ARCT - Earnings call 3 2023 | Arcturus Therapeutics Holdings Inc.

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Operator

Greetings, and welcome to the Arcturus Therapeutics Third Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Neda Safarzadeh, Vice President, Head of Investor Relations, Public Relations and Marketing. Thank you.

You may proceed.

Neda Safarzadeh

Thank you, operator. to Progress Third Call. welcome Update XXXX and Pipeline and afternoon, Arcturus Quarter Therapeutics Financial Good CFO; Today's Payne, CEO, our our will President call be and and led Andy by Joe Dr. Sassine, COO, will Chivukula, session. CFO Pad join our for the them Q&A and

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

Risk XX-K the not performance. performance filings may from press disclaimer of Please see SEC. known earlier to these unknown are statement involve and with statements that Forward-looking statements. the our materially the assumptions risks, release guarantees by company's forward-looking cause most and recent section They our Factors in those as subsequent Form today or differ uncertainties on the issued and as implied and expressed well results, actual achievements

only statements In of to addition, any over as I any statements. And made. specifically update such are will date such obligation the with the disclaims forward-looking to turn call statements that, Arcturus represent our now views Joe. as

Joseph Payne

to Neda. I'm to update again, my you Thank It's going vaccine, an our be on remarks everybody. with monovalent regarding you, begin progress COVID-XX good with ARCT-XXX.

its NDA primary ancestral against immune The vaccine which which the of Following noninferiority III safety Agency supported ARCT-XXX endpoint, was was Devices Vietnam. is Medical Comirnaty. booster compared demonstrating the new primary in The favorable strain or response under in vaccination study, III controlled prespecified Japan the pivotal submission achieved III to series study, Phase booster Japan's active SARS-CoV-X and Phase study III the the from clinical and as Japan and a conducted conducted Pharmaceuticals drug ARCT-XXX review results vaccine placebo-controlled an efficacy studies, Phase by application by Phase is PMDA. an currently

durability superior X, improvement was variant this the collected [indiscernible] comparison antibodies previously Health against X Phase was antibody clinical consistent with against I/II FDA-approved X the multifold post Updated monovalent at These SARS-CoV-X an the boosters Valencia. a ARCT-XXX booster Conference that vaccine, key secondary XXth data in multifold ninth of recently as monovalent at In endpoint. heads-up showed the and BA trial titers and International In Omicron Omicron was the ARCT-XXX superiority booster ESWI also a Phase were presented to neutralizing presented of neutralizing preliminary and data months response Influenza in Berlin. boost demonstrated Phase addition, mRNA mark. the in III and durability III at and were Conference mRNA

December. We NDA relative response booster Seqirus, mRNA and by conventional and series underway approvals Meiji a the COVID-XX. other partner for marketing this are approval level The the observed Pharma, track and a And STARR on data, vaccine at we clinical administered of were effective platform primary data authorization markets. lower vaccine to next-generation the clinical application next-generation that for mRNA an potential immune safety tolerability offer is collected technology longer-lasting to technology. Based vaccine ARCT-XXX a a ARCT-XXX dose mRNA filed major and in vaccines. next-generation XX% X date, of in the may the platform on achieved all benefits This technology, to which compared review for believe to clinical an XX% this seeking of in is benefits that All differentiated STARR we technologies, platform submitted supported Seika Japan lower micrograms. mRNA as of mRNA the approved is level dose with highlights Europe. application support older remains CSL is This these ARCT-XXX the to

in and collecting the by vaccine of of approval XXXX. In participants unanticipated has progress scope of of and XXXX, vaccine XXX with vaccine the The planned the We're delighted results we platform to for PMDA value study clear clinical mRNA of believe QX our bivalent as bivalent pleased line target are the to trial Phase COVID been initial opportunity data and mature to by in top We the today ARCT-XXX STARR vaccine with the this broader Arcturus continue validation expected Comirnaty. achieved enrollment report therapeutic summary, STARR comparing immunogenicity QX next-generation programs. followed rapid mRNA have we provides vaccine are in that meaningful mRNA reached We year bivalent the platform. well. ongoing next-generation III

