VXRT - Earnings call transcript Q2 2024

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Operator

Greetings, and welcome to the Vaxart Business Update and Second Quarter 2024 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, Ed Berg, Senior Vice President and General Counsel.

Edward Berg

Good afternoon, and welcome to today's call.

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

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

Steven Lo

BARDA-funded of FDA planned turn then with to programs our a IIb and to Today, and I'll in-depth that sharing all our for the call over and Ed, this made discussion you milestones. for norovirus. afternoon. have we thanks Thanks, upcoming on the detailing James for COVID us norovirus and for I more joining to forward conversations progress look Phase of updates recent both COVID trial

to goals the one I report Project at receive pleased set we of out as halfway midyear. were award we reimagine how initiative billion award Starting the It Department of of that $X more Health vaccines have by and vaccines this innovative to promise NextGen's and Earning opportunity Services we under we with COVID our NextGen. durable also and globally that Project XXXX, to therapeutics million $XXX our manufactured to we up quite date of provide distributed the am is against accomplish COVID-XX. Human to on the delivered largest BARDA biotech I've imperative the to call protection with Vaxart that for strategic advancing contracts The in across the our to update point underscores organization. to financial our joined we has of been to to the in at company I technology. on platform. had confirm and commitment your solve March, entire This in solutions hard have ours, goal a who in with believe of some deep is all reason our of functions challenges company of also transformational as X the focusing After that's oral I I of questions. Since time vaccine a our groundbreaking and CEO, the opportunity particularly of technology greatest the a cover are the science open execution team spend in given our driving and new thrilled by the platform. valued I will threats. At why have our the work through great Phil confidence June, can the the infectious potential It to Vaxart. Finally, highlight bringing and society's months announced of innovating serves before program, mission. are joined pill disease to develop broader urgency

trial. ongoing continue this and detail Phase an will James FDA IIb we alignment, shortly, dialogue have and to will As with their we pending initiate productive

long-term potentially we program. line trial goal achieved over the mothers, In of we which on norovirus our positive focused clinical the transfer. and months past to antibody help late top Phase protecting for can lactating in Turning I meaningful infants program, through announced us April, our step next achieve our are take poised results passive XX this progress to

funded As this the & Melinda was Gates Bill Foundation. partially by a trial reminder,

previously II recent Phase data, to these compelling addition we results reported challenge from In encouraging study. our norovirus

Our pipeline, we At yield to confident additional affected program approved contribute children the be for this requested Norovirus as each annual alone. is States old States work children FDA to X overall our at contract sickens positive dialogue according norovirus, to and care under continuing and outcomes, risk for clinical to norovirus results and of least look this million diarrhea. are severe annually. Without age vaccine that of disease death. to of disease and economic such at their It symptoms time, pathway have program. and symptoms NIH, that adults steps an XX help in cause the component from gastroenteritis that is next will and includes years that sharing will longer highly United people constructive high our We continue essential including norovirus with the United XX% information. contagious data inform norovirus strategy to regulatory vomiting billion an The the with this disease. continue discussions global approximately of including duration year, is people program clinical leading Furthermore, $XX.X an XX we our who the forward miss continue active burden will the a virus to and health. will remains acute for against in

would I touch on financial our to like Now briefly position.

to clinical-stage ultimate novel we and it enhanced commercializing achieve to towards vaccine. biotech corporate our our takes financial capital realizing into XXXX, goal our runway goals. to a in position, us As significant resources innovation groundbreaking of continue company, advance our extending allowing By invest a

focuses oral mutating mucosal vaccine may the key mucosal of various approach our on than believe will cross-reactive our be transmission, is to preventing a existing be that disease we especially against The success. at differentiated promise space, for vaccine immunity viruses that better vaccines. in pioneers strains As

FDA, to but call review still to on posted the over remain program. I'll discussions sharing to our this BARDA-funded a in people forward programs. safe and need we of our proven, programs. keeping advancing a James of is science the committed COVID further next with updates diseases. trial our steps you our from being health, progress recent now detailing ongoing to public The our Phase For norovirus crucial turn keeping in IIb We from look infectious the and COVID-XX norovirus provide is

