Vaxart (VXRT) 9 Aug 222022 Q2 Earnings call transcript

Greetings, and welcome to the Vaxart's Second Quarter 2022 Business Update and 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, Brant Biehn, Senior Vice President, Business Operations.

Good afternoon, and welcome to today's call.

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

and get make results, forward-looking financial planned like would including statements conference during and started, its Factors company's everyone statements, report on uncertainty most other pandemic XX-K update extent the process, annual conference and we financial Vaxart discussed the the differ product to call development over this required of may to undertakes due this section that call number Andrei? recently reports obligation described filed as future statements turn except to these ongoing the the inherent by clinical Vaxart and or including call, materially no statements call, statements with the and other Andrei in guidance, about periodic Floroiu. this could results those about progress, that of COVID-XX in -- risks its now Before development Vaxart's remind Risk clinical regulatory and I'll regulatory law. the I to Actual business operations the forward-looking strategies of SEC. in including Form duration and forward-looking any important from impact filed of trials. its after a factors,

joining today. everyone, us Thank for you, you, and Brant, thank

and our have investors in our quarterly our a this frequent time. couldn't outline our on have Vaxart's recent This is more call to June many with in during milestones. many, is, and discussed at providing and Vaxart upcoming progress As review years, call pleased first we it XX, communication, to better happened opportunity to fact, are committed

full vision as particularly could noro a significant we offer Vaxart. for we world we across of COVID-XX is the has how at here to just a to and a reality, allowing drives protection as Our same impressive immense has vaccines -- full world that where which generating all enthusiasm vaccines like people vaccines faster while believe are to for around Vaxart's making targeted here with potential glass superior potential oral our our oral mission immunity. vaccines a It this special tremendous water, vision Vaxart how thank how that tablet more the our revolutionize mucosal purpose. easily is discover pandemics. the world. current we have more pill them us the tablet provide benefits future Indeed, well would vaccinate cover vaccinated oral of the validating harnessing at to and they vaccine potential is as ones. the oral the class, shareholders, vision think by Equally among improvement be vaccines we applications, fight over of tablet could full our power we the as well during oral of been potential important, revolutionize believe could realize vaccines pandemic that of And spectrum Vaxart painlessly and where

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Thanks, Andrei.

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researchers recently, Science by And was again, Just Medicine. preclinical done study -- at data with published a we published Translational Duke in in hamster this University.

that the protect We've candidate our when targeted variant. Wuhan also the S transmission. the vaccine S protein preclinical for reduce hamsters could challenged shown airborne with protein data our could for of Omicron SARS-CoV-X disease Omicron-BA.X demonstrated think demonstrate I COVID-XX or candidates and two vaccine S-only

in locked against administration or that to and responses candidate up primates have we produced as as in S-only well of mucosa the nasal vaccine to IgA IgA IgG the non-human increases suggesting COVID-XX the SARS-CoV-X. of a the preclinical the significant S+N increase data serum X,XXX-fold Additionally,

to vaccines strains against vaccine the case again, beta a challenge animal this variant of passages is And the such has recent control. in a compared viral all reduction strain, the Wuhan. significant other SARS-CoV-X vaccinated on if one titers with developed the were as Importantly, even viral nasal in more

and norovirus the I'll that who are efficacy important are mucosal Cummings growing In development. vaccine we James Clearly, candidate. steps and we committed turning will to to address great the create our and candidates, upcoming and health vaccine vaccines promise, vaccine body steps speed and public for to clinical robust that investors. and now to data holds our of safety addition recent of believe over we for technology review others taking turn important value next to James? promise call can our challenges into that milestones the COVID enhancement demonstrating

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vaccine In our near-term terms we have development important in steps, next milestones program. several of really COVID-XX

we're the year. First, COVID-XX of third data preliminary in study this on track clinical Part quarter II X from the Phase to report

or Phase only candidate II/III Second, S+N XXXX. on we either trial decision a in of make to advancing S intend HX to a our

advance data-driven and following next to potential evolve to a development, well we're we're candidate and as a currently maximum company, the FDA Vaxart strains around the are determine novel once evaluating evolve. of only guidance, to both to Phase science-based III selecting the viral variants and a we'll enter from Also, our with emerging stage ongoing mentioned, based results in continuing the as As vaccine people the approach and future. science to benefit to to committed we Wuhan determined recent investors. clinical to best trial longevity as In have really had candidate them of likely data that Omicron-based have II the the of as to consider from Phase our the candidate. Andrei S candidate at S+N and we a candidates once protection globe to to strains the circulating likelihood against Everyone a providing provide high on success

continue also trial the with India. work a to in We to Phase government Ib Indian initiate

