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Altimmune (ALT)

Participants
Stacey Jurchison Senior Director of Investor Relations and Corporate Communications
Vipin Garg President and Chief Executive Officer
Scot Roberts Chief Scientific Officer
Scott Harris Chief Medical Officer
Will Brown Chief Financial Officer
Seamus Fernandez Guggenheim
Kelechi Chikere Jefferies
Mayank Mamtani B.Riley FBR
Jonathan Wolleben JMP Securities
Call transcript
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Operator

Greetings and welcome to the Altimmune Year End 2020 Earnings Conference Call. Currently all participants are in a listen-only mode. A brief question-and-answer session will follow the prepared remarks. [Operator Instructions] As a remainder this conference is being recorded. It is now my pleasure to introduce your host for todays call Ms. of and Director Altimmune. Communications Senior Jurchison, Investor Corporate Relations at Stacey you begin. Stacey may

Stacey Jurchison

operator, everyone. call. Thank participating good Garg, and you, morning Officer. Executive year today be XXXX our call Chief in Thank end earnings the conference Leading will Vipin Altimmune's for you

members Altimmune our Scientific Chief participating Officer; Scott Harris, executive Additional Medical on are Officer. today our call of Scot our Brown, Roberts, the Chief Will Chief team the Financial Officer; and

session. can A remarks, end section we will on question-and-answer website. our was hold Following the company's release the year press a XXXX issued prepared with last be IR results financial our night of and found

and begin, Litigation these expectations, subject Harbor our XXXX. of we results remarks those to those materially Safe are from that to like statements of prospects Reform and forward-looking impact that that Altimmune COVID-XX under cautions risks results actual trials for could and everyone differ operations, clinical about plans Private the to Act purposes Before its provisions including future of cause indicated, Securities to operations. constitute uncertainties I'd related remind business and forward-looking on statements

obligation date. of statements company events does circumstances only on earnings to please discussion the statements XXXX. and the the risks could the the February of For company's release undertake that Tuesday, with read on disclaimer today's some reflect morning the this any today's risk press XX, filings after available our and other this company's issued conference website. also the and now that you as to future forward-looking would factors of a cautionary to direct of call statements these in speak results, our or see factors made or affect on contained any I Any in And SEC. occur forward-looking statements update not date,

of I audio With on As call will Altimmune's be a for and that, is Vipin will the Garg, to call conference recorded over now Executive available rebroadcast Dr. reminder, Altimmune. Officer this turn website. being Chief

Vipin Garg

Stacey, today for a business everyone. say a and shareholders. appreciate hesitation results, for Thank financial Altimmune you the and good year We XXXX XXXX transformative you, that morning proudly can was discussion I XXXX operating and outlook. and about joining our Without us

impressive Our each our value to the five value in had development our our historical efforts groundwork and of pleased us in enable we candidates I'm reach the unlock lays so history candidates many clinical opportunities product we build as beyond. say to to have to such opportunity development. that advance portfolio an novel XXXX inflection points in with to our has the Never portfolio of value.

developing and about medical Roberts vaccines As unmet attributes are provide are detail differentiated that you from the and more needs will in may Scott peptide shortly hear to therapeutics therapies Scot approaches. Harris we intranasal and or have treatment solutions novel potentially believe from favorable existing highly

and Brining pandemic. clinical As developed COVID-XX this a has offers important currently COVID-XX this profile authorized trial. first of in year, development, and from a for optimal could we in Unlike viral clinical AdCOVID vaccines morning candidates, AdCOVID mutate, history become the candidate for vaccine critical deployment, development Virus. the vaccine concept vaccine data re-vaccination. innovation improved our ease our target with for could new our need potential vaccine AdCOVID the AdCOVID X more nasal continuing for the expertise SARS-CoV-X response And believe our cavity, administration in preclinical benefits creating AdCOVID The we the to believe of virus leading nasal to be the for If clinical successful, vaccination to use for product vaccine candidate immunity of in with Altimmune in pediatric grows and If population. against that subject enrollment with parallel we variants a Phase will the fight field. influenza and and offer improved we rich to tolerability the to stimulate transmission. vaccines COVID-XX the potentially mucosal our preventing transmission this pioneer findings announced and ability urgent. potential safety the intranasal clinical Last the which increasingly in block experience in

to T-COVID COVID-XX, may data are its ability study provide our we among immunotherapeutics the in Phase on progression severe this progress treating progressed X/X COVID-XX. approach look and truly differentiated prevent also into T-COVID a with novel ongoing clinical to and toward evaluating investigational other from We testing things, XXXX, our forward program. to pleased