James Cummings

Thanks, for vaccine for believe clinical Steve. is Echoing We pill Phase evaluate Steve's comments, IIb COVID-XX the in we appreciate key to provided our XBB a funding trial. reasons. Vaxart this significant X by funding BARDA oral candidate

our in BARDA for recognizes a a interest their next-generation strong support. need two, us government program enables it to an it comparator. the have U.S. vaccine. further the COVID excited as to mRNA demonstrates and First, And platform validate against clinical trial We're our large earned from

among the against better believe infection. body We are the candidates' inside the a this to that trial belief the to candidate It our and mucosal the the other our the versus evolving sites in safety body tolerability surface continue of build inside demonstrate improves a our which eyes immune responses for at immune will a cross-reactivity vaccine particularly nose, variants We responses is our comparator. absorption that significant impact and linings mRNA compelling COVID profile with and have vaccine data vulnerable could vaccine for are mouth, mucosal found of that candidate. surfaces, along

and the details safety Phase randomized, a IIb comparator-controlled candidate older immunogenicity and vaccine efficacy, determine double-blind, pill and provide XX,XXX stand injectable clinical trial infection. oral The of our the comparator. in I'll multicenter, of study. COVID-XX healthy years with design against currently trial to receiving additional against study relative an The an in mRNA States, immunized anticipates Vaxart's COVID-XX enrolling where this approved an is receiving previously we vaccine and adults, in Vaxart's X,XXX approved Now XX vaccine initiating approximately X,XXX adults candidate COVID-XX study COVID-XX design mRNA United

infection primary of prevention any some had asymptomatic the all be the COVID. efficacy the of of compared study vaccine a immune approved characteristics, discontinued symptomatic completed or for efficacy should to COVID-XX at symptomatic induction and and will analysis an Vaxart's probably when and either all the of high comparator The disease. and have the of subjects subject expect measure and risk mRNA Primary of who visit will events. performed part for incidence participants study candidate baseline one mRNA disease. As in months when XXX injection XX% performed vaccination. We it we measure adverse efficacy reached. XX take that least post past will An be relative will been for COVID-XX have anticipate enrollment. complete interim at may X cases disease, to be is mucosal participants about endpoint have systemic months clinical vaccine It The efficacy for analysis

cross-reactivity, endpoints, and for designed blood, we including look nasal responses. For saliva will

points aligned Data data to will of enable also we swabs. ensure as will trial systemic We've all on immunogenicity, second study meet the we and and many as use Phase trial-related will size, XXXX, initiate clinical to we or supports for with will weekly execution. with with the This and that are These take of early a independent Monitoring and IIb study CROs, complete, take we analyze aligned focused analysis safety, Safety and half a Subjects FDA for the study. BARDA participants. FDA. response. remain alignment from that some addressed mucosal team. we questions time costs. We diaries tolerability the specifically notes can frequently Project with must engaged review take electronic trial Our FDA's process Currently, expect large the does this NextGen quick of preparations, of but to work initiate the will their Funding on regulatory overhead study and Board pending date are before to the other data with the trial an safety and to DSMB ensure

we patient now our completed XXXX. expect and of enroll processes manufacturing to launch the second the before announced, previously first As preparations of trial in half the

share We our program. for feedback steps on potential our FDA next update FDA for norovirus our protection our data norovirus an I'll on from program. discussions received and regarding the correlative Now constructive

norovirus lead date, the vaccine. Phase Our GXX Lee, challenge requested a Financial that Presently, process additional dialogue II call FDA. I'll reviewed the finished bivalent discussion submitting financials. to once our and now our study also to Phase the candidate information bivalent the hand the Phil brief clinical findings study of our of with the our further our for which that our FDA next of our the FDA of steps of will Officer, We're with include II discussions Phil? component vaccine dose-ranging norovirus we to in feedback. and Chief our discussion over and will determine information,

