Loading...
Docoh

Altimmune (ALT)

Participants
Stacey Jurchison Investor Relations
Vipin Garg Chief Executive Officer
Scot Roberts Chief Scientific Officer
Scott Harris Chief Medical Officer
Will Brown Chief Financial Officer
Yasmeen Rahimi Piper Sandler
Mayank Mamtani B. Riley FBR
Jon Wolleben JMP Securities
Call transcript
Due to licensing restrictions, you must log in to view earnings call transcripts.
Operator

Good morning and welcome to the Altimmune, Inc.

Third Quarter 2020 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. Please note, this event is being recorded. to conference like Jurchison. to now would turn over the Stacey I go Please, ahead.

Stacey Jurchison

and Scott a for Harris, participating remarks, Officer; session. Financial call Chief be you third you, the Officer. Brown, night Officer thank Thank section Officer; operator, Chief members Other everyone call Vipin Chief Scot earnings website. of today IR Roberts, with prepared hold Chief and call. of the of Will After XXXX was Altimmune. be release executive we press and quarter conference will quarter participating financial question-and-answer Scientific the Leading A the can will the third team today issued on our Medical Altimmune our Garg, found Executive results on last XXXX Altimmune's in are

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

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

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

Vipin Garg

and appreciate business you joining third Thank quarter morning. review for financial and good of Stacey, a you, today We XXXX us results update. our

year much swept session. Stacey vaccine intranasal as global and new be Will Brown, believe Chief candidate will potential Financial has frame. transformational As our outset shots we that to inflection as so AdCOVID, an in to as call are we we time goal Chief months. develop third this five pandemic clear as and In year, a combat shareholders. over novel progressed our the At I'm are proud of had Scot opportunity in Altimmune to accomplishments, XX time, build promising much Chief Officer; candidates so After history Q&A value many our the the remarks next have our they Officer. on Officer; our around expertise a crisis. Never we and the the Roberts, so me continues on our mentioned, to joining have mobilized a promising globe, we rapidly clinical for Scott particular, to points quarter and prepared six that exceptionally in been our relate candidates, especially COVID-XX investigational of development. today XXXX the the Scientific Harris, our we compressed advancing Medical to a hold our achieved the has towards busy

COVID-XX as are uniquely offer to approaches, and T-COVID. in a product promising other candidates therapeutic a Altimmune significant advantages the therapeutic These solidly positioning therapeutic of development the initiated also and arena. vaccine significant compared differentiated player We intranasal

During we each important made advancing the these quarter, candidates. third of strides

We AdCOVID, EPIC with Phase expected to quarter data which of commence I T-COVID. of in on readout track to clinical continue study study this the Phase we a I/II initiated is preparations QX, a initiate XXXX. And

at preclinical With Alabama a mucosal University lungs, potent against presented we of the well stimulation at the response, collaborators reside AdCOVID, antibody the the of CDX in CDX provide new that XX-fold for and and data respiratory virus the of cells tract. IgA can antigen-specific Birmingham, T our in support as AdCOVID showing that as compelling

tract-focused immune measured. strong the respiratory antibody Importantly, to these addition serum-neutralizing response, in responses we unique are

agreements to through commercial plans Finally, have morning, AdCOVID, with for multiple dialogue vaccine and agreement Washington advanced ensure up an manufacturing an announced further offers partners execution we we our commercial for readiness. In commercial in scale of of The working exciting with manufacturing to our to promise This an to our clinical data with trials the help D.C., advantages our raise active capacity strengthen conjunction announcement diligently effective of for activities, we Lonza, with COVID-XX. these awareness intranasal and approach. commercial vaccine yesterday from the maintained policymakers Pfizer is of vaccine the preliminary readiness.

Phase Roberts AdCOVID describe important some promising that being fulfilled in COVID-XX We data an not attributes believe could generation As are believe have vaccine by candidates. confirm role vaccine play of results the the Dr. the we world's Scot unique our shortly, observed, very that armamentarium. preclinical if we will CFO, I first offers that the AdCOVID

Aside peptide and progress made in each also from we ALT-XXX our COVID-XX HepTcell, which third promising NasoShield, deep have the and pipeline therapeutics, intranasal quarter. including important of and programs, vaccines broad of a

preparations a also this we begin II Phase track study commence year. vaccine study of towards to treatment the trial anticipate the a NASH trial the the of continues of Specifically, I during anthrax end from towards of enrollment advance to in begin ALT-XXX completed and clinic the year-end. quarter, that Ib this also to HepTcell, are to of we quarter. we a ALT-XXX readout completed Phase on for a Similarly, scheduled we before later and clinical NasoShield Phase

of underway and get trials these as period see, the we As lies you momentum catalyst-rich shareholders. our and of can Altimmune have clinical significant ahead developing each