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in Moving disease peptide beginning XXXX. With in ALT-XXX Phase advancing through ALT-XXX made development. stride candidate liver HepTcell ALT-XXX category. and development Phase an programs, X We our think HepTcell metabolic based the X is important into promising and disease specialty both

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see in multi-billion to reach significant points its this inflection in this compound platform drug obesity a address potential both a dollar market, Given are excited data advance we and NASH year. to and

also year was perspective. raising from capital formidable a Finally a XXXX

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Scot Roberts

at AdCOVID everyone. our morning our a deploy an development fight Altimmune from as devastating It's perspective, pandemic. to good programs we and Vipin, scientific especially to part you, clinical and rewarding been do initiate to Thank expertise T-COVID year this help for

systemic dosing AdCOVID local and other single-dose in mucosal has Vipin intranasal potential both most believe track. that simple protection neutralizing As vaccines, for the from antibody unique potential the immunity has mentioned, we and authorized it attributes respiratory distinguish provide to currently notably

we've years, helping is distributed in anticipated our AdCOVID, role both technology a NasoVax key refrigerator and for the Additionally, at to its stored and can room same be global tolerability excellent important seen for platform and facilitate in could and temperature which clinical studies, COVID-XX with are on in play NasoShield based vaccine an and vaccination believe then we be AdCOVID crisis. revaccination, to health the ability

year protein compelling T-cell infection. titers, killer and arms also T-cell I the dose memory preclinical T-cell CDX systemic were with importantly observed against IgA mucosal AdCOVID. serum encouraged showed by the IgA build and the the finally, past T-cells mean the on most we enhanced importantly, viral there AdCOVID. memory University the data Alabama resident specific established to all during a these data new lung and very with induction by yield the of importantly year, accumulating disease for studies Also COVID-XX lung believed collaboration a that, of We track of the we spike immune data primarily level results outline the During type to demonstrating and strong immune and to the Briefly preclinical system that AdCOVID activation data these resident spike completed showed and three single at high of viral of And protection of adaptive preclinical with tissue protein an combined to the response results. response in may the robust respiratory associated University of with poised expanded intranasal neutralizing robust antibody in Birmingham, the the Saint of provided of combat responses our type of were collaboration transmission. following Louis pronounced the the

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clinical make children. use and the in AdCOVID well-suited the of demonstrated needs As intranasal and tolerability trials pediatric setting NasoShield the as administration expected expected attributes that meet for we NasoVax to of it suited a ideally believe our profile are in

pediatric strategy range clinical long on our we the We regulatory of will remain segment and develop AdCOVID. population as focused the for

be allow further vaccines, may in from perspective. should other point that refrigerators, candidates to AdCOVID on in and data stability, temperature room at use. we distribution Based addition I've and extremely have years other potency logistics attributes I for COVID-XX discussed differentiated the AdCOVID AdCOVID out the expect Finally, vaccine potentially without to demonstrated extended loss earlier, for from making intranasal to from is would in practical storage transport simple which

advantages the on solution as a continued our programs. other to clinical landscape. the I'll believe the turn Harris update COVID-XX become data a our of our if Chief virus could the in to that the of an call we Scott provide and important Medical leading Officer, vaccine over player Scott? to pandemic the AdCOVID and AdCOVID clinical of our now global Given expectations, presence part approach, support the

Scott Harris

morning good Thank and you, Scot, everyone.

dose As That is AdCOVID at between are and and receive of into and from a XX Volunteers given levels considerable healthy trial in will the a meaningful pipeline AdCOVID pleased Phase at very vaccine program. anticipated the data of said call, To clinical of initiation the for the Vipin Phase Altimmune immunogenicity one will year recap of announce clinical adult our important X evaluate known advantages of with development of an our today, briefly the a year. this spray. of candidates readouts advancing five perspective, clinical potential administered and we There up said the ages volunteers nasal safety AdCOVID AdCOVID approach. throughout the outset the now to three is X in as trial intranasal XX. XXX interest to our

