ARCT - Earnings call 4 2023 | Arcturus Therapeutics Holdings Inc.

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Operator

Greetings, and welcome to Arcturus Therapeutics Fourth Quarter and Full Year 2023 Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Neda Safarzadeh Vice President, Head of Investor Relations, Public Relations and Marketing. Thank you.

You may now begin.

Neda Safarzadeh

operator. you, Thank welcome pipeline and Therapeutics' financial quarterly Good Call. to and progress update afternoon, Arcturus Today's led CFO. will and call be and our Andy CEO; President Sassine, our by Joe Payne, Dr. join Pad CSO Chivukula, the and will our Q&A them COO, session. for

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

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

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

Joseph Payne

investor our you, today everybody. We our Kostaive providing you It's on program. good again, with Thank forward begin to our on to with look my will progress regarding Neda. be call. quarterly remarks update I updates an COVID-XX vaccine

adults COVID-XX COVID-XX and primary a of MHLW, III a a and efficacy Ministry mRNA older. vaccine study subject and Phase Welfare, studies, trial performed the XX,XXX years for clinical as vaccination for favorable granted including several Vietnam well from for Kostaive, Labor booster Following as Kostaive results in self-amplifying XX Health, in approval Japan's booster Japan,

CSL, of to our we the our a the our vaccine alongside historic vaccine now mRNA global STARR registered. platform Japan, messenger partner, look innovative applications about CSL's RNA milestone to platform. Meiji are partner Seika And This and in be self-amplifying self-amplifying forward the in first exclusive future Pharma. We expanding confident approval proven marks as product increasingly world

an active and study vaccine, conducted Kostaive dose whether included initially sites vaccine third in mRNA The this in Spikevax partnership doses or was conducted was study healthy Japan in Comirnaty. partner, study The approval booster's Meiji Pharma, X The with III Phase the an with further of immunized controlled of by supported XX then adults is in is based health global Comirnaty Japan. CSL's that Seika company Japan. a

disease months and the durable an compared post-vaccination a The results Kostaive the shows strain, more antibody X/Xth response and new emergent COVID-XX Comirnaty. persistence. broader the BA.X/X with original the by dose against data Arcturus immune provide Wuhan totality variant Omicron collected X were that superior both Kostaive the for Comirnaty should analysis at variance of in and induces protective to on efficacy advantages Based SARS-CoV-X. of of that achieved to date, advantage mRNA self-amplifying of clinical future anticipates caused

The immune study Kostaive assess to post-vaccination. to safety is the and ongoing participants durability of XX collect months up will continue response and data in booster

track to on providing in further detail and party launch in of Meiji distributing updates Pharma the the in pleased releases. We Seika press launch Kostaive vaccine as remains be are for pertaining will this report to the very Japan Japan Kostaive to that year. official responsible

is preferred. response in commercial The and COVID this WHO announce broader Kostaive a clear the course, important Kostaive apparent variant. Japan the stay that follow. will Kostaive vaccine, to COVID a vaccines. durable immune potential clear, mRNA and and to here here there is for other regulatory has boosters need stay. case for year and In becoming each updated the need. COVID Thus, ACIP is the and recommending runs expected is X to the of the subsequent agencies more significantly to stronger address Kostaive very is for a distribution are conventional The April, In once-a-year global due approved is also presently manufacturing longer-lasting health it's

to and vaccine pleased vaccine to study response LUNAR-FLU. self-amplifying the of partner, healthy dose Overall, safety investigational candidate I XX This XXX on Phase care. Phase quadrivalent company, influenza. the younger and adults, immunogenicity I which the planned in licensed this initiated with are is of to I'm seasonal of clinical mRNA be So the our adults and standard includes intention assessing XX for the comparing along older individuals, with XXXX recruited CSL, with a ARCT-XXXX, announce moving January in our dose-finding that the study.