We expect multiple data coming the readout over months.

towards our meaningful to programs are each we points. advance these Importantly, well of inflection capitalized

to I'm very ahead, on to I on to an over updated for provide and our portfolio. pipeline look call please progress. related clinical Officer, Scot our ahead. future you now who the a potential update provide go turn forward progress company the candidates. our Roberts, Medical I Looking update like Harris, about our to Scot, Chief to would and Scott keeping across our AdCOVID, will then, excited

Scot Roberts

everyone. Vipin you, morning Thank good and

single-dose tract unique to AdCOVID, currently COVID-XX As we in advantages, single-dose mentioned, are advantages have simple to our Vipin intranasal administration. in which the several among single first-generation protection, candidates candidate, something route development. very the Key compared special the the and potential and in vaccine intranasal vaccine believe, of immunity respiratory confer we these focused has

respiratory adaptive responses, the appear next. to administration strong that During data, important to the similar high immune the responses in potentially serum. three of the addition the activity the to and at data describe systemic be quarter, serum-neutralizing a robust of antibody convalescent arms that titers and intranasal of system, Altimmune tract single our demonstrating of activation announced dose reported immune in activation system These intranasal even elicits than in localized show included I'll that higher compelling broad all following This partners the preclinical immune UAB AdCOVID.

protein T-cells. a Specifically, T the the where able precisely viral cell resident cells lungs in want you'd also of animals, combat killer towards respiratory the are type stimulated infected biased CDX that to the kill the we killer of to show spike response the to This of T-cells to infection. infection. was strong AdCOVID a vaccinated majority clear the Interestingly, that stimulated T-cells were can them

clinical comprehensive the T-cell Finally may induction of resident antibody protection XX-fold disease recently the specific published provide observed tissue enhanced with is a lung-associated These submitted were following in of online influenza to and with that mucosal from immunity. an publication. of a we meantime, to was additional AdCOVID nasal The with be mucosal preclinical from mucosal are these intranasal data dose. AdCOVID IgA response against data memory where transmission. preclinical protection. at to in level the peer-reviewed has preclinical elicit and vaccines, partners on together AdCOVID importantly, UAB to correlated of our increase the unique IgA associated with two spike immune are AdCOVID protection continuing In demonstrated evaluation the IgA single in and to vaccine ongoing fourfold disease mucosal studies being to presenting We a and response expand This well above increase level for the studies. ability collaboration found based a protein to forward look

working The in mucosal all important, selection and blocking and regard may an efficacy. expertise sterilizing think elimination play of the T-cell Molecular at with of immunity entry Microbiology the to extensive that models to in with and our and the pathogenicity In of a collaboration Saint the of the be nasal that administration to in the to mucosal dosing Dr. good delivers by the James has intranasal especially SARS-CoV-X why University. is in critical is respiratory the COVID-XX. addition, preclinical towards Brien We'll Louis tract. is cavity immunogenicity be mode immunity recently others important will studying Department addition replication transmission is we and virus Dr. viral and There in explain I'd from providing conduct body. established intranasal cellular the to to a so we site Brien of directly Immunology to vaccine and of animal role of evidence Brien, COVID-XX. virus immunity known studies. Altimmune faculty like vaccine used of directly Dr. member stimulate route that the the as We what exclusively effort And that infections of viral respiratory new route of

after And in will experts While traditional the can in mucosal cannot it via the data AdCOVID. we're candidates. means immunity immunity From while expect common in route the respiratory allowing important vaccines systemic differentiator tract been intramuscular vaccination specialized community-based that the to immunity vaccine freezers not vaccines This potential a T-cell distribution nasal cavity. provide that first-generation blood, logistics systemic delivered excellent Based believe very many stimulate mucosal some transmit AdCOVID from immunity be further to immunity. nose one reasons vaccines induce perspective, sterilizing the resident why recommended carry a need of virus a you've in for for may as the with without for stimulate at other along AdCOVID centers We titers, antibody conditions of developing, we and of stability other have neutralizing on is will the even vaccinated. and is from storage the it the others. the strong still differentiated. see required to still mask their after disease individuals vaccination, wearing these This may be still people protected and

