ARCT - Earnings call transcript Q3 2021 | Arcturus Therapeutics Holdings Inc.

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Operator

Greetings, and welcome to Arcturus Therapeutics Third Quarter 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require Operator assistance during the conference [Operator instruction] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Deepankar Roy Senior Director of Investor Relations. you. Thank

begin. may You

Deepankar Roy

be And CSO XXXX and Update Financial for Hughes, CFO, Medical call you Doug. and Chief Payne, Therapeutics Andy our COO, CEO, Call. to and Third all Sassine, will Today's us. Quarter Results Pad joining by good you, Joseph welcome President Chivukula, afternoon Dr. Arcturus Thank led and Thank Officer. and Steve Corporate Dr.

matters the during that would I to everyone this like are call made statements of harbor regarding Litigation not Before the we begin, Act forward-looking are that remind facts Private historical safe statements Reform XXXX. within provisions Securities of

achievements Forward-looking by with and and differ they those statements expressed risks, the disclaimer performance cause FormS statement. uncertainties, today, earlier of section assumptions well unknown not release are involve that see forward-looking known and Please actual and materially or the guarantees XX-Q the from Form SEC. implied in and Company's press may risk issued on Performance results. filed as the factors our the as statement XX-Q

of any as our call to Arcturus now over disclaims such events, information, obligation forward-looking Joe? represent reflect such the or November to date XXXX. future views statements statements I specifically any are only With circumstances. And that, update addition, X, turn statements In made, the will to Joe.

Joseph Payne

you our [Indiscernible] joining all. Third for you call thank Thank afternoon quarterly today. Good Hey, to Deepankar. Quarter

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Secondly, variance the it's updated of target widespread to currently been concern.

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elicits preclinical to vaccine titers neutralizing demonstrate demonstrating our pre greater Gamma, strong ARCT-XXX approximately -clinical ARCT-XXX, antibody that NHP data Delta XX in primates COVID XX SAAR, data disclosed we've neutralizing to ARCT-XXX immunogenicity first-generation non-human and Beta, CoV The than -X, While previously Alpha, candidate. variance. help fold

approval ARCT-XXX we Phase efficacy these to to commenced and efficient provide with This large and variant assessment cohorts operationalize X by an that In non-human Use XA month thereafter. that addition, potential that cohort COVID-XX. and August for responses collaborators, I we've trial, Phase our we the working from the But first was a data or X based October, cohorts. an administration study the of had a trials, X randomized dosed Phase onto safety VinBiotech when enrollment. are this strains It initiated we announced of with Vietnam will XB enrolling. to in quarter path approval robust placebo we to early of as of Phase also upon first announced quarter participant an to in and for EUA rapidly ARCT-XXX. the XB as study had participant the into EUA All and Phase Vietnam X Then lead phases the progressing of in first observer-blind advance study Application And have clinical been Phase Biotech. Just Emergency enrollment this ARCT-XXX Vin assess Authorization active primates. full shortly an gave begun trial to controlled funded cohorts and the now safety last XXXX X/X/X closely both in immunogenicity human Ministry participant emphasize and had The individuals Vietnam. in XXX has controls in following the Phase last Health its to Vietnam Well, and the XXXX. the early have pause efficiently Then want apply to and X just shifting against and XXX cohort observed XXX T-cell XXXX sponsored of designed

This around immunogenicity to participants. Phase And of will the our X X been data provide call regarding enrollment of in is be target the The the this participants. thousand second thousand days sub against are clinic. authorization Phase the to was team, move for enrollment X, a pleased candidate, XX,XXX size Vietnam completed. The in immunogenicity of Xc, has extraordinary this Phase a is XC trial, from filing is non-inferiority anticipated X of the -- December. in potential data potential While and is to to over half given it Phase cohort sub designed total week. non-inferiority XX ARCT-XXX I'll to XA of of XC evaluate application size emergency expect this meet going our we from the to study has has the with now Hughes, the ARCT-XXX T-cell cohorts to XX,XXX Hugh XB enrollment is this the form efficacy we an we'd Xb approximately single response. The us sub in includes the excited The And that Phase also is a Xc full CMO immunogenicity XX Phase meaningful, in The for together and XC target to basis the safety to differentiated of with approval completed or XX,XXX which single ARCT what participants administration administration This phases participants, the Xst study enter the a immunogenicity is combined safety are U-XX. cohort. ARCT-XXX of details XB enrollment to cohorts expected COVID, The mRNA ARCT-XXX that study. Phase Dr. basis from ARCT-XXX I'm X/XA of effort now previously study vaccine. our of XXXX. Phase a vaccine today's and onto week. Phase and about Phase non-inferiority with of more ARCT-XXX. to Phase sub-study report the resulted bring of over are in Officer shared The EUA discussed COVID a we participants. Medical and and And And other Steve use Chief be now amended. Phase filing the Vietnam very of ARCT-XXX form expected the X, data completed data will today AstraZeneca's XB meet later an I'm or total X/ in apart. the that have doses trial call moral, vaccine study

