ARCT - Earnings call transcript Q3 2020 | Arcturus Therapeutics Holdings Inc.

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Operator

Greetings, and welcome to the Arcturus Therapeutics’ Third Quarter 2020 Earnings Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Safarzadeh, Head of Investor Relations, Public Relations and Marketing. begin. may you you, Thank

Neda Safarzadeh

Thank you afternoon and good everyone. operator

Development Joseph and Chivukula, CEO; are our and joined Sassine, President by today Chief Hughes, Steve Pad We Andy Payne, CFO; and Dr. Officer. COO; CSO Dr.

date cash Before Litigation we remind except any and made statements that development regarding for candidates constitute results forward-looking responses could supply and statements including like to risks results, or including, the company’s the the by subsequent of they Factors” obligation otherwise. Arcturus’ filed current other the historical of performance. clinical from with the a supply Form materially by the for and required vaccine year trials, including as of likelihood were programs, management’s purposes future Act this Safe fiscal statements XX, candidate expectations unexpected agreement financial speak on management of company’s an risks the the Company’s agreements, Any provided current status Except such COVID-XX future initiation, “Risk December statements, everyone limitation, XX-K we without inability result forward-looking Securities conference factors update uncertainties, facts, call only of in achievements of and in clinical submission on that March on and historical potential completion the disclaims of performance this general revise statements in by or information, made, a for the under and design Actual uncertainties of of I the or XX, the discussed and communication, forward-looking may those future or as statements Such Coronavirus or Harbor, to product XXXX begin, which on other otherwise to and that Private results many Report law, any clinical based involve Reform SEC. and would with included are the those and prevent circumstances, Annual candidates, to to those and operations, the questions differ on planned projected intention position, any XXXX. the and involve other heading of filings of new XXXX statements in substantial as SEC any whether manufacturing than success to market statements and the result develop market or as conditions facts forward-looking statements. or events ended company’s are and

Now Joe, it to and Joe the CEO. is Please President go pass my Payne, to call ahead. pleasure

Joseph Payne

working of to Arcturus Hey. significant and Israel part our therapeutics vaccine together joining of Good the them, scientists Pfizer like all, is and their afternoon their begin, announced to milestone Thank you, congratulate quarterly back, thank Neda. for I’d for for We call this today. believe exceptional right the this today. accomplishment. BioNTech and especially earlier To you to since team Singapore in and protect to in partners very of this just of messenger therapeutics from and is supporting all RNA global messenger COVID-XX. Thanks Arcturus vaccinate RNA be we’re fortunate validation us. in to community, this us effort and each to Congratulations

you cystic stage and begin CF encouraging mRNA remind from results Singapore. To today report COVID-XX. STARR with to or LUNAR-COVXX, we're the are Today, as to performed fibrosis. are evaluate Duke-NUS immune which strong pleased activities our for has program being progress, which excited and our pipelines or and advancing the tolerability regimens development. with clinical School, transcribing ARCT-XXX from progress developed clinical time I'll is these two response, replicating very and made study or made both RNA, of announce We're and being development the to or to first deficiency. initial we've And of earlier candidate ornithine Phase in and The collaboration therapeutic the vaccine to most evaluated programs. in clinical humoral our by known highlighted results our in this deficiency safety ARCT-XXX transcarbamylase and recent objectives clinical also self is X/X our to our on-going ARCT-XXX, including Medical for pipeline determine OTC also be and further ARCT-XXX, is candidate, dose clinical COVID-XX preliminary administration cellular Arcturus While advanced study. substantial programs,

a suggest detail our that that using Development doses low proprietary our with administration. results, further may technology X/X self-replicating our they protective in mRNA a Phase single to Steve encouraging Chief mRNA provide which this approach at Officer, immunity mRNA STARR minutes, Our produce based vaccine potentially only and few to will support investigational

We Geometric data, interim out advance of plan prime regimens. younger Now single clinical we to in five observed X.X adult not Mean saw binding antibodies XXXX. of based seroconversion seroconverted. adults. participants Titers of with in all exceeded XXX% yet on our IgG cohorts boost a older micrograms, along One The of low dose has these

which models. antibodies This to time that encouraging. is continue time or progress over at ARCT-XXX The messenger similar The X.X we're possible. seeing that's levels. been data XX,XXX for RNA, We fight observed reasons selected, course and will evolving. at or the adults, different GMT completion. low still exceeded older such activities adults manufacturing animal in extended ARCT-XXX So be our vaccine. dose level is for one why of focusing In We important preclinical GMT as activities, similar an The we activity made IgG that clinical humans. are addition dose from in in mean that look mRNA dose. collected is quickly clinical what with the global is for stage in with advancing a be our geometric this specific of tighter study COVID-XX. dose conventional microgram parallel younger we've believe as We our against all of to the could STARR increase consider in the development was and later at to this data We that forward on also the that XXXX in remind time we've manner into studies binding the group exceeded published technology