In fact, AdCOVID When our we COVID-XX Health to temperature, simple, expect to ability reducing scalable manufacturing with vaccination process, distribution the simplifying for vaccine. AdCOVID centers has simply – to room and and at greatly World Organization's expectations ship costs. have the exceed to its potential the significantly combined

a mentioned, have vaccine from have intranasal virtually candidates in as previously NasoVAX will believe we with demonstrated studies excellent AdCOVID I safety been as NasoShield. our profile, characteristics Finally, that these indistinguishable clinical placebo and

hopeful the are COVID-XX vaccines we wave that course, successful. will of first be Of

However, opportunity believe quickly, we global second [Technical or like safe important but vast safety. that vaccine and effective there's several of It's that beyond primary important. of we vaccines that strongly immunogenicity we symptomatic next-generation indicated be next-generation complement effectiveness, goal respect options wave CDC that a vaccine protection the vaccine available Difficulty] supplement AdCOVID with requirements. and for have advance our to file will disease considerations Recently, logistics, with the from vaccine an to improved

has COVID-XX tract. provide it first-generation potential in boost regimen. the vaccine, We AdCOVID different to is benefit effectiveness the combination-vaccine considerations with the and IgA well a combines of provide mucosal necessary suited other the the particularly that combination believe two to for respiratory understanding that providing single-dose One to is activity a vaccine these protection. the That the while the of also activation regimen because of is vaccines of T-cell

launch AdCOVID well. manufacturing are to using In of of scaling Phase We setting clinical AdCOVID. parallel that exploring with a and the are currently X/X testing we possibility the requirements these efforts, as commercial in the potential of meet process

and formed Harris viral manufacture potential already key AdCOVID provide on manufacturing pipeline with strategic manufacturing will the discussions now vectors partners. partners will over other Scott continuing I have the an our programs. have call are to and deep other Scott? turn in commercial We alliances of with experience we that update who

Scott Harris

single- We a AdCOVID to evaluate study Thank XXX at the Phase anticipate including AdCOVID regimen. X begin two-dose this up safety excellent a you, The to mucosal We're to serum subjects antibodies, Scot total immunogenicity immunity will morning three plan clinical and trial serum-neutralizing levels of nasal the IgG, and and to good year. responses. everyone. progress dose either enroll trial or making T-cell receive with and will

Vipin data readout other pending immune and this to XXXX As well-tolerated of we development. candidates, in our expect placebo. to Phase are prior mentioned, intranasal similar anticipate from a preparing quarter potent move on rapidly profile first we safety vaccine into responses with the study the X experience in results Based

AdCOVID intranasal profile the of safely We for addition our be adults, intranasal to down with parents get these and years our is adolescents vaccine vector and now teachers vaccines appreciated the to to trials in back and adolescents combined and school we the exploring to of confer prior that In the return children parents. transmit would It that in to a of simplicity them clinical use virus clinical SARS-CoV-X and ideal AdX to study children an believe study allowing allowing demonstrated potential safety also work. heightened of delivery to excellent are to in groups two ease opportunity age. in to

authority. progress Australian NASH, from X to significant development. Human GLP-X/glucagon and the program made Phase recently clearance our the on and this Clinical Notification and the we Australia received Trial dual with for agonist readying a also quarter filed during Ethics We We Research in have Committee regulatory receptor begin ALT-XXX

for we squarely the follow-on before of will this a XX-week XXXX. anticipate be it data will with Liver readouts forefront The conduct time on we we of trial weight positive, year. the clinical in to as Disease pharmacodynamic parallel In study, that which we or a We planning XXX study. Phase ALT-XXX to this the are but Altimmune the expect in dose enroll endpoints dose be the place conduct NASH had event We significant of expect trial subjects value-generating single-ascending X ALT-XXX If loss development. the study in this with six-week in a of NAFLD. patients this a trial by are could in will quarter study Fatty Nonalcoholic in of reduction towards of have and the Australia. believe in planned end lines fat, U.S., to or primary approximately study multiple-ascending XX-week end liver trial commence dosing this are to accelerated originally conducting The first

We the trial expect a data readout on this in third quarter of XXXX.

