ARCT - Earnings call transcript Q2 2020 | Arcturus Therapeutics Holdings Inc.

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Operator

Greetings, and welcome to the Arcturus Therapeutics’ Second Quarter 2020 Earnings Call.

During the presentation, all participants will be in a listen-only mode. Afterwards we'll conduct a question-and-answer session. [Operator Instructions] And as a reminder, this conference is being recorded, Monday, August 10, 2020. I'd now like to turn it over to Neda Safarzadeh, Head of Investor Relations, Public Relations and Marketing. ahead. go Please

Neda Safarzadeh

and operator, everyone. Thank good you, afternoon,

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

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

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

Joseph Payne

afternoon Thank be you today call Sassine, happens you, to which to for quarterly Andy joining Hey. Good Neda. CFO. also thank our all, birthday, today, and Arcturus

has STARR So, two COVID-XX diseases. and opportunities ARCT-XXX of stage a ARCT-XXX progress a respiratory Arcturus programs wow, clinical and company matured a by rare tremendous focused quarter candidate liver been. significant our and clinical what made highlighted within of development deficiency progress, vaccine OTC program. the mRNA the today corporate disease our into is which recent it's vaccines The infectious has on company

of overview advancement ARCT-XXX, with I'll into I'd provide is the we're to ARCT-XXX like highlighting known which by clinical highlighted is as also an programs. begin and about progress excited corporate Our these of so LUNAR-COVXX. ARCT-XXX each why studies.

and efficacy the balanced testing and following has well-tolerated we improved package, response, very profile clinical be product which with a lipid and for -- profile observed may an induction. We single two Arcturus injection potential low And robust pandemic we've trademark. ARCT-XXX. Medical by these studies, due the combining mediated we administration registered called utilizes safety mRNA STARR a to may of low an side vaccine, vaccine the COVID-XX improved potential clinic. differentiated and dose, seen reactions, single our immune responses robust of observe delivered and of lowered vaccine when particularly LUNAR, injected mRNA have as characterized and is preclinical Our a system of the is and to potential is incidence we're what is by humoral developing strong candidate combined shot T the technologies including mediated self-transcribing and Duke-NUS a extraordinary cellular STARR, T anticipated in in based effective or an these preclinical immune cells a CDX delivery partner this School. demonstrated preclinical supported also on ARCT-XXX replicating in highly cell technology, Arcturus vaccine, provide with durability which This cell and extraordinary trademarked ThX/ThX our a technologies, with the administration. And response, since ARCT-XXX. dose ISRs with observe we CDX a efficacy By may

Further, to out virus neutralizing to resulting We continue a antibody potent titers again a low in have dose, increase seen at after XX dosing. antibody neutralization after just strong response, a administration. vaccine single days very

vaccine study which study Medical has adults screening, immune Phase response older and vaccine the will the viral in XXX ARCT-XXX, is evaluate few co-adjuvants. within healthy in dosing, with Duke-NUS the collaboration young next we're completely School cohort viruses, days. initiated first anticipate of no X/X safety we of and adjuvants, The simple, imminently and Our adults. conducting devoid both of no volunteer no beautifully there's This and to vectors, up

clinical the transfer product to our providing manufacturing We vaccine and completed technology sufficient COVID our continue processes support advance We vaccine to successfully studies. activities.

have pleased manufacturing is We of of now second recently agreements and as we doses a signed stockpiling vaccine. hundreds in doses Arcturus completed a definitive of and Israel sheet made millions and of XXXX ARCT-XXX to the With to shortly. well-positioned the to annually with thereafter. we continue term Arcturus Our serves binding Discussions and addition agreement, millions process Singapore manufacture towards has potentially with reserve pertaining supply supply to progress. Ministry to country, countries supply to expected is COVID-XX support campaigns is to of the manufacturing to supply foundation now progress are which with be larger the our come. Israeli proven in to additional partners, Health

