AVIR - Earnings call transcript Q1 2021 | Atea Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals First Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call up for your question. I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications of Atea Pharmaceuticals. proceed. Please

Jonae Barnes

outlines Good financial welcome today, results a release Operator. first Atea we everyone. plan press XXXX we quarter conference which afternoon, you, to And Pharmaceuticals issued to Thank discuss. topics the call. Earlier

our Jean-Pierre well me then the Officer, be President that Presentations the Executive Chief on call Event as today today the to Chief of Corcoran; the by and the Chairman Founder, of call. Financial slides will Executive & You our Janet Q&A can going Officer, release, and Chief Vavricka website Investors today’s Chief as for of Sommadossi; With access Hammond; be John the press Atea, from at Development Andrea available also we’ll portion ir.ateapharma.com. Commercial reviewing Officer Relations Officer, Legal, area section

COVID-XX On presentations will clinical the publications for the scientific a call review review provide Andrea and treatment our milestones. will will the of a will AT-XXX today, our for financial progress Jean-Pierre provide recap recent of update of dengue Jean-Pierre and for AT-XXX for fever, Janet upcoming the AT-XXX. and treatment

you the Before that and mentioned begin in risks forward-looking today’s contain discussion uncertainties read. the Securities which statements release and uncertainties to press encourage you today’s recent like These call, with will Exchange remind company’s we to as risks two. filings on that outlined slide and and involve I’d are we the in Commission,

the call. over actual that, Our to materially differ turn what on results may call With discussed from I’ll now is today’s Jean-Pierre.

Jean-Pierre Sommadossi

today. afternoon, thank joining Good for and us Jonae. you, everyone, Thank you

and of drugs mission to for severe of viral to continue the and discover our We develop meaningful diseases. progress antiviral prophylaxis treatment make

prodrugs are prevention for pharmacological have treatment diseases. viral uniquely Our and suited that nucleotide pure of these the properties

antiviral including of of activity, polymerase our selective advantages, viral patients a worldwide. offers platform Our administration all and life replication many conserved convenience all cycle to RNA scalable essential target polymerase, candidates are designed millions potent viruses. highly targeting these We enzyme manufacturing, to critical -- and the drug of believe when

important conference very our have clinical micromolar. results a slide were also in and consistently Phase Chemotherapy. preclinical against the Research preclinical in at to COVID-XX March supportive Gap]. the our presented vitro on included activity is the International for been results, as the SARS-CoV-X As ECXX of reported communications invited AT-XXX, overview meaningful AT-XXX animal Infections in Antiviral supporting AT-XXX so in on include achieve the SARS-CoV-X Opportunistic predict a underlying of three recap validate the level data replication, for the on Agents is of presenting from Conference on demonstrate [Audio this modeling our Retroviruses data last and rationale in ICAR. tract should we on the of manuscript We X highlighting the The the present Phase treatment well far or drug mechanistic lung initiation site call, X.X Since levels our and CROI. publishing a AT-XXX preclinical to Conference Antimicrobial models, scientific and results year, we as the above data X drug levels as for lungs. potential and active of These be results these publishing at or respiratory and favorable We which

AT-XXX metabolite of difficulty pipeline diligently polymerize. data in and preclinical encourages have the support interactions dual clinical unique comparing to of is A antiviral elucidate to against manuscript us accelerate mechanism development and this expand This diseases. action growing evidence review. triphosphate treat peer currently molecular and the a of of we for with addition, viral and and active submitted to of of variety RNA platform SARS-CoV our been has very and our biomarkers of worked important the on body is In AT-XXXX, AT-XXX model prepared in

now me turn to Janet, will call Janet? over Let clinical who the review development programs. our