endpoints to rapidly NASH full trial Phase transition to expect a of We X biopsy-based XXXX. the beginning around on

an We are United States the the to still XXXX. in on middle of in schedule ALT-XXX file IND for

showed of ALT-XXX for excellent announced improvement the dose of an observations, intolerability other titrate GI We is GI adversely better GLP-X trial on tolerated the candidates. to dose-limiting weight will profile. X in toxicology studies, tolerability the Phase our than without loss similar adverse and no on has achieve our molecule also impacted of liver design need which therapies the and fat which GLP effects and the results that believe Based recently we preclinical

program. Moving now on our to HepTcell

is a studies study you will apprised of Phase for as disease. high minimal believe in the and patients clinical prevent of of B. The safety receive Safety X other X opportunity double-blind response. Clinical T-COVID The clinical Switching for to randomized We Prevention a of this keep multibillion-dollar and who for therapeutics worsening activity protective on XX work data with T-COVID is be We enroll gears We need trial is to doses. EPIC onset being endpoint XX% placebo the Phase hepatitis the in functional that be shortly with elsewhere Patients on mechanism COVID-XX. chronic primary the HepTcell new unmet important is trial would criteria X HepTcell or in from of track designed to symptoms. intramuscularly our Depending either with setting we're is all oxygen alone hospitalization. will begin a The cure effects early of symptoms. total older anticipate functional readout are assessments remains having HepTcell we with cures. treated currently trial quarter. designed therapeutic The to saturation population patients to Efficacy non-hospitalized develop to enroll evaluate in with commenced trial in of analyst worsening endpoints to six as hepatitis recent approximately in administered patients Worsening evaluate study were advance. a chronically in X:X B progress to as the virologic to developed reports. or after and patients is Phase of a antiviral of decrease in EPIC HepTcell Phase stone secondary up as are intranasal pulse primary chronic the XXXX activated stands of COVID-XX that the the The virologic XX combination trial intranasal our for a which administered The and we and potential rates T-COVID need reflected COVID-XX. achieved The therapies this Trial the in to response the XXX these a of goal patients once-monthly X being immunologic medical the intended to calling COVID-XX, clinical of our defined with proportion T-COVID dosing immunotherapeutic patients years a expected in the antiviral endpoint in are for milestone an or for disease. it's approved this in this of

are data first the from actively on Based not this the T-COVID prevent could prophylaxis being new which are we and development sites or against potentially Phase current for have add discussions next X/X Development Research & be we screening and respiratory regarding pathogen we Command. anticipate trial or the to in early this If use Medical severe XXXX. with enrollment continuing as that quarter because we Army just initiate sites readout of year SARS-CoV-X, Emergency post-exposure study. that rate disease by plan to study clinical of successful developed. If a the is yet Authorization. to more trial multiple could pathogens commence other have We XXX% for vaccines the any pre-exposure a COVID-XX patients, and respiratory successful funded Use Recall U.S. a enrolling

third also had of NasoShield Xb that we Phase quarter, anthrax. in the we During enrollment clinical announced trial completed our for

We from expect readout of toward this the study the end the data year.

NasoShield Importantly will if remaining receive our Phase stockpile. NasoShield Will? contract quarter. which shown the be of we our is million fund be update $XXX.X will turn and now effective over national call strategic awarded who Brown options provide Financial to clinical -- could to and be to testing under to eligible BARDA the stockpiling I for financials our on with begin Chief Officer our an safe in Will the could II

Will Brown

and Scott you good morning Thank everyone.

warrants July, XX from increase our million is in facility proceeds receipt in and providing had million. More million of completed quarter results. investments SEC from third from I a the our $XXX.X to our afternoon. offering we information million from of comprehensive year-end $XX.X XXXX end Form of the For with the our cash XX-Q yesterday in approximately and $XX September financial the will quarter, exercise short-term primarily proceeds call, found $XX.X $XXX.X from a today's totaling The filed proceeds attributable on At XXXX. third brief update balance be through of at-the-market can million in public the be

pipeline With our into XXXX. solidly these candidates proceeds, is to advance Altimmune capitalized

will and demands of up cash As of a scale in for utilization AdCOVID these both the noted, meet Scot future of the periods T-COVID of product Roberts both COVID-XX to driver be manufacturing candidates. major

in impacting T-COVID income government statement. Revenues current the The $XXX,XXX reflecting period the payments U.S. the of of And at our non-cash primarily costs shares revenues same expenses development X.X initial candidates. during fourth quarter for AdCOVID now $XX approximately million $X.X the accordingly studies quarter the in an related $X.X ALT-XXX. contract were the to third result payment filing increases our the the contingent by in Also increased for Turning for the has during September costs quarter were split quarter. stock-based successful the compared year. and million third associated IND-enabling payment milestone spend the the to increase Research as of we triggered a ALT-XXX an for to with program. CTN ended October. quarter a T-COVID of in and in XXXX development in The attributable for the end increase paying development been for million shareholders period costs increase were liability compared Australian year-over-year milestone last third will is of the and with to million XX be to