Ministry to on in the the to With efforts, resofarm with support minutes. a other signed track to countries manufacturing partners, a our of this supply and constructive economic ARCT-XXX. Catalent and to discussions of COVID-XX We manufacture part on vaccination numbers In stockpiling an Arcturus Andy to development few earlier a and to [ph] with consider remains is supply today, of of second Arcturus Arcturus that pertaining and be important supply details more we we manufacturing substantial announced is and have continue the agreements. agreement country's August, with to sheet Israel of country term vaccine. Israeli And reserve providing addition board going Singapore strategy. support Health the additional Singapore to in doses. core binding the also

Now to shifting focus deficiency. ARCT-XXX for OTC

the lunar milligrams cohorts, the study. to X escalation three Phase We point continue our top great enrolment steroids OTC And even we've study two, subject now was per make to of here of top OTC Phase patients. We've in point States screening. not is report our dose all completed including deficient program. Xb X, United cohort. pre-treatment We're four point that a point the of in initiated and dose necessary, for pleased in kilogram progress commenced first dose our with And

the pass I a in program, provide quarter Phase as now there the call Phase And ARCT-XXX results for Arcturus. new one to pertaining transcarbamylase study Steve? from So to our ornithine to review as X and detail data X/X report lot ARCT-XXX to Steve there's well deficiency more

Steve Hughes

report enrolled I'm study with participants. Phase ARCT-XXX is adult the that pleased XXX including fully to cohorts X/X of Joe. Thanks, subjects older now

dose the older X.X three and in are micro in in single like both Before two ARCT-XXX the younger adults. go both a detail. we study older this have micrograms single cohorts discussing micrograms to and in boost or XX randomized subjects and and evaluating also placebo The XXX.X ARCT-XXX study, is of single design received measurements priming adults, of at five double-blind time dose fashion. data, cohort either dose a the adults. in injection In The micrograms some and over I'd measurements. younger testing study They

greater adults are have years are XX subjects older one Younger the injection age. subjects in placebo. received date, To XX and than range subjects of adults XX to of XX XX injections, have XX at and received years least received two ARCT-XXX, of have

cohort. includes analysis including older the interim from adult dose cohorts, preliminary Our single all results

up safety to two microgram after at at cohorts, XX received data For subjects younger vaccination, for dose. the least the are at currently day available point. immunogenicity cohort only now dose up vaccine, five have XX least the one results time and dose These all include adult the of days although to

data for robust day at time the spike anticipated. at later Although up points cohorts, results, Based data dose this not to all the have subjects anti in data and goes on is the point neutralizing and protein XXX% seroconverted subject and not the only younger than cohorts, XX the only antibody further time, study at single that a in immunogenicity for with IgG, doses one the has GMT antibodies adult XXXX Titers all immune seroconversion IgG in response greater cohort. older yet was adult cohorts. three the observed are all in evaluated

cohort forward and greater the dose, into X laboratory. greater of the patients adults, the dose studies. the XX,XXX in for and antibodies assay At in micrograms selected X dose adults. younger COVID-XX GMT the in microgram to X.X have the X was than neutralizing single further same mean than the XX,XXX. within We two observed In in XXXX the older greater PRNT regimens take tested titers The than plasma the convalescent single X.X microgram titer was geometric micrograms dose XX GMT and range was

as therefore evolving. weeks labs However, assay the evaluated complete subjects BSLX the a later points performed is all as takes results few processed. be this to And a for cohorts study, get to on-going have in is not still it this at has and the a time data in an samples

to only antibody XX up data the single and continue that the after example, rise cohorts For day to titers g indicate XX dose IgG neutralizing day day XX. the results through have