CSL, developing on to progress. global strategic Arcturu's which with collaboration our exclusive and mRNA commercializing vaccines next-generation make substantial focused is Our continues licensee, is and

which program, now to also restoring candidate move ARCT-XXX. activity support initiate to This replace continues to a thus FDA. both RNA cycle as next-generation soon. I'll with on LUNAR-FLU improving OTC dietary reduce being clinical the with could scavengers ARCT-XXX metabolic Phase those from X cohorts face operational evaluated the adolescents for is funding ARCT-XXX today, Phase the United single-ascending conducted OTC dose our in ongoing in subjects. II currently damage. of medicine This and in patients. designation with cause of LUNAR-FLU to all ARCT-XXX known intending in disease designation Ib study utilizes preventing functionally and therapeutic deficient disease. planned neurological investigational progress a in and drug to partnered ARCT-XXXX the pediatric Phase ease completed in States Arcturus' the rare that ornithine Ib dosing the messenger the and has clinical A study in and and life has X enzyme of ammonia designed quality OTC being Our total in platform, protein and liver, urea Phase studies XX is for CSL. adults is from rigid now is we or patients mRNA trial, is adults restrictions deficiency. transcarbamylase need OTC that the received for deficiencies. The a expected multi-dose begin which and is are I crises study

The We sites each in in to dose HX XXXX. first United and expect the of development in rate challenging being plans Updated administrations remain by the various for services Phase or and final participation. II of Europe continued adolescents interim XX taking is participant. We with the adding are Kingdom study and includes guidance patient to occur committed of enroll and biweekly actions quarter data address levels Phase the and ongoing ARCT-XXX XXXX. The II evaluates to enrollment we improve study fourth expected the to OTC to to of in X screening is Europe study half database to adults and lock later conducted deficiency. up this up X ARCT-XXX,

each candidate Moving ascending completed dosing now technology, a is for enroll an in the of clinical to administrations safety forward fibrosis Phase results Arcturus' first delivery. pleased Phase study with to enrollment that in inhaled report New across the LUNAR delivery this an to half XX in initiated in at single-dose I X presenting cystic RNA Ib have healthy study tolerability cystic bronchial ARCT-XXX. participant receiving we to of messenger cohorts. appropriate up Zealand is patient to a New adults which our has ARCT-XXX We dosing designed X therapeutic formulated look in study enrollment of of which and cell been scheduled first Phase in We optimized study in with fibrosis Zealand, XXXX. We're program. with of ARCT-XXX I X epithelial for conference subjects

In CF to the We Foundation. support $XX In from grateful data sincerely October September, in rare its the to disease to ARCT-XXX. increase million guiding advance the for are presently of XXXX, continued financial interim received HX pediatric the ARCT-XXX agreed is organization XXXX. Arcturus designation FDA. commitment

eligible receive a indication, a subsequent a a priority FDA approval As application different is ARCT-XXX product. such, marketing to of review Arcturu if achieves for for pediatric voucher

A CFTR cells, pass of and level above the November. showed New in airway the data KALYDECO. And continuous Fibrosis with disease prevent the ferrets clearance restoration Andy. model, KALYDECO successful The vivo modulator new as call of mucociliary the also of at or CF in epithelial collected maintained presented study activity with administration in now data I'll of Cystic that, treatment to American known was This to proof Conference require transfection ARCT-XXX a with progression. the GXXXD. ferret North was with NACFC single the