the For we compared the legal our were quarter development. $X.X $X.X expenses of G&A compensation, to towards reflecting period advance costs third multiple million year prior in candidates and XXXX, professional million increases as in clinical

law third losses CARES Our that and tax a our the the tax represents approximately estimated portion XXXX carryback have which to with Act. our and of IRS net attributable by refund filed collect NOL XXXX changes enabled $XXXXXX quarter the Note which loss. to claim million represents expect quarter for XXXX benefit $X.X we an was the of tax income

share Finally quarter QX XXXX in per for $XX.X turn equaling the Vipin? XXXX. same net to compared for closing back net $XX.X share period now third with the was I loss for remarks. versus common loss attributed $X.XX year to million over in per to will million last QX stockholders it $X.XX Vipin

Vipin Garg

Thank you, Will.

throughout us for over value-creating of accomplishment much next is several remarkable a the the programs year-to-date. By with productive with of we'll heard months. novel each been these to five our made pipeline This reach candidates over fourth allow year important the development to end an exceptionally you've stage As the next of points clinical readouts in exciting and have inflection for product sets front. company all this progress quarter on XXXX. candidates our anticipated advances Each has -- multiple data the

Importantly, mind a one-product company. are we that keep in not

medical two vaccine multiple our platform, important risk-diversified therapeutic call maturing portfolio technology both Never been financial advancing the reach a and building pipeline, platform these this your next ahead support portfolio opportunity procedure? We for candidates Q&A. to Q&A potential. our thank summary liver our address I in the call. Altimmune opportunity excited our on our momentum could third conference I Once audience and a our for months we months. formal see concludes about now have each and significant the with you continued solid and participation important the the shareholders, clinical the the product have realizing we needs ahead. and we to our poised you several in over as instruct please more remarks. foundation for Operator, to Altimmune platform opportunities evaluate on fully your will then, peptide-based candidates open and novel for In quarter intranasal committed for in of milestones proof-of-concept each I That our candidates for unmet with again, are with for

Operator

you. Thank

be ahead. Sandler. now Yasmeen with will session. will the We from [Operator question Rahimi question-and-answer And first the Piper Instructions] Please begin go

Yasmeen Rahimi

Hi, and and that from start off team. yesterday with, first Trying granular think A of saw data lot one all number the get mRNA effectiveness Maybe for given XX% uptakes. to a the you you that one. So mucosal investors. vaccines questions. for is questions Thank pediatric I of then, running raised from a into to the we to to efficacy a that about achieve a vaccine a -- vaccine forward immunity move second one pediatric know approaches that And what that's mentioned understanding, you're do intranasal population. having similar planning better bar? we

that off to question. achieve a bar to check that? And the requirements What specific So what is have need are that? NASH for I then you

Operator

Apologies here. on Vipin, maybe I you're here. mute speaking believe you if

Vipin Garg

Yes. I on mute. was I'm sorry.

Thank Yasmeen. you the question. Sorry for

in space. just anticipating me yesterday. for development in start by congratulating forward moving I And our there been attributes. bodes out colleagues preliminary we presented vaccines additional have would the -- be had believe think hypothesis be COVID-XX vaccine this. effectiveness. They that it think Pfizer. be think that we And have we well for delivery addition that working would we some attributes very good needed at been results candidates that I all And that first We Let to believe the great brings intranasal really unique that's would with. We other

So of we quickly to in effectiveness let turn Scot that it perspective sort through put walk saw and that, it yesterday. to Pfizer me data from over you the Roberts Scot?

