AVIR - Earnings call transcript Q2 2021 | Atea Pharmaceuticals, Inc.

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Operator

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

Following the formal remarks, we will open 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. second Atea we everyone we press XXXX that quarter conference which afternoon, you, discuss. to and Pharmaceuticals issued plan Thank to topics the call. This

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

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

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

Jean-Pierre Sommadossi

is now rates, is impact variant and Southeast countries there Atea challenges devastating for severe is create It impact Good and become Asia, antiviral this projected put most XXX,XXX where you that clear significant now the treatment COVID-XX, make given cure last account America publication Delta India Obviously, begin endemic. discover we’ve vaccine in and United including this becoming become essential of unmet us States which infection develop and everyone, lower of viral to and are per to It and a has meaningful in strain. which for regions prophylaxis where vaccine founding, rates antiviral afternoon, a we I Since pandemic remained at a drugs of X for lower Thank we and efficacy the against new treatment, for new platform for will the demonstrating approach COVID-XX source XX% joining the in against the steadfast like particular where mission for South we’re diseases thank presentation. Jonae. all our vaccination multipronged us you, on and Slide the seeing prevention. in forefront Earlier new a have can today. and be patients. abundantly new will recent our for day. we and therapeutics variant is a solutions the currently of medical a believe from concern, cases need back year, the fight

expand a for and to variant significant which XX% than the patients, it contagious, reported as Delta example, been as we contagious patients, much are new accounting the more this, be for are all And vaccinated, strains. of the highly also earlier of as almost even children, in and further as For cases in breakthrough has population. infected number fully cases replication vaccinated in chickenpox, now rapid hospitalized XX% has seeing

or I'm identified and now sure highly infectious so, particularly is in months lambda probably as and variant, countries. we Delta spreading In in will addition and about U.S variant, the X another well, the in dominant variants America the first South other concerning and Peru that talk in to

intervention pandemic. in derived administered [technical acting X, AT-XXX, dynamics, these meet challenge believe at oral from evolving our positioned tide nucleotide therapeutics, to of become platform this We given agent, particular, direct Slide in that help the a antiviral will to orally project is and Turning difficulty] pure stemming be the this uniquely essential solution.

As is And RNA To mutation for both domains SARS-CoV-X. provide high now highly inhibiting treatment. Essentially and we bodes a viral RdRp, which that this is antiviral enzyme resistance, this the AT-XXX broad the we can mutation. PXXXL. had affecting know, very we at variants to well And of and hypothesis. note, by its we baseline critical functional polymerase well. we polymerase, I'm barrier patient for NiRAN believe X AT-XXX sure a in different currently dual this coverage there as all Wuhan Phase in trial, variants the viral activity is believe transcription. are predominant the targets of validating actually And you would that conserved hospitalized polymerase, that And this with antiviral this date, of XX% the the to a original along against RNA that replication RNA mechanism is please And today basically virus responded believe gone. this both to say

hospitalized study in amount reported antiviral on in developed infection. study know effectively efficacy to AT-XXX, releases, data compelling As primary you emphasize that is results target we site are the for with as about tract SARS-CoV-X showing we data reach a I where data this of the DAA the first as the the as respiratory X lavage you as review tract. for is And that talking and lower you reported Janet, of been clinical that contrast, the we Phase press COVID-XX. measuring show respiratory our Phase our of the Janet want is lungs which in in share the Bronchoalveolar will levels are will drug And RNA being patients. drugs, interim well X demonstrating today, new recent believe demonstrating has significant investigational

used but prophylaxis planned for why they as for studies further very important for program as COVID-XX. we've provide for So the this confidence also development data only not our that's treatment,

we continue in our we would data. Janet? oral in achieving studies As partner review Janet are antiviral fight to to of with of this to easily global like parallel advance direct one multiple acting Roche, against providing our And administered turn I the global goal step an call for a clinical the closer now, this pandemic to

Janet Hammond

Thank Slide I'll X. begin you, Jean-Pierre. with

evolves, pandemic program. generate technical the and nimbly data from development we AT-XXX of are As optimize more the our COVID-XX and conduct to acting program, we design

we we're study leveraging study in and lessons better X studies can you improve six see our from serve hospitalized each have in learned running As of here, AT-XXX AT-XXX patients the probability global to and X of setting. of Slide our Phase outlines success. currently parallel, our

