Vaxart (VXRT) 9 Nov 222022 Q3 Earnings call transcript

Greetings, and welcome to the Vaxart's Third Quarter 2022 Business Update and Financial Results Conference Call. A question-and-answer session will follow management's opening remarks. [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.

to welcome and afternoon, today's call. Good

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

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

for us today. joining everyone to you thank And you. Thank

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this data Sean in which can find in Tucker deck, more available investor will also on While, detail and on this now you is our our more new review website.

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Thanks, Andrei.

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our to the excitement to and for be to of is today's share momentum enabling in our wholly who focused advance for Looking motivated, are a has vaccine investors us we as diseases, and everyone emerging inequities and build vaccination call, truly the we infectious vaccine ahead, has passionate potential the solution overcome pill on and to joined team and support and Thanks excited that oral that approach access. on historic longstanding who new mission. especially Our challenges I continue our to our to

the of begin call. portion our Q&A will We Operator. now

Duncan question is from state Instructions] floor first question. your Charles Cantor Please now [Operator the you, comes Fitzgerald. Thank questions. Our open with for

made progress is this on say for Pete on quarter. Stavropoulos the past This let's Hi. congratulations all Charles,

planning 'XX. or phase two with the the norovirus know a I So candidate bivalent in that I to question XQ the vaccine XQ you're program. initiate have on

of differ size that duration study? be or other in the on can studies And conducted of you the and you other looking you immunogenicity at of and efficacy how this speculate Sort and will the from one will norovirus the

Thank to Sean, do take this? for you to you you your this? take want question. want Sean

the thanks Yeah. Again, Pete, question. for

basis the I immunogenicity Again, be study before, two two the the approximately subjects, is be placebo. readout expect it'll one, believe basically efficacy in study FDA plan, the of think hope year. some dose I So I I mentioned the as as Phase and would to end don't serve different XXX there's be the study, an But meeting. time X it's levels rolling again, will forward that going described. immunogenicity, will middle it to to we with next this endpoints for

right, in And sort move the an you of oral of And make 'XX? how on terms All of of challenge challenge on sort in to a thanks. Can study? later, proceeding? comment enrollment is norovirus you track XQ, are

Yeah, it's reasonable at a rate. enrolling

Our QX of we is year. see will data, expectation next that

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one COVID out on there authorizations And specific Omicron boosters. and also thanks. there's question for Okay, data program,

program sort impact how of your sort platforms, which vaccine does different bring really of going forward? Although to and on candidates you're thoughts this your

with that mean, Omicron. Yeah, gone Specific. definitely people obviously, there's are I

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you. Alright, thank

Sorry.

can add If here. I something

all the think vaccines that they of are injectable I you So, if we is shortcomings looking, know backwards the that want.

a vaccines how that's going for especially bivalent being I And and this see change So wheel the really Omicron protect here therefore, to against the so the because after you opportunity we here, of these change. faster than as variants when you the uptake emerging of vaccination they because to demonstrate one designed why a in new that cross low variant need you reasons to evolves with potentially And immunity, sure hamster have or the the get are past. are demonstrate of to but we fact we're vaccines not think don't reactivity off And running pandemic can that vaccinate. keep you variants.

Thank you. added studies. and looking data forward for to you Got the human some color from definitely challenge the

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

really And on maybe question. few This piggybacking questions appreciate off here. Kazmi update. a good team. Mayank, asking I afternoon comprehensive Hi, most is recent the for Sahil the

cases we're and representing XX% prevalent. Now key the getting or of seeing than that so point one more BAX less

study? dose how your along Just partners and far you identifying for challenge curious with use the virus are

Sean is okay, this it. don't take -- ' Hi, you

that's Yeah, the BAX we're I we we're think informative certainly standpoint from doing terms of really testing looking right in now a the Omicron -- more of yeah, don't what vaccine. is like at challenge,

actually from very to well. important. responses immune that, as start if well the how again, we differ quite as and I thing well. will brought our candidates One we Andrei is BQ variants well it seems we BAX, noticed be will expect do earlier to happen, is monitor up, and okay, against it BQ And to those as Omicron coming will this against right, that will and up You're and is now that have do note, X, what our could the their vaccine

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Sure, this question. I'll take

