Earnings call transcript Q2 2023

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Operator

Greetings, and welcome to the Vaxart Business Update and Second Quarter 2023 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.

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

begin. may You

Brant Biehn

welcome call. and to afternoon, today's Good

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

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

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

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

Andrei Floroiu

before Thank pill today. year, today's on look we briefly you of highlight to you, the the and planned second have will to opening we recent program ahead vaccine call oral discuss milestones On program. the remaining your progress We'll our of questions. call, for joining for norovirus Brant, made and our the half you thank us all also COVID for

evidence within It norovirus of pleased dose candidate our to mucosal means study potential validates this will potentially line that advantages that the from groundbreaking X out results is of of Vaxart’s we vaccine the on data and that for ranging growing timeline. as platform review During top explore this body what we a James important it data builds vaccination. point vaccine. the bivalent our our second to report stated are preliminary positive provide quarter, for Phase oral

are mucosal very data vaccines programs to of And is immunity. far a The our clinical have suggests All across multiple we this thus feature through and distinctive platform. protection, reduction that response of designed important durable generated broader, could mucosal trigger in our both our the immune protection, advantages; viral immunity. more a activation important and broader serum several vaccination transmission, mucosal cross-variant provide

would important other oral pill is The oral potential injectable painlessly and format. vaccines of people that vaccines doing we feature vaccines a are about than vision of that Oral are and making hard today we how so fundamental so pill future is distinctive of are allow faster, reality more to our us a vaccination the vaccines vaccination advantages more them radically globally. pill lot working we achieve. easily change with vaccinate think vaccines. could to This The the

is We no potential public the to we development is most countries, about excited and for health are have vaccine delivery norovirus gastrointestinal we for both Vaxart, developed in is program. there clinical norovirus Norovirus advanced approved the in Across oral believe that our and system. of designed administration vaccine a vaccine. issue the significant formulated candidate

a and vaccine that leading number myth XX are this this potential to program our And alone. three-year annual the resulting norovirus cases to virus the U.S. in than the high. of burden to has More significant disease the across year, the tremendous continues more has in U.S. $XX as million disease infected be each people spiked billion of norovirus We the than in carries. of summer, a least infectious disease country believe story an the at burden address subject

to achieve we on clinical track this milestones and remain important Looking ahead, we have both. them two year,

this induce the to milk evaluate in vaccine ability And year in the of candidate then reporting and X our we study norovirus breast this year. & Foundation challenge Phase Bill norovirus anticipate to of infants. to vaccine Melinda quarter to ongoing Gates our the GXX young forward top line we look antibodies trials initiating candidate First, of clinical transfer funded data the of antibodies from third

develop a based to I program. To over vaccine turn progress COVID and Coronavirus our James, COVID-XX better there Before on be I cross construct constraints, this pathway demonstrated call to want that the an on to continues make update brief profile. time immune have favorable has believe a provide data Vaxart’s date, reactivity mucosal our seen vaccine. a And we program. on in the to may we oral Vaxart

they updates become next as steps will assessing available. and We’re provide

Office Response global by encouraged support efforts preparedness Recently, the of ahead new the announced next House get Preparedness and very proactive U.S. crisis. pandemic government's approach strongly to and the the of Pandemic health global White Policy. We're to

As we of stress and diseases other post against emergency cope a [ph]. pandemic, stronger the must build phase with infectious future we defenses face we

and pandemics effort. Vaxart to vaccine a that improve believes ability is to our cross-protective fight committed future could

that in us. strongly see, our before and what public As for could excited are you believe the potential we for the can opportunities lie it and of global mean technology health

Now, our norovirus more to review turn detailed the call program. of I'll over James a for

James Cummings

We from ranging these we vaccine our positive bivalent for Andrei. data clinical highlighted made significant the progress Phase believe norovirus in we Thanks, quarter, candidate. preliminary dose the top second data oral reported have to candidate for caused line the that study GXX, by this over have in promise norovirus and We X of show of humans both GXX more disease vaccine that and Recall broadly, our vaccine two years. majority XX the contains which this the past seen genotypes, date candidate platform.

study enrolled a this the As in XXX United sites States. three at healthy adults reminder,

X vaccine, Phase for development. XX The and open-label, Each to high placebo. high-dose had were vaccine low sentinel arm dose to vaccine dose first arms or The the randomized determine were or subjects the blinded immunogenicity and subjects in endpoints remaining a placebo received double XX the primary XX of subjects. safety and order subjects had level

take Now results. a the review to let's moment

results robust responses, showed serum showed and increase difference Both serum trial dose in the across of in immune no July described high medium between arms. all statistical the with one. As similar responses to relative XX at we antibody a day detail in announcement, the doses vaccine preliminary our day doses