COVID-XX. review in we results, to moderate patients the as protocol with by But controlled, respiratory to to study tolerability, amending the environment objectives evolving a its former insufficiency. multicenter endpoint efficacy. assess progression double-blind, from placebo evaluate primary COVID changing apparently Before reminder, antiviral reflect safety, clinical AT-XXX to interim are is this a Study the virology randomized, and the

limited the standard now number Going in progress care. to changes to of that of due cases the

XXX and adding We to exploring a up Part comprised alternative be doses will patients. B of cohort also

were activity in distributed arms. and data analysis. we America, patients In Africa, sustained COVID-XX These against AT-XXX, X with broad of representing for The X. infected delighted indicating virus COVID-XX Slide beta and SARS-CoV-X study a which XX South geographic XX hospitalized from the antiviral They patients in positive XX June, announce XX% across valuable of countries to patients X were from setting. SARS-CoV-X and results rapid high-risk were America, study Europe, interim patients North diverse variants, of enrolled patients analysis in footprint. of the array representing to were our and variants the treatment included baseline the Phase with at over IgM included a interim seropositive were Phase Moving from hospitalized measurement concern. by with global from and with of seven alpha lineages equally virological

and had observed seropositive As other expected viral in baseline lower patients studies, load.

sustained the was between What baseline by group. greater mean the XX% The from the greater lower comparison way of X, infection that respiratory Slide a present rate patients of part to of acting the and the of of in onset with placebo is all viral an differential decline and the help virus deal is experienced cohorts expected. reduction transmitting the tract history receiving likelihood to load, remaining the important the difference these load viral be Phase viral is is with all antiviral. of with Continued diseases load is is of in maintained to decline natural whatever virus, A the Day lower the risk patients and infection, direct AT-XXX and viral virus through load the driven X. a able the reduction disease. drop administration the immune system valuable which in two in from attenuate logXX X.X shorten X, On is

quantification we value to health of in nasopharyngeal expected, is viral consistent [indiscernible] pronounced antiviral more with progression. replication the and than less of And swab lower the phase Slide rapidly critical and are XX, multiple of XXX infection loads. XX, immediate strong activity disease subjects the higher antiviral SARS-CoV-X AT-XXX level across viral was reduce this seeing rapid an test, on is as enrolling On again, potent signal. Slide a by as And of with measured pre-specified a With analysis. was the in it DAA and impact in inhibit copies. early RT-qPCR as

minimizing with in lead evaluating TMD, XX% was as in study, threshold placebo arm AT-XXX a patients virus left demonstrated compared the And target adverse of undetectable XX% to when or not Earlier XX X were see Phase the at time, the graph a recovery In also the the achieved results previous time. to AT-XXX tolerated. events. the can to infection. faster patients of negativity related studies, PCR had X drug right, In graph these the safe early generally in X as X% stricter this at the may no in clearance and serious RNA RNA no the in transmission with viral consistent and Phase arm. there detected while to You Day arm as still detectable well to Day AT-XXX

and lavage levels lungs lung from levels lungs. to cells the this fluid, results find moving of from here in that and in measured is washings drug lungs a you'll the the lining the drug called study, the measures XX, obtained evaluate through surface Bronchoalveolar from and Now obtained Slide the new

levels For per confirming the in drug the in or milliliter, the site XXX daily. AT-XXX infected first primary lungs And the milligrams of the which in twice antiviral, drug reaches and in COVID-XX. both healthy volunteers as drugs time implications micromolar administered exceeded airway with nanograms a the important target these XXX levels epithelial in in target corresponds ECXX were infection prophylaxis target achieved primary direct even for with acting AT-XXX, treatment efficacy X.X cells. of has is that human significant vitro for This and levels to

which Slide mutations we the By on a AT-XXX. to it could believe treated XX, be into the in cells next seen And is variants, catalyst that generation As of with introduce is new for the mutagen. patients. AT-XXXX immuno-compromised viral the not freebase SARS-CoV-X mutations does confirmed analysis Such infected not especially AT-XXX, sequencing genome.

in the of new no administration are are a should weak of for of that and more drugs. needed most be human metabolism are drug-drug of the volunteers, abundant is current healthy drugs and addition, interaction XX% in for that CYPXA, that accountable AT-XXX In substrates. cytochromes clinical liver, study adjustments and indicates than CYPXA CYPXAs the dose inhibitor

So this should make prescribing simpler.

