Provention Bio (PRVB) 9 Aug 202020 Q2 Earnings call transcript

Good day, ladies and gentlemen, and welcome to your Provention Bio's Second Quarter 2020 Earnings Conference Call. [Operator Instructions]. At this time, it is my pleasure to turn the floor over to Mr. Andrew Drechsler. Sir, the floor is yours.

Operator. you, Thank all quarter you us Provention on And results for conference second financial call. Bio's thank joining

Joining today's Hoitt, call colleagues: from the Provention Bio CEO Co-Founder; Officer. Ashleigh team and and Commercial Jason Chief Palmer, are my

including of prospects, preparation indicated same. of across may factors, and forward-looking for important activities the materially including recent Factors future. Actual precommercial potential Any plans and a as statements file discussed matters our let developments and forward-looking Act these teplizumab timing today including various teplizumab commercial the forward-looking time harbor statements those annual of from candidates; and include runway; make Risk the our only. and safety, the provisions XXXX. success of business remind use our we on business is of the the differ potential of COVID-XX Private for anticipated those cash product our and in the our today about and our of purposes potential projected planned in constitute by that that as with various half These statements the First, SEC for other results on XXXX company section the other we which remarks result future plans, me in BLA; Securities and the of the results, including will filings second efficacy with approval Form XX-K, under of regulatory financial clinical studies for cash teplizumab in in and expectations, clinical report and SEC most on the safe the you may projections, views lines, make impact Litigation statements Reform our represent the

documents to views the we we our the disclaim may files today. date so There not specifically views obligation future, XX-Q management's to in these today. at you statements, of I our encourage uncertainties website these point Provention and our me information carefully. discussion Prevention's as even regarding financial of elect to earnings under if These forward-looking and our filed Therefore, would We is as review being statements was rely you risks with to forward-looking at complete are statements our the condition. at on change. SEC. that factors you XX-Q well encourage The financials. do QX documents as With While any includes forward-looking as our and risk to section. also analysis our reports these more subsequent any please Investors available financial representing read some said, statements, should update the www.proventionbio.com, release to in that allow provide

our XX, for proceeds share. offering. includes Ashleigh loss preparation million This teplizumab-related to primarily $X.X $XXX.X $XX.X quarter follow-on June $X.X the $X.XX and cost of cash, quarter in precommercial equity the expenses. medical basic net from As during a per the net as The $X.X million proceeds CMC the net million XXXX, program and equity generated our follow-on $XXX.X marketable P&L affairs BLA million, million of diluted balance was the of cash securities detail attributable well perspective, over second loss a we the year prior prior was net which costs costs shortly, of From balance the common million. second increase or will stock as equivalents at-the-market as sale of of to June under and offering of as from well

share. Our the basic net months XXXX per of X or diluted loss was first for million $X.XX $XX.X and

activities date. of cash the and our and of continue infrastructure focused XXXX, X operating U.S. Consistent in potential half manufacturing and in approximately first was teplizumab second for our teplizumab and with first U.S. year. and our and on ready The regulatory particularly our in second key and operating for approvals current lines X months Our for our driven a million we to $XX time organizations, $XX were regulatory teplizumab's ended the million. to XX, expect XXXX as needs preparation the to by of the out months plans, launch manufacturing the positive continue quarter to in we use was next to June scale $XX.X build spend marketing progress related commercial CMC, activities cash-based million expenses precommercial commercial for in potential

fund an operating With We update launch will that, to be expect approval me for on over projected the cash Ashleigh potential and to securities that our into turn current equivalents teplizumab. let and requirements sufficient the teplizumab. marketable cash, to call of

Ashleigh?