Now, moving on ARCT-XXX. to

advance to continue prevent with ornithine ARCT-XXX RNA patients utilizes limited clinical X for the to transcarbamylase preclinical expected a on deficiency ARCT-XXX data is improvements LUNAR protein murine restore the ornithine and program robust deficiency. plasma transcarbamylase models, liver delivery transcarbamylase ammonia neurogenesis a ornithine normal OTC our activity liver by platform deficiency to disease in for treatment damage urea ARCT-XXX need It's We to options. transplantation. like lipid-mediated volunteers. survival. is deliver liver. messenger been results Arcturus' and in with is in being that developed serious study enzyme supported OTC in and call of healthy Expression of OTC demonstrating strong LUNAR-OTC of that and to increased activity, and Phase resulting cycle the all ARCT-XXX potentially and the remind dosing neurological expression I'd in that's

months OTC Our clinic, been been study, program is now observed. reactions Phase no required. into the No related the infusion have two in and steroids now X pretreatments have

we provide us details our are ideally and later respectively. initiated enable engine mRNA this will familial to recently significant programs and also a the our intravenously the resources more both proceeds been So, Driving each targeting clinical Influenza vaccines in dosed hypercholesterolemia LUNAR-flu approximately opportunities to in programs, certainly detail to gross commercial progress made more ARCT-XXX our will Andy therapeutic pertaining flagship cardiovascular in raising very significant for we programs our suited being company ARCT-XXX to is requires year disease few and for minutes. promising address excited believe and our two in new condition. technology provide has therapeutic. million and call. Steve LUNAR-CV about successful R&D this $XXX advance and influenza are We've understandably and

Kurata group, In as in biotechnology the progress we as across to team and with welcome a a member and sciences have nationally from expertise. addition he corporate Legal a and our attorney leading Group. in life transactions. recognized focused Life company. Life Practice intellectual Mintz, legal Lance's of to joins partner pleased pipeline, Officer. certainly appointed have recognized the the made Sciences him profession Lance our is I'm leader the property our Sciences transactional was to corporate Chief strengthened leadership where us the and R&D Lance we Lance

have has that development lead added, who thrilled to programs. vaccine join of have our influence Kelly Novartis. the at and from of COVID-XX Dr. to our vaccine us agreed influence We We're Lindert her Lindert, and our joins vaccine also she led prior Dr. franchise, to including team. Moderna

on our development the We on to Steve be remainder the exciting obtaining for clinical period our expect you, Steve, mute. year initial programs. to from data and Arcturus. ARCT-XXX. you look stage forward more a I'll very of to provide programs, detail ARCT-XXX call We pass be clinical to to two on now ongoing the might

Steve Hughes

After candidates COVID-XX. mRNA, well spike Remind modifications assessment I'll we Thanks, the protein, process, in candidates, different screening full of that Joe. a multiple on as a was comprehensive mRNA you, conventional evaluation for the replicating expressing domains both version. of I and the different mRNA vaccine modified spike as start preclinical self and length ARCT-XXX, selected protein. goes of self replicating Yeah, ARCT-XXX, a on mute. with our

and will Medical X being tested a both immune in of response seroconversion a doses pHX a subjects in to biopsy with rapidly enabled plus Phase with aged accelerated And number seen in would neutralizing larger us data cellular it be has study Authority, the adults, we escalating move a there's to The We studies. The a to XX injection XX part administered XX response. XX. animal low with years Our old. antibody with doses. Singapore, and administration has as two study collaboration robust screening ongoing allowing X doses is Phase in there. older robust dose dosing X of preclinical Phase response into to demonstrated Singapore selected well CDX helper parts. with and the data will to discussions Duke-NUS commenced clinical single be has studying have Sciences close adults then at adults as Health CDX These and School with response commence X/X XXX% anticipate studies in our conducted younger younger In single in low microgram single into

the trials. favorable looking to initiation transition the discuss to plan initial We to clinical ARCT-XXX in with forward transitioning of are stage QX program. a rapidly I’m late obtaining clinical we timeframe now and data data

at this other plasma U.S. exploratory based five endpoints, end. dieticians on XX to preclinical volunteers year will with We’ve related for Xb help fourth first this in study, cohort Our subjects to Zealand. that clinically urine. subjects this OTC conducted study Xb X September. levels study the ammonia we the the ongoing being in levels cohorts, to In acid changes which being patients Actually, therapeutically the on we background Phase elevating track remain dose three healthy plasma dosing multiple three study therapy. screening significant fact No In conducted study we’ll the no multiple relevant lab including on is is start In of in no study despite adverse events. by reactions, in Based we’re most ARCT-XXX. deficient the ureagenesis, selectively will activity, in significant dose plan subjects first And and on dose of diet. within the levels expect will this OTC New sites values given. in infusion And and evaluate Phase is our motivation occur steroid-free and all orotic week. the data. study being guide is complete biomarkers completed evaluate