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Phase the to II the end norovirus We QX. from quarter of challenge XXXX preliminary expect the first the of of report beginning toward data or ongoing study

and challenges. faced operating how investors. participating to realize thank Vaxart, also volunteers proud and has pandemic global many like the landscape. contributions team light the supply clinical at the in especially Before while the chain transforming and with ongoing others to an studies Andrei, our our like call everyone I'd academic have our I thank of collaborators helping to that I'd their vision to that of I I'd our clinical in global in our we vaccine like us accomplished, for work to and challenges turn back am say our

we put your job will Back us, You've to Andrei. in trust over and done. you, the get

James. you, Thank

say the and Q&A on we about cash session, milestones. let to few Before words position move upcoming our me a

as $XXX cash strong until This half XXXX. of in XX, a and June financial position XXXX. the year provides second of have We runway equivalents us with million with cash next

will over which Now trials of Selection to line is XXXX. India Updating is is of vaccine candidate follow. let year. After ongoing start for the Then this this construct in of the challenge of the XX QX of Omicron data the II Phase at COVID-XX milestones candidate highlights expect expected next using is study half trial or second Phase to selected XXXX, clinical bivalent our line COVID-XX in clinical me human second expected norovirus of quarter expected Vaxart's important in plans half the expected trial this in construct. share finally, year we quarter first Phase Top so. the year. third is from QX the in XXXX. to determining norovirus after our the the II expected end of the the And vaccine quarter the in of the months top COVID-XX that, the the trials in start or vaccine IIa COVID-XX of from next of advance year with data first early U.K. vaccine of study start

developments important X.X important the point. over including value many to next inflection year years, So

to now portion oral has I Q&A and call. the to thank our our support unlocking for value work potential call and hard We'll who thus our of to are the of continue Alex? towards our today the everyone We especially unique begin us platform. pill investors to joined want very excited full continue who mission. to vaccine

Instructions]. [Operator

with Charles Cantor from Our first comes the line Fitzgerald. question Duncan of

congratulations and Stavropoulos the have forward all Pete Charles. team, on a Andrei questions. is for couple of movement. I This

In terms this change. is of -- oriented towards

as a make you responses getting protection? approved the the from such data as authorities In require primary can that in do you have a the the terms or think a about the have generated filing larger not supporting approved vaccine booster, potential efficacy from generated as spoken a have And vaccine, as to FDA study with of regulators what IgA guidance? between sort if regulatory of the a for the data vaccine of correlations agencies you challenge a especially clear provided and EMA is would case COVID, booster study and that,

is This you. James. Thank

sort that we've So close U.S. the X here the States with well things the regulatory with on own FDA of with as both in HMRA globe. in and One, dialogue countries U.S. answer. been as authorities the contact United the EMA, other continued outside our across

In will why think it our in I terms on hand. really And data challenge having pathway forward, study so a of that's important. is really depend

key taking against in challenge answer getting, So a infection. look I of at a the terms think, study, protection

So a of virus we transmission. virus decrease a at of having a marker a is look in nasal decrease have immunogenicity, taking shedding of protection that shedding to important, up teamed but very so can also -- with correlative

the It would also think of the will in X X helping, or study the disease that, solutions, solutions way is I that think very more what has on will for regulators disease, [indiscernible] Phase there clearer that what structure situation on faster see idea COVID-XX those pathway SARS-CoV-X, think, those well I X in of death, And at out and strain virus follow-on then a If also more quarantine, causes pandemic issues based some depends questions, more an getting as with know sloppy look the we a to next-generation long editor like, a a more the globally a us forward. give but more of decrease inform farther. more if so go gene variation. case of really is time. we that I symptomatic

trial initiate on the in the know XQ. Phase that candidate bivalent I you're Good. vaccine planning one question of II And norovirus program, a to

the other how has And do and Sort with differ studies norovirus? combo study? study? of and or this size can immunogenicity conducted you study study at the of will challenge may duration a company efficacy you this be that sort looking the enable speculate of you And on that will the the from immunogenicity think and data on in registrational

