AVIR - Earnings call transcript Q3 2021 | Atea Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen. Welcome to the Atea Pharmaceuticals Third 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 questions. I would now like to turn the call over to Jonae Barnes, Senior Vice President of Investor Relations and Corporate communications at Atea Pharmaceuticals. proceed. Please

Jonae Barnes

outlines Good financial welcome afternoon, results a release operator. third Atea we everyone plan press XXXX we quarter conference which afternoon, you, to and Pharmaceuticals issued to Thank discuss. topics the call. This

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

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

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

Jean-Pierre Sommadossi

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

nucleotide enrollment, AT-XXX will only on interest, and platform. In the data direct-acting AT-XXX for trial antiviral designed progression candidate major COVID-XX activity MORNINGSKY administered protect Slide complications. agent is our including activity protocol to is a have X. AT-XXX infectious the amendment in antiviral Delta. and of long trial variance and potent purine rapid COVID addition disease updates our assay the from against concern to to new derived development vitro demonstrating confirming virus the antiviral Phase against for the III MOONSONG and it's financial number to prodrug accelerate an a of quantitative product results, of AT-XXX or begin I AT-XXX for data for we potent plan to review, from including the

weak no is that of across as which all a a and transcription. chain generally -- interaction metabolism COVID-XX targets. intervention since shown mutations highly with clinically critical we essential dynamics becoming expect share safe cytokine to stemming be with adjustment drugs. a Uniquely, than dual this therapeutics resistance is application and RNA the AT-XXX it viral no and administration viral medical polymerase, was enzyme is will XX% and targets the expected in -- AT-XXX be for core also of -- not toxicity terminal potential reproductive is well dose mitogenic, the a we enables with will activity providing is substrate thus base. note, more AT-XXX of account it's mechanism variants in pandemic tide introducing a the -- relevant and Of AT-XXX which It conserved you create few And studies, Given tolerated. minimal future endemic, drug-drug In is and particular in in of new evolving inhibitor to minutes. of the high drug surges. for all AT-XXX to of the antiviral and particular variety without

make worldwide -- continue and genomics evaluation of can results make clinical surveillance symptoms. prescriber of should prevention. challenges to impact trial more has differences well clinical viral ability also and of challenging These Slide create this to variants as rapidly our such Ongoing improved the X, identify the kinetics in variant. variants as because treatment On concern and So execution our COVID drug new candidate friendly. for

circulating subtype -- endemic on variants been outstanding the number. or has led The for to continuing a with variants neutralization will spread and Delta an new The severity. come transmissibility, increased evolution plus make disease years been to of this see Delta of COVID-XX ay.X.X interest carries continue mutation. to called additional almost have have associated -- resistance which As of the with X,XXX you can chart, sequenced ability with

basis, the contributing Although XX% remains the the of accounts most in original dominant U.K., from recent variant research and on Delta mutant a the -- September is new this just surge X% than up more less global infections of the now for likely early evidence Preliminary plus more frequently of between Delta strain, an wave including XX% become the fifth spread and Delta Eastern household other Europe viruses global in and among members U.S. COVID Western and the suggests likely with will and important in other areas. XX% that compared to

X. Slide to Moving

drug candidate highly of you and know, of including our a evaluated slide. concern the -- SARS-CoV-X AT-XXX As with dual variants was viral We this can believe confirm is against recently original We Delta. of interest, polymerase. that inhibitor recently, RNA human Consistent of shown including mechanism Gamma -- key average AT-XXX, the Alpha, free potent isolated the -- maintained previously have advantage against AT-XXX, in variants in with which fivefold or it's that action, cells a potency it's tested, the candidate you in variability XXXX primary of micromole mechanistic assay as this around we The targets assay Delta. all virus see major this conserved data approximately the in to the early drug -- X.X vitro. base assay more against

I in With database turn than over have million SARS-CoV-X of we review detailed SARS-CoV-X In a Janet was sequences our over will the the less that to for found more mutation X.XX% fact, date of now site the programs. analyzed and clinical near active call deposited polymerase. to that, three the

Janet Hammond

Jean-Pierre. Slide X. Beginning with you, Thank

our XX you can running robust this clinical of on slide, includes in six see As AT-XXX are program parallel. studies which

AT-XXX from next program key cohort the results the XXXX-milligram patients advancing in of our There real our slide these updating from each of dose this hospitalized which We we first the BID year. are updates and lessons in time. half better are to expect leveraging next include the learned and in of two on study

and end a to a refined review will we I point, enrollment III patient update MORNINGSKY are dosage. accelerate addition, completion. plan primary the of protocol In end we presentation. my the towards population an a amending And MORNINGSKY trial increased have Phase the new with