AdCOVID from in indicates at dose. While vaccine plan influenza We in the Alabama after effects that to preclinical study. and single boost effective study experience both from prime be prime the of of platform the our Birmingham a University should experiments this

anticipate samples, a to safety the Phase the and study serum cell evaluated We T of tolerability, addition and from trial second nasal primary IgG and this XXXX. titers, mucosal IgA full responses. quarter of the neutralizing immunogenicity In will endpoint by from binding out AdCOVID antibody of data antibody be read in X

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of As expect and pandemic will remain opportunities, the we to into clinical the our the the will second we address and data, path to constantly opportunities. continue development quarter, adopt evolving in nimble Phase visibility understanding needs guide X most have shifts which importantly these to these

our on where Moving made X/X progress. Phase T-COVID solid clinical trial has

or of and infection, have and X and factors or on safety The and to require dosing while COVID-XX are trial ensure independent committee – trial and readout soon these the the X. for death cohort patients outcome. completed enrollment Based required We data more first for protocol meaningful number commence second maximize more severe modified patients about protocol them rates age readout. anticipated or those the demographics that expect confident quarter which safety study one the will monitoring to year. XX do cohort being readout, to safety as in over study To sufficient the The hospitalization because on data We the probability protocol minimum extended, have rate patients changes overseen those chances or are a enrollment, years COVID-XX includes cohort to-date. have of focused cohort of the higher final these will an been of with past the with quality the a that and no optimizing in the modifications higher And significant at the COVID-XX complications. being this severe we to cohorts been has such evolved number further the risk Cohort of this this cohorts, and meet has efficacy. final by was risk the study both older, and third is data predominantly are study in protocol criteria one observed study signals modification and timeline of second of meaningful from changes to of enrolled a risk of the occur feel evaluated enhance thanks that now expect the we XXXX. a to rates

of worsening to designed was the with evaluate protective T-COVID clinical early in patients trial this preventing reminder, potential symptoms. effects a As in COVID-XX

in that endpoints need to the protocol study enroll If patients disease in first-in-human the of biopsy believe early patients The rapidly a is enroll quarter third potential milestone of shortly Australia, avoid to program full our commenced receive Phase as we our dose study, in X% based ascending a December the the which associated can are fibrosis plan will remains in study NAFLD with provide the as into Australia in and in let for ALT-XXX noninvasive liver saturation, we that NASH with have XX-week this readouts T-COVID in expect compound. multiple clinical with any incorporate this of to symptoms. of ascending timelines. and as single weight major incorporating is particular to These six-week improved to recently are in continue and dose by programs. NASH pharmacodynamic primary are The in into to We fat who was clinical clinical we trials. of study. fatty quarter proportion once We trial, candidate non-alcoholic we extension an hospitalization. six-week X in and randomized XX-week placebo loss advanced expected maintain study loss The intranasal pre-K liver administered update XXX endpoint reduction efficacy resolution approximately XX-week year improvement one-to-one significant We up now non-hospitalized in have second in GLP-X/glucagon and initiating or data trial as study Phase potentially well weight achieved expect XXX liver transition this need and on on in impact the worsening, oxygen study COVID-XX being of reduction fat as weight markers GI patients tolerability. expected the outcomes this a setting The the market been a on or onset subjects data XXXX. reduction the defined study. amended from Also dual-agonist or trial inflammation after XXXX. substantial. XXXX. endpoints loss NASH positive X of primary permits data balanced to profile for the pulse therapeutic, fat, and dosing year like a opportunity gears me important The in liver are with such Shifting a liver unmet for for an Last now, ALT-XXX weekly decrease the in XX-week