by has excited of new now our provided validation for gonorrhea. discovery decision programs disease initiated regulatory I'm the to LUNAR supported This clinical approval is technologies regulatory STARR by Kostaive. announce vaccine and Arcturus and first Lyme of and that

vaccine ideally are technologies for Our opportunities. suited infectious these disease

and vaccine billion. wholly-owned X being platform gonorrhea. X and vaccine $X disease programs, now partner, new Our estimated exceeds market programs our is with global infectious The discovery validated vaccine opportunity applied these diseases, to global total discovery Seqirus, for Lyme CSL X

to on now I'll ARCT-XXX. move

crises for transcarbamylase, is replace or missing cycle cause deficient functionally deficiency. the Our the activity restoring OTC urea neurological liver, enzyme therapeutic damage. OTC, candidate to messenger or designed and preventing ornithine RNA that in medicine This metabolic investigational

those improving and restrictions today, life thus ammonia the that scavengers the rigid disease. of this reduce protein need quality could OTC dietary the patients with for ARCT-XXX face ease for

Our in all and XX of Phase United with has Ib patients. enrollment dosing the cohorts study single-ascending dose completed States

and study X is study data to Phase participant. the by to Phase and Kingdom interim II dose QX ongoing for Europe in with share The administrations XXXX. includes of X up adults to end United II company The up expects The is each OTC divisions. adolescents and XX biweekly levels the enrolling study evaluating

thus and an and restoring lung designed This now replace our of Moving Arcturus' is to missing program. with medicine fibrosis, LUNAR delivery balance deficient therapeutic functionally the or cystic salt in formulated technology. candidate RNA is ARCT-XXX ARCT-XXX investigational inhaled transport to the messenger CFTR for the water.

Zealand Phase New subjects X a in the single-dose healthy across now dosing of have We ascending cohorts. XX completed I study in

In is QX up in designed cystic study participant study The clinical with We dosed ARCT-XXX. track enroll Phase of to X a patients with remain Phase Ib we interim addition, data Ib X Phase to fibrosis in adults to each on receiving in have Zealand. Ib XXXX. share administrations New

November drug, XXXX, years exclusivity ARCT-XXX approval. promote X received plan. qualified for the for trials, FDA to the design In credits fee of to Prescription in market significant Fee Drug from Act Orphan development tax overall from an eligibility the waiver for The designation the Drug Eligibility provides regulatory of guidance the and application User Designation potential FDA for clinical receive development upon drug incentives of FDA. the including

centralized February process, call from of In access fee years Commission, which pass exclusivity. and XX Andy. the Orphan with will reductions Medicinal ARCT-XXX received the to XXXX, Arcturus protocol And that, now Product assistance, give to market Designation I'll authorization European

Andrew Sassine

press financial a Joe, everyone. XX-K, details reference XXXX, The performance. of issued includes statements early afternoon, filed and summary you, year-over-year good today Thank for next ending and financial December be financial fourth and fiscal the XX, release more which Form the our week for results. earlier also on analysis will provides and year quarter Please

give I Pad Seika Pharma to from JV trip was venture. Meiji where excited Japan the that manufacturing first Before ARCALIS I the our of to Kostaive the about begin self-amplifying very opportunity and manufacture partner happy approval and Axcelead, am to Japan the everyone mRNA wanted Payne, vaccine brand. from executive I we and our Tokyo, the Chivukula, financial Meiji some with our you report Joe to in review, in the world's highlights in met recent teams under

closely very for the second partners the our Japanese the of to of working government are half and officials Kostaive local with XXXX. All of launch in prepare

of and grateful our their manufacturing financial government support to We Kostaive partner, are Japanese deeply for the ARCALIS.

from releases of will in on Seika Going regular provide Meiji official the updates this forward, press year. Kostaive official Pharma launch

of summary I slightly XXXX XXXX. which million of $XXX compared will now by reported to in million Revenue XXXX We CSL million XXXX. revenues results. during $XXX.X recognized $XXX.X provide from to our increased was of financial million, a $X revenues compared during quick

flu that also to agreement vaccine BARDA with $X.X an led significant increase We million. progress revenue in made pandemic of the

