Vaxart (VXRT) 15 Mar 232022 Q4 Earnings call transcript

Greetings. Welcome to Vaxart Business Update and Full Year 2022 Financial Results Conference Call. A question-and-answer session will follow management's opening remarks. Individual investors may submit written questions to ir@vaxart.com.

As a reminder, this conference is being recorded.

to Senior webcast Vice like host, to now Biehn, Brant President, would turn over the your I Business Operations. you. Thank

begin. may You

Good today's to afternoon, and call. welcome

our Sean Joining Executive Dr. Lee, James Medical Chief Andrei our Vaxart Chief us and Floroiu, our and from Science Officer; Officer; our Tucker, Officer; Dr. Cummings, Founder Chief and are Officer. Chief Phil Financial

company's call, to financial Vaxart future and started, statements get regulatory planned that everyone or we statements its remind about financial clinical progress, ongoing I’d including results, like the make guidance, business may operations this product Before forward-looking and including statements, conference development trials. its during strategies about its and

section important could discussed the in from those Factors inherent periodic annual on of differ the date regulatory obligation statements other Form the in most and no clinical statements results undertakes development due after to XX-K with and Vaxart filed materially of this Vaxart's in including number described call. factors, other risks SEC. and forward-looking uncertainty forward-looking any update Actual of filed process, report Risk reports these recently to a the

the turn to Andrei call Floroiu. Andrei? over now I'll

to you all and us today. joining Thank Brant, you, thanks of

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initiate study this expect We to in XXXX.

potentially communities towards believe potential our systems submission body trials growing We look individuals, our we the approval. currently candidate and our underway, vaccine and and data norovirus on benefit a advancing path to candidate, forward we expeditious health of a may globally. bivalent that promising norovirus Based FDA has have

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of We vaccines latest given evolve. For reasons, We not is believe continue chasing strategy limit the the new our manufacture vaccine. these society, opportunity against is will guidance these that provide threats. variants how an and that and to for it variance the viral risk current or will administer regulatory commercial course, the and company for best to protection there takes that any develop, long emerge that know ongoing

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we that Phase potentially may be data vaccine, the of pan-betacoronavirus COVID-XX is mucosal coronaviruses, virus as genus our SARS-CoV-X vaccine to the within from cross-reactivity SARS-CoV-X, Xa a betacoronavirus. emerging the vaccine virus vaccine. Phase we to-date new MERS-CoV Moreover, make reported studies substantial pan-betacoronavirus of based a other or on oral coronavirus the the easier believe to with would COVID-XX a an able threat that SARS-CoV-X, some variant, X create future-proof candidate, other whether and a it betacoronavirus sub-thesis are causes

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Andrei. over call I'll the now to turn Andrei?

take strategy, partnering moment and XX our to billion Officer. Chief experience want I than on in Vaxart’s joined of team a to in and Sean. Lee, years $XX brings more Phil Thanks, Phil in December transactions. new welcome now Financial nearly M&A

on on have we're of behalf board. team, to Speaking entire Phil? excited the leadership him

marketable million, Andrei. release. with XX, equivalents, advanced Thanks, norovirus compared securities XXXX as to The as the Vaxart and of results our restricted million decrease financial cash $XXX.X press summarized we year September The details are due of in program. ended year cash $XX.X today's for the full cash, was used in primarily of XXXX. our to cash operations

funds As into XXXX. earlier, of Andrei runway noted these cash quarter second the provide

to his turn the call closing Andrei I back remarks. for will now

Phil. Thanks,

X bivalent expansion We X norovirus the of are the GI.X trial, with of momentum starting initiation the with Phase trial. XXXX and Phase our significant norovirus

program update norovirus to very data to success have vaccine prioritization are a Moreover, on design the candidate. believe can well several we a we bivalent provide We and for Phase of today, to and sustainability. we clinical investors important announced can ourselves support approval progress. which our also with our need we trial strategy set our course believe will norovirus against positioned inform milestones generate of our we the future X that optimal to that our the with portfolio The resources us of the will prioritization measure