and initial transformational you parallel, for BLA Thank X, you, all with TXD, teplizumab organization and the light strengthening market business the Initial or our will for the groundwork value FDA we diabetes, plan in symptomatic We to reinforced quarter or the you we recently goal across for are in of presymptomatic potential in setting insulin-dependent rolling on data, us the launch. joining approval further assuming teplizumab, for today. which mid-XXXX. implement thank the and tremendous clinical made today, progress stage review, laying building priority of a some teplizumab. a key confidence for completing presented research, potential our lead In of of all XXXX share opportunity to Andy, as targeting launch especially has of candidate our proposition of delay patients, our our bring also submission type continue as the our to we remain known In prevention our market increase we achieve to track for patients. PRV-XXX, X areas

of these approximately data onset emboldened insulin-dependent the by of X from the course patients XX-minute ADA's years in of that extended teplizumab, the show At-Risk a we follow-on of scientific were daily TXD weeks, data consisting significantly by Study at These Specifically, June. X TNXX presented infusion the to a sessions presymptomatic in median XXth single continues a delay another X-year clinically of over adding Medicine X England placebo, the to New previous highly and increasingly to of statistically which precious. are only months, X year. results be weeks of or would highly not compared delay days, X months about delay XX they We're talking a in median Not all reported the significant. as remain last relevant, Journal

the patients was family. presents year's beta Ask new this delay of delay data the and any our or life-impacting were or conference, Wow. TXD system confirmed C-peptide presented signals patient presented a beta insulin-secreting receiving but a cell a X TNXX X Consistent characteristic of serious at not believe insulin relative the production. increase placebo. The It's is cell presented in cells, in which reboot disease-modifying in year's of a opportunity functionality the their cells that own with destruction secretion. No underscores insulin recovery therapy restoration levels, is the only an preservation suggesting type restoration of beta C-peptide and data the follow-on their which autoimmune teplizumab life-threatening levels or demonstrated just destruction, decreased beta or as and cell study a this that ADA for potential immune of the delay reset and person's of in to also sick investigational a In years, at the disease. dying C-peptide, function measure determined diabetes, first of of by incredible. administered autoreactive and time, We of ADA the progression but data course single of safety teplizumab. a T TNXX patients contrast, the further

highlight our extraordinary Leni work, Chief in hard when CMC rolling long BLA leadership the plan rolling Biologics. to remain I teplizumab would the file we are our getting President on and quickly submit and outstanding end consultants, undertaken our and also teplizumab possible, under BLA selfless our efforts, Dr. submission like partner, quarter the of to being clinical Provention this X, employees TXD Officer, the of modules. laser-focused Senior dedication complete track by schedule Medical module Sharon on Dr. of submission. of are our BLA and work as We Roland. we and and speak quarter by the cannot Ramos; the We progress Bio team community highly Regulatory manufacturing strategic of efforts Affairs, excellent remaining AGC on full hours more I with to the as our to making Vice of excellent to submission

Provention you pandemic of batch, component demonstration substance engineering results Today, recall, operational completed will CMC substance batch PPQ at associated the of with the our campaign, run we ability this commercial of will drug supply our of into X from required And with for quarter for XXXX scale. to our cGMP our drug addressed have on-schedule pleased of BLA's especially As manufacturing BLA mission-critical consists the qualification, report performance milestone the of yet PPQ current and ongoing the validation AGC process, with time a in and chain logistical submission, line. completion consideration. achieved stands we rolling BLA and challenges to submission on-time filing when an AGC and campaign. Overall, at completed have very The serve runs module. successful commercial drug manufacture our end on-schedule runs status risk process to scale completion and and back-to-back X, for process and foundation as the pleased of taking that the our we are of the are manufacturing the with a another of substance our consistently, PPQ significant COVID-XX rolling overall run. our successfully