One that, of course, that the the we're terms something to on no about that challenge the things and vaccine was we is if and of efficacy of order when challenge expectation be of low really, percent will you're the as really on well, be virus, I one doses and but I so could of the was would successful, using but in GXX high will challenge done something XX% using would again that efficacy that results -- is on was the will be ago, said some leukocyte that's end, that be XX% study years what it that there's it Having RX higher it several and believe and published XX%. odd. been idea have that call

challenge understanding, correlates that from models what a large of protective, are your again, are using that standpoint quite process? great dose you are So, of as part the can and the a vaccines

luck, Thank Yeah. at Andrei congratulations Appreciate was progress. our you the thank added GXX. Great, That great. very the on best questions. appreciate the really all and you. of you And much, color. I taking

much. Thank so you

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my for you thank question. taking Hi,

Holdings global self-amplifying commercialize know, may company to Oculus announced collaboration and vaccine you a recently as CSL a So vaccines. mRNA develop Seqirus

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you for Yeah, thank Thank question. you. the

Andrei. So is this

And definitely does. pandemic bodies. well governmental a with call preparedness we as is least as that various lot think if our you saw in it see conversations at and quite and pandemic preparedness emerge COVID, think was a And about theme recently, government oriented. I what was I that it agreement, I influenza

been may And best a future against, of awareness in COVID better COVID, is you importantly, be interest waves against but or specifically there healthcare potentially we there therefore, we future the is vaccines way the newer technologies. governments, realization injectable if pandemics. need current But with think that generation investors I the that to weather need So to increased fighting these I prepared specifically, more go. just to And has bodies not pandemics from think talk and flow. an growing

So know I your if answers don't question. this

you much. it Thank does. very Yeah,

I would add we also science increased in hope our large that this sector. that from that see the interest translate in will biopharma will

Right. Thank you, Andrei.

this there queue. to call Senior business At are the now of in President the questions will more turn no to call. I questions Biehn, investor Vice the time, portion the no of Brant operations moderate

Thank you very much.

to answer in. these partnerships one individual have this expand Andrei, a while if have think Now of you I COVID-XX little we'll I gave? or to do that that first push what's covered programs? to want bit or we for approach was of some that. want investors. turn expand in norovirus don't But number just know your that to you potential questions from either you've on came a we questions, I out And think been covered the questions analyst

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continue abroad. So or in whether open partnerships, U.S. the be to we here exploring to

question going fitting Vaxart's do where And next is for the see you. be one next into you this Sean, you. to COVID-XX the gen candidates Sean, is Thank please. vaccine landscape?

vaccine been chain already because in vaccine requirements, a medical of infected. of needle such for because those pill-based who a cold we Obviously as fare and see vaccinated standalone supplies, immunized certainly or personnel. US the haven't and have large Sure. other countries, whether Well, our logistics been people of lot as

to a going be other of populations. booster We lot really complimentary it's see in So, a it's vaccines.

be Now, we of we better from creating mucosal potentially it make responses. and as we booster protection variant And of can the ours transmission. might know a certainly we with course, think immune tested bicoastal mRNAs. reducing standpoint and And have the cross bit that

And Vax Excellent, looking thank specific in good will for absolutely for next target Sean? the be Sean. this platform What infectious you well. this at you, other are the of candidates diseases one their would as any part indications, second And be you future?

Well, we indication I targets that are could have a mucosal from obviously, in viral-based. vaccine that to and I the after. response good at benefit think essentially looking go be any certainly thanks. really that can past But Sure, think

respiratory vaccine respiratory enteric, HPV, pipeline with current RSV, would cervical something be as started that's which COVID-XX, be Our would which obviously that well dysplasia. includes influenza, pathogen, respiratory as something norovirus, we

lots of going lot is new use, to the easy ones different because to can we platform of there's again, a go discuss very not today. targets for. So And, I'm

Great, thanks, Sean.

covered next current on expand opening you one think what's that during a I your runway? you could your But little a the bit question little remarks. bit? is, this cash If

Sure.

second But So in aggressively to quarter that into we is two XXXX. resources sufficient programs, that million, progressing plans said hand And we that want with third more to on perspective. the ended $XXX.X which I our this half includes continue the clinical to COVID-XX. financial norovirus put and our of we which execute means have lead

additional two make points. I'll So

significantly, may First, we levers to we near have term, compelling the if the pull appropriate. we catalysts that that be this that we could And is to opportunities new second ever or funding that more runway medium us. think extend are in believe that would there compelling create for

Excellent.

expand bit, of of a on what guess are guess. bullet little I funding company I that question next maybe little head the kind so the we for the the plans sort bit, And just last a

I available that mentioned continue the engaged we to the in sources various Well, governments platform around world. funding We pursue us. potential presents very to remarks with my to that continue we compelling to current opening be so technology. our think advantages

course. we So discussions that result guarantee opportunistically done accessing again, some point funding. we've may of is past, remain the as and market. these also But hopeful capital at conversations We're in strategic partnership pursuing in no there