to dosage, to a the placebo controlled double-blind, setting trial to in AT-XXX Phase mild our randomized, activity, XX. to evaluate varying chain antiviral or trial half the variable X COVID-XX conducted safety and show its in patients measured collaboration enrollment baseline this It's Moving And patients. QX, change continues patients transcription challenging when entry advance. study and is second study importantly data with enroll outpatients. window adult early with clinical to which point. challenging and eligibility up of AT-XXX unpredictable, the been will evaluating is is being infectious, It's endpoint and trials This across multicenter, additional become continuing in there in AT-XXX outpatient antiviral Roche of virus seasonality. expect has Note, for very MOONSONG, sites X spreading proof-of-concept powered Slide a helping specified disease is moderate And open as pharmacokinetics doses. this that by to The around of polymerase the There studies. industry. of not limited recruitment. the for statistical at safety is Phase reaction into are in or QX, the significance. in without with SARS-CoV-X of that late supportive for drug. from to activity, results cohorts world, we reverse RNA, is a surprisingly in XXX over multiple time for the profile trial it's this clinical primary of amount studies our COVID-XX The do for seemingly the we're confirm the year And

As our onset. Phase with multicenter This approximately to adults currently the enrolling patients COVID-XX. it will conducted to with anticipate is adolescents and that we continue the outpatient United deviation mortality. randomized mild require symptoms. moderate global will the improvement for States. moderate primary in partner trial X Roche attended hospitalization. patients or advance without with be enroll and requiring the trial, of of placebo, a efficacy our stresses it Patients We enrollment, outside or highlighted medically X,XXX of XX, an stable must the to evaluating COVID-XX on with COVID-XX or Slide COVID-XX, At hospitalization AT-XXX symptom being setting. and also visits Other in not measure will endpoint The MORNINGSKY mild trial is a and time or patients efficacy of AT-XXX number of compared will patients the be time include of endpoints days key X evaluating within

of accruing results and/or Additionally, Phase antiviral Patients secondary AT-XXX the predictive the the X,XXX the is also on study conducted This evaluate expected approximately currently spring, Roche. in months and will COVID. among III, major collaboration in are rollover the exploratory to was impact patients biomarkers study recently from lung to a study an the second follow currently to from other option half that X XXXX. AT-XXX. into and long-term on enroll with and It's We already endpoints, study has identify trial will expect response of of patients. evaluate initiated

to John AT-XXX turn commercial John? now app. me over the Let call for an

John Vavricka

Thank you, Janet.

are the XX. to both tend through we to four asymptomatic Turning patients were were broad testing Slide active and and present the asymptomatic, as be treated. disease believe symptomatic purchase, they're active from active employers for travel. accessed There will would proactive of although There's would all stockpile. segments. We as disease, schools large and exposure these include populations third target view -- which which patient the both symptoms patient opportunity. post as see we and area at disease is pre the market prophylaxis, as And be large finally purchases segment government and for well And

pandemic, is We each different when unvaccinated HXNX also look the consider to at communication. last motivations, vaccinated Compared it considering and XXXX. and of these important patient with in to segments people in

government within new efforts meant U.S so the biggest risk the pre government of was the or approved of for utilization treatments approval. prophylaxis differences exposure remain availability And currently that treatments to oral stockpile moderate therapeutic or the chose recording There to system, this immediate readily that outpatients, and active were the and therapeutic EUA available agencies in Current there NDA during pandemic. government U.S billion One oral are FDA an a offering. $X.X for government COVID-XX to patients, antivirals is high post offering for discussions we and target appear an mild following with distribution treatment.

over of call during likely that preparedness treatment impact it I'll stockpile With to the the COVID-XX, the government to that Janet. will back similar stockpiled U.S also global We believe overview, now that they future given HXNX. also devastating is turn what highly for

Janet Hammond

quarter. our study we of with treatment portion Slide AT-XXX of On the of is single was successfully and and making as portion that XX AT-XXX now to multiple study pleased the up review completed, evaluating Andrea of to the initiated the also the AT-XXX, of is turn and financials. Phase objective been also ascending are for Dengue. has establish call to a doses future prophylaxis dose over Xa to selection Dengue this It the dose tolerability for trial expected studies multiple program John. safety of ascending trial, The for that progress XX, I'm Thanks, With report for of dose the I'll The fever. roll to also patients. support and during to

Andrea Corcoran

Janet. you, Thank

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

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

note development That our milestone, under in payment closing for now and Jean-Pierre XX, remarks. of As in $XX I'll June the cash Roche. equivalents does to received the July. the Please was XXXX, that over agreement turn June not call achieved $XXX.X company include license cash were this million. with back million