Andrew Sassine

payment Joe, XXXX reference and September most recent you, today XX-Q release CSL. The earlier of afternoon, program and performance. Arcturus COVID-XX for Please to with more provides fund used a everyone. the ended achieved our press be issued good financial also year-over-year $XX quarter details will milestone Thank a analysis LUNAR results. the and financial development includes for the million milestone summary activities third for The vaccine statements CFL. financial on from recently

that believe carried differentiated in financially ARCT-XXX study for to the manufacturing efficient the collaboration. that ARCT-XXX a with Japanese We leverages development PMDA and two are Phase represent new III supporting very Furthermore, out product in the and vaccine application we external Japan, was booster manner disciplined ARCT-XXX The drug market. regulatory government. multiple plan highly could CSL option manufacturing for this agreement for distribution [indiscernible] patients. with are in a pleased with [indiscernible] by will marketing, well the sales as products has being our coded Pharma manufacturing collaboration Japan the and product the the related and responsible as funded Japanese ARCT-XXX to approval, NejiSeca and Pharma of Neji Japanese be vaccine the Secure, an of in whereby coordinating this

hub substance build development player Japan. state-of-the-art facility. To to in landscape. a product used by poised CDMO of government. in mRNA key a a talent awarded designed the has manufacturing is to our a drug construction to template located the drug mRNA-based facility. to our $XXX funds manufacturing the research has as This We're construct been and mRNA and drug as production of being DNA in Japanese vaccine mRNA These biomedical are completed already to catalyst million well become mRNA and therapeutics capability substance the formulated date, global drug manufacturing Our strategic support

therapeutics We strain. emerging to leading manufacturer and a become expect of an facility a of days mRNA-based with vaccine vaccines ability the to XXX viral manufacture within this

to substantial to equity to company financial We years expect provide position. this coming dividend meaningful the our entity due over our

their We third are Japanese government for will for the the quarter support. now XXXX. financial I financial greatly our results of summarize of appreciative

Our primary technology partners. pharmaceutical fees was collaborative and fee, consulting reservation and with from fees, source research biotechnology related license received and revenue transfer of development arrangements and payments from

from agreement $XX.X XX, increased as million increase $XX.X agreement attributable during Seqirus compared BARDA. Revenue The XXXX. with XX, million, to September months increase ended September the to months collaboration compared million months ended X X revenues with in revenue the to XXXX. to and by X COVID XX, compared million the was months X XX, increase less operating XXXX. to from the reported $XX.X of other compared year from customers. Total XX, revenues attributable with The the primarily ended XXXX, ended Revenues CSL recognized was increased months with offset $XXX the months by million primarily This $XX.X grant X during as months of ended X the with revenue the XXXX September September were program expenses CSL for XX, [indiscernible]. in prior September we $XX.X for XX, XXXX, ended XXXX related recognized period. million agreement September September the for the ended million the XXXX, was For X $XX.X primarily an revenue increase by collaboration

related trial manufacturing primarily research and $XX.X million consultants, and year, as as primarily executive, general legal September months other fees our clinical to development for and administrative with facility-related expenses were and G&A ended costs, personnel-related and ended well primarily The clinical expense by XXXX, and administrative R&D to primarily count X expenses, expenses comparable travel compared in expenses in and expenses research reflecting function Our activity. R&D services headquarters contract increased consist increased XX, and salary, well expenses and September expense associated supplies accounting $XX.X personnel expenses regulatory million clinical research expenses. increase for and accounting resulted were last the from organization, due head comparable expenses. of in research conducting and and facility. for study external the related XX, period million year. costs period and of an consulting million increased benefits professional new $XX.X X and consists vivo rent laboratory compared personnel-related with General the last salaries as legal $XX.X the manufacturing in increased XXXX, of administrative, the months with performed

XX, loss million net diluted the XXXX, $X.XX ended million XX, of with months share a For a X $XX.X or compared reported September or loss $X.XX net Arcturus of approximately cash XXXX. diluted per $XX.X XXXX. the per of and ended share XXXX, December million cash XX, restricted September equivalents as months September and $XXX in were at X XX, $XXX.X Cash, million