So it's great question.

will what it this of not a at but correlates terms be in study. would immune that through look II, like, a will Phase study both look Phase be next So a III, there

will We'll have from some we of coming we some looking of We be leverage study. data And our collecting be that data. will efficacy. the challenge preliminary at

of inform think a I study. study, will help inform we step end of larger, in robust terms once of our all next will the it challenge our get help that to more

that challenge discussion. approach, together bodies So at next looking late study, at amalgam of for results dose looking year again early to will be QX which further in that and confirmation with the QX, the of regulatory taking

you All driving in if do right. norovirus you could And one actually, the don't last in if a fit do benefit you say, greatest who norovirus the and you this from And U.S.? see vaccine question, about think When scheduled, actually I see the mind. vaccine, vaccine? fitting where in

do in lives gets of fitting us most latter But where it Well, who we in most So and in lives. benefit? everybody, affects for the and affects portion dramatically the schedule the our norovirus early it the right? see

seen those line, annually with Hopkins Johns over the the ill United across report XX $X to for XX XX, this, very age we frequently see terms up the or this another are children age as symptomatic again And norovirus billion who just X of alone, And the the disease. with the we have U.S. population of after spike of not So billion. in on cost, in then age is States cost may just disease. the infection, on the in

that, could are people hospitality from healthcare other the people vaccine. there the and but workers, are population norovirus benefit older So These restaurant military. the younger providers, the in at that who population in affected, look industry, folks populations, a all most when I it's then are

in terms of wide at it look So vaccination as distribution a very strategy. I

comes Capital. from Raja Brookline line question the Kumar of with next Our

on congratulations progress. the all Also

some with Phase data, infection is data saying II in protection. to regard So also there that provides previous the Omicron literature

your S-only on to provide ability production the Maybe start with just of again X? to what thoughts So BA.X be and we can are that. the Wuhan

want Sean, finish. do I'll and to you then start

sure. Yes,

that previous Omicron way out, that from noticed great infection natural pointed Yes, with have some as be a how evidence, against forever. know that think proceed. It the from injected infection subsequent would not the long infections. I don't natural may is titers you wane there the provides will to some protection that last. last People as We vaccine. immunity as well

proceed, pop of whether that As things booster, that one the our think that up. protection Wuhan things one, is were know we with against we want other I to can that's tied

when We as well seen of mucosa. cross as when nasal at we especially by -- look by the reactivity T have lots look we at cells

like evaluate have to potential we also that be we So our out evidence using to that forward. could we can But and going the There comes probably our likely clinically an is the BA.X/X, good cross can to I be to we by issues more standpoint, best think Omicron that we're reactive. from cross-reactive, the is address think trial. feel figure that what James we that that path on is improve approach there's the it when of more

Sean. Thanks,

use strain. like have We'd Omicron studies. both BA.X, impact in what we'll recommendation this to strains, as the the We'd inclusive Phase at So that or of model to also to forward is data then to is that now that as we challenge data-driven data, the like approach of to terms as X of a the getting other end, looking be FDA the well be Part mentioned quarter II, into in what from larger have doing but as to move and we BA.X.

So more follow as the comes in. to data

Okay. ramp have? the quickly the able to how on How Wuhan constructs? And do the manufacture supply. up are vaccine And new next of of to you much you

I this think -- is Sean.

because now supplies move and of the study, we proceed we supply, that Number from constructs. I not we have make we I shape the think II new mistaken. think control Northern quickly I'm on if next our within California are two, very manufacturing manufacturing to Vaxart Phase can believe standpoint X with to that great different in I "facilities" in internally, now

So James, to do that? add want to you

Sean. No, I concur,

I to previous our look the hand capacity S but I now think not in more with with only being construct to you the destiny We mentioned, spot of forward that control have, that as product on future sweet terms do we're in from studies able production. follow. just