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chronic to B The is currently activity an achieved in chronic Hepatitis XXXX rates HepTcell program, Phase our medical development a as is important was to be patients cures. Hepatitis Phase to monthly in X trial approved Hepatitis doses. infected six be will in we our X for successful. HepTcell we a develop B end points The dollar neurologic point trial response. other this secondary patients functional functional protect and opportunity mission ALT-XXX virologic evaluate The Moving for Phase HepTcell readout immunologic designed therapies achieve up of program. unmet participate response study HepTcell disease. B. of chronically primary end important on The need expected milestone total a another safety, cure was Similar antiviral enroll intramuscularly administered assessments with once convincing to multi-billion high to to X of XX in milestone this with remains of XXXX. minimal the our data from and of having for of first criteria, half the in of to We

completed dosing year. we Finally, the last was in before coming weeks. our projected from trial Xb be The data Phase to of in available we wrap-up NasoShield anthrax readout for trial clinical this

followed developing the the stockpile Will? Phase with be Will clinical X under could sufficiently awarded now We stockpile. and Financial is Officer. strategic call And turn if fund to NasoShield I to over Brown, eligible the if be immunogenicity. As by million that, will be national We our Chief in the BARDA, shown testing contract contract remaining safe BARDA. NasoShield with a to with our options under NasoShield we're receive the $XXX.X could

Will Brown

Thank and good you, Scot, morning, everyone.

with proceeds Altimmune's with our ended financial XXXX offering in update year-over-year call net and investments in the results. the and can the filed net into and of in The under equity our More cash corporate our from a on our public approximately may from Altimmune Sandler, is which of from today. ATM we result exercise stock be purposes. feel I'll SEC receipt million B.Riley common gives $XXX the million entered providing found $XX Evercore, a which housekeeping operating good XX-K with million Piper $XXX XXXX we the a us issuance $XX increase and short-term warrants. brief optionality proceeds measure, an of be year-end comprehensive Form totaling of corporate to net and million. general sell today's information future. For cash to is for in million common this capital stock Program in distribution from proceeds offer into Today, agreement up $XXX the and We working

manufacturing advance ongoing XX of We months are anticipated pipeline clinical of programs. operations advanced our from progress be in capitalized cash least candidates A development. as our trials through next AdCOVID sending utilization our XXXX significant and towards scale-up solidly to at results clinical we will through element the directed

$X.X net as milestone stock-based Altimmune's year-over-year in compensation expenses in General the ALT-XXX. well with benefit statement; manufacturing payments related administrative U.S. increased due our in to losses. revenues in compared the was development attributable The programs. utilization for T-COVID was XXXX. compared million professional in timing year-over-year compared expenses includes The $X.X for to acquisition in increase increase expanded increase the revenue $XX.X development million primarily XXXX of the the to The and year. our in clinical income contracts million Turning in Income is XX, and the million were operating year, trial of workforce increased $X.X XXXX were million change COVID to employee of as liability passed to Research reflects from the attributable to prior to contingent and which during $XX.X XXXX, the CARES Act temporary NasoShield in and as government $X.X ALT-XXX additional The in increase revenues an the may is prior activities tax both year. million XXXX. to carry-back and and XXXX, $XX.X to increase million an attributable XXXX, and on in costs associated to of regarding was AdCOVID,-T March costs. compared the $XX,XXX changes

per it primarily to in and G&A to collect million year to loss the attributable the common net was compared to prior $X.XX holders year will the refund and development for is expenses The higher closing remarks. federal turn of revenue back in filing We net over and per benefit. year. this Net higher share $XX.X $XX state income tax now and in million are research in loss the net expenses the benefits. cash loss increase for or XXXX December difference process stock with Vipin to ended his an loss Vipin? attributed $X.XX offset claims I XX, authorities or

Vipin Garg

Scot Thank over our for Harris tirelessly and effort now The team juncture. poised this has in Scott us entire has make candidates to important of to year you, dedication your remarks. Roberts, Will the year. tremendous With the past demonstrated this each portfolio and brought Altimmune important advances clinical development and

period heard we you call, this catalyst-rich on of have a As and data ahead us.

anticipate we to T-COVID, and potential with data these NasoShield we address needs. today. We're from advance science are we and company XXXX. that anticipated the much programs And readouts time successful, have in If we HepTcell multiple the in positioned these each and of of with we one anticipation patient As data proud has and medicine AdCOVID, short four forward believe to programs XXXX. in unmet of important come extremely outstanding where future. look best where a a as ALT-XXX

for We touch progress forward to the and and for keeping our again, procedure? for the support of our Q&A concludes will please the that audience our you Could remarks. year to you your appraised participation portfolio. as of continued instruct the shareholders our Operator, call for potential on unfolds. you I today. Altimmune full your and my on Once realize thank opportunities formal work the We and keeping look continue value to in in patients of tirelessly