Finally program. Fibrosis Cystic for our

LUNAR and in have in the deliver seriously We promising filing cell now the effectively cells to on collecting later approaching to is RNA I'll able this our showing And cell effectively technology non-human platform to delivery messenger candidates data we Andy. to to primates steps that mRNA forward submitted. bronchial pass rodent epithelial IMD And year look XXXX. is additional on development and to the call surface. an translated

Andy Sassine

offerings. our all welcome institutional became like And of thank to their everyone, A highly sophisticated shareholders our number not would Steve. Without investors investment you, existing raise month. an I helped validation, as for good would and public of shareholders, behalf like the last Board, I support shareholders management million raise. us of our our existing and been call. $XXX as Arcturus, we the for of our to grateful successful new in of new and support investment recent biopharma this and team would their to Thank approximately we new new the which On part afternoon additional funds with are have

fiscal our including to The shareholder continue diversified and summarize. strong release issued our revenues driving and development includes source XXXX, public offering. raises currently for April of and will recent very with second company year provide our resources financial shareholder payments $XXX a Arcturus’s enable biotech I statements base, arrangements the earlier of research essential the primary obtained advance this have and through from to approximately The We which arranging from offerings, quarter of collaborative press and today; is pipeline capital combined partners. million pharmaceutical licensees will briefly received value. –

the quarter second million For The with the associated a of reported $X.X with second months in primary the collaboration quarter collaboration decline $XX.X compared XXXX. OTC from XXXX. $X.X the the in ended relates for to the revenues reason that in million, revenue, XXXX, of CureVac million in company of reimbursement primarily, June three decrease ended XX,

$XX.X same Singapore were million recorded related three we license awarded CF genomic expenses and $X operating by vaccine Total for The partially XX, June contract XXXX. synthetic for approximately ended current months of a the sub quarter our $X.X million, signature. XXXX period compared $XX.X with quarter the $X.X in under in earned Additionally to funds the of of expenses one-time XXXX worth the funds million Foundation. million revenue million operating the offset

offering share. at successful cash of added to $XXX.X per Our balance and $XX.X cash cash of XXXX. June $XX $XXX.X XXXX the company December our XX, the proceeds quarter, from to million totaled of the million end net Subsequent equivalent as of million public XX, at compared

position subsequent sufficient support been million. have for $XXXs.X the raise cash more to two expected the current years. our cash would pro Our pipeline, on current Based balance, is including to company's than forma be operation

the our achieve shareholder institutional our investors I We comfortable biotech recent manufacturing continue believe has update needed forward a vaccine base to COVID-XX our with meaningful company to position. to ARCT-XXX. provide to pipeline strong We would drive cash progress add regarded offering on current value like the resources highly our public are and for milestones. from an several we creation to

have ensuring And of importance a expanded we we by into We we the the our discussed capacity a placed have Catalent, our manufacturing base demand producer biologic meet vaccine. the partnership previously in products. on to of leading entering May, anticipated manufacturing advanced with have

of drug technology XX-gram successfully substance. have to plan the We completed transfer Catalent plan and batch

of to to capacity thereafter. of plan. continue Our hundreds to And this ARCT-XXX doses have doses year, been manufacturing ARCT-XXX to of activities millions proceeding of and we expect of the have produce millions annually

please back For be call more shortly. details, refer will the to filed pass I'll Joe. our XX-Q, to which now

Joseph Payne

a Sure. it definitely portion feedback Q&A, was during Thanks, of of him period with think we I call for just before got that progress It's hear. proceed Steve's And that some Andy. been remarkable to for we difficult Arcturus. the

he through. asked script investors, been if reread that just a we've So went he by few could the

then hopefully time. Steve, the proceed and we'll So thereafter. if clearer it's right, it can bit be a little okay, this a Steve, second, Q&A give connection All if you will with

Steve Hughes

Okay. Can hear you time? this me Thanks. No better problem.

Joseph Payne

Thank you. Yes. Great.