Great, much. thanks so

the for Sean too we're date, I'm COVID-XX. repeating what's decision of try there's and COVID and a says one questions rationale construct from to here. together XX timing you for of updated first in put coming vaccine it So for please bundle so providing that lot to them changes provide previous any expectations? and We'll over the going not some much the

This from construct, our on COVID is of Wuhan of solve trial makes half Phase our constructs move forward X a candidate pathway. our vaccine the study. to and in XXXX. course, were the COVID S S-only construct challenge the X plan on us responses for our and second like to challenge we well, against see select this plan, cross-reactive we our Omicron Phase the the Wuhan. N hVIVO up the Obviously, And could development thought the data based for strong Phase speed I research. X in the strong the newer We to the think allow working

you. Thank Excellent.

think you've study And But commenced. on hit on for sort question study it. over our we that get question really is the the on one of already. also we'll just for challenge Are timing follow of Andrei a for is about I second what you, Cummings could reiterate hit the the same track on he But challenge half And this timing is XXXX? if the to what's COVID? for Dr.

Brent. you, thank Sure,

So we second of to that trial going XXXX. had this in said the initiate half we're

make that. us for on that it also We that looking make And ways possible are would would we're to sooner. -- track trial start for at

And so we will those paths obviously once make announcement. identify an

Great.

next you. this one's Sean, Okay, for

be for to September? additional when, in data The the top-line releasing If Phase Xa announced you from Xa you As so, insights Phase beyond will trial Sean? COVID. is, the trial do question that

new that the the the something the obviously, to will have Yeah, in we're end expect there's month. new of And site release, when at up, available. we Diego continuing San up to I things at present coming we Congress when analyze it's release coming it data to interesting gained. World insights and we've Vaccine will that And

to the Andrei, you COVID you. one's come Thank again. challenge this to next going back and study to

do positive, accelerated are challenge an for vaccine So results see path approval? you if COVID study

bit that pandemic, challenging depends And depends state also that results because challenge Well, on it question, the of from so it our a of on time. a at study. really the

the in at and regulatory in COVID-XX. outside both states we several authorities, the against to our global U.S. with are the platforms So of FDA, touch of application look here of

these decisions, on but the regulatory needs. pandemic, based different not this the also during seen, acute on of authorities strength data, we've make as So, only often which their how are unmet

protection, confident a variants, forth, remained on is various proposition. but really very now, the many we it and really and So, pill answer we to so needle and free challenging provide talked against that can question benefits advantages of protection that compelling a remains about the so vaccine based durable that of

to a is so much. couple questions. going of your Thank Sean, you construct come got We've way. this

and The of take question a you study X Phase question, is, a hit it expand will challenge last your potential Sean. a the bit kind the factors initial and what first answer. you on The gets into inform construct to one, trial? you little

right think I now. Yeah,

subjects study well data CDX guidance think are our take the to challenge, Omicron, thing vaccine. are neutralizing boosting since as from go ability against a and and that gotten is standpoint add additional bicoastal mRNA in Further of vaccine deciding elicit already I the the trials profile, we have were an T-cell most going to from important provide to might forward how antibodies when as IgA people response. know, what challenge do you

is the with by be cross the you time is, excellent. of current omicron the to over question Omicron are construct? gave. is one you The And really if obsolete Sean. our of construct an reactive, they next Wouldn't that why complete? they starting And expand is S-construct is the questions about somewhat can on answer other maybe Omicron when question and it similar analyst's ask kind your

obviously, certainly about and Phase a we X. language, we have a our think existing the reactive mean, we I are this X I tighter I'll the bit. Phase talked and Yeah, that Maybe cross responses constructs. the with little little constant of both be proven

and we again, be we to good, other want make wanted Because best at we I least we're forward. preclinically. Omicron to the going the are vaccines to look to have at However, the scientifically to ones, fitted rigorous, compare them and constructs, mean things sure that

the Omicron think be days. Omicron In will one still that's commonly I terms seems family up more obsolete, popping of be things to but well these change, the whether

So.

