Vaxart (VXRT) 13 Nov 242024 Q3 Earnings call transcript

Greetings, and welcome to the Vaxart Business Update and Third Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Cost.

Good afternoon, and welcome to today's call.

Joining us from Vaxart are Steven Lo, Chief Executive Officer; Dr. Chief Dr. and Founder Tucker, Scientific Officer; Sean James Financial Officer. Medical Officer; Lee, Chief and Phil Cummings, Chief

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

to a results development these on due Vaxart's periodic Actual report other Form annual materially filed forward-looking uncertainty the including of those the differ and in recently Factors Risk other and clinical reports with of in discussed number XX-K inherent could from process risks the and factors, described filed on SEC. most section important statements in regulatory also

to obligation call turn now any update call. after Lo. forward-looking the this of the Steve? no undertakes Vaxart date I'll over Steven to statements

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Thank you, James.

we earlier, for feedback our for received constructive and our correlative As program. on potential Steve data from steps FDA the next protection norovirus mentioned

potential may we we the correlate. antibody new identified our that protection norovirus, functional data review associated of from with While before with requested proceeding FDA have clinical be further believe response a

the current experts announcing consulting guidance reviewing with and We are steps next FDA program. the from with our before disease

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Phil studies preclinical a to HPV Lee, vaccine. on financials. stimulating for call our the Phil? and have characterize now discussion hand the further of antitumor our brief additional CFO, our We I'll activity over immune planned to

$X.X Thank third on third results the of Vaxart $X.X government from primarily third in quarter into for the of in of of the performed runway are to recognized from XXXX the noncash cash today. Inavir equivalents revenue XXXX. was the contracts today's BARDA. Revenue third under in million, quarter work release. Vaxart cash, of in current our from XXXX Bill was and quarter our XXXX the of for in Vaxart summarized quarter from Sean. Gates for quarter million the and The was XXXX with for related third investments of XXXX to everyone, Revenue anticipate to million. Based revenue XXXX. Revenue you, ended financial primarily your the continues compared time details quarter plan, $XX.X Japan. royalty & of press cash Foundation of Melinda Thanks, scrap sales third

We the your call will open now for questions.

from line Instructions] Li Oppenheimer. Our comes the first with question of [Operator Cheng

This a is Oppenheimer. us. [indiscernible] from Maybe couple from

IIb I'm before the I level curious remember projections? And can study. interest First, on from the Phase COVID-XX II maybe And -- talk you about investigators. current And Phase on study, progress analysis do you just potential how also, versus if you the about in enrollment based so your on accrued. talk certain about you interim internal see of planning norovirus a events my second interim still program. do number the to question the are analysis

can more received provide specifically, kind wondering you maybe on color of Just some what data FDA. the clinical if new values the And feed is from required?

Great. and then Steve. Thanks. is questions. other address for Sean I'll over to turn first I'll it your This thanks for And question, the X. the

from interest to marketplace remarks, the problem quite patients. just in vaccines of just uptake interest. And be were we're the there's from is in opening Your any enrolling a investigators good study. with now, and as tracking pretty question mean vaccine. still haven't the in I with had the of what saying terms related just COVID right in happy we SENTINEL level on XXX getting to the participants to we're And we track enrollment, there

hope and on our $XXX So it over the an turn million. from well, I'll that's And interim analysis. announce we perspective, Sean to we reach update to shortly. going when the

Yes.

In question safety BARDA, terms signals. partners and analysis we efficacy interim of with the your our considering on would that evaluate interim at analysis an are

clinical XX we -- complete the full our and indicates be to previous study post through that the Preliminary data all may However, will studies that immune complete are commitment vaccine mucosal and the vaccination explore months in trial. will response for trial. injectables, from something focus we our participants throughout visit be triggers that is superior the our preclinical

want feedback sure make norovirus. capture we was around And correctly. just the last your I specific Cheng, question from then the on to last FDA the question just

-- can I'm you curious also with required for next And us were share Yes, is kind FDA's conversation. of what any specific on the of feedback about clinical the step? kind specific data

Sure. we obviously, Well, the discussions the had with FDA.

to details get what at of meeting. be a clear it Our Phase of meeting. IIb the like this and is we clarity Phase time, aren't II we but the requirements will and at terms a to into an we got II did study get the in some goal get forward in Phase We feel end be, path successful discussing

comes next Mamtani of Mayank question with Riley from Our Securities. the B. line

the on Congrats progress.

assessing, seems And in like love mucosal lot looking on sentimental for gone safety a FDA the vaccine, clinical and the immunity the enrollment listed are related And very XX-day you is the to study of has your Would on relative quickly. anything potential endpoints blind you're hear are could assembly nasal expectations seems you are COVID kind So comment for of DSMB here? the . of like looking the mRNA and endpoints also, separation terms analysis. their? [indiscernible] cohort it or T-cell you for thoughts What your there there how serum to on the managing

then on could quick I follow-up you And any If provide have color? norovirus. a

Sure.