Phillip Eric Lee

Proceeds Vaxart runway quarter continues we of to quarter Bill of quarter XXXX Foundation. summarized from approximately of for of the second to cash of study investments activities XXXX. $X.X to the our million. Subsequent release. Revenue the trial. be quarter Thank for & today. received of ended under IIb from $XX.X from of quarter you, primarily in for second of XXXX recognized Vaxart Phase million Melinda startup the under our everyone awarded grant in compared details work The in or or the Vaxart's BARDA press BARDA. was COVID-XX clinical continue anticipate quarter was payment equivalents used Revenue to Gates will second million with cash revenue second in financial payment XXXX. Thanks was $XX.X from XXXX and $X.X XXXX today's plan, in the Based with of James. million the the the of close XXXX. performed second second contract $XX.X performed into work results a Revenue on cash, XXXX primarily the your January million time recognized quarter, for from current are revenue Vaxart's

open for call your We questions. the will now

Operator

And question Charles from Instructions] Duncan Fitzgerald. Cantor take first [Operator our we'll from

Elaine Kim

Kim Elaine on for is This Charles.

provide additional the be on program, FDA? to prior how comparison norovirus studies color the design you do more Phase by details that the Phase requested you've of trial that conducted? will For the you II was anticipate And IIb the in can

Steven Lo

and going to I'm ahead turn he that of over question. the James since some for thanks had Elaine, go provided the comments. to

James Cummings

Thanks, Steve.

put the would impact agency. I preclinical nature information think, expect, the are you'd trial, of for on the that specific of on you discussions disclose ongoing, there as reviewing details certainly around when the next asked, that I most we'll discussions. with discussions. time, with that we're consistent steps IIb as don't companies, think detailed is FDA program, and and details which FDA was When providing that's clinical norovirus have after depends portion this our share and So practices, That's ongoing out. of to those not data. the norovirus second we have the again, And can what Phase that discussions those finished, At

Operator

Mr. I'd at [Operator And to Berg turn the Instructions] the no like to time are floor phone. over further questions. to Okay. address there questions written this the

Edward Berg

Thank you.

been have have We that questions submitted.

from And if additional to And remain Phase IIb before Dr. one? related information study? this can I The to first what getting you is, what FDA the think is initiate start study? their needed COVID that, approval to steps order the in address the Cummings,

James Cummings

you. Thank

have to dialogue with FDA. and continue We ongoing productive the very

to We have and look addressed resolving soon. comments some the remaining forward of the ones

like ongoing said to be discussions. However, before, detailed as these information not most will companies, I as of the nature providing we

We the an in advance of and subcontracting startup trial manufacturing trial, our vendors. processes Other with of trial in would we to supply you. warranted. produced have launch substantially completed key update as have preparations various sufficient this the go to of site Thank vaccine We activities the include of in the provide activation and order plan forward.

Edward Berg

IIb IIb subject initiates, Phase What adults recruiting the are COVID Phase for for Thanks. A face Cummings, process? the COVID you enrollment in on trial might XX,XXX follow-up our once challenges the the study? trial Dr. describe question again that

James Cummings

view Thanks. representative study to for this COVID-XX management United be enrolling of trial, with recruit. population XX% to of the the our our opportunity XX,XXX for high of at very this clinical this of disease. We participants an States, we as expect ability risk the really of severe demographics In the trial team considered subjects demonstrate experienced to

disease, factors age of those coronary and asthma, things diseases. diabetes, artery XX, of lung kidney with or some BMI would a And greater chronic like be than increased obesity

Edward Berg

Thanks.

with is COVID question ATI. the Next the the and again on contract. is trial contract This

you to achieve the do for payment in For -- what for IIb funds study order additional through for, the milestones was and the earn to COVID Phase from $XX.X need BARDA ATI? Phil, million what

Phillip Eric Lee

to achieved to a had contract that executed in a fee and will we funding contract, So initiate was this single specific remaining to million with already COVID-XX million rather payment as execute really the trial. The but for we actually $XX.X continue that up received CRO. milestones, contract tied $XXX is referring -- actually reimbursed milestone we a ATI we the to because not you're be had we and earn costs IIb Phase contract because the prepare,