Janet Hammond

with would continue infection recovery, to treatment their with believe impact our similar shorten I’ll challenges global the for a multi-pronged partner that This complementary meaningful our phase believe early COVID-XX. or challenges or the both prevention including accelerate it may lead to essential potentially be we program and the with clinical role of approach attended has treatment that in AT-XXX, overview and Jean-Pierre. face of key COVID has COVID as a in SARS. evaluate believe treatments which pre- we DAA with replication a the of a reduce for the an XX maybe visits. with of ability the medically potential you, to conducting vaccines. XX play inhibit disease product use based that are the and the in virus reduce We to It to COVID-XX on to will time impact treatment candidate prevent begin the the of paradigm slide ways and Thank as profile, oral aim can view post-exposure health. We potential also We direct-acting COVID-XX rapidly currently progression, for On we lead reduce DAAs to on that the can in hopefully prevention Roche. five, to globally essential to is viral address to that sequelae. exists an DAAs and use transmission influenza. These all with antivirals will prophylaxis. the are objectives of AT-XXX long-term We hospitalization, and

Moving an will our highlighted beyond, trials it to plan our the roadmap will readouts a multiple as to launch. form we eventful to by expect near-term NDA partners, conduct series submission and summarized, global AT-XXX to that of six, be XXXX Throughout a with for clinical be and we delivering data year Roche. product as slide we

later in second X of half program Phase this from year. X the the quarter we the Phase from We results expect and the interim trial expect biology global data

initiating we addition, In anticipate study. prophylaxis a

a the factors hospitalization. must randomized with Patients This approximately to not enrollment will or were of attended Roche multi-center of outpatient global will The patients five April, patients Other being without to and evaluating the is excited with patients compared seven, hospitalization visits in Moving within evaluating or be MORNINGSKY COVID-XX. adults States. an At slide AT-XXX mild be of COVID-XX we X enrolling will trial United X,XXX enroll partner, the of in in the initiation moderate is for trial, onset. stable number the we requiring risk patients the require symptom measure We and announce endpoint endpoints mild currently days anticipate of time primary COVID-XX. AT-XXX outside include of setting. and improvement trial alleviation or our to with conducted medically moderate time COVID-XX or symptoms. placebo, the adolescents to efficacy with efficacy of will Phase

among study response Additionally, endpoints, AT-XXX. exploratory other are and will secondary of and/or an identify also antiviral the that evaluate to predictive biomarkers

eight, in the with the continuing with we tandem to in Phase X patients. are program, X ongoing to hospitalized study Moving slide Phase make progress

within the I symptom requiring study patients of to which this number data on to report study five some features study strict We hospitalized placebo-controlled setting, days of less have like onset. inclusion of this is been hospitalized of from patients meaningful the or would virology our in interim such a expect as with later highlight quarter. a to criteria,

In COVID-XX respiratory addition, no only support. require our who or patients includes study with moderate minimal

study be and most a setting. profile You proof-of-concept Phase main a safety for antiviral of recall dosage, conducting Phase importantly, for study and efficacy hospital X will confirm study monitored data obtain this this a to this is We consider was drug, not reason in which trial and the be proof-of-concept to supportive for will the is where the that X able statistically part. we

AT-XXX PD Moving trial to activity Phase slide compared safety, antiviral and PK the X with evaluating placebo. nine, and is of outpatient

the is enrollment the X sites. this The statistically trial expanding continuing initially the is proof-of-concept the Phase if important in study the tolerability population should with it we a and challenges is this used, the where be target is again, of U.K. safety supportive of the data, setting. This approved. for is the drug same will which outpatient globally, majority powered. Once trial alleviate Phase encountered and For setting anticipate not X and is footprint

now the of continues prophylaxis to treatment in for and double-blind, selection in patients. settings a initiated multiple-ascending study Xa enroll the to we single- of March, our of up advance. the Phase fever. to study dengue healthy future to establish In to the and Subject XX. AT-XXX, XX pharmacokinetics also The dose tolerability enrollment evaluate treatment objective as just subjects. to Let’s randomized, study and program -- tolerability slide to dengue is turn AT-XXX of AT-XXX of a AT-XXX in and for The dose out Xa is roll of fever safety placebo-controlled, on Phase support prophylaxis anticipated safety,

report We I’ll study data financial. the that turn year. the With now of over overview, X the expect to review to of the call in for second the Phase from a Andrea half

Andrea Corcoran

Thank you, Janet.