Scot Roberts

Yasmeen. you questions. Sure. Good morning, the Thank for

Phase the also out wave So, that to on -- that level here. Vipin and that indicated, else was Phase there likely data be to first the as happy, based effective sure were was X the so we a out, And effectiveness far. the turn vaccine demonstrated preclinical surprised data that it Pfizer I'm I seemed the and of think and vaccines and looked with at in along everyone that was X other time they to happen high we that at weren't we expect points

protection antibody of might think of the that neutralizing be relatively take-home I low. one that's level for might the messages required be

a very, very good high know, Pfizer you it job but did wasn't level. that, As on the a

vaccines To neutralizing of able And immunity. antibody that be opportunity associated about creates that, that's a level to multiple your of an think achieve certainly the mucosal so for role I initial with to protection. question

to immunity key the and mucosal COVID-XX been in Of the we've respiratory importance cavity, especially with making SARS-CoV-X. such to grow respect tract, respiratory of in viruses of course, that the our discussions, nasal because for that as story

T that better for those up and infection cells, having situation obviously have so a don't control IgA respiratory-associated mucosal represents a of than sets And perhaps activities. that vaccines

over mucosal COVID-XX the development How it? about arc is of conversation the high overall was all these antibody. and discussion concerns that body. to the and to immunity, in the can it? of the at look you and focus of we get Initially, If it's Then Do time. of it the neutralizing vaccines, virus for evolving of be infections can seed highlighting number SARS-CoV-X role high also other like and of the that importance that a replicates parts the way of evolved spread the to KOLs levels the nose

it think closer mucosal specialized that? convenient we has How at cold really a as that logistics. the And an going ship can a to central recently, protected themselves people infection or going getting the turned which disease you'll And evolved to far. the how these have what has stored? Is requirements? conversation pediatric be EUA, get be and populations. the discussions vaccines stop care from number the they of chain the And that, is to beginning in use And Can still I things possibility think then are even conversation on spreading these the transmission. to freezers shipping highlighted on take around more I be of things? the at so is Following community, to that is towards we a again to I that do believe a doctor's the office, from as see site to it are yet have real turn of and others, people vaccinated been

block logistics check childhood issue, use having And of a later AdCOVID to pediatric the really appropriate vaccine chain boxes. mucosal of and adolescent to so especially that, is all the able immunity, ability for points all transmission I think these those essentially that's and cold

area. that can effective aspects this be as along, all in vaccine. is start that, important other there that we are continue And believe been so fantastic significant think the an I a we and make to have for world we've to a contribution But many saying that

Vipin Garg

you could the about talk Scott, pediatrics? And

Scott Harris

and And Sure. thanks, morning. good Yasmeenm

viral there vaccines in science of the MMR, and So vaccines. strong to children for vaccines very precedent develop a many other is

would disease children return parents Pfizer to the their their effective precedent the used be we to agencies agencies safety genicity with allow administration profile route and parents, that the school pointed disease a not this like injected. whether of of with this really get One because that ideal. that reactive that. be down and believe the tolerability there's space to do the very plan encompassing to AdCOVID question, as whether of And children influenza, which we can to as their the parents in the do start children, to of are we vaccines at and likely severe the vaccinate that accepted intramuscular of to years, route had younger injection, formal at point, typically the It has agencies. would of intranasal with day-care children, years very by well So vaccines And the two for the fashion children. pediatric based plus to we to argued ever this. would believe most going could children with down return could We've we that out be But for it well And to to are where a and work. the nursery severe transmitters teachers vaccine get least would need our children administration, but be discussions in the anticipate in should and starting descending-age be precedent the is potent kids. comfortable exists age on questioning, school vaccine allow or and children older less the the an

Yasmeen Rahimi

tolerability, made one effects. was then those with early in Phase some GI nonhuman were you is GLP-X we seeing jump NASH we that the side if And into program in the we that primates that GI no see be gotten chance not So queue. the again, I will question, comment had Can nonhuman back around Scott. no transferabilitiy -- from the I'll preliminary observations don't of if data of be maybe primates GI agonists, study? had nonhuman that could on sort very And fall would a remind whether if in primates, us the the you in Thank showing X tolerability other helpful. you, with there the

Scott Harris

Yasmeen. you, Thank

of So limited. the is the other domain and summary public the But programs approvals studies amount basis of in public somewhat of tox on that the other information information of demand able data and toxicology this translates they to only significant in have humans. intolerability the our observational are We models intolerability studies. identify, incentives we to the not they're in seeing describe their from

concentration achieved concentration a a the this basis after that that peak injection is that to the ALT-XXX GLP-X with intolerability. compared subcutaneous that agonism. reduced have noticed We mechanistic We drives peak for being

better that mechanism high-level that So tremendous up advantage titrating to that a over allowing dosing and which rather also would start but will we from in commercial than forward our in maintain our is tolerability not going have dose of programs, will titrate also long time, observations period a we compliance. right support need the animal view protracted

Yasmeen Rahimi

Steve. Thanks Scott. you, Thank

Operator

And Mayank Riley the ahead. B. with Mamtani will next go question be from Please FBR.