So important. so later these points time

performed Phase over yet be neutralization will micro from that the have be study. the we This results not few antibody Additionally, neutralizing our test the do weeks. using next will for X we

more in share therefore will titers data these data the the neutralizing as on coming We weeks mature. antibody

adverse there been the have to T plan cell later of pools Cytokine and to CDX no responses fever peptide injection adverse systemic at the No severe response the have event was favorable and ARCT-XXX ELISpot ThX side and judged includes events event spike T profile. adverse event be related. well and deemed tolerated and that mild, has withdrawn bite, of receptor to have staining tests doses local majority was The drug. to insect dominant stage reactions no multiple Cellulitis life study, now showed and responses. forward protein. there spanning clinical unrelated to full SARS-CoV-X from There have the to Turning been cell the This or from CDX the to an and been was take seen one study been treatment pools the adverse serious a observed. are subjects we by generally to serious be investigator response The binding events to was domain. that trials. peptide of had

as trials. from we collect pivotal regulatory to and discuss continue We with analyze the we authorities weeks data study, intend data to the in move towards this coming and

with prevent Moving deficiency ornithine of for need deliver with in limited OTC to these lipid-mediated patients is restore deficiency, the and normal now transplantation treatment the Arcturus' in serious activity our disease a ARCT-XXX ARCT-XXX liver messenger LUNAR to potentially transcarbamylase patients. to damage expected program. transcarbamylase delivery liver. to utilizes urea options. Expression OTC liver and enzyme RNA developed is cycle being of ornithine for the platform ARCT-XXX neurological

X.X placebos, have no in endpoints to dosing XX total all the well was primary and all hours and adverse as severe designed favorable page. that detectable kilogram. and have escalation for were the safe In We placebo Subjects tested completed and the well X.X beyond were Phase doses ARCT-XXX to ARCT-XXX safety anticipated And completed kilogram in evaluate poor preliminary as The subjects secondary as dose study in demonstrated were too our is study, with has recently active lipid on was study, early and this study between events per and plasma milligrams milligram following SAEs. All events. there ARCT-XXX subjects per healthy and visits. included controlled a pharmacokinetics also mild data No pharmacokinetic a randomized doses cohorts X ARCT-XXX were generally double-blind tolerated. profile. to and all no volunteers. has and drug our X, shown were therapeutic tolerability trial were severity Most X study adverse study there respectively. The administration.

of Finally, OTC the United the the commenced in deficient conducted is Andy. in pass first IND screening. Phase call X/X patients, has being enrollment in and ARCT-XXX study onto the now States is which patient I’ll under currently

Andy Sassine

Steve, includes press financial issued and everyone. briefly quarter year The which today good afternoon you, the of summarize. Thank statements release for I fiscal earlier third XXXX, will

currently Our payments partner. with current [ph], pharmaceutical and research revenue primary our collaborative from licensees and biotech received is development and source of from arrangements

in loan The revenue in grant in compared with $XX.X Research $X.X and XXXX and associated For with with current in of expenses LUNAR in ARCT-XXX by million, the XXXX. in million LUNAR-COVXX $X.X million the the were Development manufacturing today, the through awarded QX services quarter the sequentially on of the increased $XX in will The relates and contingent with operating of vaccine. funds purchase of the documentation. million Arcturus revenues of and two $X.X XX board to $X The the from XXX $X.X LUNAR-flu expenses each increased Fibrosis commitment. vaccine approximately third and agreement offset, for financial manufacturing of up program, million our clinical an the delivery to manufacturer quarter Total our terms proceeds the Singapore or related Cystic by to X XXXX. earned increase $XX of million a decrease the was to approximate in driven and OTC will used primarily will materials ARCT-XXX collaboration partially third decline third provide an million LUNAR-cardiovascular. expenses. Singapore quarter, OTC succeed CureVac obtain certain announced due days XX the sales. June Foundation. expenses, company costs in and loan under reimbursements vaccine forgiven. for loan will pipeline remaining million of important economic the our development be ended mostly funds recourse of million be million by quarter personnel approval additional a Under EDB commercial $XX.X supply compared within of The with program, the primarily for the of does equipment, on that ARCT-XXX XXXX. Earlier The ARCT-XXX development same driven royalties operating quarter and period of new from Yes, be were agreement, repaid regulatory not collaboration future expenses the million limited the reported

as to These as in our have at efforts million doses scale next of have manufacturing XXXX. in to Arcturus foundation prices, for potential company additional vaccine millions -- Singapore global supply an to agreement XX our to global laid Along produce impact COVID-XX we partners, opportunity has the manufacturing positively supply ARCT-XXX support the continue XXXX. right our with support shipments to of ARCT-XXX pandemic. agreement, and and ARC existing up EDB Additionally, ARCT-XXX into we resources believe of entered to $XXX Israeli other the hundreds well of purchase to to the over and with first pre quarter up the the a negotiated of months deals company funds expected with rapidly provide the