we this ongoing, immunogenicity have and encouraging tolerability an X have Phase discussed We from enrolled study. And previously preliminary fully study. data the ARCT-XXX

greater Specifically, for full seroconversion following to at study shows day length from of than immunogenicity the spike XX IgG XX% antibodies binding protein the a ARCT-XXX. data single-shot dose

to by and been reported, discuss entity At we're our inclusion per time, the X selected Phase ARCT-XXX agreement, vaccine by funded trial global unable sponsored has specifics. previously further for entity. it's As in COVID-XX, and this the against

time in understandably are has against so been turn we for COVID-XX. now will Steve valuable Hughes. the over global support, which very to Dr. However, group'S I this fight the grateful

Steve Hughes

Phase ARCT-XXX some with reasons would by to Thanks, the additional X mentioned the changes details Joe. begin for about study I the Joe. like design to

participants period placebo-controlled been Consequently, reduced of Ministry it of was roll-out on two vaccine you COVID no vaccinated. has In therefore placebo of Phase Health the know, XB with consultation the eligible lopsided many very a almost successful vaccine As Vietnam to fully collaborators population prolonged Vietnam with time. and biotech, ethical not for in maintain deemed in our longer the to months. period was

we based immunogenicity now included with on comparative in vaccine has though additional potential The COVID-XX inform approval to in study. sub-study made the because vaccines in our chosen because Phase the this in a this vaccine XXX. approval to AstraZeneca data Ministry of also protocol full of could population comparison X, is also authorized new obtain amendment has path Health that for this Phase immunogenicity opened Amending by white comparative are ARCT Additionally already already against comparison order Vietnam of prescribers add XC as also to immunogenicity using Ministry same the ARCT-XXX. vaccine. COVID-XX however, protocol the expedited data an valuable for are AstraZeneca the non-inferiority a there's ARCT-XXX Health X Phase using cohort, Vietnam, the available timeframe. will This potential in take advantage be And data assays Vietnamese with path for to of

the XXX from we is ARCT-XX a study in cohort enroll X-X Ornithine disease. as study ARCT-XXX primary series Authority involved following a X booster approved for now also analase the the initial the off of ARCT-XXX, [Indiscernible] study naive vaccine our rare this no treatments with the or and gained and turn to for is In and [Indiscernible]. now while therapeutic cohort Singapore Phase pleased ARCT FDA trial cause booster administered disease, This of involve together next-generation I the both root will other vaccination the continues in to addition with Trends the with Vietnam, with participants. a report Sciences address serious Health I'm vaccines, as approval deficiency. compound of fully that to candidates a OTC that to to ARCT-XXX vaccination and U.S.

study the restore studies. top [Indiscernible] to Transcarbamylase X for with attractive to We aims that candidate ARCT-XXX of had within of previously estimated expression This was therapeutic the Ornithine I a completed is dose transplantation. preventing neurological This of Phase anticipated potential per has to liver demonstrated that the healthy patients we've deficiency. administration that and the based kilogram. [Indiscernible] pharmacokinetic activity therapeutic with Our OTC upon dose dose damage associated an with milligrams [Indiscernible] the up volunteer escalation range normal enzyme need restore preclinical favorable profile ARCT-XXX, X.X our and

and study The double-blind, adults will obtained efficiency. have -XXX, enrollment companies that trial The at dose that placebo-controlled, to adolescence anticipate role under involve X initiate to clinical ARCT-XXX from Europe, very commence ascending in regulators countries currently in Research approval and -- Phase review adolescence proceed single study study to a so Health we authority The multiple additional approval by adults randomized, is sites. currently both and designed we're and II QX included OTC multiple nested in recruiting EU UK. Phase dose We upper design is ARCT XX for multiple soon. XXXX. anticipate a is multiple the we