CSL XX, upfront million secures XXXX. approximately milestones as We September from have payments of $XXX and achieved in

and future milestone and continue We program ongoing expect of from the pre-additional development programs support to CSL that to by receive payments COVID CSL. flu the will vaccine

Finally, programs. In summary, achieve cash the extends strong now expected near-term happy remains the end and and we current the to a report multiple through of financial I'm company position pipeline based resources in program. value-creating milestones on XXXX December the runway will the call for to Joe. and the has with the sales in to beginning look in pass anticipated report over vaccine product the Furthermore, commercial Japan, now to therapeutic to the we years. I in potential XXX forward next few approval believe

Joseph Payne

first we're and and our a critical about the make Arcturus. delivery with achievement mark to and platform product platform continued LUNAR later December in technologies progress We've Andy. Thanks, the ARCT-XXX. milestone progress The in messenger for and for proprietary toward potential our would development RNA toward stages approval excellent excited clinical definitely advance

And over for I'd the the so questions. like with to to turn that, time operator

Operator

first The Rahimi comes Instructions] Sandler. [Operator question from with Piper Yasmeen

Yasmeen Rahimi

patient first third Japan vaccines update any hear expecting queue. for approval. on an you should CF when enrollment dosing, commitment cohort approval. in clients XXXX data data would the terms with maybe I And is of to in planning and to Question to should of given love XXXX, vaccine asking complete, your into one. upcoming order on the is are that the the us the to steps thoughts back time program? we The at report patients? Japan's if are the there small congrats the be to bivalent on the the opportunity we is I'll question be expecting program for That's X get is jump you then terms Many Or of question in of two, next a and directed

Joseph Payne

or associated We're unfortunately, to whether primarily responsible do the orders, is government may that. government that's the from that for have sector approval soliciting ARCT-XXX. of Japan. orders With insight private respect the collecting be ] MEGI in with [ from or we into those not

platform But I'm in that. approved. So address cannot unable until happen a asset is order or particular clearly, to the

respect dosed able next first we're speak fibrosis. to being we've the if won't patients for data interim Ib any the support provided shortly, to more So fibrosis. that the the first but be the I patient Ib that. With for data the with is indicated safety than Phase recruited and willing to trial to detail share year, on required, getting is to here respect Phase cystic of in to the of half cystic guidance tolerability those of -- We trial

for when Now this another a the asked you bivalent. about data and for program, is question

to this is to that And soon, going guided at so yes, the are enrollment just data fact, be providing bivalent the -- we've notes my booster I'm year. looking confirm, yes, completing data, very next But later we in month.

PMDA approval anticipated in line approval or data in an 'XX. QX expected QX top and is So of

Operator

question Myles William Minter from The Blair. with next comes

Myles Minter

in just out optical an a that is December. previously, I'm in us been it. and I of and fourth approval I've fault Just would the And not PMDA which like any monovalent the potential follow-up. there a conversations there be going request maybe your wondering quarter, just conservative, shown but Did And why X-month Meji But delay now. from what data you vaccine on durability to October there's more great. you've was clarity nicely. know of because been have got own, regulatory the of there from you've say, that's October I relevant point Meji's view? anything that's of think to panned else saying

Joseph Payne

No.

for was The data was prerequisite data not. a endpoint. Just the day the X-month primary XX

to data and in look regulatory consideration is is this guided as And into However, agency forward. again we've going regulatory aware they taking the December. approval at approval that

Myles Minter

Okay. sorry, And a -- then was there? just maybe comment there

Joseph Payne

No.