Steve Hughes

and unplugged apologies put so now. my some different ones headphones Okay. for in, Yes, just

again. I'll start So

both our versions. conventional starting as mRNA ARCT-XXX a encodes with spike different with So, screening full-length vaccine well XXX the for evaluation an of self-replicating self-replicating a messenger process, that we spike of multiple expressing unmodified comprehensive assessment the messenger program, and in and protein as selected candidates after preclinical different protein RNA modifications domains and RNA COVID-XX a

a data low neutralizing Health clinical authority, and biased data a Sciences dose to into Our us in discussions response robust accelerated rapidly to administration a our and with doses. ThX preclinical X/X low response younger The Phase cohort an with XX tested CDX+ commenced in older with and animal the administered XXX% of well be of anticipate dosing than immune X move parts. studies, younger selected the to These doses subjects study Phase robust study seroconversion at collaboration Singapore our we doses School old. conducted X, adults number Medical age. injection aged The T-helper antibody as for to XX screening have close adults adult of single will years will and two as We’ve ongoing and greater microgram cellular has The escalating with is demonstrated allowing be both Duke-NUS responses has the larger a enabled study CDX+ studies. as Phase In XX Singapore. imminently. response. the years part, includes being in single In single

favorable X the clinical five of In initial obtaining discuss early We our XX late now I’ll Phase we or QX looking ongoing transition data, QX. data plan enrolling in New study, transition levels clinical this to dose forward study, Zealand. we're healthy volunteers ARCT-XXX. In stage are to This rapidly initiation to trials. ARCT-XXX. to in we're of evaluating

multiple no We have complete The significant that New the local reactions, being the haven't no cohorts pre-medication any Zealand we Phase completed anticipate difficulties occur over three changes study In control, any in don't study, with days is evaluate given. which for the of diet. to been will to subject’s U.S., this significant plasma with Phase therapeutically no the multiple of steroid by track acid cases our the situation lessons levels relevant OTC three the dosing this will be AE, on exploratory ureagenesis, XXX plasma now, in lab fact of subject week, OTC-deficient Xb study. which endpoints, there we urine. guide we all to therapy will to based study The related background conducted and study, year-end. data. fourth first with and no all of means cohort is Dosing values, other clinically is In study, the expect Xb in first on COVID completion and remain subjects activity, being and under the that infusion the despite screening the evaluate and orotic September. will upon XX levels, biomarkers dose ammonia, including patients is in start help plan in predicted at dietitians dose sites in preclinical and

we finding later rodent the Andy. data development to in Finally, turning on non-human is that I’ll showing that is RNA promising epithelial and have able expressed forward on LUNAR platform to program, effectively to to RNA delivery call year, messenger this primates, messenger pass this to our translated fibrosis and effectively and CFTR now And the cystic is cells bronchial deliver candidates our technology pellet we IND surface. into the look in protein cell selecting XXXX. an that

Joseph Payne

Well, back it's milestones you come Thanks to for This open anticipated ahead look Steve, later an progress. in with to I me. fine Joe. clearly call readouts continuing now is on provide operator, clinical we have to updates time We data think appropriate this is And year. and exciting questions. to the our forward to

Operator

from is Certainly. Fernandez Instructions] ahead. first question [Operator Seamus Guggenheim. from go The Please

Seamus Fernandez

that for your particularly you eminent helpful that? dose is Great. actually questions, things. that dosing. achieve a script. to -- bit bit be help just -- understand Thanks you a taking about us if how for just the you Number separately, little couple could of can attractive, timing thank prospect my understand talk and guess, of for us just you -- better then bit also be perspective, something one, help a can Joe, for little construct And will said thank single think you a little a is would you the I repeating could the for having I and

eminent general hoping can that, little it's a bit quarter or I seeing, the how to week? around And is of data, the finally, quarter, of you many brackets when end give of some of Just see a just the a sense us sense of you of then, is towards that data beginning third we this and what should – beginning said. think, fourth worth guys the anticipate the patients we get

that So a little And you hope then press into or with. question announcement? release of, bit up I'll an can to a you one just would what clarify I last follow had incorporate