And for enough Okay. try forward move norovirus bivalent, planned the trucks have the also with trial? you II to Phase to

at way both bivalent approach, things speak. as will looking dose planned, as we making confirmation be a those looking again, products a With well. the study, we're as yes, And currently people This We GX.X at in are well before. outcome study them larger that GX.X. as a put

turn the Thank to in you. I'm showing Brant to call back like Biehn. over no further questions the queue. would I

Alex. Thank you,

that questions been One so to written in do actually we've opening come in on one. statements, James, the think, that few India study. the And call. what your with you a got commercialize is as has Maybe it's norovirus we've have the skip The covered on next that like. we So I guessing I'm one, product. clinical when you the a question about development Do the can asking probably want to briefly does look address plan a James, norovirus. it's that? question we'll clinical

Sure.

we're II Phase looking currently QX, in Phase have embarking mentioned, of I on QX as a study. undergoing next beginning year. right also we at candidates of dose data And confirmation of end bivalent a towards And we're So II that the norovirus our norovirus vaccine the of program, challenge forward. now, should we're moving

And a to of have potentially the FDA a So follow-on term. those data large studies look and a from at relative with I discussion that's both large, think by it takes Phase the III.

with I think of could reasonable number correlates more immunity. having probably we a move forward

to on then as comment upcoming III the that volume, that think data on based Phase observed, may it's just from the III study, immunogenicity onto Brant, well. a with efficacy be may at So it's in help hand, And on you we all? get And think good process. the shape I data also commercialization. want be Phase will after got I it do studies really that

sorry, I'm thing. ask? that didn't you last I James, catch What did

you of do that terms piece? to address In all or commercialization, talk want at

sure. briefly, real can I

So subsequently impact for And when accept norovirus rotavirus the really did. government the of covered was the country. that I key the what in Economics think on economic health a currently have get for Health that's perspective the it. I used we think publish well and year governments, you're one vaccine U.S. all to market this to in And rotavirus was disease both we the and this study things vaccine willingness the we for every that commercial from that has the well showed that helps know XXx because talking that pay in effective about the done an to probably

So U.S. would terms from this that to XX good that that one believe think age thinking questions that's perspective that the phase. in population, get we're a over population vaccines we it commercial of you probably used that from currently used had And in of back answered under like the for your I looks earlier influenza then X the the

you. thank Well,

some other just questions here. at I'm looking

throw House questions I'll of you over So month's last I the first. COVID in to came think this James, couple White one talking of about actually one Summit.

and results late So in key what Summit White House the of were the some following takeaways COVID July?

Thanks.

solution value didn't virus. was the on as importance problems. the through were and especially the virus of to to that first this there an see So of changes, vaccine door regards a vaccines we the need of variant overall There acknowledgment generation pandemic, mucosal recognition close it to first a with we but X our immunity. Gen And of the was great those mutation potential step, get vaccines

meeting, the there quick. real a just said I'll quote Collins, Dr. to During question and Iwasaki, from was it Francis response Akiko

by think pill I an mucosal immunity a approach. a is like Vaxart elicited oral vaccine promising very

In lot emit of fact, oral we virus from cavity. a the

So to the got cavity. have well the really transmission, the want defense as as have you oral cavity you if and system nasal prevent to

it I know think holds a is data durable promising for I Phase responses. I showing So promise. the lot of trial

blocking and transmission we to just those more I to thing And multiple different need we again, meeting. my are -- resources need The be can think for get not bet vaccines. that's think test those Akiko's on help are because going I to we're words to the but better, at approaches that to there. the one we words -- tried work

there's of is that, forward traction what to results to more again, an doing So looking understanding follow. I we're and think gaining

The next Sean, bit I you, Thank come James. think question a is really little you, to more is probably preclinical. going this to

So Sean? intranasal vaccine vaccine how the question tablet from oral Vaxart's candidate. be the would differentiated is,

good Yes. I that's mean a really question.

it intranasal We on things work can when challenges to and the in humans. is there's we of real that And in easier think both we to much top intranasal preclinical, that developing pretty believe tablets that of terms oral some it, of new that to know making responses. comes are and administer certainly, just well One oral been vaccines. just

to block because the flu the immunity is works that the example, only For lot use. kids vaccine in flu of approved better We much seems have out to intranasal FluMist. younger that know don't a

going causing something is though just been some standpoint nasal intranasal potentially again, the effects, intra-nasally, delivery. up The of and when same community And other could vaccine can there's -- the think the some flu ended pulled palsy, be you proximity but from market. still of example, it an of severe simpler is oral intranasal that caused you of rather that be Berna Bell's we have potentially end brain vaccines forward, Biotech and to was issues. both from potential overcome, thing sort for Those off that vaccine the provide deliver the the user is because could the get there