XXXX. The successfully December investments QX and cash and raising million primarily to due at Our proceeds to $XXX position public cash our pass Based two approximately the equivalent XX cash balance $XX.X pipeline, expected current sufficient the equivalents cash more in now equity is Joe. $XXX.X and of to cash company's cash offerings I'll is to on end in operations the in totaled for be support years. as million to of of back increase XXXX. than million through net two compared call

Joseph Payne

progress for of period clinical certainly strong Andy. a been It's development Thanks, Arcturus.

ahead, period clinical Looking of an eventful anticipate updates. further progress we

the In that weeks, ARCT-XXX response. role regulatory the vaccine development. to with data the important obtain program with the top as clinical study encouraged coming in With we've COVID-XX patients. the play for program Phase We is plans highly ARCT-XXX clinical anticipate has authorities, we also further priority. possible two forward together Advancing to X/X enormous we obtained. And an respect our ARCT-XXX additional as this obtaining OTC global initial data. finalize quickly our We’re potential we corporate and program will believe to anticipate results

programs, a stage steady you the on promising year. point, next forward development earlier clinical providing proceed. look and can we At with our in the to this powerful in ahead open Operator, we those stage platform medicines making progress addition of questions. to mRNA develop programs. applying to we're number please In line updates for And our go

Operator

the Instructions] question question. proceed Our Fernandez Please [Operator of with you. comes Thank Seamus line first from Guggenheim. with your

Seamus Fernandez

for question. Great, the thanks

little So the guys get few to specific the you provided more that here thanks and specifics just additional for call. trying on bit a

provided. the sense of the of give you Just or get can a up made against with know, the also, you that plasma where convalescent the saw of plasma levels, the convalescent trying plasma and in up you neutralizing types antibodies patients data convalescent these sense different that convalescent hospitalized plasma, just us how comparison terms patients IgG metrics just a to how these the and better predominantly that titers the of you've

of provide the the of know on Thank older you. that'd relative titers population to finally, give question young convalescent convalescent that the adults, The you in titers? as if IgG as serum adult a adult antibody well second information, great? for could again, you same you terms us that just us neutralizing be just can then And population, the the of sense young exceeded the the is serum, patient percentage

Joseph Payne

ahead. go Steve, Sure,

Steve Hughes

for some I the of you of Thank point can question time. this but the not that parts all question. at Okay. parts the address in

we geometric it up graph a from most this don't the felt ranged hundreds neutralizing point, several was mean need titer at that that It XXX. for neutralizing those from into XX comparison. around of convalescent have We the the those. So have. we We for Those antibodies for binding IgG the were XX had to that to plasma got, that antibodies we post for convalescent plasma. important antibodies

subjects. the younger plasma, both and convalescent Within includes it older

from age weeks couple age. time So XX after of subjects several weeks to of from years range of of to XX there's collection illness. in onset range a a And the

We and that moderate you both have the subjects, last the the that convalescent plasma part subjects majority had? of mild, in includes category mind the just have disease, severe as characterisation. actually question with of the repeating mild-to-moderate you Would

Seamus Fernandez

it's the convalescent exceeded exceeded adults levels. at or if older or least Sera, Yes, met young and of percentage possible the share the to adults that

it think wasn't, your I But regard. commentary was wasn't in this morning it in press if release specific. there some that

Steve Hughes

So data maturing. at that this point, we is still the have

cut interim is and an regulatory it's So submission. study. this an analysis ongoing primarily -- our to of inform The

other essay, data Not some to can in other be way a because study. tests get BSLX the antibody to in lab. purpose we're our it so queue people just those has this to subjects and performed with time actually neutralizing processed it all by the takes for -- in a with next tests a is cut we the study doing from this advance time rapidly later analysis So for that have points completed

weeks. actually sample the test from takes to several taking So process the get

full consider technology, we though later to important quite rise don't thing on the points have the what to our are is because the reason, actually antibody titers. antibody see neutralizing And time that yet for that for time. over continuing data So is we titers other

the position be At not we the to this titers. we're weeks. that should So point, coming a in further on antibody sharing over color provide information neutralizing really