Turning to Slide X.

to virus continued has evolve, it of the regardless obtained has be virus. This trial antiviral in the next important to the have a for assay on to simply direct of to of virus COVID-XX new assessment acting or the this virus all RT-PCR is assay fragment. MOONSONG available accurate difference from virus measures ongoing a infection. the by quantify now the review ways obtained an As forms infectious RNA non-variable of which I or we sample, intact replicating AT-XXX from infectious is so assay. effort, addition optimized viral quantify considerable the impact from more infectious whether virus the is it results using that because should -- from will After

As it outlined challenging utilize and of patients in our highly Previously, but SARS-CoV-X on Measuring live effect sensitive -- related partner, the field our assay. type advance. an virus methodology this Slide -- of been an from has our assay highly antiviral order -- candidate virus a has quantitative quantitative the virus very optimized, our of data in drug using assay. is evolving live is swap qualitative more important specifically for XX, collaboration sensitive Roche, samples developed during by development virus, and CRO, the reported the with to infectious assess live was in from

so -- the XX% equivalent all -- from A B asset three we in On seropositive the approximately with XX, majority the are cells rapid -- or in or is at the to the fragments population, Earlier and positively baseline As samples possibility by was by viral assets three patients today, level is [ph]. enhanced infected reported RT-QPCR this -- low-risk Cohort viral SARS-CoV-X milliliter. And the thus that the -- with placebo secondly, highly XX who and that newly of noninfectious note MOONSONG assay to negative, study B we with actual at infectious six this a assay as after very no which in detected incubation, of was eliminating -- milligrams MOONSONG thirdly, cohorts culture. were infectious key versus being susceptibility sensitive. slide, -- high- quantifies Please illustrated and developed reporting it as inoculated specific BID SARS-CoV-X analysis days potent of Slide reported. overall includes viral infectious only in This modified it is load particles virus X,XXX demonstrated including half optimized with positive qualitative, AT-XXX line virus immunostaining. can a accurate. virus both had -- approximately The of virus, of per reduction the patients determine patients Firstly, previously of cell has advantages: of positive treated

Turning to Slide XX.

subgroup a Cohort actively a X.X In suggested X. to -- between study patients reduction robust with results show Phase response exploratory able MOONSONG the X,XXX population A see had the II Cohort of analysis effect are This viral in patients. RT-PCR and hospitalized dose also BID We these the a B, risk in in underlying administered Cohort patients treated B. reinforced same data of and the load And health with -- conditions. the in treatment high milligrams day at

Moving to XX. Slide

amendments pharmacokinetics placebo. a approximately which MOONSONG as randomized lessons rapid trial MORNINGSKY receive in Phase from and trial are safety recent the We, the with as plan submitting well Leveraging operational Roche, AT-XXX patients a footprint from Slide milligrams outlined AT-XXX twice as by together measured multicenter, trial approximately global have the trial. activity, and quantitative, antiviral sensitive Phase results, in virus to and sites antivirus III X,XXX of MORNINGSKY I MOONSONG AT-XXX additional infrastructure evaluating XXX leverage is As III in detects these of geographies. placebo-controlled existing from MORNINGSKY to and randomized, clinical infectious X:X the it's day capable live X,XXX data just assay a expand the global outlined, new or other virus the as of to with site double-blind, the potent replication. Phase effect we II XX highly support

lastly, Roche collaboration daily patients Patients to who X-month, individuals. to enrolled later evaluate received twice high-risk And in increasing unvaccinated have MORNINGSKY long-term AT-XXX spring, a the or X,XXX We MORNINGSKY. to study to in will conducted in of BID. AT-XXX to Amendments endpoint follow-on following: alleviation in option to placebo the only with trial's of in COVID Refining COVID-XX-related from second end time the this patient report half symptoms become primary data hospitalization point to of MORNINGSKY all-cause point. XXXX. the in expect the The Changing of improvement a mortality. our end or COVID-XX include to primary population dose study trial from the be milligrams in secondary previous XXX milligrams long the include enrolled to comparison

Let's dose controlled randomized, dengue now and of and the AT-XXX, treatment XX. to program prophylaxis the double-blind Earlier this and year, Phase single initiated tolerability multiple our ascending AT-XXX placebo turn subjects. of Slide on fever healthy study safety, I of in to evaluate pharmacokinetics a we

the single have cohort. the the of ascending first cohorts Part We are study, in complete cohort X, the ongoing. Part dose is two completed last X And and

of expect We by conclusion study this year-end.

to South XXXX, dengue than our expect in and of fever a America. change the XX The primary for the II the study adults greater to in next look treatment and fever In During Asia financials. call XX this with will positive we now infection enroll assay. turn and point the apprised results hours trial, first progress end I this the half that, MS-X on probable be of over AT-XXX we viral of in load will within of of our review you dengue RT-PCR Phase to We degrees forward year. from study will important With antigen keeping of for baseline. Andrea initiate test

Andrea Corcoran

Thank you, Janet.