XX, serum IgA, included conducted bivalent norovirus limiting for in no adverse that vaccine strains SAEs, in for that both was were toxicity. vaccine-related a to Vaxart. similar with doses serum The the GXX IgG, also dose by previous day and placebo. serious Adverse or favorable event the BTXX, those and profile the arms to and were vaccine well increases tolerated candidate safety studies events similar no rates both GXX demonstrate At in norovirus results seen

end the this responses. ongoing and our Phase serum cell-based challenge an could larger available of support at and will meeting we Xb out U.S. study data a Phase the from expect to XXXX. data with that preliminary help date. study data inform data from like a norovirus in later in the assay I'd FDA, for study selection X the and bivalent levels our totality dosage of were point of The Mucosal be will potentially

of immune norovirus norovirus norovirus. help reduction This X a which immunogenicity and I'll now and identify and/or Phase efficacy of candidate. may responses monovalent norovirus the the in measuring a secondary protection is turn to also to vaccine the between challenge correlative risk study, the infection safety, our to acute study vaccine GXX gastroenteritis

to top ongoing in study study and we is of report the data quarter unblind and expect third during continue now completed, line the XXXX. to double-blinded this Enrollment current

in our We of to progress the a bivalent updating continue candidate potential toward on forward norovirus in we look to you BLA months. believe the We our proceed as submission. coming

discussion now our Phil of hand call brief financials. Lee, to a Phil? I'll the CFO for over our

Phil Lee

details second of million the of to Thanks, XXXX press was the $X.X our second for compared grant was Revenue The no from James. summarized quarter of results Gates revenue the quarter in financial quarter the the today's of Melinda Vaxart’s for & of in XXXX second Foundation. second work in for Bill recognized performed Revenue primarily release. quarter revenue from are XXXX. XXXX under

XXXX XXXX. as decrease to marketable partially compared $XX.X Vaxart XXXX. due advanced was equivalents, and used securities cash March offering you $XX.X our third for June cash XX, The which of the of from with runway restricted quarter the quarter as all offset of to public today. cash net extends the into by company's we of cash program, operations was thank ended primarily of in your a million behalf norovirus expected On proceeds of $XX.X like million XXXX. of offering The I'd cash, in us completed million to second time Vaxart, at

for We open the now questions. your will call

Operator

[Operator be time, we'll question-and-answer this Thank conducting a Instructions]. session. you. At

Our first question. your Fitzgerald. Cantor question with Duncan Please proceed from with Charles comes

Charles Duncan

and on Andrei Hi, Congratulations progress. quarterly the team.

to observed, how have remarks. you prepared by strain, norovirus data feel the you you So during and study earlier from study that responses dose, a that right for you data do lower you on let's believe you the a the touch generated quarter, need Phase top higher preliminary or to do suggest say, you natural immunogenicity about in data go you the at ranging either to look dose And X it bivalent the the or response? infection in line this after compare candidate dose vaccine the announced hand? do the this When

James Cummings

Thanks. that take I'll one.

pleased fairly previous with the that consistent that study date is we're norovirus from So data results. to study

The at that's we the a mucosal stronger to responses at preliminary I make day the pending. That we will data, available in think forward. serum a later recall July, assay doses robust data, announced in all line relative showed we that data immune You assessed XX. Once cell-based moving top decision and across we've XX can date. be

Charles Duncan

one Thanks. program? for James. And All a dose two right, what versus are regimen a thoughts your regimen on also, dose this

James Cummings

dose adults, think I for regimen. one a

Charles Duncan

seeing norovirus into right. move XQ, we the as All challenge data from study. anticipating we're And

like find agency lay to the than meeting? from X you you take quantitative to and perhaps you that for perspective end out encouraging of rather Just to the what sort wondering Phase can would would if see a would qualitative of like

James Cummings

And note on the before also, them. should data announce Certainly, don't in we have in or to this from later mucosal we that want stay cell-based assays, of year very to responses in be would results encouraging. data GXX track and previous that of I looking challenge. forward then the terms project we're what with studies we we've QX seen noro robust the if

be decision So as a for that inclusive of made that well. we will

Charles Duncan

your or you you Phase have have when Vaxart thoughts next meeting, alone I And forward, see just a -- study? the of X the but do that of last to expect in program do operationalize Okay. sort sort partner? have anticipate And you driving question you or again, of to know bringing

James Cummings

pass that's the and okay. half second take to half I'll off the first Andrei, I'll if

see before study going the challenge think this to study as we'd my FDA. XXX from the as data from to again, the standpoint, I like that well

us section lead to Phase The then lead FDA. on the would to with larger second end I as you soon discussions study that portion would of a of as Andrei, of comment the do the as be Phase second And mentioned -- to question? a want that before, us could X XXXX. X