Mayank Mamtani

team. taking and my morning, question, progress. Thanks for Good congrats on the

So IgG And Pfizer recent maybe comments How beyond your obviously neutralizing you publication? original your them about Dr. of how preclinical thinking the specifically work are did neutralizing the DOD, Because models and thinking compare including preclinical immunity, compared us following with Scot, up you're a on some is are maybe could for and the all of on just ultimately sterilizing this? partner the maybe that on on focus with in lot with importance AdCom, then, efficacy? commentary as sterilizing the obviously titers educating you immunogenicity including Brien. validate on that? on doing on both contrast specific experience? talked the with and of titers regulators And and How you immunity. was at to

Scot Roberts

Sure, Mayank, you and thank question. the for

to it preclinical with to did Pfizer, what IgG had extremely does well data, neutralizing respect we how concentrations as and titers. serum how high it did that So compare show recall as our

wild-type of approximately full XXX titers side titer virus. reduction to XXX the neutralizing with So neutralizing

identify robust a AdCOVID those being values stimulate So of first able response. immune as systemic all to

get titers. in high approximately get single very we so influenza a commercial consistent flu our -- intranasal we dose And with intranasal antibody dose do high where saw that's we vaccine. -- neutralizing the to what serum serum titers again antibody antibody program gave equivalent titers do And and

high to data serums. high how neutralizing people is Rosetta and correlations XXX. XXX said different that anybody's. coming than titer XXX this their higher among It's the expressing other will it are to be able the high around very we're and systemic induces was intranasal a some you antibody but if a IgG Stone use as while in We approach, as make our way, response, So measured as around with highest. And most appears in the convalescent to I

confident immunity are ability believe T that to and IgA Phase through circulating the and are that antibody addition CDX, that similar our only populations and together So about with show that able killer cells we around ones the there study. were give we cell, what route feel respond mucosal to not poised to resident provide right to we T stay infection. systemic with able that what the to this in resident now has to I we are strong the lungs in But protection X show generate Pfizer done immunity very to that

be immunity of is think will and broader makes mucosal combination it this if to And perfect you help possibility killer and will sense the CDX effect protective overall that's that in response characteristic going importantly the comprises So transmission. IgA over and sooner. for getting a of RX the T lowering that and a lung unique that cell the offer the of blocking I with this AdCOVID critical pandemic

Mayank Mamtani

that? validate How further? this? Maybe trials how regulators As Any clinical about Dr. about comment with a thinking even think do on currently to think follow-up. animal Brien, are are you this about you thinking or models you

Scot Roberts

of boost a clear AdCOVID a along where point will feel or I bring T lungs response first-generation ability prime-boost. because be immunity to again on that the advantage. involved of any that makes our with vaccines this first-wave that But this cell sense, systemic And the this combination of the we mucosal think represents response. lot Well, Dr. it immune heterologous of the the in this of is with work Brien in is

the So regulatory laying be the initial And looking conducting that sharing and I for heterologous prime-boost approach. data think those an for forward trial. helpful clinical data we to will study agencies that at with look groundwork those

Mayank Mamtani

need the specific thinking prime-boost first follow-up? How are you'll the What Phase decision also single-dose. AdCOVID at I'm for because think you much Thanks to a So you for doing to curious you how would in quarter do order then And some of taking for you Great. that? just placebo-controlled make point X/X, and that. terms on plan about that the trials think communication obviously have do to in infeasible? move become

Scot Roberts

is… I here think Scott

Vipin Garg

Scott, do want that? to you take

Scott Harris

Yes. thank Well, Mayank. you

evaluate -- different of vaccines at to stages. our immunogenicity we'll be So able our vaccines

after So have and a obviously the prime-boost. we'll after the result prime

at will that trials. all unblinded. will evaluate to there But comparator If FDA be forward. Ad noninferiority trials about Authorizations. Com And occur I that any not -- time be and would per be requirement going there's for be any there active approval kind will problem not the controlled any no placebo Emergency there a those will small of approvals with until ongoing Use will continue week do We overlap. be or a think over ago any conducting there trials

have will So that we the that the we conduct program to believe planned. space we

Mayank Mamtani

GLP-X agonism clarification. about how for sets, the THR-beta you with Great on with question one that a the the maybe of -- GLP-X with staying with we compound Scott. XXX. Thanks one. ACC see obviously so that are light dual have In And was think starting combination data quick to should including we with AASLD, you

going you the terms weight and here into reduction fat how liver you about had So that thinking loss follow-up are in first of quarter readout?

