VXRT - Earnings call 3 2023

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Operator

Greetings, and welcome to the Vaxart Business Update and Third 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@daxart.com.

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 Counsel. Ed. ahead, go Please

Edward Berg

welcome call. and to afternoon, today's Good

President Joining Officer; Officer; Dr. Vaxart are Senior Philip Chief Executive Andrei Floroiu, Vice Biehn, James Brant Chief Officer; us Business Financial Operations. from Lee, and of Cummings, Chief Medical

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

Cezar Floroiu

norovirus highlight you, and recent our progress in the back we'll today. clinical to on thank today's all you On of have program. Thank call, Ed, autofill us you for joining we made

milestones before briefly the questions. opening We your will a our our discuss call also provide program COVID at and look to planned

II of We released validate to important our from platform. norovirus third encouraging X vaccine quarter, program. data the During took mucosal steps we top trials line Phase our

think both James trials vaccination The the the Phase next paradigm as our like key which there then we will we we has oral know. stage from the dose-ranging potential learned trials the these drive believe more transform I'd of data II candidate study. generated we norovirus steps II in Phase But few bivalent our program, you how in for and nourovirus norovirus both from what over these to for beforehand, go program. channel from of First, our from points our vaccine study this findings of at share a to will detail. and terms of norovirus have scientific are this

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James Cummings

We Andre. believe and both candidate platform announcing promising studies. to trials. norovirus this II the during to our program for top strides I'd shared summary you our line provide is third for separate that vaccine a with great made clinical X overall. from we've of data now like We vaccine Thanks, Phase high-level the data in date quarter,

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of inoculum to norovirus which X vaccine were The challenge that an study placebo monovalent our XX% X. II immunogenicity monovalent challenge vaccine. and candidate VPX safety, This to IgA to norovirus GXX to XX% XX in HPGA candidate. This that IgA strain dose of placebo our not objectives day study for evaluate vaccine healthy placebo-controlled was compared the was XX, cohort relative and the a Strain efficacy to The norovirus cells or serum they GX gastroenteritis the norovirus a AGE serum IgG relative GXX in and AGE, Turning received then efficacy on and was VPX and AGE challenged norovirus of the relative norovirus participants by its specific our received ASCs, a the Phase the shedding, determine immune XX. days the of double-blinded, reduction the in the in day antibody prespecified acute were through oral XX% single study, primary On volunteers candidate endpoint which norovirus results norovirus secreting protect infection. show reduction vaccinated Norwalk the or endpoints. a clinical measures study caused vaccine and primary significant A of to statistically and blocking the infection, and the responses reduction antibody of or which against responses placebo. randomized, specific with significant assessed statistically in with X norovirus viral strain targets compared met

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go for analyses how ongoing, steps will are previous from additional trials next norovirus of we the us terms our determining these forward. help in In norovirus data the program, and of

meeting include a safety would FDA end bivalent call in of confirmation meeting on track for to to steps States. Next obtain you, XXXX. remain Chief hand order the registration data of the of financials. our IIb now FDA our the the the Over Phil. discussion I'll candidate Phase of to with sufficient over for for Financial Phase end by II United Phil dose inform to Officer, Lee, our in brief We a study an

Phillip Eric Lee

our revenue scrap Thank the financial recognized was under was are no work XXXX for from the quarter $X.X XXXX third The third revenue third the for as XXXX. third performed you, your of the all operations into in for used quarter today. runway third of cash current details million Gates company programs. of cash Melinda for today's third quarter to $XX.X restricted anticipate as marketable compared the XXXX of Vaxart million XXXX. decrease equivalents, Foundation. of million quarter XXXX. XXXX to cash James. $XX our was the ended in the Bill primarily due from with of primarily compared securities Vaxart in The release. of and cash, press of cash we in XX, June advanced you to results Revenue summarized The Revenue quarter and to of quarter continues Thank time

open now your will the questions. We call for

Operator

Our Instructions] from question today Mayank Riley. from Mamtani B. first coming is [Operator

Mayank Mamtani

If I going couple clarifying can a on protection, ask correlate the additional of on. analysis that is questions of

could could you Phase you IIb at bivalent do you need for the Just this there there's if confirmation dose protection? sets core share. color get study. And data maybe the And are and we any monovalent looking the both for

James Cummings

Thank you. those. is This I'll Cummings. James take

our in the continuing that from protection, terms challenge So we're study. of correlative analysis

As challenge a challenge of versus you strain monovalent that inoculum. a vaccine monovalent was recall, may study matched

being look have used, as we would to that and ongoing. As that of confident comes mentioned, When correlative the are it we'll challenge analysis protection, study finding correlate is protection. the sets data we towards certainly a that we're

study with look correlate FDA. We the III a as lies. and IIb certainly time. to the study is based impact correlate this from or analyses And importantly, past more a of challenge Phase then on at be dialogue based at that studies on the how But might that will would the other determination where Phase the

end still which to hope additional for Phase with I online a on II for is, still of of IIb end as from would Phase the garner bring we mentioned, safety us study Phase to FDA, data to XXXX. of be While schedule an meeting II

Operator

Ian from coming is from Jeffries. question next Chan Our Instructions] [Operator

Unknown Analyst

for Leon questions A This us. Roger. couple is from of

first potential the or about guess is IIb Phase one II the the study. I So Phase

timing color and the and any enrollment design in So study terms number on of those... of the

James Cummings

I'll is that This take question. James.

and it an further may the IIb beef used study Phase II more Phase somewhere study. moving at will overall our XXX be by immunogenicity would who least maybe the the impacted safety be for FDA. article along lines but that of So of direct numbers to meeting the look and individuals had forward. so, that of the received the said, would some design test And somewhat with of up analyses end That be be at then or

Unknown Analyst

question study. that I like I I billion -- challenge another mentioned remember X potentially you'll think another maybe do So

So around considerations what are that? the current

James Cummings

Certainly.

