initiatives are our and our to the of stop out call financials programs by our out here virology COVID-XX, coming human excited Finally, the Paul? prospects discuss identify eager metapneumovirus to respiratory we year-end. and over early development to of quarter. by With the clinical and

Paul Mellett

our you, Today, XX March schedule. XX, year quarter are I would second September like XXXX. reporting we remind to ended everyone on Thank reports a Enanta for fiscal Jay. results that

for revenue as on HCV quarter, million. sales lower the patient XX% for of was product compared The on XX% treated the million below and as reported XX% Royalty revenue decrease which discounts, sales, a was volumes total the quarter reported approximately at calculated of rebates royalty of have AbbVie. sales. and contractual product period in This and revenue primarily consisted of same HCV on MAVYRET setoffs, $XX.X XX% of by at remained royalty of to now in adjustments MAVYRET rate million total a compares the revenue to royalty sales revenue AbbVie's of by driven approximately last rate XXXX. AbbVie's VIEKIRA earned product for same sales after pre-COVID period are X% certain global royalty For total $XX.X levels, of $XXX year was

and highest Therefore, at As XX XX%, the are quarter royalties the a royalty ending on our for a our royalty tier. ending reminder, fiscal year rate calculated were calculated our lowest first royalties calculated December our calendar XX March royalties for basis. year rate quarter are at for fiscal

You in XXXX Form our our can royalty XX-K. schedule review tier

our to Moving on expenses.

can For period to report expenses financial the with call period quarter was The in for Net loss benefit million when March to development to same related year-over-year. The our loss income for General compensation tax to per benefit million approximately open the now $XX release to of due details for the headcount due million will ended tax period Further the XXXX. common additional of XXXX, in CARES marketable the the $XX.X million income same X per in million quarterly to common and benefit million in million months filed. administrative diluted $X.X trials the press the The I'd expense. ended the ended research of available the was and recorded loss, million operator to XXXX. loss was X and XXXX, on be of carried period Enanta lines a compared and $XXX back XX, $X.XX quarter in XX-Q company's $X.XX the of cash of months March Form under $XX.X of XXXX. pretax due increase timing coming XXXX. XX, questions. back X to the increase $X.X Operator? compared the months tax compared March Enanta $X for totaled XX, for the XXXX. or for and an and which are to share, period million income in Act corresponding XXXX, an $X.X loss net or up a in turn primarily compared diluted like our was for ended securities. our be available the the same $X.X expense was for a clinical in share

Operator

the will by while Q&A begin stand we We our Instructions] Please now compile question-and-answer session. [Operator roster.

come Our Markets. Brian will question first RBC Capital with with question. proceed your Abrahams from Please

Brian Abrahams

and all Thank there. questions my the nice Hey, you pipeline. to the across taking for see progress

First question as observed particular more higher in RNA study differences some the you lowest you're milligram can you with on and little concentration on doses, as a dose? XXX, granularity the in across I maybe well of provide declines the this XXX bit looking trough guess, is what X optimize that to

Jay Luly

Thanks the Yeah, for hi, Brian. This is Jay. question.

the trough are high pleased point So, regarding after at trough we're levels. XX-hour the time basically trough a measured levels, And so really, dose. levels given the just really the to see

As the lowest that attributes just you virus other And know, the the have you'll you on kinds pressure of a product very any or we builder heavy bank you whether with helpful viruses. the that all confidence make, at see the we RSV when of see concentrations on those that candidates during such it's it's day.

very we at So the which trough also protein-adjusted saw levels well. but good the saw at ECXX, XXX as very only XXX XXX trough about high were group, we not dose levels

in we it X all the study very - even guided in trough this, then, the lower doses, viral such exposures say, But arm these NUC on third and XX on seeing was final based volunteers, with importantly, with done all so together looking and out But XXX. study, so have I of and load we And this along at and saw that and the with as for data about and HBV good we're safety we patients, good the and So once at confirming we've can in of study top that we days. NUC-suppressed the going is exposure doses. healthy PK far, we'll get regarding we've a same that out safety the put reductions, virology that that concentrations. isn't tolerability it a what again, as very, much levels and see these it tolerability