Operator

Thank line you. Piper first [Operator of comes with Sandler. question. Please the Yasmeen Rahimi Instructions] your Our proceed with question from

Unidentified Analyst

to you type you some activities [indiscernible]? what are for on very on Rachel X COVID the targeting develop AdCOVID take for with Thanks investors And will us Yasmeen. to Are it Thank variant? metric? combat is taking This new questions. you. long Hi. of provide much to on color going size Can how our emerging additional

Vipin Garg

Yes. to that question Good Roberts, do take Scot please? morning, you want

Scot Roberts

good and morning. Sure

the the So the that preparations one underway South circulating variants shares UK, the of a the California. currently We a new of against York the African. there's variant are in making include here commonality African, a one vaccines see in that South New primary with lot are that

within have us be region prepared to bioseed make stocks, easy and preparation vaccine so released a GMP is changes and a to the is those create it's And used these manufacturing of so variant for for for where the – to circulating. our conducted number and trial these goal they make in in can

So this about with ahead our information best doing and have to that the make getting of can them all ready-to-go these really us, available execute. the curve, variants we that's is then to so

So to the fairly into and then discussed best current available environment is. same ours vaccines, then that quick advantage earlier these is quickly puts respond vector all to our and whatever a like have the manufacturing is for whole us as process for we've dropped which tremendous to which the us process, is the of in the position to

Unidentified Analyst

you discussions and trial? regulators can on how we some regard for color are pediatric when And going And also helpful. for considerations with pediatric timelines design incredibly can That's in on you. provide to you. expect details Thank trial? Thank

Vipin Garg

that take to want question you do Harris please? Scott

Scott Harris

we Sure. because we're discussions middle a implement that not of point can having this those final, looking active at but year. with There's Good agency. really nothing now trial right are the the we're morning, disclose pediatric to discussions in Rachel. current the Yes,

Unidentified Analyst

your Thank you so on much, and progress. congratulations

Operator

Thank you.

Our with Guggenheim. from comes question. Please proceed with line of Seamus next your question Fernandez

Seamus Fernandez

question. the Thanks Great. for

on congratulations advancement. all yes, the So,

ask Just here. wanted a to couple questions of

love decision with I to proceeded off us; I have move XXX, you guys these and – the single the dose got Australian of obviously, trial update the expand you've ascending First to forward know you that's could kind weeks. did XX

single tolerability do on you the To with us your us trial would in the have follow-up market ideal really be can the some – to to with on especially guys a or the what a are a profile, with in start potentially or terms need in other already Incremental little of transmission just the poised to partner are type two. And be vaccine from those So visibility have as of potential program. the bit it prime dose just ascending discussions you that you update players of from could sense given that partner boost. in of or that assets program? opportunity product of some mark like a let's and seems for you a a reduce general boost think on to plans, us antibiotic unique I but couple collaborate you give prime positive the questions,

Vipin Garg

Yes.

So Scot just the ideal good to about that morning order – take first. prime questions the candidate the go in maybe prime features Roberts, question describe of the and take we Seamus. Maybe these boost want to and can for do – your boost? reverse you

Scot Roberts

to good morning, Seamus. Vipin, Sure. happy and

to about way So well-tolerated the the it's a you and with at off individuals can block Cutting growth the Obviously we're community the a and and because as think respond to you of through pandemic. wrestling and wanted we transmission move vaccine to forward through that want what's that other best these the start variants virus that, is that advantageous. clearly that transmission pop-up so. vaccine

and significant clearly a profile anticipated offers transmission to immunity, and infection to whatever exceptional a advantages. as And without so which we is think boost block best AdCOVID our suited tolerability mucosal block that regimen,

response. the beneficial then response further into strong weak a you the can say that, the T-cell be to because administration, a be respiratory So those a improving – than immunity. response that immune said And a boosting also tract, pull more I is obviously going having prior mucosal that T-cells helpful will with boosting

probably there sense of but are general better the thinking about how in that our that's some second So, some I we're with nations, things. and think tier