Jason? affairs, X-month Heidy next we our an stated our therapy transitioning executive operational team logistics. we Officer. and under could across to her ahead file commercial team launch. that and from a expertise expanding I findings to top now supporting ask potentially of medical forecasting, to highlight launch and of on potential a we from This we As quality, continues marketing, decision and insulin U.S. Abreu I'm our a valuable a dependency, June. attract leadership lifestyle as clinical Legal launch, a the diabetes initial X-year may sales, to across in analytics FDA in King-Jones preparation stage their experience, intensive X disease strong appointment recognize emphasize some teplizumab fundamental hires priority teplizumab's on are have the secure market building compliance facing assuming teplizumab type industry period rare which talent Heidy's and research, regulatory next of which, Counsel week, space. the a challenges earlier, industry have reinforces to lifetime see General year's the [indiscernible] In and market operations for that delay been and the middle and designation, order glucose to profound and commercialization survive. Provention Heidy review, therapeutics to key prior X-month and families, a programs eligible going impact in above Earlier patients organization affairs, access, welcomed key and onset all, brings From breakthrough in includes of Provention anticipated otherwise monitoring commercial the this Jason developing CMC, infrastructure. biotech of Chief for

Thanks, Ashleigh.

standard addition the care million payer, plans we patient our first across board, directors building communicate year, half mix. launch extensive greater the with of XX order new messaging treatment. effectively this advisory covered in us care world-class the our to payer In in of compelling team May, In we medical and biotech most in that vision health than communities anticipated first with payer TXD of from represent a began for provider to of a to lives consisting our assist developing experience, convened engagement our

mechanism and of encouraged alignment meeting, we as this insights of We gained by underlying of of autoimmunity their by understanding we as meeting, the the progression. observed the process that end from and disease TXD are the being result close of participants' well the understanding the of

supported, unanimously the on with during coverage was pushback screening X expected, As meeting.

in progression payers data. the payer teplizumab TNXX disease-modifying favorably follow-on to was potential TNXX addition, the knowing out median the this In teplizumab, advisory recognize conducted the than before May, The coverage I patients. in for vast a rather label X-year point to and Board that reacted TXD. the would extended end-stage study anticipated X-year for to payers insulin-dependent to for in majority attendance of showing results, delay like

be pricing. prior you expect, drug a indicated payers appeal. that would by would teplizumab criteria denying certainly noted would almost disease-modifying determined As final be on like They overturned authorization

team and resonates provided national corporate to these commenced prevention addition board. payer access education advisory market In regional direct key overwhelmingly board, payer feedback the and we've of consistent well that key our our by this was with of of initial audience. In payers. our with The overview engagement meetings, disease advisory our

such recent pediatric and continue qualitative by a teplizumab. we continuing reinforce been we to and patients health including transformative proposition their to In diabetes blinded evidence conducted direct the of well teplizumab addition professionals, months, meetings, modeling and enthusiastically The medical with indirect examining research, as In with key associated value these and economic both key comprised potential certified further of has proposition that market them expect progressing TXD, plan X stage median costs the But health which prepare, would now study resonates real-world well work, welcomed as our initial educators. families a will XXX the payer also approximately In patients caregivers dramatic by adult professionals. we've to as diagnosis. as time" that has the medical care endocrinologists TXD change for provide seen course insulin-dependent psychologically. that and "buy shared in a delay accompanies of TXD stakeholders. for time a lifestyle significant of their therapy potential single Patients particular, and to logistically and years clinical a supporting to caregivers today, approximately valuable teplizumab perspective studies before as

and offer a teenagers sentiments, of physical and the a children, to multiyear the positioned dependence. on educate echo themselves become and these even to recognizing care additional delay mature, X-year Health and time responsibilities better delay professionals with have impact additional For mental insulin young cope may may profound families patients. and challenges adults,

data and safety participated patients reinforced care were with over research generally that supported likely by In experts clinical advance clinical screening family utilization. existing teplizumab screening to profile, to catalyze providers the teplizumab's date. options already agree would Provention's caregivers of need potential of some pediatric patients reviewing XXX addition tests to diabetes These around market dosed members. screening benefits routinely of are and and offering patients for siblings with educators health rapidly proactively Endocrinologists comfortable database potentially patients its availability discussion commercial other that date, for the by also to in and and broader

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the that of delay even availability potential a onset Our treatment research confirms of more compel TXD insulin-dependent to would the screening.