much saw viremic what's study time response core short inhibitors that have going that We're or a So it's from been at some were suppressed. typical from strong package. to it, they the you there. a all you I far depends longer to of was and you're we the it RNA of their I'd of what ultimately really have very patient X-week NUC, Again, call RNA scheme which is been study. were, time generally that But is may the how suppressed see. period a in also of exact the a not underscore starting see levels in, When want DNA lower strong effects the so - are to grand which and RNAs already will partner run. population trials forward on looking be not kind see may this, what that the you period,

there high XXX And there will coming patients without you study the in will single viral be a chance have a a agent. loads, in a what the along have So agent does to have manner will dose-related DNA coming see as NUC their see elevated. to so - single a

is far The incredibly about. models. very It's you very animal we've our So, so again, I'm potent virology Preclinically, molecule. as strong. in-patient now, so got first excited And good. It well in data works very that pan-genotypic. know,

get the to forward will installment, expect which be quarter. data, which we Looking later to this viremic next

Brian Abrahams

any I'm know tenofovir-related of tenofovir any effects? events X in And those concentration? I and just it. potential any guys you of mild, changes the look Were consistent potential side And AEs? Got but did curious, appeared them adverse X grade for did with pretty

Jay Luly

don't believe have so. to I'd that. on check I

conference at AEs put we the it mild. the cohort - AEs final have was, observed think out again, we'll in. all the were But once I were when the information a

Brian Abrahams

queue. months And NASH? forward mind, potential for determine views like don't Thanks. be then and I'll looking a path you'd the are you for in those coming to more One look what in if hop might the latest paths forward what in strategically? it. your Got What me, back

Jay Luly

Well, again, have ongoing X we studies.

Obviously, is super today. have with potent the most So compounds, our FXR. which EDP-XXX a molecule. X different that's potent It in follow-on we it's FXR like development clinical with looks

certainly that's that attribute observed, we pre-clinically. So X

tissue is other that. the The targeting of

out profile. So versus of why an build you target we've that I if index, hypothesis the efficacy will, from better laid tolerability think and engagement and how a could to

that alongside an patients as in And on to to interim conclusion. we've run so, or then to midyear. we're study. And ARGON-X know, look that, of and EDP-XXX analysis data to as the also, to its at a alongside study see going at on we'll internal in let at going doses looking have we're expecting Internally, We're subset looked we with ARGON-X just now. an said, that with that. we're have interim doses And you previously share goalpost

So we or molecule as data all we molecule to it's versus at. target-engagement/efficacy tolerability, ARGON-X very had whether stated, affected point but B. COVID look calibration good We to a just about have have A hoped Again, that midyear, on it's of America. in to it and earnings happen, some in But - in midyear. QX. South early around to And it we that's but in our have looks should August Europe going not be sites that's hoped that like had our

very combination, look for be makes to used in opportunities. that particular, on of that seek up year development doses here molecules target tolerability business or and of can - we'll be about possible in then most and The looking dose that that So as profile this could and combination be interesting we're in including we as all drugs their identify doses goal or either looking what sense. see here I the is the used for early aggregate combination. and opportunities, both could that of at in engagement terms could data, mean,

on but stay front, that's the So tuned that plan.

Brian Abrahams

so Thanks much, Jay. It makes sense.

Jay Luly

welcome. You're

Operator

Yasmeen Please Your next proceed Sandler. with Piper Rahimi you with question. from will question come

Yasmeen Rahimi

is of for there the progress part taking of if I X, separation change the also, the on time-dependent And can drug-related a XXX? really this that and questions. updates. my occur you, then I'm part I what help milligram maybe there were AE number difference then, reductions. tests the done discontinuation? us like was be that you to questions patients any that And Was in Congrats between the are one team. X. serological is, dose small. and sort Hi, And of X? X to trying And was you XXX-milligram for thank did first one the recognize dose That's XXX week viral deemed group? at load get continued led at at guess, sort understand and to that

Jay Luly

Yeah, answering the guess, AE the was I possibly second first, question drug-related.

So it was scored as possibly.