Vipin Garg

endemic, need just it's add would to of And COVID-XX becomes out this realize that an yearly to we're disease if that important going boost. I

people matter the So it beginning. doesn't received really at what vaccine

need you're after-after-year; a boost. to need to going You're going

So immunity, we this transmission as a boost a vaccine, and developing of well-tolerated be and we any have and as the really new long safe that's you course blocking used think vaccines. can with existing as

whole So data see develops. will along the how but dictate those we'll obviously lines, that, field the

Seamus Fernandez

development targeting AdCOVID can; FDA plus trying an lot variant advancing guidance. about in variants updated terms and how own talking maybe how about can what's guidance. get And variants? thinking just Obviously in you FDA your your constructs, prime update sense to how about of I of a particular a the you're you boost, you're those are on intranasal guys we possible multi-family own Are if vaccine, guidance a the variance there, of I'm in thinking administration, about the updated targeting thinking there's us the but original

I that's probably with investors the the question that big wrestling are think right now?

Vipin Garg

Harris, want do you regulatory Scott FDA Yes. address guidance? to perspective the the

Scott Harris

again, Yes. Seamus. morning And good

that guidance written EUA. – under predominantly the are that was to vaccines was oriented So

clinical to a the done vaccine how around full correlative trials. to would but effectiveness done Clearly vaccines there's as that by to to a a words to not need We guesswork of that will be rather of a on So strain. that clinical other hope that be trial. apply going a immunogenicity, oriented than in a there's establish bit currently could protection, have based

in but new be base boosters concept order the have do this be potential So of to treats but against the strains. is. there rather against readout, current those an there's going see there's not a agency that variants vaccines get don't clearly to have the would great currently potential the than full on we're not Phase And what And trial, in us. based that to of a X a to clinical immunogenicity interest use a how protection that the conducting again, know would we

Seamus Fernandez

Got it. Perfect.

Vipin Garg

address you XXX? the question And Scott want Harris, to about do

Scott Harris

Yes. Sure.

because protocol any happy commitments far, are look proceeding to regulators. trial way at the now. we very analyses, constitute with Seamus, we'll the the decision that enormous is the provided about be So are not a and announcements to so the would in disruptive would made not made to We've right which make for data

that I way well. ahead second third is the readouts moving the we're It's and weeks very quarter. in we is have general six XX trial going to progressing and which positive the what the for for in taught will in quarter; say So weeks believe can the we be

Seamus Fernandez

program, that's question. my Okay. one just question, sort the NASH U.S. in do sort just wanted Can the X full into study IND from perspective, NASH that have just from what you are Australia, initiate of to using data needs full with the those that get a Thanks. Phase final of the advancement us update Maybe terms IND the forward? on And just the structure final of you the and can going you sense you of believe data? the then of

Vipin Garg

Yes, absolutely.

sponsors, trials, chosen their FDA is but Australia of So very many the with clinical the X filed outside often, cases and in and before particularly U.S. that. have fact go Seamus most the to comfortable IND very Phase is

how coming data. So of in we to the program trial the we'll And later fact set-up in year. support to clinical of have Phase puts discussion preclinical Phase data, we And we at That actually program clinical coming designed will time this was in to specifically will from than to the IND obviously IND, the us the much of at the presentation. filed it with a We great a have anticipate discussions. is trial the talked IND process in clinical were middle terms the just in with clinical because the be which data approximately about that. advantage of X X data earlier that rather

the the feel XXXX. about initiate the very we're very of X we part with So confident first in happy trial and that ability to timing Phase

Seamus Fernandez

That guys. much, is helpful. Thanks so super

Vipin Garg

welcome. You're

Operator

Thank you.

Our of next Chikere your the proceed Please question from question. line with comes with Kelechi Jefferies.