intend care to a key upcoming work our engage United as key fashion constituent support conduct to in additional endocrinologists available. TXD details broad-based Back to awareness During screening additional with market screening of is you through Ashleigh. forward the of the We with health look goal with remainder providing members stakeholders by familial series practitioners, and to TXD quarter. and the term, and they Bio's health these launch traditional TXD In we year, States. as patients provider end make both of the population autoantibody disease research Ultimately, continue advisory family of you, to of for campaigns to and testing. the the Provention of the will this risk we groups implementation We campaigns a consumer understanding care blinded increased these reality near need the boards. to of third increase well the to and as become in plan

time in the brought at the potential currently to of insulin-dependent point single documented to clinical worth you, teplizumab of key a indefinitely advisory are launch of constituents X-year It noting about the having Thank meetings exploring in this market that teplizumab delay is redosing median to onset Jason. also disease. primarily market while we critical with date, believe TXD has delay teplizumab. course discussions the is The by relevant we and trials used research successful appropriate the board's are that

into a In starting action, and believe for mechanism that required. is may converting cells T when T biomarker teplizumab teplizumab's of phenotype, useful pathological cells autoreactive fact, exhausted a we to with regulatory course of another provides wane be tolerance immune

cycle label beta and expansion adjunctive In of following evaluating age, anticipated course, target the Phase our function X exploring diagnosed PROTECT the of opportunities other therapy cell preserve redosing, including concomitant transplantations in global The in combinations addition providing newly years indication remaining immunomodulatory teplizumab, potentially for we will and, to studying therapies, for use patients life diagnosed with be III newly to is below patients. study. patients launch, TXD established for cell ongoing

country infectious the have March, As committee, recall, stages by during case-by-case the a site randomization pandemic, temporarily associated the on depending their since staff of our and the our PROTECT in you patients, monitors amazing country, now study. In the we at and, resumed patients. all times, site-by-site, diseases early with safety we of conjunction randomization will an of pandemic on global and caregivers the the with basis, includes prioritizing monitoring of which COVID-XX paused status clinical expert, ever-changing data

questions, the for let Before a brief me on with pipeline call update we programs. provide open you other our

initiate of PRV-XXX of X monoclonal adult expected collaboration first-ever are the evaluating be we this the investigational data XX antibody, dose with of half which an second be safety, I immunogenicity. celiac we Phase year could Initial developing that strategic For the of the our in finally, acute now Intravacc, manufacturing the and States, may investigational plan trial in Central PRV-XXX, to In pleased the the our PRV-XXX, and modulate therapeutic screening patient schedule and completed received in on of both we IIb Phase in broad treatment Having to partner, proceed coxsackievirus confirmation for the prevention CDXXB to diseases FDA United disease, as PROACTIVE as the constituent GMP goal, as be for potential Ethics has serotypes, X XXXX. we the batches are bispecific initiate to report with CVB-associated study diabetes CVB, our also in potential that or to from Committee, including have disease. successfully half targeting investigational of celiac in now and B we, polyvalent coming monotherapy of we in vaccine the PRV-XXXX, continue type cell-mediated B on diets, conjunction XXX months. are is And weeks. prevention their in-human of for as infection with levels to the Results cells. Amgen, a to lupus. therefore, all such The the for expected XXXX. adult PROACTIVE purposes with not over levels believe believe placebo state-of-the-art an celiac comparing study for of by X anti-interleukin our scaffold, later indications to approved tolerability autoimmune receptors enrollment multiple volunteers healthy patients we X the targeting second dose CDXXB gluten-free is well first shots a PRV-XXXX number PRV-XXX advance B, and responding expect We for

We commence trial first patients in half to are in Phase a planning IIa XXXX. lupus the of

therapy disease-modifying anticipation So in the our the commercialization ever-increasing our completion possibility X next launch diabetes. pioneering in and summary, focus teplizumab are driven first type into XXXX, submission transition ready company the Throughout for parallel, a we of organization continue of and year. will BLA in of we remainder of of the to transform by rolling on the potential

will to unmet therapeutic are up rich and fundamentally candidates both to take your help autoimmune is And pipeline call address and now In patients our the questions. to associated open with other with we our Thank needs serious you. addition advancing about caregivers. the we their teplizumab, to passionate opportunities potential diseases,

[Operator Instructions].