The In milestone J&J our with for Vinbiocare discontinuation achieved fund majority and from of of development Arcturus milestones XXXX, in the COVID-XX decrease within of used by to continue activities XXXX. quarter programs agreements the payments in and 'XX will CSL. The flu vaccine the fourth revenue million driven were the to $XX.X CSL. in LUNAR FY mRNA collaboration be self-amplifying

the XXXX. XXXX, $XXX.X year ended Total $XXX operating XX, year expenses for million ended December for December compared the million XX, were with

quarter of by the months expenses. want $XX.X XXXX. operating with million due expenses $XX.X lower XX, to from to expenses XX, $XX.X the ended For were sequentially X December months I total million declined XXXX, fiscal December for third compared the million X that operating manufacturing highlight XXXX ended

manufacturing consist clinical R&D organization, studies clinical facility-related costs, and in vivo to external research and personnel-related related supplies consultants, research primarily contract and expenses, Our laboratory regulatory conducting expenses development performed activities. research and expenses by of trials

expenses million increase expenses the our year fibrosis The program $XXX.X development XX, XX, internal in to to well for development effort the December continued as and programs. for to OTC CSL and and million were and year Research compared the BARDA progress ended XXXX, $XXX.X were our XXXX. December ended as research cystic attributable

have discovery in technology. increased in we investments stage early Additionally,

expense headquarters in gonorrhea expenses count San vaccine million expenses to compared during disease head increased G&A increased The and research $XX.X and the travel and million increased facility resulted to an preclinical in XXXX $XX.X as personnel from rent XXXX. salaries, new as The well primarily increase expenses company related with initiated its with Lyme discovery were programs. due associated consulting Diego.

will G&A total expenses anticipate We XXXX consistent remain totals. for with XXXX

net net $XX.X $X.X XXXX. XXXX, the diluted share of XX, Arcturus $X.XX per year December approximately ended December For XX, million per compared or share loss ended of in or diluted the with $X a million reported income year

million Prior equivalents a share collaboration. months X with approximately we December million a X December XX, December or income net year share $XXX.X the as and per reported diluted a from our XXXX. per million upfront loss XX, net ended $XXX.X million ended CSL of and cash $X.XX restricted for $XXX XXXX, diluted as $X.X cash $XXX included XX, or million quarter XXXX, For were payment $X.XX of December XX, the XXXX. of compared months of Cash,

milestones approximately upfront beginning as and in with the November million XXXX, $XXX of achieved XX, deal in payments December our we XXXX. Since of have CSL

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

the the of strategic current on and I total that report the programs. through to relatively demonstrates improving business outstanding cash plan. XX.X would million to approximately shares have highlight at happy a extends on I'm fully remained runway This shareholder to XXXX for a Finally, our also basis like continually based we consistent value pipeline shares. as row commitment years now expected first quarter in diluted execute X management

believe we forward summary, potential a we to resources in value-creating In has vaccine next December for programs. to milestones back financial pass achieve therapeutic to Japan, in sales the look report in the strong years. position the I company product the Furthermore, few call the Kostaive with and multiple in will and Joe. approval beginning commercial remains near-term to the now

Joseph Payne

Thanks, Andy.

excited We technology incredibly platform. achievement our of are continue to mRNA validation Kostaive. and make our This with product an excellent first is approval progress, we important and delivery about

to So the over with operator that, the let's questions. for time turn

Operator

from Evan Our Guggenheim question Security. with comes Instructions] first [Operator Wang

Boran Wang

me. for Two

recommendations kind like week. encouraging revaccination how vaccine could may implemented, more what internationally similar markets elderly First, regulatory on durable and recommendation last talk we've see it internationally gotten to the seen additionally, and I'm both feedback and ACIP be Japan FDA you've Europe? in you if on a of in wondering if was

NACFC, many trial? if some in OTC to from data, share updates to patients wondering forward we expect looking can from getting second, how as can XQ closer And we're you each

Joseph Payne

this on provide about not ACIP. now recommended. annually. we're Thanks, elderly, in because we new the COVID-XX recommended the regular We, communicated that has wanted also address We're very see they the that to call course, X vaccinations the by April for to COVID Yes, the information first, I starting Japan, updated to happy Evan. question be may and fact in vaccination, that of appreciate, boosters routine especially government but and the XXXX they recommendations Japan people recommended elderly can some that will approved they've recent that