Myles Minter

stepwise the Maybe in to have a program. patients on dose fashion. Do just one cystic CF fibrosis those you

them together? for clearance a would receive dose you patient? these the next patient So patients monitored X a administrations and in at safety get of dose can single all be time Or X them to before

Padmanabh Chivukula

-- That's Pad, we Yes. anticipate cohort all is We anticipate the altogether. correct. dosing this and

Operator

from The Guggenheim. next comes Fernandez Seamus with question

Seamus Fernandez

couple So a -- here. of just quick ones

key we from the drawn terms or flu runway going steps possible progression just cash, understand Obviously, potentially really help that programs sort -- milestones milestones of XXX it could And the lay out whether applications key sort it would COVID what of seems XXXX? of the just program, more quite potential hoping see of the the advance. like the be through the into a terms significantly perhaps could out us as more the perspective, you in absolute of XXXX that maybe guys percentage as move some but of is through be forward forward, milestone program In of catalyst of know percentage other the other terms, existing CSL, if And as programs? without in where numbers, not XXXX of jurisdictions more COVID these a we in what's now with broadly. from

to we of is or indication among thought really recruiting this it's indication demand might very of the this nature what question, just the It the given smaller and it challenging begs previously? too pursuing that trying a just patients be hard sort a keep this of to a has the back just been the queue. On just then is just better those view get second Is OTC, in question, of consideration sense the given patient that then potential breakdown of milestones? I'll frankly, population? recruitment to excruciating, how just they're the worth not find, the So there And than there it just there jump trial?

Joseph Payne

the Thanks, questions. Seamus, for Sure.

milestones the some First, through I'll as near-term walk you've asked. of

is relevant with we've occur half to starting Ib That Phase to I first and being database interim later data, programs, going Phase data quarter. locked of the to deficiency With for the II internal we're program. that lock indicated our OTC our the OTC Phase with the XXXX. database is program, So respect this guiding

Now shifting CF to We're... program. the

Andrew Sassine

let answer Joe, question. that me

is correct, that's trying obviously, to? to thought financial runway And was I question Seamus, to the I think no, what thought. Yes. And going -- think to. that milestones. understand the with that's cash were programs. he No, what I financial the referring the to pertaining what I Okay, you referring was the

a they're And program and because when certain articulate how relationships a right? give not when don't what's freely individual Fibrosis we more the to CSL of the right? specifically we critical them with were lumpy, we go contribution is people, going I'd Cystic that don't that very the the catalyst able guide as the perspective of and you be to of as that to have kind give in we disappointing outside and well typically the to they're know program forward of So be from going and start you initiate Foundation. terms feat. And for milestone the burning on achieved, frankly we're would be what to those the we guidance to when we accomplish of that as milestones announced achieve here amount cash we able rather BARDA So

$XXX And to more. So goal to divided the even number take come our be by our burn. down if of basically about cash, that you're years you going bring will million to in close

$X when timing programs. be development So to understanding the that's of milestones out the there's Obviously, the in. X X pretty billion come it's they're critical to going guidance in spread over significant. over consequently, And milestones to

the market, revenue certainly be in we supplemental, commercial the least do in will at for or we And And did. included meaningful. our enough to we be and you our and that them, revenues that update are have X how into funded achieve years. Without we forecast our we milestones no revenues operations. provide certainly have them we able milestone we well forecast, will any explain hopefully, comfort They're are next in that would impact considered as XXXX. So earn to will they're assuming significant on pretty going why

Padmanabh Chivukula

And the Seamus, bit more a color little program. I give you OTC can on

can that typically And a And has are some centers, to it's As course. compared rare disease programs specifically, you conducted to our we've slower, vaccine. done the recruit research the work of which slower with trial in be phenomenon. well-known OTC know, of been

then to we've help the trial. key stipend we've a near concierge So potentially that we've try going things in And experience. added to for can part is bit for action taken to and are to a this patients' we've recruitment the we've all pay that a patient up. There enhanced X speed speed service term quite a implemented And in of we be lot done that up of efforts the that's so their this of recognize also needs. patient's to

in near also of both So terms to I opening the sites and these things in in -- is more and think term. going up help recruitment