Joseph Payne

prior the the to Sure. to questions. looked the Seamus, joining imminent, dictionary said With call and respect for for very-comma-very-soon. in it and I the word today thanks actually Hey, the it call up

may the soon. in So mean? what what And will respect with the potentially -- and does you begin do to a respect the a tuned. next so days. will in on be address And heard me, there is this be imminent first that the of the very-comma-very-soon very substantial true addressing it's that, vernacular to just data, have the question. data the we data respect be I'll I call we're stay dosing. today use the data preliminary With why by word shot, to With by I QX. the QX. language to but is QX, Steve messaging provided definition weighty timing team some It's Pad few with But but of that

the Our of protein delivery that vaccine preclinical or self to continue weeks, technology, two to called set and mRNA technologies, our replicating COVID-XX shown system of has XX so kinetics mRNA over extended link in neutralizing contains three duration a days. antibodies a replicating for self If period the a that full expression increase LUNAR. expresses data spike the two

vaccine, internally see in You just vaccines. do that experience other especially messenger with conventional with our any not RNA data

a technology to the that. of may been durability at a But requirement second how delivery remove shot, for play may that to kinetics that So continues it duration proceed. the extended delivery dendritic for I'll as leave technology, the respect cells optimized because well. to has action delivery or With role

Seamus Fernandez

predict the what a that is we're -- follow then as preclinical wanted expression any just a your Can I to low if guys study. effective enough dose? bit be in just of very of think your that for could bit really get the little give kind And would you trial, the you immune escalation levels as or of and response? that the you likely drive to seeing to in color but a a robust know studies, with just just I regard, preclinical studies characterize a structure provide entering us know to are question. up where would you dose safety little regard

Joseph Payne

dose, that With microgram address him dose respect will I'll remainder can to the -- let is what's initial be question. initiate but dose the the to effective your the Steve X call. comment of the microgram or I on single study, I'll a

Steve Hughes

Joe. microgram dose from and all The is the dose Thanks, we're I'll for have RNA we're dose. that X other then they take escalating Yes, dose there. actually that. with than Phase messenger highest a their of lower Starting that X vaccines testing still chosen

low and we're within very, very low So doses. escalating the single double-digit microgram range low are still

on, stated the tested And anticipating that into subsequent previously range. a we've therapeutic clinical question? last and than going seen that we're that. call, As somewhere the be hoping microgram to earnings the Does I think to the effects to X-to-XX dose we're human's further in – responses difficult the range take until, stands your But and trials. and answer comment dose in forward it's up that's

Seamus Fernandez

you. queue. Thanks. that's the back I'll No, Thank jump Perfect. in great. Yeah.

Joseph Payne

Seamus. Thanks

Operator

and line Baird the Kumar from go Company. ahead. Madhu with is Please question of next The

Madhu Kumar

messenger one those prime so with those a likelihood starting Hey, kind dose questions, of what everyone. two like possibilities robust doing do than for booster, for Thanks taking profile and the about To think vaccine single another? but existing person versus one and a ARCT-XXX. how idea of the out safety kind for our having better of you a plus is versus vaccine, your another potential of RNA extent

Joseph Payne

Madhu. the is for Joe. question, appreciated. Well, This – yeah, that It's thanks based on

reason, for for scenarios we've what But could expected think some etcetera. booster comorbidities, or of the preclinical likelihood single want But based to sort whatever realize we've whether right? sort due individuals people data those to you the it's collected, subpopulation. do it's be that happen, shot have elderly is of well, What both of upon with single prepared of as We or these sufficient, administration immune to was there's either highlighted a as respond, to is is subpopulations of we've that each of and collected suppression data seen bit every them that's that suggested. reasonable. if not some and I that pre-clinically important that, plus a the

So on, other which single very administration clinic. administration I at either. with We'd all focusing be are But our the best think we shot be we intended ultimately, would a least data pun and But scenarios. shot, both are that because differentiating the single have two the that fantastic vaccines. in happy to be to give we collecting, no would administration, one

Madhu Kumar

like Okay. pun Joe was T-cell see don't do you believe data – need there, the that is us? profile on shot single clinical I what is good for But Like, sets, have the shot? a what humoral be secondly, out antibody I and clinical based would works profile profiles for to you believe yeah, intended. a to we most like this the think single

Joseph Payne

is what been But to Right. antibody humoral response they induction. this you're in expect to you've with respect CDX I cellular and Well see seeing seeing to-date. not especially the clinic immunity from fully is would additional that we're going and response, seeing what strong vaccines vaccines as enter we're the a a clinics

there titers that's days, different over So neutralizing antibody our focusing on different. that to XX shown humoral immunity, is how pre-clinically continue increase we're we've

will does is will hope T-cell vaccines it see response, what out in efficacy means well. prove could to go sure than we'll that to models same thing duration more mean and up will neutralizing respond there, robust our but the of the we've that higher haven't that, It seen is the response as vaccine differentiating studies be and in something and that Because that. durability the see – preclinical we a so, percentage with rates as that or the there. well. that, to-date other prove the so to these of extend other ultimately we But it got we will CDX vaccines, even protection the, our out saw people does animal, mean is it if also humans? We that vaccines antibody that that got titers So have of mean we've that higher the and

we as very in that as that clinical can So, data. early be be CDX something trial will that interesting is will early to learn induction this

the addition data response. and growing to the, neutralizing increasing humoral the antibody or In immune