Our study X the U.S. other patients OTC single-dose Phase remains of study, to ongoing. in the

screen open for additional of to enrollment. We centers participants additional have and that continue number a

pre a ARCT-XXX, necessary our clinical of studies of our program, made -clinical move briefly we to mRNA for have -- we progress and fibrosis we in candidate have trial cystic Moving submission the to XXXX. now to half to first And cystic for ARCT-XXX continued the application clinical enable studies. in anticipate fibrosis to the

XXXX. also continues good make advancing And in progress into vaccines vaccine pre typically clinic studies. efficacy, improved second we can Current we anticipate technologies. poor relatively flu vaccine the flu program and the of our half flu -clinical upon in believe this with that mRNA Our our to be have

to adopted the have advantage mRNA be circulating will target now on to vaccines to able the In of Andy. based addition, being pass flu our rapidly I strains. call

Andy Sassine

a some issued of go financials year financial Steve. earlier 'XX our for provide metrics to everyone. transition a on XX-Q The third clinical afternoon, more a for the and performance. multiple present strategy and programs quarter in manufacturing of authorization use Today, and operating release details summary And our will sequential will emergency press as Company, the our includes regarding today provides Thank our as statement also over reference continue of Please details I and year-over-year good financial you, fiscal pipeline. potential analysis later for we performance. the in with we stage to prepare Vietnam. some I

our provide cash insights some will and I regarding Finally, rate. position run expected

vaccine -XXX and our of we that mentioned, VinBiotech largest part and resulted who and Vietnam's arrangement was targeting the clinical our concern. next-generation million significant in expenses. ARCT-XXX over have a heard, and manufacturing very is have group, a sponsoring Vin in VinBiotech, our we of one variance trial had COVID-XX and studies, with well $XXX partnered this ARCT you the in has of partnering corporations had of As productive candidate is quarter have development significant program. funding Joe savings

strategy globe. up in group with XXX and our track partnership to continues Vin can produce by to diversification facility year. doses to on potentially in the manufacturing thereabout across next be production supported per Our partnerships million remains begin year the Vietnam, The

product, Europe, [Indiscernible] partnerships our production. for and fill now As drug and drug last in we the finish in substance, have mentioned USA the call, Asia, manufacturing

continue We I to runway. or we some doses. receive to provide the vaccines expenditures emergency vaccine plan cash use on more our color could authorization, produce hundreds capacity the expect potential to one millions that and of forecasted of want our and for have to quarterly of

OTC, to $XX Year the is two for expected and material, This time the increase million continue our Our is million long about as Fiscal to X each lead build pipeline programs and pre -launch relate quarters our nominally COVID ARCT-XXX we in flu, to supporting Cystic 'XX, of expenses potential vaccine inventory candidates first expected $XX current The increase next in including to raw quarter. EUA. and fibrosis, amount expenses $XX approximately averaged approximately remaining total G&A is stockpiling, quarters other lunar of vaccine vaccine. the recurring operating of million attributed in and R&D in fourth to

support million. Our to call cash the Based our now end will cash quarter balance of pass third pipeline, Joe. I at on back for Company's was is current $XXX the position operations years. expected to the be sufficient to X

Joseph Payne

Andy. thanks, Hey,

please your As we today open interest your progress in Thank mRNA advancing At substantial have all our vaccine Operator, continued proceed. point, -based you for heard, our now make tourist. questions. look doubt. therapeutic here our this at forward platforms. keeping We we informed to of progress can ahead go Arcturus, and line no for the to time for you and and we've

Operator

gentlemen, from and line a Please [Operator your with instructions] this the Sandler. Our be comes session. Yasmeen question-and-answer with first Ladies conducting at Piper will Rahimi question you. Thank of question. proceed time, we