I'll you that that twice with just actual year Japan quote for to update a aged of also the new underlying elderly, workers. another the website website, medical the if MHLW And they but vaccination and people recommend go older XX and conditions care in health those from

of all clearly people of will these year, others once the a remain a sets that's free twice charge The So well, be of and X communicated. each vaccinated as year. will of while vaccinated be vaccinations

So a very there's need news for the we're elevated for for us for of good because these support of -- that durability but conditions are the -- developments, those going and underlying to course, with also those charge, of in field, commercially. free addressing to Japan of and elderly and health workers remain which, medical that course, the helpful vaccinations be care us is their

With there the the updates But second looking elderly recommendation respect ongoing, vaccination for CDC. for we'll to Europe, there's those no and are European that been those be -- discussions shortly. by

about just X processes therapeutic Evan? enrollment Now the you also programs, asked for additional questions correct,

X all we're we're group. no data clearly the X for We what want interim to Phase shared second We're we on track. to guiding on program, in that's patients, to CF recruiting remain be data still communicate Ib estimating. quarter. to in our is that placebo track some That's in that communicate something patients that and interim

relatively that's milestone. near-term a So

And the details. With to guidance program of likewise, specific provided we respect on haven't the maintain numbers, end OTC we those our and for specific QX. updates

Operator

next Yasmeen Piper Rahimi comes from Our Sandler. question with

Unknown Analyst

This for Yas. is on

have We two.

top step the Japan? you is success? what the OTC, cystic in And data you would would say line? for First, should we rate-limiting types of for and fibrosis what say And what orders expect

Joseph Payne

for to time first speak line over the -- orders for Andy? getting to top data what's turn can what's respect on Andy programs. in the with I the the But Sure. limiting question, Japan. to the rate data I'll the therapeutic

Andrew Sassine

in earlier be and And think No, they'll and with I going positive articulated press had the to I as driving officials meetings making releases we the Pharma is Seika call we've that Meiji what very the some think and Yes. announcing appropriate. bus be all here, executives. they're

over of by and So encouragement there's articulated forth. that patient this to going recent please government about just is right? of is people which to now so the be That's was XX, kind compromised continue million development the certainly issues stay to tuned financially the including a support immune not people, this million that XX -- kind that have population that and and XX Joe is

So chronic illnesses.

XX-plus everyone looking of if that shots, in the So X, vicinity at million multiply somewhere if right, doses, conventional X mRNA. by you're -- X gets potential of you boosters, right,

you available. they can. concrete And kind just Meiji information domain, reiterating public soon what's we're will So certainly of give as in the as what's more

So stay tuned.

Joseph Payne

line data these CF or be for And then biomarkers for near patients, normal we're pertaining looking and are to to OTC, the of these Many top ammonia in for change on ammonia OTC, specifically to scavengers. patients at adjusted levels. to

another if indeed acid urea the urine measure, OTC evaluate we So glutamate orotic other including is itself be is can that in that and the the and can there's biomarkers amino by cycle and acid measured. then impacted case,

are Ib. actual been program, this line -- biomarkers administrations for of as at as we're CF respect that trials to has terms data. of in going plenty administered first These time safety therapeutic X be So this Phase the primarily to in patients. the looking measure these top in to With is

meaningful establish spectrum some And will and very to tolerability Pad either of to to be add patients. for track and sort Anything so record of of it that, CF us for a Program? safety

Padmanabh Chivukula

respiratory well functions think at to but sure be and I tolerated looking mainly dose what a going safety, be think at also that the various patient to population. for going right, this we're CF, you're looking I is making is we're in

So I some those be would happy see think we of to results.

we Phase primarily regard was reiterate with safety we a the obviously just about OTC, to want Ib that then talked And to study.

very presenting soon. coming be data conference up will at we So that a

thanks. So

Operator

Whitney Our is next from Genuity. Canaccord with Ijem question

Whitney Ijem

Congrats the all progress. on

Japan. on is in COVID First one from me

I X so perspective your and from balance those think of orders through revenue-sharing fronts, a X kind how you both manufacturing you understand on as do well from the as orders when there start? sheet us ARCALIS, P&L the benefit can flow or help will