Madhu Kumar

a Okay, question then great. And thinking OTC of so the for Steve, program.

steroids healthy profile regimen you infusion OTC the in haven't the per could patients you any steroid urea disorders, for therapy difference seen treatment? have need Is haven't far terms there to that So, deficiency so in that different that as might be that steroids would such to a need they require reactions seen of any ISRs, any think are cycle healthy of reason in a volunteers. course with there compared volunteers

Steve Hughes

to Thanks. That's no different volunteers great way. or the view healthy terms the drug in We're of directly to infusion. the to immune population will data a that point to of a at and there's population. is going From confident we're of tolerability patient of the the the the translate in safety reason their all system and seeing question. react No, believe that patient

Madhu Kumar

Okay. And kind patient that of healthy into that looking volunteers being all Xb of PD how kind a could healthy then What done of that you're PK you study in interest urea XXX the help of that mentioned you OTC kind from of stuff. volunteers be cycle give study, is or people what from was at is the are ahead -- Phase data sense the assessments there You patients? done? any feel working, point interesting of to of data from to and being

Steve Hughes

-- lot the of are to all question. obviously, your population, cycle factors like of the normal. volunteer the I Again, in-house factors, urea The Yes. relating a

they're applicable, urinary they're in such not it. orotic the people and a ammonia change a except tightly levels So, volunteer they're neglect aren't of going healthy etcetera, not to in acid several biomarkers cycle as because regulated just

we see this is would that improved biomarker four as we five was informative with doses dosing, successive do did the we looking study. be move. Genesis, a at hopeful over be data something saw that single It But previously; studies would great something are what we're we animal if and moving over, your administered. said our incredibly post see that in We

dose study or to single study. expect anything don't And doesn't in the the more in we study if volunteer even we're in a going so to And patient bells any ring move and multiple that substantially dose alarm biomarkers in see populations, anything. healthy similarly,

possible of significance the we quite Was to that see single statistical achieve answer-- studies it's that biomarkers. that just don't in bump enough a So dose on

Madhu Kumar

PK of you're how readout terms kind study would you time. good of the volunteer there's meaningful think like over exposure no be But in that just tele getting from

Joseph Payne

volunteer to So, is have readouts anything a healthy sure good idea about CK a CK. is expression we going of not while urine from the really plasma give the CK us what both do protein is testing in phase in I'm study like. and

safety the in of volunteers, to longer bit the that to trying But yet, to some get on be constraints person. system develop we're So working But normal, able we're in out. taking healthy it is critical as biomarker so enough give detect than back. our a in biomarkers. the is let’s to for we one normal the with have vendors a everything's with the particular changes a see to that the to trying regulated little biomarker say, actually that That's don't changes sensitivity a data handle kindly That's come on challenging. person to normal data

provide with I have think. an later update So, a to on at we'll you that call,

Madhu Kumar

Okay, excellent. Thanks everyone. so much,

Joseph Payne

Thanks, Madhu.

Operator

question line Please ahead. is Li next of go Ladenburg. Wangzhi from The with the

Wangzhi Li

to Hi. escalation the for dose data. that a Andy. the included vaccine just another first data expect I is think also where Whether my name. it think dose new quarter this question And is week expansion I Thanks think clarify Happy Birthday expect fourth year, to data to should question. My is COVID-XX or I the taking you a about this ARCT-XXX,

Joseph Payne

Hey, everyone to the there Phase and we a this phase look on escalation at that X/X as to periodically. we then transition expansion encourage dose dose in Wangzhi. phase, will is ClinicalTrials.gov study call definitely Yeah, updated a so

So, with the data is Wangzhi? out, just guess question, correct respect to -- I to rephrase your out when come trying going to tease you're

Wangzhi Li

that we wonder, quarter. data because Just got you the fourth in mentioned

Just dose and dose clarify is the escalation be data expansion that data? escalation just post-dose or cohort will