Seamus Fernandez

delivered question, in If I Pfizer separate a can obviously, BioNTech certainly impressive ask an the result. data came

that predict agency. I type might achievable a I is You context, likely single if dose investors what guys you us the to looks threshold the from sense part in because, single the the vaccinations, with dose dose hoping that what the, doesn't was general you of what give just threshold think of you might efficacy, like? bit the there to a in sort know, exactly what, data, little I the think bar be have is their what a be what of of is a vaccination concern data from going the know, what it single think same

the your the BioNTech to you does when should can support you moving with a the Pfizer data, that XX% XX% vaccination upward shift will if confidence that? bar XX% to it and meet from dose that to could that a that and, single meet threshold that What's So were data the see XX%? bar, we to

Steve Hughes

and comment one add the wants you to if to have if team do free I Well so. feel

a likelihood I that agency to proceed is collected that think of rephrase therapeutic, the in that's fair in data given that's far? think this us I think I to the say, your of question to there. we've And what's so advance regulatory And allowing high. reasonably

And I so I'd it. to, we're going high evaluate and that this think to And likelihood able of this mature advancing be the And the high. is refer will to to. succeeding to metric like to in I that us very continue technology think to be

Joseph Payne

over protection consider most add universally, considerably not with there there's disease of and with that lower around we're part disease. Yes, of reinfection actually important in to like subjects reinfection also have subjects have handful established. only of and to the point that isn't antibody world. a this been that severe color at again, seeing COVID with I for over with over falling But time, a titers mild It's COVID just the that, recovered disease cases subjects mild

required aren't protection. clear think of antibody I So high is sky that neutralizing levels for titers what is

other whether call titers of to this nobody cells knows for And I cells. is mind as important than protection than disease T in a bear T disease. antibody more The point important are

of authorities speculate promising moving week, looks and into moving single protection a regulatory data talked dose they I what's so and going with in forwards to looks single from forward, the see we're this experts most that detail development. to premature in clinical confident we've our data the the our with in stages think And to exciting conversations important it's regimen And next are the about discuss dose. to more terms be that a characteristic of vaccine, as to with

our we'll advancing So further and that single be in we confident about very excited doses clinical remain program, confident and development. very

Seamus Fernandez

Okay, in queue. great. I'll jump back the guys. Thank you

Joseph Payne

you. Thank

Operator

Thank you.

next Our of line of with from Please coming your is question Madhu the Baird. Kumar proceed question.

Madhu Kumar

everyone, for questions. thanks Hey, taking our

our ARCT-XXX kind So as well. one of relates to first

is ARCT-XXX kind decision Or data up So the this set afternoon that the X/X put additional morning the that of you their decision both for announced phase data there the Singapore economic to arrangement making? basis really this guys trials is and development board had influenced today? their out you

Joseph Payne

to I extent Medical very that of the we get, and are U.S. study the that's development is, and well the outside information this and activities. managing where is continues think what and short the the that. School develop. feedback yes. data. we They comment But and, is of Yes, as Singapore And, energy The overseeing Duke of U.S. aware it positive and that get running can't I many to answer Duke our of lot on a share to and

Madhu Kumar

or how are as there start pivotal studies with all overnight aware, does trial that you're is timing as you could for you on doing things? for that year consistent is your perspective ARCT-XXX? also early as adjustment a like a came the and end, Phase seem article news Okay, X out by with for

Joseph Payne

Both regulator continuing already having with the program. with a regulators had to shortly, the discuss at And with X and Singapore FDA moment We'll be discussions conversation in have package. also with part program. week. the be FDA the with we'll design we're a Singapore X for a HS regulators. We're of very phase as discussions pre-IND So re-engaging those of Phase a with our this discussions we've our included overall discussion

I until the comes think we those So comment on further or we've timing. any discussions, don't next concluded can make really actually what

Madhu Kumar

OTC and last XXX Okay, one on one deficiency.

terms PK much no Feel the so sweet in dose of want there's there, that the get hit a in with you far? kind seem think exposure spot escalate concerns. even you to of reason far do dose of Given of how higher obvious or expand to seen conditions you've you so you safety relatively to if further so there to seen the those mild kind seen the Is given potential the far? to you've look not OTC kind can like have