Andrei Floroiu

Sure.

and bring decide So of norovirus the programs discussions once advantages year to to we're the the Vaxart which to maximize vaccine are will have large [indiscernible] the as as the has and options And those alone. obviously norovirus we competitor space, closest open our to value pharmas assets late And it and and patients. data. noted stage and medium-sized entertain sooner earlier and as this evaluating such partnering you pharmas in are going interest appreciate, there many vaccine can disadvantages ones will

Charles Duncan

and to thank our forward look for challenge the I data, questions. study right. you All taking

Operator

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

Mayank Mamtani

team. questions congrats and afternoon on progress. taking our Thanks Good for the

the expectations. just original than of challenge faster monovalent has study, and gone enrollment tell execution So what kind from can your I your for

your dose a incremental already apply that? the work IgA? study So of would then around infections, [indiscernible] you able with learnings may on you data medical prior could may execute bivalent here and to just financial conference we then deal may remind have or hear bracket see your that ranging that point of commentary for may on you to what [indiscernible] you have so with at kind us you're that? And to your we up. challenge maybe could on how the comment look data mucosal you concert some norovirus, to of some you the are year data, report this And to present look you just presented a obviously, study some to and get maybe you previously so additional, had you some bivalent have could that targeting? love in when follow of time executing when kind scenarios on to you Is there And the this these question I what seen would

James Cummings

Yes. Thanks, Mayank.

immunity portion, on may is the the take Tucker, expert in a immunity. CSO, in chime he I'll mucosal world have Sean mucosal first So as

statistical learnings recall what So aggressive size you'd study, look the Along studies and a in more for are severity see important. immunity challenge than much a what this think effect challenge in on from to The of sample a we're with nature measures for the how understand our or have they're health study including immunogenicity do world. in what is a descriptive the a the built all the in And decrease infectivity, mechanics to be. terms in analysis clinical So that safety looking are typically, at, as I potential the of shedding, the primarily real looking that, of very decrease and works. number a disease global norovirus, at vaccine’s this then taking effect we're the and things vaccine that we acute at correlative could really for looking this, of gastroenteritis might viral causing severity? from these on or standpoint impact we're be

For norovirus be to listening those thought gastroenteritis traditionally are more seasonal presentation. the is call in in, on

and at So to continue only norovirus month norovirus certainly the large there said, cetera. or look when very the Times either the seasonal a that the where you really One in in et in lines, have look of any take months. by or CDC cruise robust States occur, to year. have That on here in a outbreaks are at distribution the of homes the website outbreaks take winter York New United database more nursing for WHO’s

seasonality the it some So of opportunity look challenge I they to needed, think impacts a round. because And when a individuals take in the year should the executing we forward norovirus, move both future infection at I viral is spread challenges to is but that we’ll that, think there of to in people traditional that have that be and best think the available the model we is study. recruit

mentioned, and we're on forward data deliver move to fortunate to able you As to time. study the very be this

excited very that. we're So about

we're specifically you looking terms immunity mucosal XXX in the I immunity in asked For of at question, of terms for mucosal the what the study. think

if right? to small Dr. asked mucosal And the immunity. Sean? the That have comment on be For as immunity, he'd yet XXX historical that like study, just a he would that, we mucosal don't that for I'd upcoming, program make Sean time. Tucker ran at the

Sean Tucker

it's Yes, a Sure. good question.

really a if in X So it and mucosal ASC talked nasal if or even over the that get previously, in that at you fold get or [indiscernible] carefully. XX of or between to reported we've a about of up look working number response count, nasal around to we subjects we respond terms terms increases of somewhere response, XX%, responses, you're we

So as GXX response our a expectation mucosal is that similar will the well. see

Mayank Mamtani

there. answer helpful appreciate the I comprehensive it. Got

that baking forms financial funding? Just how or year. funding next to, Could Gates be on Melinda in XQ you from much it runway you you're of non-diluted incremental Foundation the kind to clarify of any even guided other there, government extension

Phil Lee

Sure.

So I really of current terms on runway think in plans Foundation, based our guidance, right. Gates existing it's grant our from and the our

determine of [indiscernible] again, now, the we for for this based no we on at data existing once study, new and then incremental existing spend, the and we'll from But and So next see the study needed. XXX path all grants grant our kind as forward time. plans -- the it's steps

Mayank Mamtani

team Thanks challenge and shortly from forward it. here study. look taking our data questions the got for the Okay, to

Andrei Floroiu

Mayank. you, Thank

Operator

Instructions]. [Operator

comes with your with proceed Roger question Please Jefferies. next Song Our question. from

Unidentified Analyst

on our for Liam for [ph] taking Chong is questions. you Good Thank Song. Roger afternoon. This

about Our X first question data. Phase is upcoming challenge the

color no data? you could go, on challenge for go give So decisions the would us some what be X the Phase