It's kinetics, as know. this or you that's it I all not and to not viral of study XX, looking beliXeve. related regards what possibly kind week With at was really that's at to loads but definitive, So was designed do. stated

of that And So there then, we'll sort weeks. put the out at data. data X wasn't

help going to we the would think the Again, yet it's ultimate and have that should for future, right EDP-XXX, of us You're would again, them our we a destabilizer, is combination agent we that table, how oral build trial which combination, small target but into study S-antigen. a which set a third it's adding looking to And the study. so agent then do the forward. will, our a was NUC, have inhibitor core this about to an small, informative you be a have RNA would to we if

in course And study why with virology. and that that's that's next important for, obviously. report later But as quarter. come the as even And we're study, incredibly this this that isn't we'll an though early is will what shooting laden so, it due out

Yasmeen Rahimi

X apologize. maybe I you question, last then, so much. Thank And

studies As EASL, expecting we be done combination forward XXX? Should models looking some much data very from preclinical head you with XXX. where into preclinical the we're on we have

Jay Luly

added combinations at and we've And the comment inhibitors, and said at also XXX. won't an NUC synergistic we core we observed have same. XXX actual So But presentation I plus seeing XXX additivity it's until have to looked what to We've of is finalized. looked on behavior.

- up we're to EASL. able the done What shows finalized. be present the to pleased at that to be opportunity have at be will its experiments. we So EASL have those in to But form final

Yasmeen Rahimi

much. so you Thank

Jay Luly

You're welcome.

Operator

come with J.P. next Please question. proceed Eric question Joseph Morgan. your will with Your from

Eric Joseph

a see to you of little time and question. the my Maybe on and about curious resolve? is low-grade next steps a XXX with are we of cure, going Thanks internal to albeit about taking I be are from it it thinking functional the safety, about I'm for thinking just or a just AEs it they hear XXX a talk bit similarly, with being the to explore KOLs what follow-up to approach, can of how vary? strategically how HBV that, of might guess, immunotherapy? X approach you of to you onset dose what escalate perhaps, portfolio, oligo [digital as will you how the the then, strategically know take longer And and whether with is look terms you program, thinking - or mechanisms multimodal [ph] in combinations your or to treatment, X course outside to continue think Thanks. get potentially patients pharm] perhaps

Jay Luly

strategically drifted off. thinking you question? You I'm last of last are the what? How part we could the sorry, about repeat

Eric Joseph

potentially Evaluating combination outside portfolio, siRNA with or or oligo, an like immunotherapy. of XXX with with your agents ASO

Jay Luly

Got it.

and with over times, to and except periods forth. any were study which different on in and that again, for They're just we mild one throughout all different regards so doses the AEs, So, again, of scattered the so noted.

this, any scattered. you when findings, sort looked just Phase unremarkable nothing a of safety to at just say really study this like sort just there's it's So It of very study whether like like this, out of X they're time. study or sort any point

be community a be NUC the guess, first a enough. years answer plus that of very so was the [nobody] had of how but for which of core. for there for some that it I looking such regards just combination at so core obviously have, that the that, Even to among was to assuming a that were [ph] XXX upside, enough, always nothing would today, many we're be So no all a were wasn't were were long-time we're be forward. that, although, summary enough. case. plus - that With regards long people really that a finest though to concerning in the going unremarkable actually delighted, now, core a could to profile done anything And, planning would in It that was for again, we may others We cure? knows with that NUC still we not wouldn't we'll we we that real study the of inhibitors, the ago announced strategy, have work pattern. inhibitor lead suggest inhibitor with functional were and the be a wondering, be future, to believe. is the an a But exciting would we we If a the never it but because core assuming planning that theory,

of until is all stands enough line So up reported. going ideally, that's got against XXX agents now will see, and and is harvest I comparative that XXX, the know have we shown we well We've agents. pursuit to comparison down going now antisense a data oligos. of in-house. them. those try we're same model s-antigen - siRNAs we molecule goes And to that our what keep you we've result know oral after is of the animal XXX the And now, been of our in versus very right slight continued

hopefully So could of we alone. possibly year but triple triple, combinations think propel going. of terms again? asset to be as combine could on into could We're it until or another We'll next our hope count if an say, the we're chance find functional But enough? triple, things, be, not. in we all-oral sure we stronger core we we and give one cure, could rest might that agent, than that Could won't and could a could core we hopeful outside something of one. plus inhibitor out that be a NUC, in-house it might NUC on it down top that's it get be, that thinking suffice with combinable an but a that other mechanisms it a about third XXX you plus I generate looking NUC could be a find certainly hopefully, gives at we XXX that you It other plus possibility. of our that's our top a kinds that

- and we've ideally patients. to same hepatitis So as the that. be been need to mechanisms dream we aggregating to strategy, our to cure the but C quality do as that That's goal clear, our able to keep is offer - provide same our many

Unidentified Analyst

taking question. Thanks the for Yeah.