Kelechi Chikere

you related in no Can quarter in at it timing morning. clarify with and potentially clarification subset for my second question hoping to, full that on data least have was Phase Phase or for about of protection. X those neutralizing to at moving is approval X? you [indiscernible] okay et And a as potential need I serum a good questions. trying for see that the why data Thanks a of nasal to some because surrogate something the running full as but asking that into I'm you a important any belief for QX into you do get a to antibodies cetera? what you're looks approval data Hi, the think you the could on Phase is before end eventual is like in this QX. there know And data mention substantive based think could AdCOVID; for Do X. reason moving in COVID well in say; my us? dating be on the I get Phase for as by PR mentioning in patients are is the markers cavity was the in that this X, based of How QX, taking potential you that on

Vipin Garg

in. you and Scott jump want to talk maybe Roberts Harris, Scot do can

Scott Harris

Sure. morning, Again, Kelechi. good

is to So be availability we've meaningful what any of we here our emphasized position. not in we're What consider data. made changes the

the I'll we on in wanted release. the meaningful to question the we're the And And results readout quarter, emphasize that the feel call the that's can to the Scot when in really we in will to occur. we data second while communication, that So to today have first that quarter. full the second occur answer. would trial emphasizing press defer in

Scot Roberts

Good morning. Yes.

going attributes need be induction until only advantage we're difficult to So studies we compare so part I based is to a and our that the on see do of unique be think by before. to that it's antibodies moving everybody the and that our point; give the going to very working is confidence immunity, because and use platforms surrogate mucosal it a of ability thing there's think what antibodies thing unique quickly expect that in generate potential And really and advanced that antibody. way to clinical across neutralizing going those time are move T-cell are those measure advancing? the real then neutralizing the a, on neutralizing is how also along will picture, clearly we take this of We the for surrogate, to to to next opportunity is there. that's necessary to, confident strong because is the

So that’s clearly a key.

the that's we'll that's neutralizing looking that something cavity, fine. at As be nasal far as and the

factors, I the And of that we that data induction the stage. role X, – our don't not the validate antibodies, the other on think we've demonstration whether or is in check expected. It's at Phase T-cell presence neutralizing the of necessarily a or of already this the get number that, with and of and of looking that number intra-nasal not clearly established RSV. other think clinical clear seen X, we're There assays And Phase those to see like and to is those, depending also. a think I so the we'll and in critical with being immunity. opportunities course other the at IgA mucosal I is studies And we have been of whether influenza have those all executed. IgA, box. for that of Neutralizing what

Kelechi Chikere

Perfect. Thank much. you That's really very helpful.

Operator

you. Thank

of question question. Mayank with with next comes Please the your FBR. line B.Riley Our from proceed Mamtani

Mayank Mamtani

morning of helps about is model taking quarter talk study transmission on good Can catalyst. the like first question focusing the collaboration it about I about Can added progress. AdCOVID better and animal you the Saint you're study? Louis understand to looking University from blockade a of you you insight A what mean, my the the and Thanks bit seems team. you just recently? for that heterologous first that What design the the what congrats little at talk of on design?

Vipin Garg

Yes. Good Mayank. morning,

transgenic vaccine activities at. doing been we're That's that very, it's are what mimics a a comparing Louis where study Saint model model. closely is mouse the RNA expert a while vaccine So is very that And and model is the for authorized the currently using the we're of in efficacies that the RNA after AdCOVID. and and vaccines

will of to replication of virus at these the be combined understand order prime tract. used looking and immune best in then and control the vaccine respiratory overall So the as a heterologous immune agents close the to single boost, in provides comes which responses, first the best addition, How which response? order

proceeds. interaction shedding of has a reduce the it system direct knockdown of just or completely, of the Obviously, vaccines remove and even can we really the so understanding transmission. if two that how amount replication, for And viral ideally effects different

the XX,XXX Louis are University. the of for there Saint at studies overview foot like that kind So that's going on

Mayank Mamtani

and follow-up the the and – comments maybe the also FDA on question, And previously Great. can I if on made on second flu. guidance experience with your

step. natural that quantities not if relative NASH But is to think quantifying, field you for the Any does was factors, FDA the should you Now, I'm when about for what progression provide? not which clear ball do that the about curious just can high. that guidance you your infection, think you to think next be be, color in positive a NASH the very