milestones data ongoing monovalent study These X study, the in for from from Phase norovirus infants. include, Phase XXXX. vaccine top of to antibodies top XXXX, X trial vaccine milk clinical norovirus QX in reporting candidate channel breast bivalent antibodies our line norovirus Melinda of to data our Reporting in ongoing GXX mid-XXXX. Foundation-funded our evaluate vaccine our candidate induce dose-ranging the initiating & Bill And to transfer candidate young ability Gates of in and

at key will Eastern leader differentiated We vaccine event. of nature host XX, virtual hope will a X:XX our Finally, the on call us program illustrate for join bivalent this as p.m. and candidate. earlier, we I our exciting that you will informative March virtual and time mentioned opinion norovirus

On leadership to Vaxart's behalf for time your to team, we of are happy questions. today, now I'd your thank take and you like

proceed. question Our Fitzgerald. first from Duncan Cantor Please you. Charles is [Operator Thank Instructions] with

you position XXXX depending the a what you I'm for next Hi, regard I on not our norovirus, wondering that would by With anticipate of agency? you of think Phase you in by the X said could time on taking but set in and guess, Liking mid-XXXX, And could you funding you had data question. meeting focus end maybe data but would a of what there. topline if the quantitatively, end taking by a to XXXX, for to roughly see, terms team. this good encouraged to of XXXX, or afternoon lay Thanks that early to I maybe year? questions the Phase operationalize in like out so would I be be Andrei couple X

this? take James, do want you to

Sure. Thanks, Charles. Thanks for the question.

the So mid-XX in our dose have bivalent data I or higher topline of terms we'll is on construct. dose in Phase based right, would X receiving or our ranging the dose study, from low people, either topline confirmation XXX placebo see come midyear. well of looks safety for we're consistent we've that with data those as the profile. And say profile platform, Again, that our looking are of safety reports seen what the product. clean immunogenicity the in as very we'll what a like data

before the place would details your well, see go be study how answer the that In terms larger of the the FDA. -- approach study -- to the go needed a I into And probably it selected. Phase of the follow-on will on and with be end agency, us X we'll numbers question, building which of XXXX. when data, of After would an be occur. would Part based Does won't results study our that I have we big, dose of but study, that taking B potentially the Charles? size That give that would in topline

Yes, We it does. look data. that I to forward think

was I I or the either that I provide R&D recently guess the firm, had year. much think about for Phil color in joined if $XX could noro? more versus Andrei question How million Phil. you wondering COVID of on it was the that second I'm The was spend,

sticking of in of year, noro then for of this is spend you percentage operations? it terms with kind COVID versus that order And same what of R&D anticipate that

a do stab want this? you at take Phil, to

Sure.

norovirus there and there. XX-K focus clinical going to spend But So, the in has What trials the obviously, I and numbers I terms a been trials significant we external the think that get of the is in -- what's best the disclosed on forward, think norovirus actually we there COVID. is we're way you that running filed. the for

in So, could of well. think largely although are will assets continuing our with majority that you the platform we spend on norovirus, as our be other

Okay, that's I my on guess question partnering. helpful. strategy. Last question is

to But two with data into noro, with it's Thanks. answer X the candidate progress be study you to to year Phase would a take you enable takes into in yet or moving Phase you anticipate a an this tango. of be longer, would yourselves? to so discussions, And probably imperfect partnering to certainly question able or rather larger regard to going X

Charles. Hi

answer So, it's though a premature. this bit to you appreciate, question, I'll try as can even

come data data, in quarter, Challenge as I the particularly strategic the So, to the going potential think that investors data is third out seen is by important too. the Challenge very and partners,

point think further. be how I terms of for So, us proceed will we a that after key decision data in