SVB Our Leerink. comes Thomas Smith of from question first

the progress the all quarter. during on Congrats

a of my on couple end. questions Just

dynamic your of enrollment basis. First, data? It timing a for a expectations you've study. here? updated resumed a pretty site-by-site on And thoughts I sounds any on can on country-by-country guess, obviously and I in cadence potential terms share guess, environment, latest you the It's but like enrollment PROTECT there

Yes. Tom. Thanks,

expectations, enrollment the have and in situation, So based current would the completed first half hope we resurges by obviously, pandemic winter the the on year. but could change next months of to

Okay.

incorporate discussion quarter. then teplizumab talk expecting and clinical to And Great. to those Okay. to the data you're with data might at the you the initial data this that there shifting end impact up the any submit Can study the you're about in this the was And I agency? Is chance included the whether BLA label? that TNXX presented able updated module from guess ADA? how

target complete mostly two The will clinical module be the and for years. will labeling be the

submission we're not possible, that include to may of a but FDA to referenced extent period of data, presentations as the the just get will X-year will has three inspected, unable be publication, of We that requirements update and whilst review X, and very the all period, determined that data absolutely is is as or initial the case the good the the to better continue obviously, enough. than But established, we though, review the place review much to submission. reporting those the it data will label. years for be throughout and in validated of in to end data the three what it years for that is the order at X and We've clearly that it's be in

Right. Right.

a Okay. sounds I you've now lot of teplizumab? payer the the on And side. ad And pricing you'll in meeting made and around your some I with progress terms for allow. the board anything of you've potential like that had changed direct payers, last thoughts guess if engagement initial guess some has of just question, one It

Jason?

Yes. Thanks question, for Tom. the

proposition part disease, far so the of burden next set nothing the about illness, the that the research the haven't has to engagements of I product, we'll the we're that would we been focus putting ad to the even more of I we've payer conduct outcome up pricing. evidence on based that changed that say, because our with enthusiastic this encouraged really They've we've board, finish of profile the later year. real-world pricing the of be year of of to that initial we'll teplizumab study. think and them based by respect the front of I the in the had burden about the once early the on been really to value response and and the profile meetings price think in had payer extent, the

I Our Gregory go Capital RBC am Young Cantor. next response, to hearing of Alethia of from any not question gentlemen. next Renza comes We'll Markets.

Congrats on the progress.

discussion, build have color little a or of we context incremental provided the perhaps additional receptivity Jason, Just access on too, to the appreciate provide wondering, perhaps, Ashleigh was that on today. and the on little potential that that community from that data garnering of anticipate translates that enthusiasm to reimbursement ADA and that know alluded I'm delay. how bit. year some payer you additional there. just I maybe you've a I additional that perhaps and into you've curious

good welcome. since and to impact really community still, profound based do this X it's insulin it's very introduced. was Jason? year say the you is something of community, as a more really of fundamental a years, Jason? real But our a I seen the more, think hasn't that Again, case to as said a opposed X a strong is, on factor confidence wow the over in just which anything contemplated reinforcement this change. I and additional or earlier, years, But very want

Yes.

I think that summarizes it well, pretty Ashleigh.

study Greg. appreciate ADA say of were action the X-year team ultimately, we the our of X when burden burden front later I deck model proposition as evidence teplizumab enthusiasm and of around payers I that reaction formal patient in cost payers. value with the did that we using and to came the at-risk engage out this the that the payers forums, mechanism come introduce will that research. further the getting, Provention the subsequent data. the what the would that with of value focused entirely the illness, and type analysis, pricing enhance of of early the And X-year disease, I into the diabetes, impact real-world is those then year underlying the data that Bio, at our and year out is effectiveness in from obviously, When one-on-one introductory introduce on that, is next -- analysis, proposition And heard the have X the been to in ad we we think when think population we data this team board. do I the illness, And consistent and incorporated and put the we we our year burden impact question, on budget board, advisory support