Joseph Payne

elements sort Andy, address additional joint those? due you So of to and yes, any sharing want revenue respect financial the ARCALIS to with do to venture,

Andrew Sassine

CSL you partnership what question. -- at Whitney. But profit Arcturus, details look not type Thanks can extrapolate would musketeer of try the We to opportunity. XX-XX certainly, typically like. look the to Yes, provided if revenue-sharing and a X-headed for split, respect have you with gross X

So X we're us, it partnership for obviously #X all company meaningful about and significant especially working people Japan, in and in to the and very world. Meiji, the in be will with excited the be who's Japan, vaccine flu #X CSL

strong categories. X with very respective you're in their So dealing powerhouses commercial

of made fortunate is in very it's going to to and kind proud respect people the government And the Japan be And that. brand And being of of it kind we're So Meiji Japan the of. having we're something course, pretty in name. with under are that excited.

going they mind opportunity what excites a the to to them. very So our this in is Pfizer, that's government compare -- gave And and vaccine, this and to think keep that we're right? I be Japanese vaccine that us fortunate

And we the that this that share financially with the world data we kind factory. to they didn't would if and the have of not opportunity, have fact supported

bet be we it's and an future. exciting the this approval going on I think to right too. And is So coming year, European horse,

excited that, highly we're it and anticipating as well. about So too,

that on you lot plate a perspective. gives there's and some So hopefully, the

can't soon, in point able details time. at hopefully, too But this go we'll into But to unfortunately, we many be reveal really those.

Operator

comes from Myles Minter with question Our Blair. next William

Myles Minter

to CSL, immunogenicity think important I vaccine one is quarter. X.X? COVID might actually you something first we the with I it And a about hear in XBB some in trial. in the maybe know Phase How have your III that guidance gets that was strain adapted collaboration for there

also factor the that is gate on sale in that a want gating I just first And a So for to sure make Japan? that's track. or

Joseph Payne

amount a that's lot bringing for platform. late-stage clinical There's up. data a collected for being programs Well, of -- those considerable yes, this of thanks there's

couple bivalent touched One soon. You on these was the comparing III bivalent that And is data where Kostaive we're to a of forthcoming Phase trials. Comirnaty. bivalent trial

will trial, able something that able to well. perform that one program in be later a us out we'll respect multivalent bivalent this XBB or Hemisphere is be how monovalent data to there. flu With cycle, incorporate other help as share year that we and technologies setting designed Southern season So to to communicate to the the for

and you and in certain these the So our we'll the prerequisite for we CSL, just for no are these programs. add? for out it ask But discussions? these of and case programs collecting The are each strengthen are for Europe, find answer any did anything partners, is to whether regulatory United States to programs Japan data Pad, packages And funding

Padmanabh Chivukula

Yes.

thing Just the that strain be aware, that just JN.X. -- to I'll is current you one seems might other add be circulating it

the season, be been it platform -- is So strain has fall we ready approved, circulating update and needed. ultimately, for be supply the we once whatever to will will

Joseph Payne

out coming The the yes. month releases message will Subsequent by be Meiji. and be Correct, with through runs distribution and variant guided press manufacturing official updated next WHO in will announcement and April. forthcoming

Myles Minter

then a just from respiratory perspective at have you data then I perspective. safety be to function Okay. anyway? FEVX data that program. mentioned the report from would looking safety secondly, a on you'd CF look you obviously know And I mean, at and

Joseph Payne

you we're address collecting why stand- For CF, yes, don't Pad, that? well,

Padmanabh Chivukula

course, at clearance And -- recruiting to stable again, be could FEVX we're the looking be There relatively we as all-comer is but Yes. as going just be we're patients. -- going signals, well. study. to we index No, -- no this we an and are then potentially recruited to in lung lot a be patients population to collecting of well. But the safety going and of reiterate,

so So just you're aware.