James Cummings

I opposed to can go. give some you go, as color no

decrease looking what in have is a at looking challenge to I before But aggressive indicators, a at so study nature. someone a compared endpoints acute sees as that certainly talk very think we'd gastroenteritis. in to I team. of and we're severity mentioned several

that sick who severity what in ill to the And get potentially with get severity, gastroenteritis So viral I those trying sick, shedding. for decrease I actually acute that tease those to because are or But would surrogate for right? we're of disease tie decreasing that like. norovirus, we then getting? a how the look think to infectivity along transmission, shedding, is secondary items could those to decrease be looking affect people again, things think to think as trying could shedding all very is in considering also I we're safety, think somewhat of immunogenicity that decreased right? And even looking ensure can, be on then out, I important at a may the shedding. So correlative that I we're that going we a might if at and we're a And dataset. are but of And immunity look important.

Unidentified Analyst

Sure. very Thank This is you. helpful.

larger could terms design? we Phase on in And study provide for the X study, any color do the guidance? So have some you

James Cummings

Sure.

thoughts. about, So hand give both of we XXX study would are we're data a or we'll data at we look think help those some that study we as the can And size the a mucosal We at see that determine I the of what look of waiting data now, study. well -- on determine the data, look XXX able the data might I like. seeing of that as you both in challenge of from be but impact the some the evidence to that taking talking see from

determine correlative of, to if Phase correlative, Phase able is mean impact decreasing a the One a those may the certainly not hand would X. having we're size X, in of factors that the it if right,

larger. study Xb Phase would So be

the but that would set it to be to done hand want acceptable people we to ensure necessarily execute now. for once FDA. enrolled I Hope have to had we those have your we the have that have met internally. be than You'd study a question. And and in larger data you be FDA, ready that enough speak don't would safety the answers would certainly

Unidentified Analyst

quick Got for last. Maybe great. a you. Thank it, one

I for information. pivotal have probably Phase in don't So the you much X, terms that know

prioritized, populations that? on what if So would you be can age comment

James Cummings

results to is would the take Sure. that specifically X, end meeting study. right? speak of the Phase The the X literally X challenge that harness. or We're is Phase the think Phase I’ll the about of think at We no in on the about now Xb study right? unanswered, X by approved timing the agency generally FDA. have I Phase interested with depend a XXX question to that Again, X the guidance there's visibility the address we which all for solution for milestones. norovirus, is more those vaccine informed once of for providing what we'd Phase I

of older would study Phase march that In X where looking right terms for, as be design, on forward, vaccine what dependent we're be think XX it agency, this conversations would we tested the have and FDA. we're now, in but we dependent with the at I the and that's on

Unidentified Analyst

you. Thank

Thanks. I us. think from all that's

Operator

Biehn. There questions this to back call no to I'd the over host, are like Brant at time. turn further audio your

Brant Biehn

Thanks very much.

questions been sent So that lot various we had ahead in previously a time of on had channels. of

Charles Mayank. think and asked now those been have between I of most

you. you And been Do smaller as don't one to that norovirus? any So I completely study a coming one's commercialization? X realistic to see timeline to path for answered or here's a think to commercialization Phase accelerated EUA, James? -- what's James, yet. I'm has this going such

James Cummings

Brant. enough. Fair Thanks,

options have regulatory timeline timing address and results for we results, the with we those just by determine we plan once on the informed data interactions discussing and study Based commercialization more to now. that will visibility those agencies, we're continue the So potential commercialization. best these for and

Brant Biehn

be fantastic, and study you. James? on going this James. your we what another and norovirus us in for one Thanks. James remind you're also hit That's call infant don't Please for And is the I looking potential for the to think implications during program.

James Cummings

Sure. you. Thank

would impacted spread how unknown a affected be infectivity and by or norovirus it's vaccine. So

approved currently As I vaccine mentioned, there's norovirus. against no

However, also adults. that if the there suggest you some that can are children, studies you health of improve vaccinate

not acquire their might we but all to that You families. and children be infect disease able know illness, can protect against

looking So of pieces at. that's one the we're

Brant Biehn

Thanks, Fantastic. James.

norovirus by answered questions that's majority of asked other have So the and you. been already the

So thank you that. so much for

on additional at questions. Investor line up chat the have fireside I take website the section And fireside answer think post to that questions. follow at look near meeting our chat future and we'll a platform questions the investors and in ahead further go can people a and of those on our and

we'll close the point, this meeting. at Thank So you.

Operator

today's and This conference webcast. concludes

You may your at disconnect for time, and your lines this you thank participation. we

Vaxart (VXRT) 3 Aug 232023 Q2 Earnings call transcript