operations of issued mentioned XX statement of and her as earlier press sheet and Jonae March in quarter this As our of the slides results balance release financial The introductory XXXX on remarks, XXXX. a are XX, we afternoon, containing for XX. first

increase increases of external principally report an in quarter clinical to increase quarter Roche XXXX, driven and For development the the first an increase expenses ended of of AT-XXX and expenses that was for dengue in to with exceptionally in share a and we primarily clinical personnel to incurred and administrative development being principally related our to our XXXX personnel increase an to COVID-XX comparison an and expenses. research first heard, in AT-XXX, expansion support consists payroll first increase pleased the in in was with for manufacturing due included expenses. The quarter expenses the developed strong due and treatment advancement and our development by is of which balance sheet primarily expenses conjunction costs the in lesser These I’m in incurred the spend you’ve as primarily of extent in organization programs. related fever. general internal to by

the on end cash the our our restricted our $XXX.X note take lockup each available quarter, of the will to for run trading from XXXX cash the would to advance anticipate recently I of were rate pipeline of beginning cash also results, like programs. equivalents financial April us previously became and that Apart million. expired XXth. We current As first and through shares IPO

experienced I’ll trading closing now back turn call this continues. around As event, volume an for Jean-Pierre the over to expected, which in we increase remarks.

Jean-Pierre Sommadossi

help administered Thank the of our milestone significant all a XXXX in and and off the MORNINGSKY of highlighted initiation global the advancement toward a COVID-XX to moderate available a easily This AT-XXX mild represents widely strong is Phase study was of data trial quality virology patients Andrea. to of providing X our X second setting. by global to start developed the you, forward this outpatient an goal of major later We fight in antiviral treatment sharing and pandemic. look program against of from half fever the the Phase for reporting Xa Phase to in dengue prophylaxis from this interim which for the and XXXX. AT-XXX, is being data AT-XXX

We report benefit in to to expect continue of these advance pipeline our drug to worldwide. this the and later antiviral candidates order and programs make to with important in We our programs progress progress remained the mission steadfast on year. patients export these --

the the drugs to We right to right the people, potentially bring lifesaving partner programs market. this and right have

Operator, the that, the support With open up we now questions. mission. will Importantly, have resources we financial call to to this

Operator

[Operator question is you, J.P. Joseph Instructions] first from Morgan. sir. Eric from Thank Your

line Your open. is

Eric Joseph

Good you. questions. the Thanks taking Thank Hi. for evening.

you or of an update studies on of X of you should there could Phase later data a partial if the maybe the in and a it’s your hoping expectations update enrollment quarter full of even bit Just and trials, and up? provide follow reiterating both should anticipated expect a we then timelines this kind hospitalized the where guide for a progress outpatients number latter, be I have it can enrollment

Jean-Pierre Sommadossi

Janet?

Janet Hammond

the for question. you thank So

either that completed have We enrollment. -- anticipating study we’re not will will

the to able believe We will patients have be the our understanding be that we this hospitalized we of provide will in study. and substantial number to data hoping our with that -- on trend of report in are we associated a I a will viral drug able connection

coming sites I really the on footprint As its outpatient mentioned considerably has stream expanded now. time the are earlier, and all study

us the anticipate expeditiously. And doses. design pretty enrollment move So to that that forward the allows we for actually, of different will explore study

in cohort cohorts So cohort the that will to of we from they -- be look will we will first end dose from that -- Roche quarter. an the at. initial patients we that there on of have And report on will a believe second data by

Eric Joseph

there it participating currently trial, factors X geographic approvals to the facilitate you facilitate registration Okay. in or do remaining number a initiation Phase and of sites are or of of participation in That’s the about minimum MORNINGSKY anticipate relates patient the U.S. distribution as to -- the you gating talk patients a U.S. there? could Is Thank you. really the to And helpful. minimum what sites

Janet Hammond

hear Eric. what -- I didn’t do anticipate hear you what I didn’t I’m -- sorry, I said?