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

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

XX, I'll now back equivalents cash $XX over milestone company September of the This received cash for our license million. the XXXX, under development with Roche. July million As remarks. in and turn were Jean-Pierre closing $XXX.X to the call agreement includes

Jean-Pierre Sommadossi

Thank you, Andrea.

As to The Phase ability III maximize should demonstrate protocol the Janet of study updated clinical we a allow the our focused are outcome. and inclusion dosing execution outlined, to end criteria, regimen primary and trial. point derisked making changes a more positive MORNINGSKY

potent critical infectious encouraging today disclosed the to rapid virus data confidence COVID-XX disease and AT-XXX have activity which give stopping progression Importantly, further in transmission. is and we us antiviral against

dengue opportunity of C the This believe what on an is progress. fever, COVID-XX, you to to We continue bringing the infections. of for and to our we technologies force look excited Atea be we to by course exciting forward all be our groundbreaking updating hepatitis change to and be very time

As needs a always, in will all address global medical with we therapies unmet bowel patients your we call that, leader commercialization the of thank Atea -- your support continued discovery, and to diseases. you With that as development of the into we for the open now questions. up operator, build

Operator

line question from Eric of from Instructions] the [Operator JPMorgan. comes First Joseph

open. Your now line is

Unidentified Analyst

taking Eric. Hi, good is afternoon. [ph] This questions. Thanks on Hannah for for the

Just a from us. few

-- III accessible? conducting your no the where that are the So the with time you lines meaningful have pill get reported stated just on the confident to on viral I load. a Pfizer Phase the remdesivir really recently then, feasibility first, effect or which How showed wanted in we thoughts hospitalization And you've of outpatient in despite death also given? minimal trial effect a or trial,

this than you from data Just on other on theoretical And perspective, outcomes? might viral then a effect reduction clinical your load take wanted translate an to get what do think set. to

Jean-Pierre Sommadossi

both address questions, could Janet, you please?

Janet Hammond

Thank you. Yes.

opportunity feasibility So conducting think it's rollout that to to in And think impressive unfortunate it feasible. the with some still lagging many provides while regard And believe in I in susceptible is places, many to an for we unfortunately, vaccine think the this I But study, still the high-risk of world, that I that ways, the disease. be across many others. it's patients is.

as further and have move plan we a have extensive an already We footprint to still extensive footprint forward.

trial. will have sites As or thereabouts I than mentioned, the we XXX in more

to And believe sure be we to be completely that completed with in we study that able understood to suggested. so and And ought that wasn't question. I enrolled regards the time I your frame remdesivir; then,

seems think true, and what really what there we're I what if showing very end large response an of I better. all whether acting I gets mean elegantly no assay. actual But target care think it's we that measured in for correlation viral such, blunt that to have and study tool that the is the I really, be able -- [ph]. suggestion are in to assay clinical virus what a as RT-PCR. think non-variable useful more and discriminate think nicely all I supportive even the And points to general between data quite we're load to as ultimately. I recognized what is would seeing target that which a in as and field that RT-PCR are a think end think of what the help virus. today really showed a of clinical Certainly, viral the when a that we And actually great. that is some addition live patient point, about I end fragment that ourselves be others particularly can that's dose probably seems And general, and And we live hospitalization about, be there. we is remdesivir to prevent virus ultimately which point support really was reported well was somewhat is show on in remdesivir antiviral to have and attempted able by some in be and between direct rather experiencing

Unidentified Analyst

for That's great. Okay, questions. Thanks helpful. the taking

Operator

one the Jonathan queue Next Evercore Miller from on is ISI.

is now line open. Your

Jonathan Miller

more guys. a for today. of some have on much couple ones taking the the detailed so Thanks released maybe data questions, I you of

II that majority is Phase You mentioned your cohort seropositive.

viral between were on long the on in XX% the high How you II seropositive And seems in X.X the and the is say in for of a following have pretty expect head and impact load viral the there really impact patients negative from baseline sort read-through there's I But majority there. It I'll my think trying guess question. not that is patients in risk. said that just results antivirals baseline. seropositive And are on last that maybe modest? Phase a scale. of on low-risk patients different the obviously pause question, do following prior think out clinical good fair clinical if at arm the it to -- Then secondly one? you direct-acting to like -- will then efficacy, broadly you the back low-risk -- And gram I meaningful patients?