Jay Luly

You're welcome.

Operator

Your JMP your Roy from with Buchanan with question proceed Please next come question. will Securities.

Roy Buchanan

Congrats question. Hi, thanks taking on for XXX. my Phase for the X results

remind XXX Can it First like milligrams, cutoff? you you chose stopping you're how just sounds that us, question that. on at

Jay Luly

Yeah.

So these just But based we to on work exposure overall. pharmacokinetics, modeled importantly, done CXX pay the the concentrations, particular we the end, doses virus. pressure all X were to make sort good we sure have that the we of And - modeled Phase had healthies. in on attention of

And information safety PK-PD the quite of did. get Phase doses Xa, the establish from out so help that healthy it's well. it's really played a we we to portion, combination that And

remind That's very at exposures. And healthy the EASL XXX did everyone, think, EASL at volunteers out put reference, virtual XXX to I meeting a very, last and the we year. again, in nice give too. study back both -

Roy Buchanan

clear inhibitor, are guys that SARS-CoV-X for then Great. mean, I specific Okay. And the SARS-CoV-X. it's for you

coronavirus Just potential close combination have in might that potential, option your you any such And treatment pan future? the inhibitor the think development curious then in have you that specifically looked it? behind of you sense a be if polymerase might you not-too-distant do at have

Jay Luly

as as starting program along polymerase so far not the the protease. is so - Well,

the pads But goes, to both science build we are forward. And up, cross combinations. goal, bring So of on be - to if mechanisms and ultimately, press hopefully, them them things way some lag other cross need the the things ultimately able to to X down these catch behind. will

X Let's And all as hope be enough. for protease other to mean, the regards world, we then We well. will do agent with I to target designed at it. inhibitors look coronaviruses SARS-CoV-X,

have that something is possibility back more ultimately, So, whereas I we me to on think, up. but say we'll want well, - a there didn't that, let

expedient that an there to potency catching scan if the of on libraries As of we did you molecules by our characteristics with with lead be so weren't against we did in activity start we earlier. process, satisfied find know, the that compounds, forth, other just earlier whereas and saw had them. we and through And virus, a see so couldn't degree

extent harvest God will different and such position the our chance, against a of So library to be well believe were be did another including approach. clear, anything us other of of look much to chemical and than ever, kinds in a doing building do great put we're different prior multiple more a sure know in versus that to to molecules, able I be in design that more work classes there's And and a we stable to we properties now targeted we very beast hit had make efforts have position to more leaving targeted hits against coronaviruses, coronaviruses up to paneled nothing to coronas. molecules as But of will really SARS-CoV-X, here. this that we kind that had multiple that forbid, what really And SARS-CoV-X. parallel SARS-CoV-X. different a we multiple we was

Roy Buchanan

a that one anything communicate Thanks. Okay. can guys lower in that the else but the that on not last MAVYRET, I sales you actually yourself, the Great. know, first marketing But than expecting guys bit then was first were and we AbbVie sales one impacted have might in came seasonality And quite quarter dynamics. understand are you quarter? drug there

Jay Luly

Gilead still input that. Yeah. also would has a what impact. take on noted, No, said AbbVie I they there's from your And COVID

Roy Buchanan

you. Thank Okay.

Jay Luly

Yeah.

You're welcome.

Operator

with will Baird. proceed Brian question. from your Your Please with next question come Skorney

Brian Skorney

Hey, I taking about IND. to just mean submit either guys. it Start on question. for sounds EDP-XXX, or have my you an like good Thanks afternoon,

initial an obviously, or can And goal it just into in DNA think development was proof-of-concept early you terms not I necessarily mean, for sort of kind RNA patients? clinical the data? how what with the should about of I then, I here, And impact. antivirus, get how we mean, wondering kind of program healthies. traditional, So SAD/MAD in can you start of it's wouldn't

Or of I the reductions? look is what biomarkers mean, be should for to of sort the of the RNAi-based is therapeutics? considering proof-of-concept? at kind really what's comps here So here kind s-antigen other important Or

Jay Luly

Yeah.