Yasmeen Rahimi

patients Thank the congratulations of team. Phase you, the on accomplishment And enrolling into remarkable really X. XX,XXX

provide granted maybe for the us to be follow-up by is some on you, you a emergency first that. is --do for Joe. Vietnam So bar occurred events then Authorization? could you question in Emergency you for some have enough you around I provide the What file question think for And December that color that when to have authorization color

Joseph Payne

that the question call. Yas I'll to Sure. Steve. for on joining pass Thanks,

Steve Hughes

Yasmeen. Hi,

in authorization for for you COVID use Actually, approval require doesn't the Vietnam. question. events the thank So emergency

data immunogenicity and the of participants part the we also show safety those the approval the participants, right participants the full study. of provided X,XXX The So event with approval, XB the COVID-XX from compared part anticipating Phase the non-inferiority subsequently. be based from And for events vaccine. from have that data going also to for form upon full some with X,XXX filing The that first will and together goal. EUA AstraZeneca immunogenicity actually the to is we're in XX,XXX

Yasmeen Rahimi

question we quite from data. maybe then Thank a that immunogenicity got you, when expecting frequently should clients are team. the be we And

and the really And If milestones think thank and some be between could would provide taking I for state helpful. now you commentary emergency the of that authorization, my cadence you questions.

Joseph Payne

I With it's respect And program of timing, with Sure. we're VinBiotech. to this Vietnam working with understood data Ministry think Yes. we that Health. -- is it's partnered also closely the

is to data. because data. have them and with process disclosure the obviously will of they VinBiotech funding So trial to the And respect the first we'll access working the be sponsoring with

specific understand, use to doubt guidance consumer of you timing no didn't we data. approval will in as it included guidance But be through So give there can going data. if the we this be the as And application process. or data or it's wouldn't deem that challenging to emergency favorable

Yasmeen Rahimi

Thanks, Joe. for I'll colleagues queue jump-in in questions. the back and letting come my ask

Joseph Payne

thanks, Hey, Yas.

Operator

question of proceed next comes the Wells question. Please with Our Nick Fargo. your Abbott with from line

Nick Abbott

congratulations for to Vietnam. partners you Hello. question, Thanks my and and your taking in

heavy Some listing here. pretty

is, question had hear First the did that the vaccinated population you in whole Vietnam? say of been I

Steve Hughes

statistics that XX the in Xth eligible in The around the public ones And adolescents. had of the been million Yes. are were were November the obviously and adults as the people Vietnam vaccinated. domain

younger point vaccinated. children on is the So

going to a further So a be it's more round about. there

Nick Abbott

That's how I see it.

more? or X/X represents million XX that So

Steve Hughes

Yes.

So is that obviously all XX isn't of range million, the wide million population it's a XXX ages. adults, Vietnam but XXX about -- the million of

there that about around it's or the fully as -- that Xth. that vaccinated about currently estimating are we're so X/X November And of

Nick Abbott

have to stockpiled vaccination, vaccinated you and to time you doses be approved is vaccine expect proportion of at how rates then, for at expect your the a do Given many launch?

Steve Hughes

I'll Joe or for Pad first that deal second can with the and pass I to then part. the of part over Maybe

continue that somewhere all so population their a its vaccinate in other that entire in the ability vaccine other arriving. the aggressively that upon population, but don't they vaccine believe vaccinate to dependent to dependent companies. in have have So sitting rolling the to be of vaccines out campaign, vaccines I entities to going is Vietnam been is promised coming eligible and warehouse upon by those

vaccinate the And a vaccine I of those population. arriving so government that the Vietnamese fashion. it's That campaign of next rollout far that everybody dependent quarter the those vaccinated is having said, promises by year. the majority large at believe vaccines a timely upon targeting end sufficient to the said has of first

to be anticipating that. actually part it use emergency early seen would an achieve in year. And So next be whether we of they remains authorization the

So ahead guidance, of respect your can of you maybe speak to we stock ARCT-XXX? are that. manufacturing to And then piling with respect with to Andy, where

Andy Sassine

Yes. for obviously respect their of quantity with guidance Vietnamese in to the but are only looking give We vaccine to not that don't the But Ministry that the Health, stockpile producing. vaccine ARCT-XXX, concern. other the the also also we specific with were of discussions variance of are countries for