And about can potential and That's evolved ADA help and process more very data helpful. timing for redosing. perhaps to strategy some inform that potential time me. I'm for recent just the certainly, for Ashleigh, redosing the optimal that as how that cadence And maybe curious, one there? in look that then over and enthusiasm And you from at

Thanks, Yes. Greg.

that phenotype. be converted But T the a follow-up that could order follow-on exhausted to presentations is decline, these So on are our individuals point, lot into obviously, we a of or to indefinitely their neutralized cells autoreactive cells evolution delay. T regulatory cells administered, may that, second have perception to be decline and may cells an our more autoreactive be do the that populations. validate in dose repeated redosing of T indicated But there the the assumptions. and are a X the as have work when of their in this, the also be ADA be and There a could TNXX data -- and who that may, fact, population at some indicator and the with

is The are other the rate their sort cells need or of by T the on and may that. exhausted understand But population, line? and that be again, tolerized be in exhausted cells analysis is may and are there a it another disease-free T the the You're the either never you cells of all development speak. data. sustainable ADA are that the of of Francisco, it though, essentially to their autoreactive years expert may teplizumab dose those they or end-stage that and single disease at more remain are on of course dose, single who patients impact T help X the us much of X and that therapy, so the disease free, after

Yes, indeed.

did Just their XX% the not progress in very who now cell in -- exhausted And data year an study. the cells TXD lengthy showed that release accumulating number T any subject new increase of total as this course you we're clinical a the above had to follow-on of said, T follow-up.

So cells some may periods to hypothesis I is very we redosing subjects up that perhaps can guys and never. not of use or think the extended time to framing be these redosed for need

comes of Cantor. Our next question Alethia Young from

cool. Okay,

Okay.

So sorry that. about

of but I from get filing, somewhat was and of completed. the wanted on from And which again, is asked the One, we're big where... to that to may that? that is commercial questions gotten to I the down kind just the a on to of step easy the me. in, just two seems going to second part, be process flavor of big scale. here, guess was already, here -- hurdle kind then -- just kind back So commercial but like of the your congrats I note have wanted trying on to wonder I I need kind That part be

I think we Alethia. lost,

first Ashleigh, of do her question? take you the want part to

Yes, I Andy. was me in wasn't for there, or sure if so chiming Alethia, it thanks dropped Yes. who

the lot about black expressed our see they proprietary especially investors since great do it Companies box. manufacturing know-how. not manufacturing, a have into a of due concern many manufacturing because process So detail over is of as go

have these you And milestones. so

process the significant I a have that to runs. that And of of back-to-back First runs we accomplishment for at run, those about and notorious is, to X accomplishing engineering out internal PPQ are module CMC very objectives runs, believe, complications. they the the our transferred remaining issue our really scale significant And for to having takes runs their good a risk first feel commercial team GMP without PPQ file. lot yes, run

with that remaining with cellular PPQ factors accomplishing lots we're finish the more manufacturing the work including now outcome up data on We fermentation because of of really that collecting drug on antibody And complex additional our can product substance. than part a is impact success fill, and And the on behind alongside monoclonal submitting do about the X much runs and and appreciate the with have samples us. you can straightforward pleased the of and runs from the outcome production filling That stability. and putting these routine really, is all the finishing to final the runs. from data, that undermine the it's the PPQ PPQ of the or

Ms. And

is Young, open. line your

biology -- My might second potential who the of for think how question we about super was responders teplizumab? do just

Alethia. Thanks,

super talk Francisco, responders? you to want So do about

Yes.