Joseph Payne

that completed the a study. has that study healthy So is volunteer

So we've really dosed as need we healthy as think high go. that to volunteers we and

study enable can also and We study have in the from higher using the these be in things ongoing can patients the the will dose healthy we and we data patient detail. as we where evaluate dose volunteer to subsequent studies well more

include quickly -- we answer higher more short didn't to doses. needed can feel higher and the as doses patients as program So we volunteers, to in in don't that is, really those we healthy it's better now the advance

Steve Hughes

And amount of intravenous Mgs just call This that substantial X.X. to people a just systemically thousands of or micrograms of on RNA, per units for through of is mRNA. the the kilogram convert to of XXs help application messenger administered we've dosing. is

Madhu Kumar

just any what go you Steve reason there on relative to said, think need based would you higher to would to rationale in thing higher? to kind need why volunteers? healthy to patients, dose mechanistic OTC a One of Is Is doses like there

Steve Hughes

not at not all. No,

efficacy milligram per So than the animal we've that based point data, dose in great is one kilogram. animals seen upon our greater

endpoints, also at the greater our looked the biomarker the models at multiple range. kilogram So in in and per animal are in within see animals different volunteers and we've healthy efficacy. looked doses and milligrams or therapeutic we mortality doses well And the X.X of

the in we've So need already that dose confident the test range into we're that well we'll very tested that patients. in range in, the volunteers healthy is to therapeutic

Madhu Kumar

much, Thank Excellent. so you everyone.

Steve Hughes

Madhu. Thanks,

Operator

you. Thank

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

Yasmeen Rahimi

progress To making you're congrats quick the of the a that number Not questions. great all on are of team, questions. them clarification

combination So single to percentage signal then of o'clock little this four release other in conversion number of one, just And your that the a out are put the a or press zero have you questions. boost? I referred of and a first is

Steve Hughes

that here. we discussed, The just data that So, just all all doses we Steve released and cohorts. to seroconversion relates

the titers, So and for titers, all younger is seroconversion all adult, have one in in was adult, except for cohorts, single seroconversion the cohorts. we see more cohort, much XXX% older young, see the subject. points. of as know all we seen in single which the the the single antibody later on, and dose don't for pretty dose we yet seroconversion, antibody older we've more adults, younger dose two data the time have now. dose, But that also in seroconversion. and see And the goes XXX% we we binding adult of In time binding cohorts, What full we

that the that cohort. will seroconversion adult confident in to older continue we're So increase

Yasmeen Rahimi

our adults over single time? felt dose and comfortable another that Steve. that it's thank four us second group? o'clock an to that a younger give point And And And XX,XXX older, increased just case, continuing microgram that thank for time you, you see question for you over thank GM is, for that So you press also ambassadors the XXXX for the pointing the us X.X we're release. response then giving out in for can

Joseph Payne

to from while the your in you Steve Can refer that, comfortable the going to increase increase Are asking already know, maybe example. refer the memory mentioned. GMTs to for animal collects animal to what day models. the and that I I the only in to his very increased I script what but day if to manner saying you my were that observed Steve? data if continued a can antibody thoughts over well, rephrase as time those script approximately we've And IgG IgG for XX what can preclinical to that just the question with particular in continue this in binding we're antibodies where refresh we humans models, XX. we that to similar day reviewing to XX,

day XX. we've XX day did Now, take time we in not humans, point mentioned but we a

Steve the have over binding And some still we we point IgG and But of package. that continuing data we assure that on cohorts, that's So in increase it's have adult cohort. yes, to why data use approximate respect people as these with the can for don’t to humans yet for on. complete antibodies mentioned they don't time, continue and we

Steve add for of and as don't have mentioned, these So we data we package. the some cohorts, alcohol complete and

evolve. It So continues this data to

Yasmeen Rahimi

I that just referenced. have you guess to thinking was day share that something Joe. you or at earlier, you, could just that compared you and XX Thank of actually time point I the was

was that the was that process? So thought

Joseph Payne

day eight, So, of XX% was older to one of Geometric day we about what XX XX. the Geometric was third about a for day Mean what titer XX. XX% it was adults of it day titer at saw Mean And the was, the

today the X it from increased So, day to fold. today day increased XX sorry – XX it three of day three to XX in from about today XX XX fold two range

rise. continuing So it is to

Yasmeen Rahimi

then that, And last out, I as you. patients one Thank know the question. doses. you of received XX pointed two

extent on doses on you two a have can what we maybe taking moving the to my may that so far? question. you then this comment which can for thank require the percentage in based forward? comment boost Sort shot again, of seen And data you So on of population