In blinded. when terms feedback question, still about asking DSMB of the we're first well, the our you're expectations, and

some saliva, well we'll safety the terms expectations. and there'll again, about the swabs So what to those of we'll get analysis our -- do it will the of each the XX,XXX will as responses. samples. in And it. I and from concerns, nasal, your be mean expectation continue and was terms Yes, subjects, no PBMCs just making DSMB systemic in as and of taking a together that or the question vaccine is at our we're how mucosal some of standpoint obviously, would end and oh, second that put -- summary Mayan, be enroll

the systemic we for induction. Again, definitely X is mucosal we're and vaccines while, the a still to see that blinded, so won't for but goal data compare immune

be at to at just that size Is have definitely time the XX,XXX. you XX-month lesser maybe maybe consider? a heard than that And could sample point, intend what to a you analysis clarify interim I could Understood.

Yes.

point, analysis the in an look at XXX was sorry, what be it's not there differences at the to that -- relative as And And planning to mistaken interim So once I'm do that protocol is corrected. the XXX efficacy. there were we was would I right of cases, between just was interim vaccines. now again, if analysis X an ,

up many we in protocol our discussions group are been period. our but months are. And XX of partners with their as to question at the will -- look So how standpoint people from again, each be variants of is thing essentially at particularly SARS-CoV-X. the over XX-month want of key very the of intentions I new end what because infortative, under part that had and that's we pop data as infected with would the -- part date. Again, believe, that And ask to this

comment and constructs. accumulating on Sean, probably preclinical then GI.X could publish point? on have the with And intend there data helpful. the you're next-generation Anything, next-gen helpful working to design the norovirus the you you GII.X this and how you you construct from at that correlates if Very picture candidates? learnings on together extent these put be to FDA And been and the that can expediting the could in

good question. Very Yes.

mice. of shared data is GI.X to much constructs both what have GII.X. next-generation be antibody GII.X, call And we terms listening what we a to responses and have or that we little bit of GI.X in potent seem more So that either seen in the

set what clinically. at immunogenicity we point seen way we up substantial things I testing is supplied changes think plan made of some throughout to that improvements we and some small the and models. Obviously, preclinical thing if structures. our have is we've platform found of in key in the that the the these We've backbone on

process -- that lists. it it another challenge. development because of things a if that from the And GI.X standpoint you important those line. easier learnings protection norovirus very a get are to from to You can it identified of yes, a to be to from the know couple lot predicting look the core question the And doing asked about lot had optimization -- makes clinical easier what for, your apply or to finish make we've

the whether constructs know the you're substantially efficacy going to study. the you when And for potentially, to look new at improve

yes, applicable we to either with So challenge things our all discussing new next-generation the have learnings been constructs. original the are and GI.X the FDA or in

Did you guys, for an manufacturing IND filing know can but line? from time quickly say guiding you an go standpoint? you the IND timing for for constructs these very I

Yes.

at our let provided -- things we any we'll this people guidance time. develop haven't constructs And We know. thing -- as further,

Jeffries. the line with from next comes Our of Liang Cheng question

is This I is my COVID first about Liang program. the Roger question Cheng from Jefferies. guess

impact the expect do the be you So would also -- enrollment on of just to it's on there were any enrollment. the considering wondering given any now And impact complete months enrollment you X infection rate COVID? thinking you in X -- considering and about seasonality do think number the months

thanks the for Yes, Liang, question.