Joseph Payne

response, responsive of data, are escalating And early dose that into is improve the timing if one of of we the our sharing timeline data. doses Well, if that microgram. X starting in more can terms very and see be people only cetera. levels et But would from simply the package, complete fulsome and study dose to there'll multiple hearty then we dose the then the evaluated not want but a efficacy, data share the

general, data data we we're what sharing and a But, a be doses scenario for messaging, substantial exceptional earlier. and always to the the expect just messaging QX, course, are But right in early is we'd conservative for set QX those package. now shared. there's So, for of value, is but what material where of to have share

Wangzhi Li

beginner dose a is, it. a is at or compare on it do the cohort? you the and dose that Got escalation versus dose, the double is the for single as follow-up more dose both And expansion when

Joseph Payne

gaps the the and of but Well, can in and they've free Health under been fill allowed feel we we Authority. -- collaborative, are any Sciences guidance They've here, to wonderfully Steve Steve, working much at considerable what terms you would more flexibility And flexibility time. I is levels, the mean modifying same in dose normally. us – and flexibility see than you those by of do know,

Steve else add? have – do So anything you but to

Steve Hughes

the say to the – is that is want single I dose Yes, escalation dose. entirely

So as part study about move we the two valuate that's well. of to dose the some Phase as where into we cohorts X

detail. we're or of cohort doses a plan and terms X to same part in the than of all few evaluate is in to subject, Phase doses into not economical in planning expansion better the the subjects of time to those repeat as So, number more in greater escalate

Wangzhi Li

Got it. Helpful.

conduct trial. in to to didn't because trial Israel Singapore – there in do get those Singapore for them, the the path approval other you and Where what's draw regulatory countries? – trial are additional pivotal countries, And just high you or the other if or is you levels requirement Singapore also – – include countries, are example, Now few you countries? for other Singapore the even going

Joseph Payne

Go Okay. ahead, Steve.

Steve Hughes

So maybe thanks if I reverse take order, asking. and question the in for

regulatory time. -- on talk by -- let’s on very, In in terms all in very point countries part then of

China, what are really on we not you that appropriately pathway and all a and really clear regulators, COVID-XX don't If States of -- or guess, trials the the demonstrate we're the that's look is recent considering Singapore But I prevention The based there's will for on. more some rapid in the in, we where in approval in and conducting announcements been some approval, to you same laster to them other if in sized jurisdictions. involves that ignore a those some Israel regulatory example, have disease with clinical difference give regulatory already Europe. you countries path of and were United favorably Canada or approvals

-- that a a quicker approval allows So approval mechanism you particular they gives it have for regulatory process.

primarily there's requires will In terms trial late conducted initiate jurisdictions. in X those development, time clinical selective, and stage because multiple of geographies the areas answer events our can our the registration. the a and enroll timeframe that number of where a to study get required so of countries we and COVID-XX, presence question? that we to it at which different closer using And Phase different your to within a substantial Does quickly be will fast be get multiple reasonable

Wangzhi Li

that's helpful. on And program. maybe the OTC then you. lastly Thank – very Yeah, ARCT-XXX

look of you at you you the PKA PKA? what for look for the the or cell do at the the RNA in for earlier do the – mentioned exactly what PKAs blood, curious components Just messenger lipid

Steve Hughes

given pre-COVID, is is PKA vaccine low, not that of measuring exposures, to extremely the in is program. as going the The our given so a vaccine in OTC -- which really at compared systemic – a we dose measurement vaccine point which is – well, there's know --– low lot be at to – such in

OTC because… the it program in measuring we're So

Wangzhi Li

Sorry, for OTC the I mean, program.

Steve Hughes

Okay.

we for messenger really the yeah of or the measure RNA messenger to acid in the nanoparticle certainly ionizable lipid and the both measure in measure urine RNA part it's although, OTC the urine. also we ionizable So lipid, program, that's possible not in

lipid. the measuring we’re So

Wangzhi Li

with you last dosing? to repeat start OTC expect program. is Got When the it. my question And do

Steve Hughes

be to next we anticipate, said to regulators would protocol, our from the just sometime the we because the some the as results then volunteer healthy with we so doses. collect trial select need going And study, year, the to That's previously guidance… go clinical

Wangzhi Li

my for taking Thanks it. Got questions.