Joseph Payne

Right.

weakened respond what responses. be, have to speculated populations the Some the elderly have single administration? administration what, will immune versus So double the population that, that people

So titer And cohorts. the cohorts may younger have binding of seen we XXXX. we've think, adult the the have seen other older case The upon with over But data, up shot mean across like robust is for single cohorts, all cohorts. a than that adult that titer geometric adult geometric the of data we've so older vaccines mean that based the with our lower the tourists, slightly even data the but being don't all I very end antibody yet. but

finding all all robust and groups we're age they're titers that antibody seeing across cohorts. So

antibody neutralizing later For don't the we time titers have the yet. points

others, so mean provide within see more color, And is do evolving, the have we data goes show are the that data in a that to what and the And that is we'll we non-viral as time delivery of not, we on. technology be if for convalescent But still we're able that doesn't titers that utilize range are as a subjects if COVID-XX had well phase. there subpopulation is respond, as have that multidoseable. and

of So product. features of that this that's the one

Yasmeen Rahimi

And answer. for team you, And question. thank my taking for that you thank

Joseph Payne

Yas. Thanks.

Operator

Thank you.

your question. is question from with Citigroup. next Our Nochomovitz Yigal proceed Please comes of

Yigal Nochomovitz

question. the taking for thanks Hi, Yes.

give Just dose to whether the Could with go a and more on little to going going provide just context decision just a to as us dose both decision of far bit the or going prime versus single make another you're as take, more little of about to boost one bit going you're a them? take both? only both only Could take You've the you talked single one you you far prime you're to understanding to commercialize one boost? how forward? Are as forward? those forward make a as to

Steve Hughes

again, At is this regimens a or in time, advance hundred several time, registration both into and into when regimens this we'll of boost in those dose advancing forward time Steve And of stage further we'll development, we're point clinical where light rapidly point next single stage into one then the subjects. this at in evaluate study.

still a humans. point to immunogenicity with protective rapidly at be regimen. registration And one although X, we that this single in that And stage just we But also definitely that very advancing has development. study. adequate that a next we're in single is, we're of just the phase we're dose confidence be dose is say single it will then the to testing regimen, single study, in doses So take why have we'll next confident the our can't which in we'll regimen, two to move forward, dose

Yigal Nochomovitz

the study on results of Okay. in publishing And do this the you near plan future?

Steve Hughes

moment will of results we summarize the the year. of the quarter in issue when complete, thereafter. is evolving. to publish which as study Joe results and publish publish And so of then ago, is we complete study little is the study have study at will the we'll the the them we're is data Yes, ongoing the next that first a stage The planning that an while this indicated

is based is premature. publish shift little could upon data a So trying that the to data that

Yigal Nochomovitz

you. Thank

Operator

Thank you.

Please from question with Our question. is next Barclays. the proceed line your of Gena Wang with

Gena Wang

just Thank confirm, the at wanted those a [Indiscernible] I mentioned for a is have want And have that to And taking just few. wider I confirm a XXX questions. you PRNTXX. mean? you the serum, for to GMT convalescent XX my first,

Steve Hughes

used... is geometric It a XXX which what's the usually the And is PRNTXX. mean, is

Gena Wang

Okay, perfect.

what then convalescent PRNTXX serum? the is number? those highest end or the So of What upper is

Steve Hughes

end that subjects at all it's upper in that the end least. front is the several disease, have numbers goes of that which and hundred but So severe way don't have I that the right me, the for upper

Gena Wang

Okay.

the and GMT come from within in you or top end a of serum, convalescent cohort? doses end convalescent single dose the two when to X to are XX titers with in, of range referring the So the top you overlapping serum the

Steve Hughes

we're No, range. to referring the

Gena Wang

between the and micrograms, single versus any of differences dose five boost terms the Okay, micrograms plan then PRNTXX? in X.X

Steve Hughes

for possible not to determination have because from the that just single the we don't us It's make doses. full the data at moment set

As mentioned, lifetime the And vaccine technology, points. we increase over I antigen have levels for our to don't the have time. continued

see increasing increasing over we So time. titers of levels

dose for the between single and able to any So dose a be the few the to it's the make comparison doses. yet we're before two regimens going of weeks

two we cohort five titers very see as in the dose dose robust do in the five microgram cohorts. microgram, we However, do antibody single