Jean-Pierre Sommadossi

our much The an making. important fall It you, Delta the power and search of our Thank the the disease. rates advance all to to our make another variants development is provide data to vaccination low program, importance clinical this The very cannot happen. play a underestimate around progress to partners closing, us. are reduce And to AT-XXX COVID-XX the global the and doing that important can in along In this role endemic rapidly goal this everything world. burden of and this with team, helping in to at the solution are we with due Roche points Andrea. Atea remained we program

be will Our success everyone success.

of label hopefully which a for dose we not mechanism have dual are variants, addressing which which Unique indicated infection. to and new no also substantial metabolized now variants that AT-XXX. in important leading primary As be co-administration barrier are RNA for believe and and rapid of is that to you And of sustained the the the has adjustment make the against these enzymes. mutagen, not today, drugs that target substrate as largest lungs, seeing targeting we continue as the activity SARS-CoV-X, progress antiviral know, CYPXA the demonstrated majority problem we very demonstrated AT-XXX future drugs drug by will likely necessary is that with site and being reviewed as we it with for high you the Janet is resistance, polymerase, to in know,

global to As X and mornings studies X multiple, from Roche, the case MOONSONG partner we parallel results studies. to with our clinical the we in Phase advance continue the upcoming forward look Phase

the call continue open this to year. addition the pipeline other AT-XXX, substantial With the In programs we later questions. an will of your progress on expect to the operator, progress and provide to we candidates, and to drug [indiscernible] we treatment now C for that, update this antiviral hepatitis with Dengue, with make

Operator

of [Operator from of comes one with Joseph Instructions] the your J.P. Morgan. And first line question Eric

Eric Joseph

first sense symptom to the kind proportion load And know of space the threshold need I to a unmet to taking from, of the trying or of trying goal there guess that the mirrors resolution, Thanks normal predict data. load resolution. curious you. access data be of how where in a load at couple safety study. the the as to that viral kind any X would sort of relates symptom pediatric the then viral testing on you a as of of if comparative we're curious the kind secondly, -- viral might symptom pediatrics to Phase stage evening. of inpatient Is is A to this guess, whether possible. JP to population to good in highlighted many the I there relate Hi, to field population. with begin decay improvement are an as patients compare kind viral opportunity. has know question. it -- get for expand Thank greater of in I pediatric clearance as to a plans or for to whether absolute I'm

Jean-Pierre Sommadossi

great question. Two

you. maybe questions? both thank So address you can Janet,

Janet Hammond

you, Yes, to. Jean-Pierre. Thank happy

your the correlation to a see load much So to around the viral cohort of very didn't decline of in in firstly, decline. symptom and patients, patients, we cohort much decay, in to and regard comparison a overall our happens question symptoms, load between small what of viral of it it's

group who in loads However, we looked had excess at patient viral the median. of the

So logs between surprisingly, load X.XX -- actually symptoms. correlation actually, of greater load, declining good than we declining and viral saw viral

really that in to And a were rapid treated would translate so who a much then with overall, of earlier, improvement to was viral came X-day associated what was approximately load more in symptoms. decline symptoms, resolution patients the and very that

plans for to it's patient be start enrolling obviously, particularly as going adolescents our already and taking have comments actually, question. and for pediatric to study, I in seen So that provided talks study, the to to treatment, EMA that a we longer important that and that that. think, pediatric to the And have with are answers agencies regards our population. Yes, in the we then plan MORNINGSKY the to I I both population in have do the regard into both roll as new think And plan, FDA vaccines because off. in mentioned, it's really

you. So thank

James Molloy

taking Great. Thanks the questions. for

Operator

Evercore. of with question from comes the next line The Jonathan Miller

Jonathan Miller

taking Thanks for question. my

the in the you that positive what post seen And trials, Since Phase do prophylaxis exposure how benefit. remind Can what secondly, monoclonal patients as to better we've big we've expect even the And recent baseline? those do as for whether Xs, majority of your percentage with exposure? think approach? some pre some the initiating oral zero-negative to acting wondering small is done responsible you antibodies. been sort results me at timeline antiviral prophy you through seen trial, direct trials we've of reads have molecule And worse? on be or of driving for one post First been or another

Jean-Pierre Sommadossi

Janet?