Steve Hughes

Wangzhi. Thanks,

Operator

Steve about And left as James. conference go ahead. from And the a Seedhouse question from today. reminder, there's is Raymond for the XX minutes next only Please

Ryan Deschner

Hi, this on for Deschner is Steve. Ryan

Joseph Payne

Hi, Ryan.

Ryan Deschner

standpoint, regulatory from or an to RNA size we'd benchmarking My what’s hurdle higher and panel, question also RNA, is data a database to sera studies in Phase X be the Singapore? self-replicating in safety complex in relative the length, a neutralizing conventional

Joseph Payne

A self-replicating the and actually one. good concept question, messenger RNA XXs. the has adjust The been I'll first since known

familiar familiar approach, a older next so the example. evaluated But the generation. with for self-replicating an technology is vector different mRNA, talked are of ours just this with like clinic generations or a that we've the of been Some has using very very is agencies with improved in and viral

So that. your you of Steve with component maybe respect to the question, second address can

Steve Hughes

again the Could sure. just component Hello? you was? remind Yeah, me what second

Ryan Deschner

with was I sera data wondering Singapore. the benchmarking X Yeah. if antibody Phase in studies the panel neutralizing come in

Steve Hughes

Yeah.

Yes, is have same do thing, we as studies, the the So is would intention. dataset interpretable intend our our others. published to we that alongside that so

Ryan Deschner

X mRNA very and the wasn't Thank studies you based one these last wanted across for doing this. thing protein how question. And seen in, into of events? no take modulate based biotech do to vaccine. mRNA you much, think fever, event Phase then Phase X, I it's in And second Okay. would to safety which on terms love possible reduce better you their vaccines in either vaccine going safety safety sort also candidate to of

Steve Hughes

less respect be I amount be lipids those immune entities, to can other With adjuvants we means be clinical that expectations trials, likely If viral efficacious initially believe profile Well. safety. a has at substantially the and And in will with repeat injected; can that burden to lipid amount RNA the well. around to human far to improved the in mRNA respond are would We directly with of the undesired to the that combined vaccine our then low related much dose the question safety lower and of and of very doses. dose responses LUNAR that less. level which words, RNA because technology self-replicating level. the remind shown be people dose the would viruses the is be vaccine, aspects lower, respect as would other I of that devoid and and vectors much to is devoid because the burden of

much So, clinical less to and concerned to time over tracking about a trial. with periods we be long have of in respect

Unidentified Analyst

you Thank very much.

Joseph Payne

Ryan. Thanks Okay.

Operator

of The B. next ahead. Mamtani line Please Mayank is Securities. from with go question Riley

Justin Zelin

for questions Justin XXX. Joe and afternoon, questions. all two Congrats I Zelin on taking on and progress Mayank. on quick here had the Good This team. thanks for is the

potential range could the on speak First, are agreement Thanks. of data in publication ex-U.S. XXX's preclinical for any And the to plans discussions other Israeli Ministry supplied of any you to color of with transmission? secondly, or on countries? sterilizing reduced provide the could doses what immunity, file implications terms for you generate and Health

Joseph Payne

Okay.

what release and respect may we're with data then We with a parallel here are subsequent peer we in data publications. in share that to preclinical to that data can Singapore. of look with respect to and collecting sharing how their cadence press trials release, reviewed initially form human of press in other share all, to of in data clinical additional with to companies a our done vaccines. going First other We have our

is we this just in of great with Israeli binding companies the of Ministry them, their had or term to strategy signed of Arcturus that large Minister vaccination experience their intend data sheet deal a we definitely to Health portions a do. population. the had -- part the seen of address a key conference where we cadence can after press a a potentially a So, one. the of had And they they share you've with clearly citizens other with they respect With that Israel, Health, Country their significant to communicated that

but So, and other considerable. their it's we reiterating can a significant questions? And the their view that I'm deal that's talking how they just conference, it very that points communicated from any be press also same so it it

Justin Zelin

very and Thanks color I great, progress. much. Joe the here on appreciate once congrats That's the again

Joseph Payne

Thanks.

Operator

it We're closing Joe out today. turn Payne any over for of to time I'll for comments.

Joseph Payne

to and Feel out reach to free Bye we're the going for for everyone thanks you close this just call. Looks will any always have if Hey, questions listening. we as efficiently. follow-up now. at respond point,

Operator

That you for disconnect and can you lines. conclude today. thank for participation the call We conference your now your does

Arcturus Therapeutics (ARCT) 10 Aug 202020 Q2 Earnings call transcript