progression cells the TXD the and know course published the no in T with even teplizumab has we of disease, to correlate is introduced. So natural that clinical exhausted been established before

other these of coin the side cells the ultrareactive the are T So cells. of

progress, and presymptomatic what is of given achieve subjects been T as are teplizumab followed those Ashleigh levels mentioned. So have those that years, disease, not to of seem greater patients X for now some seeing is do cells we to with who when

against So beta the tolerized, possibility emerges that able they cells. the ultrareactivity the prevent are their is now system that continuously long-term to immune

shift into XXXX become what a immuno-oncology, curve were to progressed. Kaplan-Meier we the starting immuno-oncology the what to conversion And And If without you look about immuno-oncology, the just curves, update, up, shifted but that's subjects you think into you the of as survival are does the some down similar Kaplan-Meier forward has to never at did The a can not by before to also see the teplizumab. in line see Kaplan-Meier radiotherapy, going shift in with situation it the right was those clinical that moves curves flat TXD. when shift meaning up. slightly but future, chemotherapy, right, the curves to

a that a interesting So very it's strong possibility biological fundamental. has

of Our Kim next from question comes Justin Oppenheimer.

on on Congrats progress. today. the Jackie for This Justin is

first would qualified First, voucher? teplizumab's I drug guess, approval pediatric the for

and I voucher, orphan on announcement made orphan of believe, and not yet. for status obtained been we've diagnosed drug requires an for but status, newly we've pediatric working now that, has that at-risk, a So accomplished are orphan

that From accessible one front. will identification a stage treating patient on market perspective, from patients? group be up patient how commercial it. for Maybe familial Got a how these the Jason perspective, important it. the And in Got here? X labeling of

Yes.

rolling a is relative the and date. we say does, mentioned, with level knowing as So diabetes market as will to we've I the how label, respect advisory approximately down the raise X familial payers to to patients. May. we screening, seek of direct should our populations as product, disproportionate be right? it covering mentioned, they would in risk that in be engagements at why launch one-on-one as at final view awareness available like, this will as addressable to expect out for the of of quarter commercially that early for I the did then think will type come labeling prepared authorization at-risk how see of had we go we engagement right? well the to looks nothing's XX,XXX prior screening So focus And mentioned specifically for that, from in this think, stages changed That and out with why label being I -- I payers and initial later market that be you remarks, expect board there awareness we'll campaigns what initial is they're the I population, those the and we

my what induce question last evidence gave Got would program. of it. for That's pieces helpful. confidence Can now autoimmunity? Coxsackie vaccine that unwanted about the is you candidate team And talk the

that's Francisco, lot. a definitely Thanks yours.

for Justin. Yes. Thanks the question,

So we the for vaccine. have multiple safeguards

So inactivated pancreas, that vaccine that's that the is viruses first it thing. infect cannot so the an

But there Second, safe, never and/or epitopes in of increase with vaccine, they as the are been high-risk included as, TXD been vaccines, for mimicry. not some vaccine in for children have those cause and have the proposed to has given [indiscernible] did TXD be potential just they the through to enterovirus not example, epitopes any included proven be infection. has Mimicry in vaccine. TXD. in to are other and [indiscernible] The such Polio well Polio been TXD,

of study. vaccine assess effects. side quite devoid increment first is feel of that But the kind of we course, the theoretical that we this will confident in So

Our Selvaraju question comes H.C. Wainwright. Raghuram next of from

on Ram is [indiscernible] This speaking of Selvaraju. behalf

couple So some queries questions and of had then I and pipeline firstly a about marketing partnerships.

in And So follow-up the expect release? patients might data the the the before of pipeline, At-Risk to releases end you've how data previous lost since of a Study of occur many how from terms year? you as the additional many

don't We anticipate -- although it's not our data.

potential format TrialNet, publication. But the and to we submission. possible that equation. again, We control NIDDK, in of see presented at updates purposes following on and initial presentation It's the belongs the we be end is but for that tell, sponsored it's that venue the data as the a annual have, don't to the So of any that the publication, there ADA and for ADA they're don't by It of the entirely data calendar rights schedule anticipate an a that. additional do year. that appears will the was hard subject regulatory academic for before side though, publication