Operator

with from next is Fargo. Kuan-Hung Our Wells question

Kuan-Hung Lin

couple percentage what were year? Kostaive, that many that a for would is of And this purchased of Kostaive touched And was X on expect CF change number groups government? how the call? for last the wondering volume have by the I you On I doses distributed that upon you Japan for program. the people to earlier how and booster a year couple and

Joseph Payne

good a That's No. question.

is vaccine First I messenger Japan. million but it were appreciate. to significant available. distributed tightly of understood in you boosters as what's XXXX, can all, over not In RNA a speak readily for was COVID can XXXX, number, number That XX

For the we just on XXXX, get booster moment is we that indicated clear government X ago, elderly has year. now Japanese touched shots -- recommendation a and the a the communicated -- as

million And million in population the elderly is XX Japan. XX to

charge. it's a the And of hear Japan significant is providing the good of these was to very number going it government to vaccinations that of to So people. be elderly free

So do speculating for to is impacts that difficult call the on to appropriate going that. what -- analysts be this me do, for how to more market that

Kuan-Hung Lin

Thanks the information. where prior in In the average booster under for per person Japan, years doses X?

Joseph Payne

vaccinations in they vaccinations Europe. have especially known the a any the of and say would that is world, rate to Japan per person. high the well Many U.S. of highest relative rate to country have for

So a and elderly for high higher. even is they getting vaccinated prevalence have the

So a very high rate of vaccination.

this project reasonable think out fill their But guide received XXXX? to go these it's vaccination. we I up it inappropriate on. would into to cards me is, percentage high to How set times that number clinic the to get be will very people for mail, these the in to what of a that free expect they

Kuan-Hung Lin

not that get Joe. less twice a question Sorry, default or year, Was number a that a person recommendation boosters was is year? year? prior the per of My the

Joseph Payne

Don't comment MHLW over on in website, which for clearly know is XX is can annually I on everyone All recommendation what the boosters communicated what's previous the X was. Japan.

Kuan-Hung Lin

Got it.

X data at of the ARCT-XXX. -- the question on was collected are be Okay. Ib mostly presenting portion, lung readout? the perhaps that those these being what's the from FEVX Phase interval will But measures And standpoint. program, for I call a got is, the you safety you administrations those the mentioned clearance, And administrations? think wondering on X between patients those also, I CF

Joseph Payne

Ib safety is primary this first and ascertain of data to Well, the tolerability. purpose comment was Phase the

effects, sensitivity, specifically is and looking events the also more cetera. like coughing, side adverse be a will as We this related CF and effects the associated at increased lung there's et severe lung side program, with

is in adverse tolerability we're more So on communicating patients. safety interim relatively summarizing the externally that's group small small severe just lung more of of and spectrum, going centric CF terms of data Ib the a and a be effects Phase spectrum in side focused events to where and

in of already even these nature. that We're are not The CFTR some other or in this, a exploratory cohort parameters on people small secondary like we'll modulators many are where efficacy better present readouts conference. But like have or the when Ib anything -- idea that. data a will opportunity an this we that which data we to definitely have later Phase expecting year see

Kuan-Hung Lin

dosing interval? And Great.

Joseph Payne

you. is are Thank administrations dosing competitive not interval it have made The that we clear We've a publicly. environment. they're shared This very X these inhaled.

learnings We the they're they haven't the far dose of I. in are. different disclosed levels how or same and Phase in We subjects X if considerable apart evaluated the XX data cohorts had the from

wanted we this wanted chest the design So those time. of at cards to our and and to learnings we've Ib -- close trial, to this to those Phase applied we just keep

Operator

Yigal from Citi. with comes question next Nochomovitz Our

Unknown Analyst

I have for is Yigal. cystic related This two to on fibrosis.

biopsy prior what And -- we in and the you any better Should on far can clarify, have at you volunteers as CFTR you the a this data healthy have a took Also, the there? versus readout. studies? lung bronchi mRNA First, volunteer seen well? CF the upcoming there expect expect function, so the we capacity lung tolerability expressions from except if that's look drug suggesting of healthy to should

Joseph Payne

outside that focused like I that. comment? do respect any data with events samples but to sharing mentioned. events lung of the you going or from be directly anything there? being be we're any severe Yes. just doing, I adverse to With think to to comment the readout Pad, have lung, There's associated from a nothing is taken don't CF we're on simply sort going Yes, adverse the