Vipin Garg

because to we're getting with harmonized do reluctant having harmonized that I reagents. a currently think assay's I'm performed close to

have now is serum to – in a compared informative. like titer sense is but when all at has convalescent that these end like so I what, comparisons quantitative really last put And stage This perspective. I the you as is think going can on. necessary be critical. critical so The available be to can values of in assigned XXXs, not that's that's a are the have things at is think the of is do mean, The what and get to exciting, we we going that – they I a like I released neutralizing that qualified IgG way. year. there we be then got. that a I and XX we reagents temperature right neutralization be got binding, This a or for up We're understand and meaningful going yet. too not And this something think what's less to what into

but to everybody each we're there really other, I of think we're though do to having quite getting these those yet. conversations wants that types have. to How close will that things not relate

Mayank Mamtani

more variants, Got a numbers of – context that I the mean but modularity I listen emerging could become maybe kind it. of could the of interesting, platform. change, was obviously final in just the to And question because under the even also

but can with it curious the timing, vaccine? new NDA I'm with differences part on have the still clear the of just I’m does like, AdXX the not in saw that up [indiscernible] platform vaccines in given may you between variant. your testimony they timelines by adenovector the adenovirus come for As the the Tuesday, platform the can vaccine which general provide versus like again, is on you from seems same prime

Vipin Garg

Sure.

right. unchanged that's really you're get fantastic. now that vectors are initial funding why and So, are RNA the the attention they where are There got vaccines in quickly the the and RNA, to as that's

the can that we landscape quickly question of is the how make important evolving of circulation variant. variance The in relation to

time short order amount And these of so and things in a month can of we ready. make very these a have in

you And are Where And the vaccine. changing work? that of plenty your doing population time have quickly. bio-dynamics going so understand is not on? There the what's to the and right

So that. yes, yes, enough, not as but also to fast fast

Mayank Mamtani

for Thanks my Great. taking question.

Operator

you. Thank

proceed Our question. with Securities. comes the next question your from line JMP with Wolleben Please Jonathan of

Jonathan Wolleben

Hey, and on the congrats all good morning, progress.

that Just if then of me. that things two AdCOVID, And that if hoping questions I like kick-off? could way in planned, could you registrational be can for was next when lot go next Talk extract question study, about NASH terms XXX. the on a what as second the look and

that of and discussed was fat you're reductions us You quantify liver body expecting expectations. in you robust kind help weight. I hoping could

weeks readout first be in this will duration? six Given

Vipin Garg

can you think of both handle these. I Harris, Scott

Scott Harris

Jonathan. morning, Good Yes.

studying quarter. a that now age initiated are initiate of the are end of larger start we a just as So trial looking as X readout with Phase the trial, would patients occur a the which that a all AdCOVID planning the which on and heels with second occur Phase we – that like of And quarter. traditional probably trial to of X Phase on right well number was toward X will in a the trial will groups, we've read-outs. second immunogenicity safety And the readout, full –

comments results at the similar And trial year. that data a That the to going look conference I'm were published weight very of X%. that but are had trial. call, in recently a question, Journal recent with also was reduction weeks, of made second published and was NASH New semaglutide trial, the to loss the they last by six England that of [indiscernible] Regarding at end NASH at that defer the trial a to not on was that

in even lost should well with and net be that XXX trial kilocalories all that it were subjects day, a exercise weeks as Now diet with six placed negative pointed subjects X%. placebo of as the per on restricted a in the out that

because subtract human in to in trial, an baseline X a that not exercise implement one which were first tolerability the X safety growth in Phase So cannot and it's and couldn't efficacy X% to study, a the dive-in take and study, if Phase at X% trial. do due we a

you If look at would its net, weeks, the be it X%. six

but with that at show we that's think we think do we're par on think we the least can we a minimum and floor, the semaglutide, that's Now better.

Jonathan Wolleben

again That's all very helpful. progress. on and the Thanks congrats

Vipin Garg

You're welcome.

Operator

final for to Ladies session. and question-and-answer any concludes comments. turn our floor you. Mr. Thank back the I'll gentlemen that Garg

Vipin Garg

and next us for Yes. today. Thank a you nice call have earnings our join in on We hope everyone day. listening you'll quarterly

Operator

Thank you. today's conference. This concludes

your lines your you Thank at time. disconnect may You this participation. for