Seamus Fernandez

And follow-up but there there's be Great. for a is though, treatment [indiscernible], there. the concern around out guess just market to size I a there of can for of also benefits. ARCT the there Obviously, demand question get any are that, better opportunity just other sense rare options as for conditions where usually, trying to

wondering I'm be it sense resources rare as it this. bring been CF assessment It's an pursuing program that as to it make opportunities. just many, if spent other because just with forward this better relates like is, advancing would would to might years program disease seem many just So the there's

you a of So trying just sense guys are get thinking? more to how

Andrew Sassine

I that's we Pharma that No, RAVICTI, fact But would able see think, great only diet. revenues Seamus, that having if the $XXX succeed, not can we annually having keeping and XXX I the think these right, therapeutics protein a normal from that generate sequestered different we're over million is hopefully, at was question. on a hopefully, to and if people a generating have with our And in did we patients And loan level, prevent a least ammonia that Horizon the so had success very they're only opportunity for -- encouraging baseline us. assuming ammonia, a RAVICTI mRNA at perspective.

company small very uptake a is steps a the the opportunity slow select year. discounted certainly, of And by profit small and to taken accelerate the have lucrative on in to believe ours. next like term in financially patients here the market half but near So we're we've encourage recruitment, first in should us the here for obviously, that I share the that

Joseph Payne

as Yes. it represents valuable mRNA flagship intravenously there's committed the platform program. into but for We value asset, that. remain also a for the dosed just not administered taken asset to and systemically it's the consideration for or

Operator

next comes Nochomovitz with question Citi. The from Yigal

Carly Kenselaar

is had on This couple on the a for We bivalent head-to-head Carly Yigal. study.

First, I affects just about wanted I Japan? guess, how generally, that to market clarify Japan was XXX additional that Maje's wondering study Japan? bivalent strategy you're outside opportunity second, commercial requested geographies more just launch then versus how by the and regulators of in And thinking in for in

Joseph Payne

Yes. future. do a for in COVID question. regulatory to collaboration we're data vaccines. for we have between is here. that the All monovalent bivalent reason in the the AGCL and have The united it that agencies their reason message Arcturus as don't we're proceeding Thank you collecting The

and collecting their bivalent future. have doing at a the bivalent just monovalent So proceeding and to add and trial and we're platform going comparison if data view the back the We're ever though, data platform, we taking trial bivalent strengthen a regulatory not to it's Comirnaty. a reason opinion will requested if with the reason that's need that or to of to But ever bivalency in there's data, prevent now. just It us comparative does than strengthen III then to changes from the with Phase the care do that time. why that the agency important more becomes

Carly Kenselaar

as Okay. Got it. That sense. then And follow-up. quick X just makes

I vaccine an specific think in and have about past, [indiscernible] talked the you candidate. maybe Meji

that the an if strategy for was of update on curious there status Just the program?

Joseph Payne

X-BB, monovalent update. a update sure. Sure, is vaccine The

of vaccine. partners started updated version monovalent have asset. Some ARCT-XXXX. communicate a of the it's about And this our to called It's again,

the us to And meaningful opportunity we're an so and on to updates to that our respect be update provide asset. there will monovalent disclosed that that those we call. next is publicly, collecting activities for around haven't data relevant With an asset, but all ARCT-XXX very on

Operator

The comes Wells from next Yanan with question Fargo. Zhu

Unknown Analyst

on for This is [indiscernible] Yanan.