Padmanabh Chivukula

patients. Again, function any just date. we're or to I closely. And obviously, are we Phase we're lung reiterate or currently some severe not the And -- we the the actual at terms haven't in seen with to of Phase monitoring biopsies, looking early AEs Ib in No. that of or SAEs associated

that. doing So we're not

Joseph Payne

With the that CF Conference I respect European is in there that. to to data, Phase we're a present preparing June

Unknown Analyst

And Got Okay. that follow-up there it. just decision sense. need there? makes going What quick make to soon. the present data no-go to see to you you're go That OTC it on do one

Joseph Payne

A Ib for go readout? Phase the no-go decision

Unknown Analyst

For the data. OTC

Joseph Payne

of readout, make toxicity. OTC one of sorry. many to be OTC have the sure challenges people do to tolerability failed about importance maintain due safety in going like therapeutics because the have we other doses. multiple we'd the nanoparticle in most competitors and to For Yes, that that That's tried to a for mRNA lipid deficiency that's past

So significant spectrum hurdle primary the that encouraged OTC-deficient jump to be that patients. of this be multiple and be going would is is treatments to But something safety we'd through. a tolerability show very a objective, by to of in

we have confidence be numbers. to want some step. readouts long Having in as trial, as sufficient we going also said increased be It that, the that of to well confidence to would We give changes? as do biomarker see Absolutely. sort is looking placebo-controlled detail a would for these next so us there

Operator

Pete question Cantor Stavropoulos Fitzgerald. next with comes from Our

Pete Stavropoulos

leverage distribution you already, not you you And if So and perhaps don't expect candidates mentioned facility I will when operational? just a missed capacity? I pipeline of if for manufacturing if know question about that the or ARCALIS. be other it, outside the to it be do Japan? And Can facility what

Joseph Payne

Andy, grab you that? to want do

Andrew Sassine

in production Pete. right ARCALIS time Yes, we've terms substance. line now currently of the for They're of kind highlighted in getting drug sure. qualified. GMP in Yes, Thanks,

of to update this status what coming they pretty in there'll news are Japan be So be year. they're doing of and the to out going some for exciting. is And the that participating them orders from

on online listen want year. you be for product early next things the obviously, carefully. probably is going all to the are those year to And this So or either drug later

And then the within of business on should a couple years. plasma be

certainly X.X can the But completely CDMO vertically partners be States Catalent and in Europe. within of they terms we global here, in and our with Recipharm So the in the fill should meantime, Aldevron integrated. United in void and

to have the is us speed. get help until where strong ARCALIS So core up void of partners able really to fill a we to

and it's determine they can vaccine X doses, to the lot going have they certainly other if to CSL a billion of Obviously, export up opportunity a make to be whether -- to countries. Meiji to chance

so by that will decision that be be with respect made that will helps? Japan. to And Hopefully, a and certainly Meiji CSL

Pete Stavropoulos

Yes, it does.

a the program. And question on so CF

X having you're doses. So

Just doses alone much That's develop is either from when safety respiratory I other that potentially actually how one partnership comes do program perspective And on perspective guess, a curious to with virus, the it of the a drug? you CSL? question. or X cystic from the any can one to vaccine learnings fibrosis an in derisk, inhaled

Joseph Payne

Yes. Pete. want questions? the do those Good to there, to follow-on -- respect questions With address you

Padmanabh Chivukula

Yes, sure.

In CF, see to terms single what respiratory want that like there's the et side coughing, cetera. to we even safety, is chest we or with doses, no make the effects, discomfort, really want sure X of

to also think I like of end at We secondary safety want doses. just we from X look So can tell for those all points right? things some fever, example,

we're forward to looking So collecting data. that

Joseph Payne

toxicology reason the shared team it's first have lot They challenges our in experience the therapeutics been us is And doing in they've why has X therapeutics, you administrations. is do do significant, this see inhaled with And of for inhaled a or with here. problems decades. is internal too, what that

moved through get success this meaningfully is the probability has why so And for up we successfully, this this if trial So trial of important. that's

Padmanabh Chivukula

positive, data is And in the proof-of-concept. question, it get -- your the obviously, mean, mean platform? the data I and what will positive do second for we what of if is part the

vaccine But expanding other diseases -- thinking as that diseases also as can applied and potentially about other rare this or the potentially course, We be platform, of need nebulization. well. a will