Nick Abbott

kind as then in follow-up in accepted, the would be Okay. Vietnam that, And the even maybe a to countries past, asked WHO. by approval if of or an you

where can on s assuming product Asia, are are of those what in us supporting this for the in who other countries? would facility there discussion be mechanics Vietnam, and how you would update in countries, So you other that sell in that's example, that

Joseph Payne

recently. with from question. of is And how strong brought Officer. he's and world. business expansion. key establishing great internationally on Merck the our -- expand Chief strategic Clearly part a leads He our the of question. we're relationships lot experience Asia there Vietnam with and Singapore, vaccine we a at and A Nirdosh Regulatory Southeast It's We've

appreciation area still in hard effort. the It's time it Asia. of an and there guide opportunity pandemic. And is that so he's that But helping with respect And in part to the Southeast on unusual is the clearly be to of Health Vietnamese to there this, And for we draw will clearly in there. for some but will Ministry Southeast of ARCT-XXX Asia. from with go respect precedents level a

Nick Abbott

a their plan and that's a that a that patients which trial, And obviously booster on but I from for maybe think gentlemen. is, and boost one study you've going, are XX Thanks, dose. prime clinicaltrials.gov is small -- you just me got booster this the study last has

So to Vietnam? more formerly the the to study in planning wanted UN booster Vinbiocare -- booster in [Indiscernible] a

Joseph Payne

an matching already is accepted a vaccines, ministries a we RNA to and Singapore globally received opportunity ongoing so active U.S.. have over multiple Well and mix the never is types help that significant longest that This from of have clearly something those of transition vaccine, an the health in and RNA boosting, messenger header it opportunity. different messenger to transition This presents now readily is booster being trial them side.

significant So reflect that a does opportunity.

more speaking our about at and with regularly respect to as collect using are data vaccines to looking this boosters opportunities [Indiscernible]. We

Nick Abbott

Thanks, great. Okay, Joe.

Operator

Cantor the of Our next Fitzgerald. Chang Brian question line with your proceed Please question. with comes from

Brian Chang

for Thanks guys. Hi, taking my question.

is that think And of you and a From Pfizer green seems receptive is there research, and have you give third a our it you pretty They region, AstraZeneca the do with pointed and follow-up. population vaccines have of light that the seems I Vietnamese Thanks. vaccines. with receptive so it mixing as mixing quite how So fully mixed to will vaccines. Moderna X the allowed they they're other be shortage bit government Pfizer a still more vaccinated government, the now in vaccines. in allow of the that different out

Joseph Payne

FDA upon assumed acceptance matching. is that I mixing think at the this based point approving Yeah, and

that specific appreciate the portion building no on you vaccines Biotech We state-of-the-art And as large point, doubt. be a the facility that manufactured or discussions substantially them is facility but this next with year. haven't can of intended Vin group those Vin had at a will -- boosters,

Brian Chang

group Vin up place Okay. gearing COVID the up Thanks. facilitated And they Remdesivir, distribution anticipate in for some in Can front, on your color Vietnam that have is us it year. some give also seems distribution already Remdesivir on for have to then the launch? Vin significantly do you they vaccine since to ramp you to And for earlier this the launch? seems group how them

Joseph Payne

want launch. expertise to VinBiotech. COVID met call most a have strengthening the Vin him on exclusively of they personally. an them is I with the with They're space. CEO and you're that remind of the just endorsed Well, our are position limited for our right, where relations. President to facilitate their VinBiotech I the our That's to warmly group group in well-known going Vietnam. area introduced warmly relationship successful folks be the a extremely and have and when very by I the the and endorsement to into ability conversation they

have no good to launch no about with we a have in So partners respect Vietnam, Vietnam, we commercial doubt, concerns

Brian Chang

thanks. Great

Operator

from Our Fernandez next question Guggenheim. the of with line Seamus comes Please proceed question. with your

Seamus Fernandez

question, few the have guys. for Thanks I a here.