COVID. So X on questions

CSL first translate the us [indiscernible] share sorry, [ the at would would update? is the to they data potential second example, differentiation you the were December, you Can recently potentially for vaccine? ] mRNA in Or you approval Conference. the, on presented with based And with and the Healthcare tell monobenregional launch So success? wait one this question after can commercial data -- like is on for how they

Joseph Payne

Sure.

antibodies, with established, data. emphasis going to safety. to of as respect response in commercial immune an the our platform, want but then more be be would touched we've So course, on that benefit leading an deeper improved already interested advantages efficacy will increased not of there's And increased The clearly, only that we vaccine but into gets has the them COVID go marketing on buyers call, very be interesting. think or implied an the this endemic here as as market in They and I a this durable technology. durability

be dose-related associated dose much emphasized think I is potential technology lower this of the So the safety benefits toxicology. the is a to that meaningfully with fact going because

much at initial a safety with antibodies lower is So to going strategy. benefits increased be the potential durability dose

you respect could Now another you had with repeat to for that the question, -- us?

Unknown Analyst

Sure.

in would vaccine state? potentially vaccine after they original So a the on X-BB approval potential based a the will these wait launch or update and for December, see launch like

Joseph Payne

wants. what with what to slots or address to time desires do market ourselves manufacturing we with respect and and to position -- is Well, lines the the approvals right the strategically want

be vaccine, place, then a proceed monovalent the an updated we'll orders an approvals So an in come. stronger if updated the we that's the in or where XXX to position approval gets can we provide that's if have approved, then -- monovalent to provide monovalent vaccine. If if

Padmanabh Chivukula

our the be that on This approval, Joe is currently for they're will approvals Once on with approval in mentioned, call just like, CSL the various But thing one jurisdictions filed earlier partner, charge other So launch we looking CSL. at in is as we the get that. I looks as to Pad. -- commercial getting add focused think Joe of we're mentioned now. And we right? his what think EMA I the

Operator

The from Cantor Stavropoulos next with question comes Pete Fitzgerald.

Pete Stavropoulos

Nice updates quarter. to hear for all the the

have your hear when expectations from may XXX. of I rough time question First you the line? What for back sort are of EMA,

Joseph Payne

a to is process. EMA. going the to on respect hearing be With back considerable This

We is We on has approval partner can expected. when that the CSL haven't guidance refer our any guided tight approval with XXXX. EMA. provided to in I anticipate

Pete Stavropoulos

that and All if bit discuss drug be the facility Japan, of you distribution the little if if you what operational and terms and of outside perhaps right. just could just leverage then when be expect venture in [indiscernible], already, capacity? not to curious pipeline manufacturing can you And do will candidates other for a of manufacturing

Andrew Sassine

I drug kind of next year is the [indiscernible] facility given finish could be in line for of a you, for that and We've that has to we've product kind drug that been question time time substance completed. answer frame. And probably guided Pete. going

Europe. So which supplying through Recipharm in that CDMO meantime, any Aldevron, the been our Japan be working we've in going and with, to group Catalent, we're other includes country current

working on like product have and that East diversification So to until the delighted certainly and be manufacturing up in other up plant Japan would therapeutic able be any that only or we Far not of support that running, is and may we mRNA opportunity running but that. to

it's address global CSL whatever hopefully, opportunity to will basis. that question. the -- that and able strategic utilize help Is to to be a going be your certainly, it on for Meji, the to be demand and us the for we to may want answer asset So a best very for

Pete Stavropoulos

And question one does. fibrosis. for It cystic for XXX just last

Again, clinical X XXX know any For markers X pharmacodynamic it's doses doses. Will are Phase outcomes. only gauge patients receive going or of sort looking Ib the I to activity? that be you to at

Joseph Payne

at tolerability objective primary success, with will of course. looking just proof-of-concept understand assuming potential -- the patients to to and if are nice Phase administration just of center data be the data a that now to indicative and safety of well in the study increases purpose to that program. bolt of Ib for That's But We'd ideal in the The tolerability. CF of regimen that's Yes. tolerated natural And experience patients. other shared what we human important type are success, is very yes. at to the the administrations excited on of But administrations safety this study are of for recent of [indiscernible] expectation be understand follow, are likelihood this point that very in show CF we and further we to study. multiple that our success X the because markers see