Janet Hammond

Thanks, Jean-Pierre.

who So with who literature to who to immuno-compromised, regard be been of date the proportion to more patients think patients extent, some interpretation I the seronegative, that, are my of are have actually to and viral far in going better has and generally and higher be viral are who tend seronegative. have also have loads And tend shape be patients to to loads risk factors zero low seropositive. to

enroll similar Phase into think single X for a -- that we're patients, ready to risk both both high I So into populations to planning and studies, where roll low a and our study.

patients already to we it's very think to and who because will be risk the high then are seropositive, likely will are risk. have who patients likely fact of that more that we tend seropositive see the be patients I who seronegative, the and and

seronegative. I think, in as or of hospitalized surprised were our you study, seropositive XX% approximately patients saw

being exposure I seeing. higher prophylaxis, are just viral and anticipate So, seronegative, see that patients With I there that start you're I'm to But because think better will or it's between with. to translate into one around a post what higher we a regard it's easy tends have to a see load more start in bar because think initially similarities of good right, with to your that they who differences or response, guessing question that, proportion question, correlation patients a seropositive.

prophylaxis ought see antibodies. similar I think of deliver what to that with the we you benefits anticipate pre-exposure levels to

approach approaches. there the you to small don't and in is pros initiate and cons to that conveniently. is need easier that of go And considerably type much an a think both can access of more that the and you I obviously, therapy molecule injection, get both are beauty and setting, relatively of

for the dose, think I duration disadvantage room extent a there be effect will taking that longer whereas suppose have on drug. less a some is And direct monitoring that But antibodies after for of it. likelihood antiviral dependent the more course, ultimately the of be I will potentially resistance. single of that prophylaxis of acting tailoring with also the a to means genesis

-- we for it and I advantages believe and think to but have very similar. there to that approaches how the both to ought in that So, general, I be both all efficacy what how think and disadvantages learn. we'll see antiviral evolves But we approaches, are

Jonathan Miller

And your plans initiate the to trial?

Janet Hammond

I'm we've in second the the of sorry. trial Yes, had to year. initiate half this

Jonathan Miller

Thanks very much.

Operator

Lugo question next Your comes William Blair. line the of from Tim with

Unidentified Analyst

guys. on taking for Thanks questions. the for Hey, [indiscernible] is This Tim.

that past. clarify wanted way First is the to FDA just rolling a the when the that know is all, does of said bit I kind the in you MORNINGSKY that Because globally, out included U.S? of

higher Bronchoalveolar MORNINGSKY patients? with from incremental lavage expect be Is that, that the especially database dose When see Can So be to details any And wave going on said from how that running. to to is? that’s much see up just efficacy you wanted you we might might the data might that? shared the [indiscernible]. check and healthy And at higher you, doses? what from the second, you've that QX first you're that share looking given

Jean-Pierre Sommadossi

I'm first second one. the some the go first, extrapolation, address Look, Janet that will cannot we in we increase going concentrations. the don't from until to over one, we but data, And we make and those proportional should obviously, anticipate have increase hopefully be Phase to clinical and data exposure [indiscernible] believe should substantial that the we in there antiviral that benefit. is the efficacy higher drug and X and ultimately we from are this that translate doses, that going at going see saw

week larger the continue same in the we tolerance So, and to fact cohorts. see to have the that expand results. And we safety. show we will are study encouraged by And obviously, now

the the you has Janet in will parallel. Janet, be street. As six the want completed, first will cohort we question? address share soon as we with to have as studies And indicated,

Janet Hammond

not discussions running first the We're currently in the not. in the It in question, So to FDA, that And U.S. the running think but regard MORNINGSKY, to no. U.S? answer it currently with was is the is I is was it in

Unidentified Analyst

you Okay. many a enroll. allow to And of or to follow-up data given running? patients Do have guidance how to on they to any do just as get you that up how that, much worth data see to might and of to that able be sense Thanks. have need when

Jean-Pierre Sommadossi

Janet?

Janet Hammond

we So of types generally specifics, comment unfortunately. I -- on those can't don’t

able I’m not answer question. So to your

Unidentified Analyst

Got it. Thanks.

Operator

[Operator at comes time. question and Instructions] no -- questions next I'm showing your more And this

Jean-Pierre Sommadossi

So appreciate. and thank for your you everybody and support, interest

thank for, support joining you. us so And for Thank Atea. you and continued again to

Operator

participating today's You conference for may disconnect. concludes you call. This Thank now

Atea Pharmaceuticals (AVIR) 13 Aug 212021 Q2 Earnings call transcript