First patients get seen to off, a just problem, can basically received significant in at problem, this what -- We've study. will or operate a placebo I pathway vaccine. this of better clinical crossover for can a a head-to-head placebo-controlled who some us study programs your be be understand help you quite an to if of the trying can feasibility point. is, providing trying bit just other the of am get efficacy approval. better And study additional the to understanding.

clarify want the the just So efficacy study achieve event-based can immunogenicity actually that's I my completion. first question. an than to rather study, if itself,

Joseph Payne

Steve, goal, shots two comment that's the have definitely we intent. Well, on. you can but on maybe

Steve Hughes

Yes. Vietnam, now Vietnam was the the moment at climbing study again. up -- are Seamus. you for I eased may parts noticed rate down have going event that of question, in is Thanks And in in play restrictions that first they've The still. the the back

enough numbers time a got Moderna to within remember year. last large and open that get both And time this So events of you short very door study is very the period events. still Pfizer of I the think

consortium upon suit to the United the and with non-inferiority how Singapore, recently comparison possible they following it's remains comparison. vaccine. document possibly still it an achieve would Australia, immunogenicity Kingdom, the so what So us the some to based And driven I get of announcement think think for be. to about immunogenicity have event-based enough registration, licensed more published comparison kind guidance with been that non-inferiority But for Canada, to I recently, what by issued an about events they've from of Vietnam etc., happened around registration already registration guidance and pathway to that their are route

of this Vietnam ready with provided taken AstraZeneca Non-Inferiority So study basically was Ministry by on COVID-XX open rapidly the the to And study for be to and one that advantage advantage the taken the we've of Immune up go most cooperation Health vaccine. of and we've and Health. Ministry enthusiasm was that compared quickly the of that the could vaccine study

So are of full conducting. And perhaps Xa be now groups Vietnamese registration. have And vaccines. Even to in receive who and is rate authorization, one to to terms who's has of the eventuality the have or -- of And understanding the X that immunogenicity trial a X, their the areas and working Phase routes tight emergency we over of X to the cohorts registration add Vietnam. data. the going with approved on we in received to we last respect full the our we're target endpoints before last efficacy which the I'll hasn't. comment that citizens in active really with entirely doesn't vaccine Vietnam still that use in have placebos to non-inferiority event vaccine, get based to cross to neither those affects

Biotech so leveraged well And been by us as this information achieve has to help that. Vin

Seamus Fernandez

Great

Joseph Payne

in numbers placebo adjudicated the There's group.

Seamus Fernandez

superiority? And with and choose Delta what -- Wuhan, of pursue regard margins just you've didn't why immunogenicity exactly to data, just you the what us understand is superiority you one head-to-head non-inferiority seen are some to the us studies. X the is and is you Delta other can help help for Maybe when understand can the data,

Steve Hughes

other They point authorization consistent resulted margins can't in FDA. we that comment with in in of time. So non-inferiority have been too used are at with much on the non-inferiority this that details use have the margins emergency studies

has neutralizing binding concern. expect, the are to are and going antibodies there, you of margins antibodies, to demonstrated based similar be ability also upon variance and as both So and the very neutralize would evaluations

Seamus Fernandez

Basically, broad immunogenicity to clarify assay comparisons. I just want that.

Steve Hughes

Yes.

So the to the the pub. of already guidance Vietnamese is very issued similar that's in Health Ministry by what's been

not of domain. yet. public and is comment VinBiotech tell, That Canada, the by for as speaking, been I Ministry to Health pathway health Vietnamese can't So Health can much of and But it's it a to the by that's studies because partners our the Immune I the the guidance, Non-Inferiority it the broadly us, on was disclosed U.K., guidance regulators, communication far Australian regulator and to why the personal is the of which about in Singapore, been to Ministry is already very from as consortium the currently registration. too similar including issued

Seamus Fernandez

Okay.

any Now Do end Aware of going to that's XXXX helpful. of data is patients in the you And initial to or available and the disclosure is that And point, EUA. data. at once have in immunogenicity that follows the likely understanding of we'll you a team the terms after of is response closer what we become how first receive from immune have that of and the of data, immunogenicity any to to know hand that fuller curious work. then EUA, the then we'll and December. And that's

Joseph Payne

for use that we've that. have on this Anything and implied Yeah, are, likely. will application, call indicated given the That's that we be included timeline we in or approval it add emergency yet, Steve and or? data don't we've to the where