work In terms you can on sites haven't projections, about and seen tell right very of we what is concerned sentinel I now the There been says hasn't of cohort closely we're CRO. seeing enrollment. that generally enrollment, be with enrollment should based feedback we any any we with and our study our that

our So all it's Sean I'll go, turn for his and it comments. to from standpoint, over systems

guess that asked rapidly there'll over all the new circulating or Yes. X cvd things about I you change X months, obviously, question be are mean strains I variants. with as and the key infection development, Well, are strains. quite vaccine rate new and

is COVID. they'll create the these right one way that we things show the beneficial we it that it's mucosal in of this our but up. circulating term we the variance with think just mean KPX I the Again, IgA that cross-reactive like platform long most now, and about as responses, be I think works is is prevalently,

So program. the about norovirus also

requested? provide what data that? on Can color just wondering you So FDA any

get, trying end commenting or not it do Phase we guidance We're get the assess have think we specific II takes what of got about we We're requirements did which meeting. right to on what clarity successful to additional requests to Yes. now. a

over this Ed Thank now portion the you. session. Berg. to And we I'll of call have Q&A reached end hand the back the of

you. Thank

quickly investors partially I of can the you we and a one more. FDA questions retail think start from XX,XXX ask to the this trial? How that to been start some gets but our I'll the and little Sean that's DSMB? We I'll And sent phase have the some timing participant answered, in. review with of elucidate by

mentioned a rapidly expect soon, company's the sentinel it DSMB going currently phase XX-day cohort, we to favorable actually. the well. goal that month this we as upon FDA Yes. think is enroll independent to the in to the are and Well, by we and enrollment which previous pretty safety second in plan And After early trial, things be remarks, I is completed completion enrollment of start data, XXXX. immediately the anticipate review our in of

Thanks.

that to trial Another trial sent in begin the question recruiting. about prep the infrastructure the was is including for

team. Well, thanks work our to Yes. of hard dedicated the

XX-day We data the are upon of favorable part well as prepared the as well independent the to initiate of FDA. safety the DSMB second from trial the review

for are and course, have confident additional to very ready next the closely and participants participate sites our of deliver many ability in investigational in We comparator worked a a have that to readiness. And we ensure cohort already active to sites sites vaccine both site have and randomized really with to phase. sentinel CRO our of with number

One more most there. out but neurovirus fully On your program, I'll question. next put program, have covered what's Neurovis it may step? your logical it, you

meeting add discuss get for is do more requirements package. to But an Phase our and data overall of end licensure. to need with II to Phase Again, have to FDA our there, the goal we and III

compelling be for package we to most and in data continue build FDA. will ensure We can deliberate that the and thoughtful the this approach

question U.S. Steve. A you Would partner? outside of a the consider the trial with for conducting potentially

Yes.

open nondilutive entities business we're platform codevelop makes opportunities funding and So companies collaboration to outside if to always sense. with States, good also with the it United our

an have world. but around only impact the So our in the have States, also not United development potentially vaccine --

Gates was definitely example, our we South had Phase And So earlier, which Foundation. open broader by trial conducted mothers as to Latin norovirus in I an partnerships. Africa, & mentioned Bill Melinda we're Sean in funded the

Thanks.

data? seasonal any your we are is Abano. you Can you such additional as HPV Another Do have regarding programs, And flu, one question. preclinical program? This anticipate updates stage for prioritizing or earlier Sean.

preclinical and are currently we avian flu, on Well, seasonal Yes. conducting work HPV. flu

showed flu, be may that ones various our strains in bird for circulating are studies not data although strains have the our of effective the U.S. we flu, As of platform the for conducted current bird any are previous potentially be

about we HXB review we these Additionally, strategic based candidate before vaccines, the and variety factors, paper timing. mentioned on constructs, a regularly our to dynamics, opportunities. our published competitive in market a resources makes pipeline which decisions company I determine of and best including and The

we continue current addition these constructs to threats pandemic to In both to programs, will conduct for preclinical development brand infectious of emerging preparedness. disease novel and

Thank this have I'd closing to remarks. questions you. That's to we for like all floor some the at time. the Lo turn Steve over

At you, everyone, call. for not public with in the vaccine health, global great supporting prosperity think pursuit global effort we Vaxart, are Yes. today's of health, of is us and revolutionizing joining working development about only we in an community. Thank our investment how on in but resilience

in that innovation pioneers approach egos in vaccines. space immunity success. introducing vaccine key our oral on as proud We to be our We the focuses to are be believe differentiated will

and So we our continue may call. look you future you on forward Operator, all about close updating be our progress. to the to promising optimistic

your participation. today's you. And your at lines this and you conference, Thank you time. may this Thank concludes for disconnect