XXX. similar it'll to be with path the I somewhat think

also might will clearly, one, that take you key reads time. a So of. able in But then the pointed we're be at out, which patients, looking right? addition at going of do of in to be will we mechanisms levels, healthies, First, RNA, X s-antigen viremic to DNA and be we'll to care our get obviously, and some into with other of SAD-MAD we'll HBV this patients as period NUC for look and

together expeditiously as clearly on will can. we in HBV get be and to able read of can as patients we getting being a early triple the hopefully as our as aims that X So

tuned on front. stay So that

the as first studies to I have next that be mid-year, see the mean, that stuff to of that saw done. on we'll what and half were aiming kind had to like in say we as had saw more do XXX, year, with healthy We we the order we on we getting have information, as can, healthies. next results dose we to it. in XXX. of other also the think, then but to take I the we knew Again, we're to we propel from to studies, quickly in because

going as detailed to healthy the the So and a patient how get outline data of I in have upon embarking prosecute studies, terms very we share we're we to that. we're think

Brian Skorney

to kind a really are we the potential for to of And, inhibitor? resistance. and potential guess, sort SARS-CoV-X the don't lead. a there's well of comfortable do I talk an on inhibitors, and think guess, the monotherapy bit the without utilization monotherapy and drive pressure. data at of, regulators your rewards we about And I that conservation hesitant of barrier context want the of know generally in of antiviral And think, selection resistance? all what about specific Great. program, about sharing mean, inhibitor ability I selection potential protease just binding I I protease you'd if pockets be know for important on pressure of protease a about I use to mAb characterized how

Jay Luly

news talking durations treatment program Correlate that. of dosing might we're Yeah. is, our or Well, thinking days X about X the think duration, period maybe short RSV looking about drug about right? and like hopefully is at of good something that

good. thing So that's X that's number

the that highly binding for after we're pockets The not that after going going is conserved spike we're survival Instead, are with virus. key other the of conserved protein. targets

the in would opportunity challenges. targets to to conserve I minimize conserved So the regions take you're strategy these and go best of that about be could think you inhibit these trying sorts if sort of

we're for. I mark the on what think So that's

the excited so early this target And well, be go next into to And in X year. to pushing soon. we're against good, so inhibitor hope protease our far, be again, those if studies IND-enabling we study Phase

Brian Skorney

Thanks, Great. Jay.

Jay Luly

welcome. You're

Operator

question. will question Tewari Your Research. your come with next from Wolfe proceed with Please Akash

William Lee

Hi. for Lee our Akash. This Thanks is on questions. taking for

being the with XXX notice target you treatment log starting the mg have the we as think think, to led in reducing COVID. And protease you of mg RNA. a versus you the reduction that polymers we I the very X is, between level? response first RNA COVID inhibitor interesting about question inhibitor dose XXX, like both well XXX Did Previously, second I on for noticed the mentioned program. any as mentioned

protease So now forward you inhibitor. a moved have

pathway. any X terms in And different related molecules do both there pros safety? the on RSV you of targets, amylase plan is as is wonder both these I comparing more different to the I cons like clinic? efficacy the question of think in as in to well regulatory test So last

Jay Luly

we pause with Maybe we'll questions, just it. keep there so can up the

small So I I'm very I mean, we We dose not response, this And XXX. - on sure. to - Nathalie, a the comment again, do in response? you study want think, dose any is

Nathalie Adda

Hello. Sure.

maybe each can NUC-suppressed starting obviously, clear dose to group. that our think that expected is you a see I the totally It we number to was complete seen dose what small in we have the have I in but would of say, clearly don't So just as think I Jay have not us, response, of patients patients.

[April look in talking we XXX with size] you with at a the viability [ph]. that and [ph] milligram of small of could very sample the have size, more bit patients, may assay if resitimic] a say the proper Now, deal again, little RNA. [most But, we're viability we decrease maybe

we doses, we the all sense. very have we once get data will the think, NUC and compile better data I across all the a So, X together

Jay Luly

Yeah.

X and NUC-suppressed So to the in this - to and see only much got if think viremic patients more very going typically. a see minority in opportunity responses. start And were we'll see them with study. the are positive this Again, in dealing elevated again, obviously, greater they I RNA to you and going larger data, the they're of dose doses population probably And to you're that small a of be patients, be changes DNA with, we've the usually, not e-antigen changes the third.

have do Some selected selected. the to other didn't studies e-antigen get positive patients that. We

[e-meg we past] [ph]. the have So in

your clinic? we're Regarding I your targets. prosecuting understand if would your there, into polymerase, question about PI right? like and question, question, we the was And take Did them both we're successful