Excellent.

terms because in of of from start opportunity here the is all I it's or you think a three with we question. the like? broader human What's questions going then on this terms it market of on. to in latest potentially, question you does broad -- papillomavirus one answers probably what vaccine? James? be And pass the Another and should look that on

kids a prevention for vaccine or There's on or and of of part depending onset right, to it And it's of vaccine. age market We the than vaccine the that less Sure. boys a fully the U.S., XX in the cancer asked vaccinated. XX XX% of and XX are therapeutic the in cancer world. it's said XX get the over globally. a potential United States, about Unfortunately, lot HPV story certainly, available the countries for is the is The on girls most the around we type. in age generally, see less actual from prevention --

our And unfortunately, future, can the Andrei? the tablet we tough an or here to bump rather disease every in that for of these That's They're of many expensive up prevention lesions U.S., year. today. that So current cancers the follow. people a oral cancers vaccine some treat. in are especially will continue therapies we U.S., take if strategy versus believe foreseeable vaccine lot there's see pre-cancerous the the we still HPV XX,XXX-plus would to into cancer from

James. Yes. Thank you,

both us. sizable our interesting said, U.S. So But it our and up strategically, still as in for first program therapeutic about unfortunately, James could HPV there vaccine here potentially also for ex-U.S. cater will HPV is what's be vaccine, market a the it an open and

So very our it would of T as cancer, platform. expansion a is the of And many role know, in important. be the applicability of very cells you interesting of

a play Sean, want of our dimension So platform, results. Phase on another you our expand this comment data by highlighted bit? I or Maybe, COVID-XX to that to little particularly could

is T Connie the was cervical suggested she dysplasia. that We by tested I could that Sure. know response reduce making Cornell thought a most clearing CDX Yes. important candidates. of a And several vaccines or with absolutely very Trimble mice. strong tumor published when were paper standpoint response, tumors markers the made they prevent Several cell we essentially -- making T they it ago, HPVXX in years result. think and cytotoxic cell this years a a and was vaccine cell We was XX the and and of T lesions when We responses mucosal nice knew there able that and to ago, very preclinically. was growth from at thing

on to our responses. show of certainly know platform and we that that so we these made And the able COVID front, type we were

indication. that bullish make if very really platform we're therapeutic have a to against our this HPV, could for responses good use So vaccine we you

we're it. about yes, very So excited

Andrei, to comes So question try the COVID-XX going I questions the but that come Excellent. a sort of along? couple What gotten or them. a to they're I'll the partnerships, Last asked, approach feed Andrei? to program you. and your for to we've is of And partnership is think norovirus would really this and similarly amalgamate either programs? partnerships potential

please? the question, last And part of Brant, the

the the partnership Would along? And speed accelerate that would program? it program

Okay. I understand.

always realization discussions potential because we are maximize open we in the partnerships we all really the look, what to about and at which the of can platform. our look to accelerate is So want ways value of shareholder

so And programs. have we multiple

discussions is detail a now. various really said, have those the and much continue moment want partnership a be in don't and to both type with being COVID-XX engaged open we in now open that we in and and position we right which potentially enter be will to in we for both We discussions of parties, abroad, entering.So to been exploring the too here norovirus. optimize the provide partnership to and That Vaxart to U.S.

for interesting warranted, will when ourselves. technology tool by development but an like and always stage partnerships We are companies important it's

so open potential. we to that And are again,

That increases. win-win the depends. the with investor there value to and because partnership, really program, on obviously, of is of program, type the Now the spilling on depends partnership there it well, that asset depends regards one the up a

up benefits our the speeding is So partnership. of the of potential program one

portion Fantastic. Andrei. Q&A Thank Well, you this Thank call. for the today. participating the of you, concludes

you. Thank

day. and Thank lines for conference, concludes you. your participation, this your wonderful a and may time. today's at disconnect Thank you This you have