Eric Joseph

participation number minimum A FDA? to U.S. of registration patient facilitate with

Janet Hammond

to the So, the and are gets as the Japan open opening is fact up countries approved, -- we in still and at including other around Europe moment come. world in countries are study in seeing the countries with the more CTA there

able be future around we’ve in good We to that with anticipate FDA progress U.S. issues the we patients foreseeable the them. enroll will we are resolved with the once making in and that

representation that we the study. there So U.S. anticipate should Yeah. of in be

Eric Joseph

taking Thanks I’ll hop queue. in questions. for back the Okay.

Operator

from is question Stanley. from next Your Matthew Morgan Harrison

Your line is open.

Matthew Harrison

Thanks afternoon. for two questions. Good the I taking Great. me. for guess,

First, that’s about the these confidence first you drug on in exposure decline X just those viral the think in know and around enrollment reasonable faced terms you issues of maybe enroll in the to you Thanks. guess, about load what get given initial data, being dosing separately, is of talk I Phase with quickly? And patients? can your of just that about you think can able studies, to then, some expect from you cohort, us what what help we interim levels terms assuming

Janet Hammond

So around very -- is that outpatient the a think X study enrolling the it’s similar an population -- really to confidence Phase the I study.

We’re for COVID-XX. mild with patients looking moderate to

Phase than which makes it’s I I study, think want a lot to more say, the would for think interventional, a lot participate. to people less I patient-friendly X it

in and cetera, Phase that collecting collecting We’re the et studies. viral the pharmacokinetics, of X we loads the not all are

considerably a that perspective, So for intense footprint, study. easier that and a it’s this confident patients from pretty we’re has to larger less ought special less because be and significantly

considerably have So we identified faster and enroll more believe study. that that actually that for sites study will than XXX we

have dose With that selected to pretty studies, our ought was So experience modeling the again, study have of be go had and from able conducted Phase in already preclinical modeling C AT-XXX we also that the with those to in some the that we and selected that that, hepatitis from we in Phase to dosing and X data on it support we which the regard the anticipate already that. X dose also collaborate derived that for quickly. December, studies the we selected for

our been in in lung days and first And so seen something And drop and anticipating we’re correct antiviral like the range [ph] what a order with the has that to and with good study. few to load good antibodies to of a in the see dose the in be confident seeing by a effect. we also approximately monoperugia viral ought the in we’re see effect, antiviral that does would pretty in

Matthew Harrison

much. very Thanks Great.

Jean-Pierre Sommadossi

Thank you.

Operator

is question next Jonathan from Miller from Your Evercore.

open. is line Your

Jonathan Miller

an Thanks for trial pandemic for the going for how -- Two this later where of inclusion different? is me, and should are to the the think course latest there guys. given about on indication? then your instance, thoughts post-exposure utility or criteria taking bit oral demand you the cadence And far for similar How XXXX, broad population are year? see in for what’s for year that little secondly, this ahead? Hey, the mAbs antiviral so a to I prophy starting this Is the be question.

Janet Hammond

answer want the then, So I’ll perhaps second. and John, answer you the to first might question

actually to that working the on inclusion prophylaxis study, with for our we’re protocol. So still criteria regard

But anticipate can’t much Phase I into you or our comment believe that of their in down give the patients we too specifics. way really we enroll So X we that will study. in teens

that we the for a profile people anticipate qualify going allow take patients population. you. disease our infected or benign the to interaction be drug. to we drug John, would with that the would is So so believe broad over anticipate We to for pretty drug to many this

Jean-Pierre Sommadossi

John?

John Vavricka

Sure.

need demand for this for of the in and to vary, continue a next One obviously, even is variant reasons. we most particularly rates an that the introduction for So to companies be see of as States, And for likely the for booster. both the United have year as with that -- continue that need antiviral need said are, vaccination couple that various a evolve. oral into the see year, we far need will and for a a vaccine the to ongoing a

the reasons will of all continue there to need see for those So continue. we that

Jean-Pierre Sommadossi

also, important direct-acting -- to of becoming sequelae, Phase XX% on is just individuals X, major we study that John, know, follow-up as that, as XX% COVID-XX. that our such that impact add long-term think got the our what’s will the AT-XXX issue to with evaluate also is I you to that antivirals of will a in

So, even importance long positive, with the to of sequelae DAA data deal that of the the term emphasize also will if are disease.