Got for it. Thanks questions. helpful. taking my That's

Thank you so Charles. much

Securities. Our with next question Mayank proceed. is Mamtani Riley B. from Please

norovirus. the taking pivot Thanks team. questions on appreciate and timely I afternoon for Good focus our also

maybe could levels And to more efficacy a piggybacking looking for comment. I this Andrei, even for the what talk it expanded for to on target So, rationale data bit be investors the be set? understand just the asymptomatic think protection, transmission, would it little of Challenge helpful prior study, you in cohorts? or you're

also if And of the able deeper very a you're types immune looking bit to correlates would are be at, you that go on helpful?

take want do James, So to you question? this

Sure.

So Mayank, thanks question. the for

In of to at gastroenteritis so efficacy, secondary what essentially reduction down norovirus. looking we're protective for in the drill data challenge at a symptomatic we're the to terms acute of looking looking at type into study,

a norovirus all transmission. shedding potential should doesn't can We're viral if of We decrease to at infection. in decrease But lot potential know also decrease the you norovirus. looking of shedding, cause take it shedding, you for an a

So those looking the two at. of are things we're

decrease facet protection. study key of a a X a feel Phase our it lines, and/or numbers up challenge. of looking correlates at of Phase endeavors of be in looking is correlates that for that to correlates another X could GXX at and at protection. sizing study, then is challenge the We in protection a This is And particular, potential a time looking

we're and the study I that calling And think, in has dose-ranging GXX. our bivalent, GXX

So correlates that study. we're on that in your then what and how look might keenly X of that to discussions a get interested with protection the may Does that read question? sharing Phase in FDA our like, impact answer

ask is Yes, The – work challenge we regulators? at, that specific answers against again little how it you've more can you dose-ranging if looking I start the do ask of And I for levels be would question. they that be And to that with -- are clarify you're X, what on to a from bivalent. maybe you dose study, before also that the do sort the does. monovalent specific you before? you compare helpful a study done the there there Phase Thanks bivalent you're think need looking you if for And very that? could a for if the taking

Thanks. Sure.

dose, of at of clinicaltrials.gov. in a of a and looking per on GXX that So right? dosage the that's X:XX. strain, is GXX dose, terms [ph], to and study, terms and the In We're total levels high of X:XX that's a X:XX for which X:XX of a GXX available GXX, dose total it's bivalent dose

Now our X:XX. high had as previous in as studies, doses we've

higher doses we'll our this as what a this in looking seen and safety across dose, we've already profile. which said, is maintain be So a would be to I other vaccines, clean

only. in. would geared come certainly, or if really performing data other In collect diseases for that. any go studies would our aren't someone have be Phase to X, until That's Phase diarrheal These we that a but while where X terms were our X gastroenteritis, we Phase in studies exploratory diarrheal study acute into of presentation would disease

the think could way at best to look the of I what benefit this study. is So challenge leveraging our be

more a there's the not annually. transmission As It's selected in consistent adult you know, population. by a populations,

lot in garnering study that And knowledge question, look protective to potentially Mayank? from forward Does so terms would answer of that challenge we a that efficacy. of

Foundation? for you maybe you if mothers or comment does. to funding just will Yeah, requirement more one on quantitatively also touch much study? you question. it initiate breast-feeding on infant and the Could from receive And that you the the And can Gates how have

feeding vaccine look people those in our the where we dabble in women, breast babies, oral at safe, to infants already at antibody to delivered Well, who've that a to women in postpartum from give of couple that ensure we find study the to one, things; questions of that funding looking, have I'll tableted who my the so milk. those breast measure they standpoint, arts. a looking amount course, but leave we're would lactating But of

that's that's important, I very of think and part this study.

looking at faeces is amount infants piece norovirus, second the in find the we or antibodies the then of against And stool.

our to the passage very on way be lactating or standpoint, transfer, looking breast some milk, mom. a think, by important. is I of antibodies of at may from vaccination So implementing the those populations in vulnerable strategy most protect this And a

amounts, I’ll would dollar Phil, call. leave the comment? you Sean, of to et cetera, the question others to on like Andrei,