Steve Hughes

participants the startup or they least XX their also so immunogenicity second and for safety XX sufficient happen, dose. from the on cohort at study, participant data XXXX the cohort and patient day after in can have days Nothing that that's follow-up

point. in processed being time after between us XX and So date and licensency database then the blood locking that lab those and there's cleaning the samples drawn a

is us So what we've the of that pushes into timeframe, kind which December gotten.

previously about application. we the So EUA timing for given

Seamus Fernandez

queue. helpful. perfect. I'll the Okay, Super jump Thanks. in

Operator

of next with Yigal question line the with your proceed question. Our Nochomovitz please comes Citigroup, from

Ashik Mubarak

and questions. you for Mubarak, on rates I would on earlier miss some Xc full file than in This you thinking if events about my guess based timeline in then Thanks. my maybe building And in Vietnam. earlier the you the still EUA potentially second for just of Jin. approval? maybe given the taking questions. mentioned is be, on There's vaccination had laid thanks non-inferiority, you X, are pediatric adults the adolescents how out question Hi, Phase Ashik the I

Joseph Payne

that yes, so infections or guiding difficult on additional the types infections to accelerate but impossible the placebo stay group, adjudicated yes. Well, things those if wave it's of that, to from Technically, then there's But yes. of possible. predict it's away we wave based an in unexpected

Steve Hughes

we and And how hard from at-risk relation boosting the into groups that current children, obviously study and we're then also include would topper boosting with well. focusing on to other as heterologous the move the

what it And age and X we adolescents, timing spend populations didn't to young down study appropriate from stepped they to the you to as the from it so the available know XX range. they adolescence about down having partners groups, discussions then X would the would for be, the how we're kids, the and go vaccines to pediatric to straight into pediatric X then range the our and currently go with for

that's this for well-trodden very So of that's obviously the work, a we're kind path and part at looking carefully. that

immuno an and been The based as largely bridging other us pediatric thing studies based just been that well. that anticipate [Indiscernible] haven't the pediatric would would is and they've they on be adult population the for to to in populations, upon approval the right? I pediatric note pediatric event, So between the for

Ashik Mubarak

you much. Thank then. Okay very

Joseph Payne

you. Thank

Operator

Our & next with question Jen, from with Yale Laidlaw proceed comes question. of please the your line Company,

Yale Jen

first investors rapid done what again, to is progressions. given approval and in risk on since--there My Good from on revenue about your potential are congrats form the the And the or likely data and that, share to be received the success phone revenue the afternoon. a might start being question should effort? think

Joseph Payne

throw want to challenge. one a guidance Andy. I revenue is always Anything Revenue on our guidance vaccine? that to in CFO,

Andy Sassine

with respect with share you cash runway the of a of Unfortunately, to perspective do revenue. operating guidance cash share call. have. do some the to trend expenses We We quarters how earlier many did respect give to did in we provide not

So I companies. Hope you forecast helpful. difficult hope But that is appreciate it is the biotech that. the could revenue for to

Joseph Payne

support manufacturing important it's do to in that stress we of place And the numbers footprint have to vaccines. decent

Yale Jen

you or Okay, in and year? Many What with have the a trials? next the approval have And maybe in That's great. then you term question helpful. Singapore in booster should more next the that that in about here maybe possibly U.S. the think potential thanks. Singapore step of related be we U.S. would study. And one facilitating to

Steve Hughes

in to vaccines -- comparatively in the have registration setting in a data study enable the actually space. registration, work be we we trial time study studies that's the at that of very us give II be that Singapore, are at are participants that clinical have the I in the set forward, trials to to also definitely being will how then participants clinical another current think allow That a farming Singapore boosting boosters three -XXX our that the point So don't the XXX, in with fair vaccination ongoing, to same since the and U.S. or the an XX the it sufficient idea series. ongoing focus. that ARCT all booster either good that in us basis XXX. of actually have will at be It for but clinical gives the we start also XXX, of starting has conducted dose. we Phase design X-month And some the been and itself that's trial and and year. behave the additional assumptions making form this study us and to XXX beginning And sufficient U.S. to XXX would subsequent XXX,

where looking studies insufficient. at two got we So booster we're getting

Yale Jen

XX squeeze that one plan question them for just Maybe is mentioned when there you provides study? more a that patients for study, readout

Steve Hughes

study a Day data we the for recruited QX the timeframe next so immunogenicity of cohort anticipate that's fully having in as receiving So year. participants through the the would the booster in is cohort and vaccines XX that

vaccines, the ongoing. recruitment is Again, cohorts priming study the the vaccination still with same of is in half but other series. The those

guidance can't about those have And give so this when data we at for would I cohorts. point

Yale Jen

Thanks appreciate great. really Okay, [Indiscernible] it.