William Lee

terms Yeah. like you cons these and like of pros the level, in any And X targets? - high there safety just in is also do both between think efficacy and

Jay Luly

Yeah.

really can - say, inhibitors to protease cons have a no Within non-NUCs. data of polymerases, broadly other no one either and than or versus knows you have rationale can speak either different yet. compelling both work. I classes to across just pros to we think polymerases, NUCs these There's with or

Sometimes NUCs really have an over down molecule. can individual it comes just safety to challenges but non-NUCs,

again, beyond were think molecules that both So, reasons. we mature wouldn't need have therapeutics I We're do. on analyzable for if - vaccines we that these the to to mechanisms think to be obvious these are working obviously can let so we what need said, people didn't both to a try. ones the That little that bit, data compelling field sets get bullish understand these very will some clinical they on

William Lee

Got it. Thank you.

do have on I percentage outcome RSV you based on specifically progression design regulatory for pivotal time respiratory my any to be discussion for infection the the maybe or selection, I endpoint on could last specific wonder, thoughts example, any about pathway. to lower the question FDA, selections, it of trials, is think hospitalization? with your the

Jay Luly

Yeah.

not you've endpoints. discussions need discussion. Xb appropriate on then these the registration So to finalize until our It's had to with agency over Phase comment that that we'll I think have program we

William Lee

Got it. Thank you very much.

Jay Luly

welcome. You're

Operator

proceed Your your from with ROTH Please with Zegbeh Capital next question will come Jallah Partners. question.

Zegbeh Jallah

you. Thanks all guys. congrats have a and on few I ones for my progress. question, quick taking just Hi, for the

just you're not something if program, could don't moving with first, have to to going you move trying the and HBV that get that? your triple perhaps a your think even if be Jay, I didn't a you toward cure, cure to approval is clarify with will have you produce if not forward forward

Jay Luly

I don't that. I No, did said believe - so if - I

You you X you have you to a you, need mechanisms of that if treatment a isn't to keep - a maybe And duration have to populations third was trying I enough, think, maybe need need add a to or fourth you if there's what isn't enough, longer add was what third. maybe certain explore patient I say or further.

what I different to no, especially, know will think premature triple that it's like this, look many cylinders. given the So so in really hits therapy one

on other or is DNA a lot virus. things immune other ability systems can to take robustly a NUC a And really but of NUC NUCs I in think, to But and obviously, the a brought mechanistic on we other we're what they interest core of the to something to which for If do of to affect being among number the inhibitors that able plus fully of s-antigen. - have mechanisms lot things, through, sort us, the anxious virus. get is foil a against pushing core points that's addition like are affect into this have a mechanism. that don't we of s-antigen,

want because all-oral an we hopeful if If keep to do that. that of for another impact. But we're a mechanism, going major to until can, we're in with rare to opportunity, agents And be HBV or not fairly finished say mechanism adding, that ultimately our a to is about we to quite of it's the add the we're - to we'll along we're other try can we'll stimulation said, done. triple, we're you If have we an treatment. now, our which talking having mechanisms it's else, knock represent track regimen, something like need more right on I landscape X able all-oral of whether down immune we're that continue the explore that

an want we doing, you to what is others what build to thing Obviously, mean, boost, an be things it other could give an arm are there to easy on think, I can I there could do and interferon immune that. continue see we could if to is to that look too, on So, out tack do.

and So to we're there's you that do easy want now. arms, about in part ways to quad, obviously of build of if things your the all thinking kinds right

clear, think, bullish into going triple. to very I - the very So we're all-oral but possibility our be of having

Zegbeh Jallah

Jay. Thanks,

Just to that. a follow-up

and longer is as of this combining in duration other wondering to of of the this investors perhaps coming toward? kind just either Just up on? our with kind is log keep to eyes it terms what Is cure that data Or analysts just be a viremic with wondering agents should and be difficult we - perhaps treatment looking what the but it for, lead signals that or perhaps one, with should what whatnot? looking of could should difference? especially we your But

Jay Luly

out back now DNA looked side. at on These we're so this safety, we've tolerability that the safety, pharmacokinetics looked Yeah. and on tolerability viral going top patients and be to a higher in healthies. the and at HBV I NUC, loads, we're had just it's in study, patients NUC. - will pharmacokinetics would particularly We've and say, in of now next the

again, what some The hopefully changes so, that can you we never to see reduction much effect are as to these changes see types is, in RNA. see should on extent, studies. RNA as want probably, it's usually we And lesser a in DNA. a viral of solid the DNA And very

be levels reduction, things and So give at safety logs green load a viral us of a will trough couple that solid light, seeing of good These seeing tolerability. all good good days, XX help [ph]. [doses] moving define really light, XXX. for dose dose again, terms future ahead green more terms studies It's the optimal advanced of with selection of light in to, green helpful in into

would for. So looking that's what we be

information of is a prequel kinds good sort terms we the today think of in I of get.