Yeah.

the and So, was Mayank, that the this co-founded provide to to just going dollar by is We we're on going details it we're us. here. leave -- not Gates And there. amount trial just said Foundation

reached have now for of the We We any the questions. online Brant conference back turn the end questions-and-answers. phone over to

of question we've be questions. why this norovirus, I'm that The now, got the make you. we number and start why for to Yeah, going off. prioritize online going make earlier? one Andrei. why is Fabulous. is a decision decision didn't Andrei, to

Thank Brant. Yeah. you,

resources. program norovirus we on followed review that, entire focus norovirus to the path the and efficient we leading important commercial our well believe an to to would review decision most the product emphasize of including as our at as really maximize and the candidates, strategic pipeline a our what our of us, be looking extensive So vaccine current for fastest for candidates, have one of it's to and us that business way

prioritize for because we best overall, in us it near-term. profile the presents norovirus is the worth reason risky the So

readouts. extends our quarter. we as to us beyond position for see program and third And or success. validate this midyear As platform way cash one norovirus we to progressing the us advancing in data And do the being those long-term program, the well two very importantly, have one our mentioned, we runway best data two important readouts and updated year, the for

investors to know. So I important think that's for

Andrei. Thanks, Excellent.

on is runway, there's questions a norovirus be the getting. all Still, And we're that relate you. questions all summarize this to try cash to number for the going on scope of they and the norovirus. of focusing So

additional So runway X in you. can a Phil, include does And funding? and study X the cost X over without study? projected Phase What's you a Phase complete your duration cash norovirus a passing to of that Phase study?

Brant. Thanks, Sure.

our it later that QX So with projected is year. is include Phase to studies cost X time. conduct XXXX. cash of runway II the a And guidance all cost does into norovirus guidance include this the Phase planned the Foundation-funded trial well associated providing the Gates X existing as as study really this for Phase What potential on doesn't trial, of and a aren't we cost at the our

Phil. Thanks, Excellent.

James, is for clinical Thank on norovirus you, the one Brant. on study. you this

the So would when X with and place? trial? And what's again, studies, from norovirus design Phase Phase positive the data meeting obtained FDA James? your end-of-Phase you is timeline presuming to question the a X take initiate X

next an end-of-Phase be have we begin expect the we studies, X well Phase from Meeting data next will as could XXXX. with Over. The X the as would that agency. and be as Presuming X Thanks. concert from in year trial guidance early year positive Phase

James. really over et U.K., Excellent. What's just one and U.S. talking funding the for for BARDA, to whether you Andrei, prospect Andrei, cetera. [indiscernible] is Thank you, the about from government it's to international you. funding. and this be going

governments -- this and shifted. governmental now the agencies as it's answer of we particularly question various interest a to attention Well, have is difficult and perceive

do. it's going what hard governments are to predict So to

the both U.S. that in in and abroad, contact and oral to in We believe transformational we general. pandemics could pill agencies, important remain with fighting platform vaccine role here play a continue our in

to So those hard the it's again, we but communications, have to outcome. continue predict

When them, I'll another of just Will the over Phil, lot to number of a on ratio? Andrei. you. questions there's split one, share to hand that there the be for question same so, over reverse a you, Phil, $X? answer but I is you. the get If shares a Thank what's price this there's, thing. about

Sure, Brent.

in the X our a believe data our in two for price would X potential top drive dose-ranging challenge next key line really stock data this as we top do the costs we as that norovirus. call, Phase as include the So study line Phase study readout for on interest mentioned well catalysts have earlier our for quarters, those we

need reverse In believe split, we this terms of one we don't at a time.

Thank hand you. that I our for wraps-up it Excellent. to you, questions today. Ms. Well, Phil. back Terry [ph],

Thank today's you. This conference. will conclude

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