Jean-Pierre Sommadossi

Janet?

Janet Hammond

thanks, John. So

and in So Cohort think XX not of and very load second seropositive that think, patients low-risk your in around of around But to blunted think, to perhaps final the question and think I patients some still blunt as high-risk seropositivity, think A. in viral other group, does of seropositive the question awaiting you're what I the answers able your was -- the think study what so the we're the patients. to placebo went than I ones. surprisingly But the really And in the the we're it were actually high increased, less, numbers. I serology in in impact -- firstly, perhaps high some XX% certainly, treated data I Perhaps I from Cohort yes, seeing essentially, the it regards B, see.

to to also demonstrate high-risk in which are are I protect But that we are if patients, But I shortening effect, cure think having you're low certain our of certainly that of the you're isn't I measure think are the easier something III risk, to symptoms. think able end able perfect virus trial. you're as demonstrate direction is although to types need a and hospitalizations death yourself for we're to those in MORNINGSKY. to who you're Phase showing you across But think the you're going been similar if those it And without of you to think think high-risk that nevertheless, these or the particularly need believe that -- harder a seems you're of for demonstrated tools refine have with in direct -- you're clearly, patients, I have and have I see reductions if showing more to antiviral. acting benefit load benefits lower effectively types the document. that in order patients in hospitalization prevent probably I'm in I But harder can others duration perhaps albeit that we viral that outcomes. the at that it's hoping more points But patients, this And board. in modest we in viral risk the is we load, RT-PCR patients there that preventing clearly measure. by high-risk

to off I clearly, loads. a higher start higher-risk Delta something. to patients, surprisingly, do with to think just you able demonstrate the And to also have tend need bigger less be perhaps

I it the story think same So, that answered tells cohesively. I quite question. hope all the

Jonathan Miller

final in are I somewhat. risk higher guess criteria? one. defining the then new And How Yes, one you

Janet Hammond

being and the forth. so think think obese, disease, asthmatic terms I in renal tumors of with think I standard patients patients diabetic, pretty elderly, immunosuppressed So underlying I potentially definition is also underlying it's -- and

Jean-Pierre Sommadossi

And hypertension.

Janet Hammond

And hypertension, disease. yes, cardiovascular

Jonathan Miller

thanks very much, Well, guys.

Operator

Lugo for the So next from have we Blair. question Tim do William

open. is now line Your

Tim Lugo

we, given a more -- SARS-CoV-X we other still to hear chronic minimizing directly additional broader and can I guess, the Thanks HIV recent and suggest love thoughts extrapolate the RNA data. polymerase resistance. kind -- around like the of question thinking the for I'd those the impressive I'd just versus on targeting was But would diseases we targets were and can previously the really and to your for -- the HCV maybe diseases between -- question data, COVID-XX? inhibitor that updated case? the correlations is correct -- And

Jean-Pierre Sommadossi

all we that there a believe developing look, of Sure. first, as several come treatment progress Well, treatments welcome we as -- options vaccines, multipronged to in COVID-XX needed. on be part approach will back And multiple really and pandemic. are

be -- than one going the other I target think that So, is don't better one. to regarding

I drug the You data mentioned about can obviously, we only remdesivir have the know given seen the the and And IV. Unfortunately, just the be outpatient. limitations.

have that of maybe going data, a clinical what very we the different, doses about time. talking trials think all believe say, all than what the not And situation to with we potential talking -- load, seen patients, the on viral inhibitors analysis right it's emergence I at issues I I protease believe of about with in Pfizer resistance. taking from detailed so the is real the used in -- world of -- in potentially would in immunocompromised used be

not launched lead at to drug was point drug, will Tamiflu was antiviral likely And no very When so see; any have absolutely with in mutation we resistance. to XXXX, all. that there one forget let's any resistance XXXX,

it the one was resistance majority Just year of Tamiflu. to the later, --

-- picture to celebrate can think I the reality be the future picture we to have should see We So, But we want don't celebrate. future. we negative time, the But I same to need inhibitors. a today. at for on protease

you the PI have not would surprised are very indicated, situation. going and an to going is we endemic new about be And strains. Janet been with combination. There to past are different combination potentially as be talk therapies, the that two going to -- have in combination shown I we be And -- believe of interesting know, that to As classes. a I

months months learned in so is surely have be come; we in today XX what be different may to So, I over and months last X to the know XX there. think would cautious what XX I we

Tim Lugo

agree. Okay, that's and understood I

towards think just that I incredibly combination been enrolled interesting. I look the the trials oral all other the we But to first we're patient numbers generally, remdesivir have that be and as on guess across MOONSONG when I have the looking while even of been is well, a to in trials a higher. take underway. much comment so it you long different took get Can enrollment? MORNINGSKY those be enrollment, patients on patient patient to maybe know time really terms how get just Because did will pushing on MOONSONG. going

Jean-Pierre Sommadossi

Yes.