John Vavricka

see to I for I of identified one asking And opening was Jonathan, a about in prophylaxis. And And the forgot that, thing cases asymptomatic with that, world. started direct-acting of be up seeing will ramp around really up lot testing you’ll we that course, a this of antivirals think, well. post-exposure case, as mention, there you’re

Jonathan Miller

what the maybe more factual question, plans do One like? look those sense. Phase for have X interim Make you and just analyses might in

Jean-Pierre Sommadossi

Janet?

Janet Hammond

interim We we analysis whether will do some determine at point. need an to

flexibly really I don’t further. at present think can is the I written but protocol time comment the think I

Jonathan Miller

much. very you Thank

Operator

question next is… Your

Jean-Pierre Sommadossi

you. Thank

Operator

Tim William Lugo Your is question Blair. next from

is line Your open.

Tim Lugo

the taking congratulations and on the question progress. for Thanks

going see I be similar the just a it But be maybe don’t decisions if behavior, I you’re of don’t trial? seem language of the mAb you to trials makeup collecting when factor? now X for the it’s run, are easier program. five a risk the genetic does any like you understand cumbersome. understand factors assuming MORNINGSKY, And virus so kind much I run, not clarify obviously, is and Phase circulating will also like significantly enriching want But trial risk different. a whereas risk how you For mAb, on data sequence to to patients in to of be there’s right within are Can days symptoms. about

touching So maybe that? on just

Janet Hammond

you. Thank Yeah.

broad to So with believe profile of regard allows to us drugs treat. a risk we the factors, base that for to look our patient

the mild XX% to up designed least without is where may. instead at XX% fall COVID-XX and of I with and the moderate so factors. and to will at of of MORNINGSKY -- least, to And to factors should up have said patients XX% enroll at with risk then patients XX% study say, risk And I least remaining should they

with Jean-Pierre So we mentioned people study, to already, drug sequence both points benefits considerable when they patients has that’s how understand risk think works without to in during regard plan antiviral think will a time all direct-acting factors with we study then entry really and for that capture populations And plan and the populations we on the to that are as other both to important. to and there potentially. sequencing, study the And we undergo sequencing. in

degree but we doing of information to the So X have plan the do that not intensity available, Phase in we’re obviously. that studies, same as

Tim Lugo

classes talk RNA out the Oh! there can of versus concern, of upon hear. target? the relatively and antivirals should sequencing and just And the of a globally about Great what just be maybe polymerase conserved to you variance targeting maybe other touching some

Jean-Pierre Sommadossi

what from for to a going unfortunately, is see be breeding ground today, variance. Tim, India we actually,

any what neuron drug that DRP acid our least not and so affect India from variants the been or reported not the [ph] by do have have site. far so the India of active do we seen the amino far function at affect And

drug that believe to against be all variants. continue we should very So potent our

the Janet X is Europe, indicated has and hospitalized patients enrolling Africa, As there percentage. significant Brazil Phase in where in in is patient the past, variance South Eastern

now evaluate as would that sub, as the vitro base they [ph] contract variance the in lab NID of the AT-XXX I system. we free in the say, AT-XXX are in Finally, anticipate

have of virology but interim in for we data, have that June, demonstrate vitro promise together be I in the to sub-quarter, a important the will hospitalized end we’ll So, will our cannot obviously with our soon to data the the also early which we also definitely will global very by especially do patient also interest, sequencing Phase we X the variants hope treatment. and have at with all same. the Indian baseline available, after have we Phase as lastly, And full as the and X the

Tim Lugo

color. the for you Thank

Operator

further like Jean-Pierre no time. questions conference showing turn I to would I’m the Sommadossi. to back this at now

Jean-Pierre Sommadossi

I am sorry.

very much your Thank and we thank attention you very appreciate. So much. you for

Operator

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

disconnect. now may You

Atea Pharmaceuticals (AVIR) 14 May 212021 Q1 Earnings call transcript