Gena Wang

comment are deployed actually mean, all in I just so Okay, XX antibody after the neutralizing others, they principally boost. a days

based the then looked So, versus compared soon do single And dose on what any you XX differences see of as related between could move you day data be wondering, as be, forward. like, question to, just to boost?

want and Next just five plan dose what X.X did so two confirm boost, a those then micrograms, step, choose X.X, decided doses we far? micrograms single two to makes is doses, over and microgram you to microgram X.X both

Steve Hughes

two the dose be dose forward. X.XX measurements single we'll dose, yes, X.X taking in actually be we'll So, and taking the study, in next five microgram

cohorts. both measurements older is X.X as dose. three was the evaluating different and microgram tolerated move we're for the adult selecting The dose X.X to microgram in So to reason well forward equally five younger dose that

quickly, made And lower not dose it whether with dose so points the higher to to advance We to single we able this a program given effective. don't at determination need the both we're the don't we for or are have doses. doses as time a the made decisions than single But order sense to information. we in move that incomplete to with later dose, make two make point, the forward

regimen. than we're It taking a we're better that well tolerated X.X five very five forward, dose. tolerated dose also So forward and was the as was microgram if taking and not well tolerated. X.X as And, two

Gena Wang

Okay.

you. Thank Okay.

Operator

Thank you.

with line Raymond question question. Seedhouse your the proceed of comes Steve from Please Our next with James.

Steven Seedhouse

you to micrograms, for this Thanks the did, XX both what you and ultimately actually end taking I with dose advance decision guess the afternoon. dosing in I'm X.X just Did confused conversation. good question. regimens? up into if the single Hey double through went and people

Steve Hughes

to see because well And lower with dosed So dose. X.X tolerability results any dose a microgram tolerated XX cohort we extremely we're micrograms slightly XX believe that with zero micrograms. grade we At did XX we're the seeing that three forward X.X the events some as dose don't XX at dose going to going opposed We at move by so to with trade-off was we greatly immunogenicity chose saw events. dose, based a single we the micrograms. and upon

Steven Seedhouse

muscle you aches, like with muscle Got things That fever, pain, elaborate been vaccines, were other with or just those makes seen those? has it. common what sense. chills, Could that

Steve Hughes

or way, So we haven't great fact, seen any fevers anything. that in are

any the honestly I in were haven't any, any We in are what, my study. seen that head grade than more at in the the in dose levels off top fevers three of study. any mild events the remember the what can't

those really were within events events. work scale comment specifically, the tolerability that can't they grade with just three I vaccine for grading So

Steven Seedhouse

pretty last on vaccines particularly threw mRNA I And then this early. maybe unfair is question, It estimates maybe enough. others, manufacturing be early, scale and question. with a our know Fair some could but dose And basis? what Okay. out too an

think at what you say XXXX? scale let's the you manufacture just do can So and vaccine,

Steve Hughes

campaigns. that to it. mentioned, very it, both think process Andy the and fill And the and in for formulate But supply large do Singapore. provided now, that's XXXX, to the I there guidance some Israel process that's lyophilized we and foundation we're some RNA finish right messenger sufficient have to manufacturing the to scale and construct, for And to we a make scalable have

the Catalent that others and partners us resofarm, help capacity, have So that here. we like with and mentioned, this we us and helping are so

very manufacturing our promising. horizon is at we're So

Our comment? an tech transferred. And have shape technology or extra is and do you And in Pad, validated good we're there.

Joseph Payne

Yes, just other one comment.

As did procurement we a $XX of for million additional an Andy our mentioned, materials manufacturing for receive efforts. raw

be we key materials can next raw So get that scale up year. ready additional fund, order they we're to with so getting to lot of that the manufacturing where in a kilogram for that get will and

Steven Seedhouse

you. Thank

Operator

That President turn back over for Payne, the have closing questions to floor Joe CEO comments. today. we is and time any to like the would for I all

Joseph Payne

we're but for thanks, free you to looks It close Hey, any everyone up if at have going feel this follow point, listening. as the reach questions. always, to call, out

We for will responses. Bye be now. as our in we can efficient as

Operator

This you. Thank conclude tonight's call. does

may time. great this your day. disconnect your and lines have a You Thank at you for participation

Arcturus Therapeutics (ARCT) 9 Nov 202020 Q3 Earnings call transcript