I information be should HBV get think DNA. addition, able we in on to just,

to see that period. going not in a You're antigens XX-day on

Zegbeh Jallah

Understandable.

just studies thinking your about I'm me later are difficult that But their the to wondering, even program, people use But when least, finding, cases. are with just I'm with XXXX, you, from pediatric think just in may getting filing those wondering high return, like where ISB included, they I for Sanofi the for pediatric, cases similar do perhaps excited, sometime it? teaser to how you're find at HBV. regions for GSK on talking affect RSV moving there very noted the drug

Jay Luly

which people more work, used Yeah, looking when SYNAGIS, I premature for antibody version a they're monoclonal used think, a longer-acting prophylactically that. and births a has is therapeutically mean, did that not I of high-risk well, been of potent historically in which - got version

to and And B, to A, populations. it just it wait then, have target see, so, you might the how the work; has and extent patient efficacy in

you're sort think One you're getting repeatedly get of get - children up see kicking natural And to going RSV down a ways, to some the to things if They when children to of partial the is RSV. exposed it's immunity a it. can build they're not to the virus, a road. they're sort the in then I need of

our exposed infection children, year prophylactic to and a get will setting be with to group what a the of to next age them RSV pediatric first it's prophylactically So treated start antibody, be not ultimately just they're is that in being first I treat. life, up of these of a out first and especially question would there. suspect season think otherwise in going RSV younger a there right? if the of season drug antibodies I treating exposed, on on that antibody, you're So their But they're go the monoclonal lot they're people

Zegbeh Jallah

have thinking of just put be mouth, for words forward? you're the want again the do or you at your but don't clarification Thanks, or data, just last a combo NASH to And moving when about agent then, get as here time, of a And last as the XXX, I program, XXX one looking in will whether Jay. the like not me, about thought be I same XXX to regarding want just XXX you'll going use single XXX wait both but know might decision be in it but hand a the a data was don't move the coming to delayed. I datasets those and at forward. you're wondering seems for little if bit, making I before to

Jay Luly

the on answer can't relating a have - data to we until the make Yeah, XXX. I we think decision XXX

better be be think anytime because just datasets chance the think it'll relevant with And the and we impact. are drug think, think classes again, ones I do see on will But So previously, of is be to NASH, the NASH, program, you'll I is as of treating find combo right? for as running and more look to to I have our to clearly. higher by against believe optimal combos to a our it a and goal need higher at them, all get ultimately, supports that to wait soon as going combination that But the dataset to X, you that do getting And doing going we've come stated going sooner data here put I into combos. something, And patients patients certainly mix I in sure. anyway they're of treatment FXR way optimally. start trials, have partner not up ultimate before Phase only that I partner make to a efficacy FXRs for

But that's harvest need So we about. the we're just thinking to what data.

Zegbeh Jallah

you're sounds definitely a on that's XXX it making a also consideration doesn't then, like but the case. data decision as wondering Thanks. And if your And is I just for combo. waiting was the from XXX, comment like XXX up last before for sound

Jay Luly

which we in be and again, consideration until up program analysis on we the for I X all see molecules totality make different our the includes complete combo. think the FXRs data. a of be Right, think I won't will able to strategy, FXR

Zegbeh Jallah

Perfect. Jay. Appreciate Thanks, it.

Jay Luly

Yeah, you're welcome.

Operator

no do we to in at to the now I'd turn Instructions] call Jennifer call [Operator final further questions. at to remarks for At this over time. for like be one And this Viera closing time, will queue. back this questions appears there time,

Jennifer Viera

you, Thank joining this us afternoon. for everyone,

not to out Thanks questions, so additional please us. have do hesitate you reach If much. to Bye-bye.

Operator

call. today's for concludes participating. conference Thank This you

now may You disconnect.

Enanta Pharmaceuticals (ENTA) 10 May 212021 Q2 Earnings call transcript