Operator

the Brookline question Capital question. of with next Our your from Raja proceed Kumar comes line Markets. Please with

Kumar Raja

why was also program, steps And with was? that? to the on XXX my with this we that? the to And ARCT selected that you clarity conducted get the could can can do think this hits taking next data versus share you collaboration? the Thanks. for you prior, And milestone more globally can in ones? Thanks be what entity, XXX what pri with other to regard are When questions. share by And what regard regard

Joseph Payne

progress to respect this just unable unable great to onto can per great additional ARCT-XXX continue Jay, that with positive program with we're our we've validation a study, ongoing was, up with the and systemically to second RNA. HBV question them. but but disclosed to Chang a we intravenously a an And with and that as our discuss of just relationship Yeah, program question, the It's comment them. we agreement, we -- question, we part And with your administered with especially of It's dosed we're the Yeah, further. platform, specifics. that announced program? received successfully it's further point, respect everything to have and a fair we we milestone messenger view

Kumar Raja

the Okay, what's thanks. and regard cystic updates? And with when maybe get happening can we program to -- there

Joseph Payne

provide some email. separately at Well CF models promising the fibrosis. there data been an have CF But showed and the -- that well-established we cystic program to ferret we -- of a can maybe is national and conference, models there some additional has been in data it presented and

studies, in pre that mature for through parallel, pre package toxicology to we're to matures while or the IND -clinical that continues studies studies preparing the and enabling the go data -IND program. all it So enabling

Kumar Raja

is finally, the with the latest regard approved maybe And what to program thanks?

Joseph Payne

-- that respect that you say? IND of indicated would in year. next year. second be next filed the or is to did The on latest program, on that's track Yeah, for flu CTA We the half with still

Kumar Raja

Great, thanks.

Joseph Payne

you, Thank Kumar. Yes.

Operator

Our next Sandler. with Piper proceed from line Rahimi of comes the Please question your question. Yasmeen with

Yasmeen Rahimi

health for first question. you on as yet. Joe patients -- much the Vietnam study. you or question. for not seen X on a data Phase the to seen But And into just and those Seamus' Phase immunogenicity Thank you Steve, taking on really X data, some you any have the my has preliminary have expedite comment shared you they X,XXX follow-up to their on so and has to been from follow-up ministry commented thank can whether basis XX,XXX my decisions taking question into Phase made whether the X data safety from a

Joseph Payne

time in over the and turn the after month draws the mid-August second timeline mid blood reiterate to and we but that taken. X, Steve, shot the then which mid-October, is can a means September where the initiated I Phase was

Steve, the was can and the mid of you to is October. referring drawn what extent understand Maybe immunogenicity to data comment. in With you're they to So the it respect blood which timing to data.

Steve Hughes

Yes.

the to prior And the data. those the phase of to from early next. that X is see wouldn't until going the we readout The moving any timing data, Health really allowed immunogenicity back. samples The as to Ministry X,XXX which isn't study participants far As of the lab isn't seen them immunogenicity data know, relevant from immunogenicity have to end hasn't back the or going point, time those to Day XX, be be December. of from November assessing

dose progressively the in next rapidly safe larger from just it's whether has so to phase on of one focused assessment their terms to numbers of all study individuals. far been the moving So of

Yasmeen Rahimi

Thank the you clarity. so much for

Operator

for for to we remarks. back to hand management time like have the all call questions. I'd the closing is That

Joseph Payne

to update questions, out progress. your afternoon Great. talk for reach our quarter you with third about Thank you, concludes this Please to us Doug. joining and right This thank us our all unable are Bye further the of to you look you you we now. updating evening. today, a if to year forward balance for great the and have you accommodate throughout hope

Operator

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

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

Arcturus Therapeutics (ARCT) 9 Nov 212021 Q3 Earnings call transcript