Operator

is Arce from question next Ed with H.C. Wainwright. Our

Wing Yip

regarding mentioned Yip first is decision Thomas Kostaive Andy CSL of couple the other is questions or So territories? Are Europe from expected -- either or So approved Japan, into in in question and that or any believe from I regulatory a plans any for this with additional Arcturus Meiji, expand This to from year. plans asking there

Joseph Payne

course, those the getting intending that providing approved say to we as U.K. that, United year But Yes. filed United the next and first Europe market, we this the is CSL Kingdom shortly driving is -- be this of that at the expect Yes, in we're and that's approvals also will -- to States. guidance then they'll be And efforts. then be on big After when is and approved. States. Europe United point regulatory thereafter. can what and going

Wing Yip

perhaps then in quickly recall We Europe is ARCT-XXX for and how the II question Can so OTC. far and slightly was II past study? discuss the the enrolling study Phase one in you And delayed. Phase Understood. for study the in Roman

Joseph Payne

program. With to guidance of the some track interim readout QX. that of -- That's end of the end provided Yes. remain we the And respect that for we QX. is data that's status on

Wing Yip

then And is perhaps it. final run Andy. Got one Okay. rate. question. one for This Cash

Japan now Just does from XXX in perhaps Europe well? it in revenue wonder, Kostaive projected or any as include

Andrew Sassine

years No. for any least cash not guidance include from include question. The of the and Thanks commercial that runway from at any revenue CSL. for X asking milestones did not did Kostaive

runway. cash with we'll So to as respect discuss as soon the guidance we're to the update able those,

a in soon. hopefully, within so point achieve do company. expand we milestones that a the we be of to And pipeline But to this be at year, to able number the enough have are long the will certainly runway very critical which this able to time, opportunity to

CF certainly see X hopefully in the be to and to be vaccines and opportunity and we're excited some pretty able next we're few the going now So resources able launching in opportunity additional years. the address be and the progress to that to OTC have

going with pretty a be to to enhance are exciting forthcoming hopefully number a that be shareholder So year to and value. respect milestones of able

Operator

Jen question Company. next Our from & Laidlaw with is Yale

Yale Jen

In the you How market, -- year or evolve that Or future? guys government? see? also whether to commercial mostly maybe in in effect Japan's is terms this a that there's do is of still Kostaive

Joseph Payne

That's question. a good

Andrew Sassine

mean you, that they're people include position Thank kind the doesn't are at news, Yale, given be vaccinated well. if so that what people good million for going the the chronic have in million I Yale. compromised to And of guidance just over or the right? a then that you population XX look certainly support, Yale, pretty is that's substantial, to right? to to has going XX government people, to of XX, want be are right, a illnesses, that as And

maybe a at of population, significant people. XXX you XX% pretty of XX% look XX%, at the part that's when to in So something the least million that,

not remember, the substantial, quite to that's trivial. Japan. So we're going it's a right? And excited in made And it's and opportunity, very be Meiji about so vaccine

the launching supporting So of that and this be proud there's it of. proud I CSL, is think very a is very government lot now. and Meiji program to is certainly, globally excited

lot behind news of a it. good there's So

really private about Meiji a when going point. make But time what something terms not the will is it's those announcements this be pay, right. government is all that concerned In to at versus we're pay of

Joseph Payne

the the is the only I And would subsidized help strong to flu record with vaccines add Yes. that in with working has with space. track Meiji to government a thing these that

been and before. partner. doing the for years, with they've we're done ideal this working So this That's

Operator

session. over We would comments. Payne to reached call closing to the have now turn question-and-answer of Joe the for I back like end the

Joseph Payne

And remaining always, back Yes. get Thanks, questions, the everyone. any can. team. night. we Thanks, if reach Good right. as to We'll everyone, you for participating out call. on to as the All there's don't as to hesitate, soon

Operator

today's concludes conference. This

You may time, disconnect and your participation. at your lines you thank we for this

Arcturus Therapeutics (ARCT) 7 Mar 242023 Q4 Earnings call transcript