You're absolutely right, Tim.

We place are foresee what with will how in the would very MORNINGSKY basically Janet, you it. aware are and share basically regulatory filed we to of finalized we we the the and enrollment authorities? amendments putting have accelerate after

Janet Hammond

Sure.

to as we we're also people should able accessible. possible. become something more have think We committing going really on -- and is that for footprint, confident able that I which areas analysis think, who have likely that and lines we the to that time to we the I can. window to therapies down this enroll believe somewhat. certainly similar and we're realize increased forth, the doubled with an vaccinated looking we potential be is that at -- we unvaccinated. committed able really what size certainly patients sample But we do, geographical also, where think the I have, believe is others particularly are that footprint to are to and this interim And more think But close still conducting become with been so doing to I are to be and

Tim Lugo

going had have think filed of another Okay, amendments? in And maybe that's been by understood. I dose And guess recall, you Are the that can expecting the protocol how details we'll year? if you be also, enrolled antiemetics signal. when I to many be MORNINGSKY -- allowing bit MORNINGSKY? you I patients higher a -- give on this guess MOONSONG us cohort I early additional from some And nausea next a in more maybe

Jean-Pierre Sommadossi

Janet?

Janet Hammond

We actively use with believe been with the are disclosed. regard it's the physicians also don't address certainly has how educate to to And actively best it's secondly, it's some firstly, a that something up that managing not to we've signal. on but something patients, of the we significant that believe in significance from of effects there antiemetics, of fact assess patients actually setting and symptoms the feeling at on. regard moment yet But we're are something these So fully particularly potential going working terms of that the don't we as it food that it we there peculiarities and understand protecting somewhat unusual. adverse were where is particular, same In were the from which site the some resulted with of to one the came all that patients all events to studies experienced. GI discontinuation adverse in the events and we that number

to to that And and best so really it. we're work how still trying out manage understand

believe that they're is don't encourage and allow of will to something want this available. allow to We hand, we something that experience suggestions. which I some it the think use antiemetics and this people because auto going susceptible make But is on to other the is to

that MOONSONG, manage. we're actively least not And around quite moment. And we're thinking further to one it's any through tricky regards your MOONSONG, a enroll at in the cohorts lastly, in then at to So the way question moment. planning to at our

Tim Lugo

the all granularity and all answers. for luck. you the Thank Best Okay. of

Jean-Pierre Sommadossi

Thank you, Thank Tim. you.

Operator

Next one Leerink. Roanna on from the queue is Ruiz SVB

is Your open. line now

Roanna Ruiz

think plan, than Hi, I an MORNINGSKY. time interim I days the had taking protocol less was you amendment symptom shorter period five Pfizer's curious, would symptom days in of onset question; possibly or as a couple I of three going than less? explore believe, onset thanks your even for regarding for

Jean-Pierre Sommadossi

Janet?

Janet Hammond

allow So to in or we're for going days patients who five symptoms have less. had

see mean, I by their versus ascertain in study. There to size analyze actually symptom surprisingly the And an impact. try I -- think was a certainly shorter duration shorter it was think, we could will certainly I than we XX% think impact, I it that whether was But small whether I has thought. duration was that. and XX%.

obviously So as as it I of is made short better but expecting. a don't was I much difference think

Roanna Ruiz

MORNINGSKY new it I by in sense. And the protocol you also like curious, was remarks, makes the run sounded Okay, the FDA. will

opening that us would U.S.? does just you're where trial an in Or right taking that great. sites toward mean the be give steps could update you now, that on that So some stands

Janet Hammond

the give you broad protocol. sharing which will in we what FDA say. that but update will dialogue, think we I the I enrolling patients to is do that hope a continue can be with positive that's study; have we And I the ongoing and about and be we So, in with we them engage the U.S. can

Roanna Ruiz

Thanks. fair. Okay,

Operator

queue. I are no further will turn the back And to presenters. questions the on there over now call the

Jean-Pierre Sommadossi

very for would your you like thank night. to much thank again, thank everyone Good you -- participation So again. and I and

Operator

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

You may disconnect. now

Atea Pharmaceuticals (AVIR) 12 Nov 212021 Q3 Earnings call transcript