Edward Berg

Phil. Thanks,

analyst the norovirus mirror Our questions program the on submitted -- questions. questions the

questions. So go other moment that the we'll and for to skip

one in ask I have RSV pipeline. decision? is We included on that that I you can RSV. you development longer to And if your on elaborate think no answer? please Can Steve,

Steven Lo

Yes.

are reviews our what what's based opportunities continually and always decisions pipeline and various company including candidate we'll to competitive strategic there, market the So what determine factors, resources on make -- our out the and the best the are, dynamics timing.

of why in can the highly we're to as example, million therefore, BARDA certainly towards of generating now, some us science focused that on near-term. And program gives the our COVID. with priority For our the an contracts up would on COVID-XX in shift more a $XXX important advance because focused our funding potentially while is opportunities reason that being data we

Edward Berg

Steve. Thanks,

initial company back months decision March? the supported your Another you. experience has join X to in question with for in Vaxart How your past the

Steven Lo

Yes.

I in our have with comments, some we've XXXX. able first impressed frankly, of to some goals we that science. to the opportunities to here. I'm been I'm as advance half the near-term the And delighted in So And accomplish stated of be already

for mentioned, As half continue agreement now is on our continue opportunities And year. work to as as plan execute with BARDA, having the as to well FDA to the our of with norovirus. right some the we second

an exciting important but company. So it's going to be the for time

Edward Berg

you program? funding the flu. -- or Thanks. make about such that this aiming you And with to to Are to Dr. secure A avian is to progress? question Sean, for Tucker, planning all planning are progress news

Sean Tucker

will of vaccine and making of and constructs improvements including should testing on I opportunistic, influenza. working vaccine preclinically, these our the optimistic or to we to in these say, funding we're Obviously, pursuit be all Yes. avian candidates,

Edward Berg

fitting Great. One into How vision Steve. you government's and question for for pandemic do platform preparedness? next-gen last Vaxart's vaccines the see

Steven Lo

Yes.

from COVID-XX the with some fact believe to I oral approved NextGen always Project we in key think that And proceed So currently ] [ vaccines. it's this trial. differentiator evident mucosal to our be going award is awarded were that a we technology of COVID-XX the the pill

very very well this to I So forward we're, of we move trial, as going long course, to transformative the for with think as continue as be company. execute, as optimistic. it's And

are are, aligned we're in like So we goals think the what and terms we're again, very I to government feeling their proceed. with of delighted

Edward Berg

Great.

Okay, I'd turn the to over like the operator. to call back

Operator

Riley. Certainly. And additional from Mamtani it we B. comes do phone have an Mayank question, from and

Unknown Analyst

Mayank [ This is Mamtani. Ali for ]

congrats and progress. our for for taking thanks the So question,

just I reason wondering had could failure by recent norovirus And comment in more is was strains? IIb the HilleVax landscape? if norovirus And your couple yourself robust Is do there So to quick a trial. I norovirus on the vaccine of position the questions. against believe how you Phase you emerging a

Steven Lo

for And through I'll Well, again to turn do we've been that some with over question. a Great. happened what's bit. comments Sean thinking yes, thanks it what quite there. HilleVax provide to is I'll And

Sean Tucker

which that I HilleVax a do be to response serum point mean, typically mucosal critical Remember our these generating in of vaccine vaccine norovirus. their that sort again, injected that underscores candidate not strong Yes. responses. we believe for really data, an may develop Sure. the vaccines produced elicit effective response,

Our maybe infants, is more and response, allow serum which we and on this both existing comparison mucosal the and X programs, is our much right going a adults the bit between with now our renders Also healthy program believe us demonstrates in successful. less relevant. candidates the keep on to to mind focused little data be that not

IgA be address think shown much when things response have cross-reactivity, others you gives about us The these that more tell the is And or outbreaks cross-reactive. about is I happen we that potential to can that strains new of better that one shown and new an is things I and question have can we you asked having other important occur. think

Operator

Ladies this participation. Thank you conclude you. your gentlemen, does thank Excellent. and teleconference. for We today's

your time, at and this a You disconnect lines have may day. great

Vaxart (VXRT) 8 Aug 242024 Q2 Earnings call transcript