Scott Harris

added of superior Right. component. ratio emphasizing was the component GLP-X semaglutide importance our one-to-one the a the far when in to In studies, animal glucagon ALT-XXX to

the expect reduction weight to will in liver to to itself all loss, of the potent liver of translate Harrison loss it's get mechanisms reduction Stephen fat, that these obesity. reduction fat that lot with the in said in fat. national to achieved a or recognize by think potent weight impressive we reduction as inflammation We levels data pure get data preclinical we really experts that reduction complement in by and will potent result in liver that of in very fibrosis. which think very -- we in the People to obesity in of So a potent, and is will fat have fat which reduction more going that extremely And reduction. liver seen at translate addition superior reductions fibrosis. in of we're addition and of in also liver reductions national obesity the That more fat But of of important such reduction potent he's liver best looking superior fibrosis. liver compounds are that affected of also that history in reduction reduction

optimistic beat the can we're the prior in So that quite studies. we findings

Mayank Mamtani

the Great. updates. question and to look taking Thanks for the forward

Operator

The Please JMP come with [Operator Wolleben Securities. Jon ahead. next Instructions] from question will go

Jon Wolleben

thanks the good taking Hey, for morning and questions.

you anything seeing soon? hoping it's time? resulting have me. if be a to criteria any need a on is particularly accelerate dynamics kind or Just dynamics or trial, whether could that's just in bit do effect AdCOVID which in areas have a hot Trial you enrollment patients? not And give on more more for competition screening slower there And enrollment you starting color will you're the do of than is was little could couple expected the sites EPIC the little any for having this I or to your think -- and

Scott Harris

Jon. you, Thank Right.

the in the had we trial, addition, back we And in were we shifted. that Defense about So a the that We more spring. of we amount not actually clear the and the planned than But recognize of launch prolonged time that line thought. tremendous It to which with that expected. had to the contracting took that Department we time was were had unexpected. upfront had a as more considerations lot incidents in was sites

implemented new locations. sites, So consequently, in additional we

we need the And like we these was planned trial. they in quarter. back the this. The of But this is the with order the We're therapeutic setting have this sense enrolling contract Department it trial think the absolutely is So optimistic of that think Defense, important worth time to line, in were aggressively. necessary affect in start extremely first readout in is we'll prolongation government. of to in now a steps the military the a a and -- of have because the

processes So, strategically back lines. set those the time to important we enable occur to decided contracting was extremely and it

Jon Wolleben

this one your that, announcement morning me, year. goal more with the is commercial mentioned vaccine you And, in manufacturing, for That's just produce to Lonza, helpful. on next

to any what additional discuss, you some added table that path whether scale available vaccine specific about commercial to it's or getting and if forward can the about are And Vigene, today? to the I was Lonza So timing. hoping, brings versus specifics you think capabilities launch what

Vipin Garg

can Yeah. take No I Jonathan. that absolutely. question,

engage that ultimately, has need a strategy been to So, work with footprint, manufacturing not to And in the you with partners our global the have produce globe. over vaccine really just to partners. with but regards multiple all because the also U.S. multiple CDMOs

in Vigene one. Lonza the additional fact partner think that's and in what's been fourth to by really one have we I with in and So are we addition discussions driven

our multiple So have has with to strategy to partners. been -- be working

to up be we when for when produce would to the parts have hundreds dosage -- set we we world, have of be So of all of in different millions that.

So to Vigene much capacity. our has facilities. some provide larger their needs. us, with has for capabilities expanding been commercial also has much great are working announced then but that also a Lonza trial partner we another we've larger point they're And for partner quantities clinical that And of at not vaccine, this

work multiple really we an going to to have expand of ultimately basis. a and So we multiple their capacity can is for have having of provide vaccines. flexibility, these think, one be to vaccine parts with issue that each the our gives worldwide relationships the facilities capacity, Because what us where ability on trying And we're is partners, at the all do options. of

Jon Wolleben

and looking progress the on forward again the to Congrats helpful. That's updates. it. Got

Operator

Ladies gentlemen, to to concludes any like would this conference for Garg, Vipin session. the question-and-answer and closing over I remarks. our turn back

Vipin Garg

look today. next for everyone listening in speaking to We earnings you our to forward on Thank Yes. you again, call.

Operator

today's Thank concluded. now has Thank conference attending you. presentation. The you for

disconnect. You may now