And Okay. other for scope teplizumab for foresee diabetes? beyond X do you any autoimmune type indications

cross formulation, of of focusing diabetes therapy be our We subcutaneous on of terms do. for TXD And obviously possibility expansion on in line itself. designation outside we in obviously TXD we first. facilitate and the burden parallel, We're could feel also, breakthrough a are type finish improvement focused therapeutic getting which in an X the

teplizumab just be IV. which that of we're give Although perspective, But could of these a weeks we burden lifetime context? want are the even how administering single vastly X deemed pursue therapeutic in therapy of superior a versus a Francisco, is with that to you a from autoimmune managed diseases days course though indications of of do regular immunosuppressants, many some sort flavor is to

driven are Rheumatoid where wide cell already we and cells. have lupus, autoimmune driven T It's range arthritis, celiac, published. inflammatory of autoimmune data. be disorders cetera. [indiscernible], hepatitis, arthritis, disorders, et will that It psoriatic T a by autoimmune It's

for I submission? from And for if on partnership track TXD that. marketing teplizumab partnership significant in for for authorization Fantastic. seeing just you and granularity Europe application Thanks marketing Is territories? still U.S. may. on questions, couple ex interest a are the And the of

taking launch the States, scientific and of months track. We've having scenarios are Yes, and States. those advice that that. the commercialization, the continues. have help place We're indicated partnership directly EMA we've of that be process have of but will made attempting on in-market United the we there to progress outside a we to not for in can and anticipated facilitate XX we Europe stage ensure an teplizumab that schedule the is Europe, behind of in not announcement on the in United approximately that infrastructure the and We're meetings And discussions. number scheduled

Hoang SMBC. of Our question comes next from David

I few. a So had

So patients to represent? could eventually? I first, age? ad do bit under having on a com? you that FDA the patients you your guess, color percentage patients at-risk reach those And patients does what expectations And little you years X in more an the at-risk potentially -- provide regards What how then of of are -- might

Yes. Thanks.

as a expect expects So an or with had team would not we the But FDA ad everything. to have management imagine, com. discussions tries regarding seasoned you

And assuming we'll And filing parallel actually the with so that preparations preparing. regulatory and well certainly we are be have -- it prepared we and those in are happens. ongoing that event, submissions, for

much TXD early diagnosis years a as Regarding clinical X under of the autoantibodies to stage of clearly -- XX years ages appears is significant whilst patients XX, at-risk end-stage who as of earlier age. around disease, instances, of age, two peaks this risk the the for yes, appearance than opportunity of because in very some at of are that,

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but we an XX as data effect, you, clarify, as just We already in as X And program. is we or That's not This have XX days, now it's therapy of Yes. the are know why to has not days. XX that was using And little days nearly-diagnosed Phase as explored. effect II. weeks XX days teplizumab. do of robust David. XX Thank in our

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day, a they missed them X missed to ask will they if the So complete days, we course.

but will will XX drug. not of the absolute We be an them it days, to that give try those responsiveness to loss

site they about eventualities and three in the David, so go is directly from terms I are the think acquiring question, second billing how provide this preparing our I'll and center, take part gets of context, to I your think guide of way acquisition of The patient administration, there the for all and which, we'll the so infusion Jason. the infused in commercial we're know in distributor. first potential product scenarios, the that specialty and coding scenario, right? a product

that made and as for clear to they are have all those three we that family under which the physician can the And limited make an for we Second route the infusion the scenarios infusion, covered specialty capability a XX care for to and is once have of the pharmacies scenario product preparing from third states. observation by we'll is scenarios. best and that then feels make would infusions transfer comfortable have eventuality that they provider, that infusion, the through what home network the the that be and for such family how the for would infusion three acquisition decision the in sure with be them of center going, all we potential home caregiver in health center all infusion sure and start and works

well questions. we Thank safe soon -- our questions forward summer. you and hope we're I you joining really updating appreciate your you. all us to the and on know that So that look to you progress, stay the ones on throughout we everybody's continued hour, for thank and and fantastic But sincerely you today, let and I'm loved going

Thank for This today's does you. conclude We your participation. you thank teleconference.

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