Pete Stavropoulos

Actually you don't right. question, if last one All mind. throwing

either an is with to of any actually partner So Is respiratory alone vaccine develop or inhaled some to this product. viruses there CSL? potential inhaled type

Joseph Payne

does great the our proof in Well, it potentially the therapeutics, overall for vaccine to present technologies. it's The concept a opportunity. platform If to large trials, and opportunity segue opportunity of combine in we're showing these.

the this, people does That the haven't guidance on future. it a give there's opportunity some but lot any platform We excitement provided general. of in in of

Operator

comes Ed Wainwright. with question Arce next H.C. The from

Wing Yip

AXX is This OTC. Thomas asking and for first question Perhaps for a Ed. Yip questions of couple

from U.S. When first the half about the you data with XXXX. from III the You what in dose of mentioned data study patients? should ascending discuss the Ib Phase Phase expect in in Can XX to see single we Europe study study? the that expected

Joseph Payne

Correct.

database to this that the data. we'll the the need lock of to timing II we've interim Phase the year, communicate data understand process, time because then through once think is the right So strategically at we gone later

that strategic is locked now same the we we database may at for time. So present Phase may informed we these and the but getting I but them yet, Phase have Ib. this separately, present decision haven't made year market the We that

Wing Yip

perhaps are both these Phase ongoing. then When switching from I expect data then? studies see a that studies should -- And we gears we Understood.

Joseph Payne

-- presentation Phase guided informed the Yes. in data we've next conference the study Ib to provide Ib of half we've an appropriate intend interim as some the Phase For next study, the year the yes, CF study, at respect we Phase of first that With first now in I market The year. to a well. half

Wing Yip

Understood.

milestone? one for This Can Andy. $XX from for us. last one CSL. received is question The from discuss million you [indiscernible] what probably the Just milestone

Andrew Sassine

Yes. bivalent in was our COVID The the to milestone related program.

will success with study encouraged the help we've and of very Japan, that the to speed in by hopefully, we're able and been that the triumph rapidly. quite progress having So we're answer And question. that bivalent moving articulate

Operator

Jen I-Eh comes Company. from Laidlaw question The with next &

Yale Jen

is CSL started efficacy. gear I player through just or that vaccine of to soon. major question this the switch had that maybe RNA to messenger some recently, given is My issues the vaccine the in back space. some flu be other And has safety probably on

overcome better of potentially hurdles think how those was have some and what a RNA So and guys your product? both that you CSL vaccine [indiscernible]

Joseph Payne

respect -- additional RNA ways. be to mRNA. challenges. disease there technology to is good that recent messenger can mRNA next-generation what flexibilities next-generation to be in lower, the and conventional that And different the there vaccine in durable. different some including space. shown challenges is flu But potential trials where self-amplifying prove especially we've dose is also dose-related space vaccine -- and that data challenges because our durability this could the and or in that's antigens. infectious important and -- And with also more the we much have technology that multivalency is may shot flu This relating are Yes, vaccines. in -- self-amplifying flu

So those of be would areas differentiation.

Yale Jen

Great. approved maybe contemplated. of also is Japan, Once for And more the well? one as they then outside was the something very in is question Japan helpful. COVID vaccine. That's being what was which States United potentially commercial that And bivalent Okay. the here, in strategy

Joseph Payne

necessarily change. by regulatory interested the not and Well, vaccines right monovalent now, in the all

or in whether So technology if whatever that an position updated does, wants, we're the monovalent. that's provide bivalent customer to a

Operator

At Payne for this time, to back you. over would remarks. Thank like closing Mr. I the turn to call

Joseph Payne

questions, soon to hesitate call. there's the out get back remaining can. for participating everyone, as everyone, any we'll Thanks good the team, and you to night. on to Thanks, we as to don't If and Yes. reach

Operator

teleconference. does you. Thank today's conclude This

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

Arcturus Therapeutics (ARCT) 14 Nov 232023 Q3 Earnings call transcript