The question you. vaccines? GXX. this. that Vaxart point next But terms you've Great, table let's already over oral believe government to officials And mentioned the the for Andrei, I Andrei, question in need So, you all will the expand to please. at you recognizing on the then do is of have thank you're and going a key place

the mean, you, obviously, answer, is I I that Brant. hope which I Thank Thank yes. provided you.

see our there at is we least how which pandemic in this is So help that interest, and fairly discussing in technology, ones. can unique, future

on but with to have So, continue are And they have COVID-XX, there we not we as which COVID-XX focus preparedness. only I said, discussions, countries discussions. beyond several on pandemic

will So into discussions. We invitation them in actually we sure I excited my I feel honored never we tangible can to have turn conversations that receive these something that remain of GXX. we'll hope eventually, like have as be the you tangible. to remarks mentioned to do But, some these And opening some support. mentioned, the

message tell many. resonates about can you I that what right with the again, is However, of now, platform potential our our

question is, question vaccine actually. is quite back over the it's All Sean come how and differentiated intra-nasal the that oral going often you. asked from thank get to you, to candidates? here, vaccine a Excellent, tablet this And we right, Vaxart's is

a Yeah, this good is very question.

from into what vaccine some intra responses immune everything nose. there published vaccine was in not head-to-head data aerosol approved least. inter actually COVID-XX there just could comparison I been an obviously, There an encouraging So vaccine, publications has The And out through are we've nasal and for candidate or seen in tell. haven't a never to not I there, that keep oral The that mind, that can It is an say few. nasal between the been see. really quite least inhaled what from fact, anything is a limited is this sprayed been the potent is China. this in apparatus is not

our quite -- looks particularly in course, no head-to-head our think the compares data done, comparison think more the I Omicron favorably mucosa, I compelling. response with think of data actually I caveat serum actually not there's

really I no true there's published basis Those, was. Russia vaccines. yet, has really it's for approval while Lastly, in don't data forward what Indian with know and moved intranasal the

I think yet get all kind means the been about cautious. it's things are the a cautionary approved. published I a think fact I'm that little hasn't little data be we should to that of And

Great, much. excellent. Thank you so

The government of duplicate add on regulatory you to don't that your I move what recently. of in I think can for what's couple Andrei a the next pathway? what's the If you was, previously sort mentioned. international questions more already One There's prospect if or not, one funding? on here. know, we Okay. want is on thoughts us just any you've handled

fact very challenge at try various could I data the And by it's, that this don't mean, continues to it's time. we're that. a will around I hard encouraging. regions they -- be needs unmet the platform do have can the better. perceived know If I if far going and to to seasons encouraged be any And to to what well address in continue how here. speculate. I again depend we world. But study be so in on very be do we different a differentiated The the

Thank you.

about couple Tucker me in got more wrapping the But a note press please, of to up. investors and you're pandemic a scientific you're I natural of event. haven't community some seen comment X seem doing company, for coming benefits would it speaking community to that of to questions the just time the a come a I that one's in buzz Sean's this This the the is alert if it and vaccines meeting candidates, you COVID preparedness importance for release workshop, that Wall understand Street like the helped about to of going create on fantastic Dr. Sean, workshop this. mucosal as vaccines, seems the to you think just November here. on for we've is the forum midst educate could

think for prompt you pathogen, big a It response it was we good also data had invited about It's think Mucosal strong not for talk to And important. scientific human gaps discuss workshop out think you talk event. participate. but invitation study, it tell response and I very us orally a there. and nasal why I was well our I respiratory me protective opportunities. for to vaccine IgA to about our conference, to provoke received Sure, is so NIH SARS-CoV-X it was I and was vaccine able to administered Vaccine information our news a step enough could was our the And The potent get. happy and really referring forward against let a a public flu the be get

a I'm to This going start you. ask to And of for one that to Fantastic. there's is Sean. couple going norovirus questions last

question this. preliminary But a I challenge elaborate bit. data The we any to already please, XXXX? could study mentioned if just you on see is, we've would little noro think the prior QX,

placebo this controlled to study prevent bias double blind in study is a data. Yeah, the

understand the ready going to data. we well to vaccine unblinded that at our unblinded. be and will then aren't how until it's point, it see be And able really We did to

the for what's program challenge potential Excellent. on study? the the then following this And last steps question norovirus, next

or the in that, we've which strains responsible year for and Sure, norovirus, knows and sure the just to GX we've have forward make everybody covered disease again, bivalent GX expected this study. adults of early for plans confirmation. And next already were began dose announced study year. And both the majority to that to late we move is

of and -- FDA. the we standpoint the the company, forward meeting just major from Phase to the end this X of is go before with step So a

Great, you thank so much.

I So very story. to for Q&A. today's the of concludes call. today's to call our that's Vaxart much participants the you. listening thank their time in end Bye-bye. Thank this all And want on