I challenge initial requirement. had to not So study. analysis information once we reporting be additional those correlate study to In a And moving Phase currently, time, an the the reported with at we've we this parallel correlate norovirus look strain that study out have then Phase it in with done have it's with GXX and could the needed, FDA. a were on could forward to that the But be on executed, GXX decision If community. to more on the IIb it be with and We'll have discussions executed. identified forward a done will if challenge, the and dialogue III impact FDA, further design. that make with

Unknown Analyst

on study Maybe one one I design. Phase it. quick Got the

know I of the and of importance measurement the that III reduction you transmission that. mentioned Phase So into

from transmission any around that the reduction? for agent feedback part the So

James Cummings

So decrease which of a on have which gathered the believe reported a shedding, significant viral may study. health an XX% what statistically III Phase relative data we policies. utilizing is would data we said, at public on in be reduction. transmission, we was That viral decrease then in actually had further standards in to large only That a shedding, the lead

Operator

to for like would turn to back I Brant now further call the questions.

Brant Biehn

you much, operator. very

number A in sources have our them So we've various from norovirus shareholders of of got a that related. questions other come interested are and parties. number from

those. Phase already. a of certainly lot There had going a is the trial and correlative to we've I answered already was think James some protection interest answered in when of for think but III them happen, norovirus also I have

James, I more Here's you, little clarification will a norovirus. bit one that on ask

So think a goes IIb line important analyzing of trial. oral But an us provide it Shortly. in the on additional for in question forward where you to the terms -- update data most time are additional is, in I to noro data can with past the path Phase the is a you here. the

James Cummings

immune the data those completed. forward more study. evaluating level look details that on we're within to analysis currently, responses individual once sharing So and subject an We to

Brant Biehn

Thank you, James.

is the talking specifically, have for you new you one organization. to future candidates... about Here's the do really plans of introduce XXXX any question in product The Andre?

Cezar Floroiu

Thank you, Brant.

the than best existing our as And focus look this remain which will identifying you create ways our of is of and to the programs. catalysts company pipeline, that of norovirus, we opportunities and as our coronavirus for progress a XXXX, on composed the many for the So value into size. more clinical doing flu enough pan now know, we believe would creation

Brant Biehn

Thank you Andre.

have. to Okay. come number you. We've this much money one's Phil, about a questions we how going to of got

specifically, cash? IIb capital you So intend question trial, to is, Phase need raise the initiate existing additional fund Phil? do this the to with Or trial you will to

Phillip Eric Lee

determined the on the program, we are conducting have steps. we we our provide trials. norovirus update of runway once we if include that, cash of forward next recap, in appropriate. guidance path an And analyses updating may to will just So currently our the And data additional for

Okay, you Phil. thank

Brant Biehn

mother Back the is to clinical. And one on study. James, this lactating

So it's is the to for time mother the question top your data. study, what locating line line

James Cummings

Thanks. We'll sense timing X subjects have that date, to To from study. full we've better as data we into a move study this enrollment. enrolled closer for of

Brant Biehn

data program norovirus add-on please study well, the the to question how an overall mother James, there's into Perfect. remind from Canada. And that us the for the as fits locating development

James Cummings

population. breast could infant. protect lactating part nursing that's ediaglobulins that's immunizing mothers protect this the help vulnerable milk, really our in may norovirus that -- strategy And in and to of provide the So increases the

Brant Biehn

about of this Lots questions one. Fantastic.

governed So outside coming funding about you government. or sources, additional specifically from other BARDA to U.S. Indresen

have I'll and for you program? Project So could lot been receive from this you asked. an or And But BARDA this still question, give the a you NIH update has ways that on NextGen there's Andre? of funding? funding do

Cezar Floroiu

Yes.

the that would with government said have to so optimistic. But program. remain we don't. were pan we of we opinion U.S. if concrete times the the have share We as in support coronavirus remain our So past to update, multiple we a we you, that

have the programs. our provide part it that over the distinct advantages, because programs to NextGen potential at be does funding continue that pan supported received those as believe of coronavirus program Looking we advantages several should program,

we update of have we you should wants share. So updates again, we to And the remain that dynamics, will to specific this U.S. any ability its belief fight improve if supported. future to program significantly when be our

Brant Biehn

Great. Thanks, another Vaccine for World Andre. James, you. Congress. Back one the to

updates the James? question is, from share, there that So can the Vaccine you World Congress any are

James Cummings

Thanks. Sure.

it challenge the to challenge And XXX results impact the So natural our X of particles. very our went be XX might was here exposure from particles. inoculum from part million infection. norovirus When generally the virus natural the data is infection candidate Don't contrasted against what vaccine to received. to well was key was up virus forget

So it's a far level because against. there's be natural virus infection overall enhanced we to in the less likely will think that protection protect

Brant Biehn

you Phil, Excellent. regarding very much. Thank the another gate financial is study. question

question much Phil, revenue Phil? over the what is to you, study and left how the be is recognized time to GATE So from span?

Phillip Eric Lee

Thanks, Sure. Brian.

the in related So and recognized of are grant rendered. revenue costs are period we the services which incurred

foundation current recognized the XXXX. quarter $XX,XXX we really currently the vast in point, revenue. to Bill the recognize I of have the of majority fourth this Melinda grant at So expect the from remaining Gates &

Brant Biehn

Phil. you, Thank Excellent.

Okay. And that our closes operator, Q&A.

Operator

your day. lines If We and wonderful so, this you at have thank disconnect then for participation your you time, a may today.

Vaxart (VXRT) 2 Nov 232023 Q3 Earnings call transcript