Provention Bio (PRVB) 8 May 212021 Q1 Earnings call transcript

Good morning. My name is Kaylee, and I'll be your conference operator today. At this time, I would like to welcome everyone to Provention Bio call. [Operator Instructions] Please be advised that this call is being recorded at the company's request. I would now like to hand the conference over to Mr. of for President Bio. Vice Doody, Investor Provention Relations Robert

for thank on Financial Thank and all Results joining Call. XXXX you operator, Quarter you us First Provention Conference Bio's

Chief Provention Financial Chief and team. the the is call Andrew of Officer; Bio members Bio today's and Co-Founder; from Ashleigh Joining Palmer, Provention Executive other Officer Drechsler, team leadership

views this today, with may in SEC statements our quarterly we our may for those as report recent free the result same. regulatory These the And statements various and candidates. expectations, make of the SEC today will section we and let begin, we future commercial resolve of runway. advisory and and timelines on and planned anticipated prospects, and teplizumab me Before including our filings success for their factors, developments Such to potential most company activities projected discussed work which Including our only. forward-looking a Any for other across potential use concerns remind comparability plans indicated our include statements. other related those remarks the the the clinical product and by timing product with and FDA of about these risk you candidates. XX-Q, cash to cash our committee and results plans approval and from results, impact we the studies teplizumab that of potential upcoming business forward-looking The the including clinical our The as with on statements Actual constitute including our filed to preparation our BLA. expectations differ as projections, commercial our materially of factors and the of in in represent the the make meeting. Form COVID-XX business teplizumab PK efficacy future. forward-looking Financial that plans. morning, safety, various other important for

if change, forward-looking today. forward-looking by specifically Therefore, statements in to as to views our these the any as statements subsequent update elect may even these at views you future, forward-looking rely representing reports point complete over files regarding with and our date these uncertainties, are as we in I required obligation at except is on to the documents will There any turn so, statements, investor disclaim we on While review of not SEC. section. These some should you law. more encourage risks, Provention's information Provention We www.proventionbio.com, the the documents Ashleigh. the available under call to With carefully. now that, do website

good greatly morning you, you joining Thank and Bob. And us to attention. support your We all of appreciate today.

four destroyed. tissue develop world life-threatening serious we in mission options, enough. It's taken As systems disrupt ago, late. present to not medicine. patients has just was we In and typically to to and founding our years diseases. Provention continue intercept pioneering around Bio life-impacting pharma intention the to our patients auto therapeutic with the how or healthcare bio immune and wait auto for cells commercialize prevent industry and or have been place. and deserve of this time, families Often believe modern disease organs Precious symptoms. simply damage irreversible good this to immune with better that already their And damaged by clinicians too It's world

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the from those industry built our and company ground addressing with capable professionals we've like-minded up of head such, on. As challenges experts

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so drug for intent number trial, Our in patients Eli beta beforehand, study. the using had progression focusing on involving Phase already our The disease strategic decade way enrolled cells was now to clinical consortium was before the by than no in original to fully the and of by had NIH-sponsored XXXX, teplizumab plant that a three of been and opening produced TrialNet, do time the XX by diagnosed the been patients certain drug preservation blind. study longer PROTECT processes available. of threshold the At more administered academic by the waiting of newly TN-XX acquiring over are Lilly, ago. stage TN of up product years substance manufactured An a in seven conducted

the Importantly, Lilly batch original the to process by to and original also quality up-to-date, records, when have the know along of substance, acquired the biotechnology and Provention teplizumab, original our way this used other how acquired a believe era. we We an comparable necessary drug manufacture reproducible, and well-controlled, into process. manufacturing lines commercial-scale transfer cell to with specifications, partner teplizumab modern manufacturing validated produced and drug substance we

AGC module. required and met parameters. Biologics, Thereby CMC and substance, the and all the our BLA's the analysis of release all manufacturing fulfilling, submission physico-chemical to specifications requisite that our drug XXXX, throughout partner, enabling Additionally, for testing completion

healthy particular we new level Lilly faster the the into might clearing containing from this our newly comparability AGC volunteers. under range, PK/PD Phase conducted drug be in Before target below AUC than single we in the substance curve, a new TXD the study, patients, PROTECT manufactured that, product bloodstream three And study dose product drug observed from drug indicating area substance. or diagnosed drug the product trial low a PK introducing drug bridging in old

safety drop, clinically within fell C-Max, of of acceptable PD Importantly or lymphocyte in this relevant the we profile PK/PD the marker comparability. other all the study, relevant ranges believe transient as peak and immunogenicity, that such concentration parameters the

clinical not As at that is certain the us commercial single informed sufficiently above to and two the is have its since shortfall this to PK low FDA cell our information for closely Lilly product relevance. likely has volunteers under with consider provision we not therapy very remains dose has might the out path ongoing drug AGC that be designation, the upon steps of work drug patients drug conclusions. the using comparability. for and comfortable date, totality observed The which and the products based it relevant AUC a threshold to either protection. require firm us on drug to FDA for translate should intended it PK Based with product the observed and safety drug that comparable impact PK/PD belief cannot account Nevertheless, original very not solution, our data our be our our will stated the patients healthy using modeling PK/PD of PK/PD study, the to AUC bridging PROTECT additional may support One in difference available or begun beta data requisite which commercialization substance or to agency into substance. the our efficacy review we in taking anticipate agreed to next exposure predicted product continues and and does enrolling clinical from time, in be be figure very yet us cooperative, to PK/PD receive to potential not clinically very breakthrough to extensive access previously, pathway, study in forward into not is the helpful, engaged, the our intended

have teplizumab to that We we available approved has expect delay the potential timelines also a be patients. with and the in will made which to need agency data, to result expected to within additional the of stated provide

our an apprised May materials, its We are briefing and the for as its historic discuss teplizumab on committee time one on an in the the safety studies to in discussions three progress. from XXth. FDA meeting we'll upcoming updated unmet occurring of and preparations you diabetes and mention committee in are And comparability the type actively find keep the considerations with along the parallel notified We to to by with FDA's These the in diagnosed TN-XX trial, with believe next comparability other agency intention us the working affirmative from statement patients. advisory the FDA, solution. of efficacy examination the advisory weeks' of and need continuing intent to meeting focus newly to data with that is us is supported steps

or assessment that, is bear study the on comparability-related understanding FDA's clinical no package, planned benefit-risk for of discussion the do the not since topics are Our considerations data comparability TN-XX questions meeting. the

disease. of wording to from teplizumab's the indication. delaying aligned help exclusively We with with to the fully the We disease options Provention auto functional progression antibodies the targeting are will from and cells. the the fact therapeutic benefit recommendation reinforce dysglycemia instead, believe two And patients while on of TXD preservation the term of this remove that, FDA's and initial beta already also pre-symptomatic, may have focus

delay advocacy patients, a regulatory disease the the lifetime quite diligently, TXD Such educators, population. an a importance much diabetes look opinion investors' and clinical advance immunologists, for to diabetes of waited Our would of younger commercialization we of to on the as year and to understand reviewed members our and of other therapeutic standing as leaders, this We that realized a important and first otherwise their and pioneering advisory especially hoped patient long breakthrough, critically patient treating key team insulin endocrinologists, for have for type sugar for some having the innovation and stage and has who organizations, patients, forward time of monitoring for that present the families has so one nearer be this therapy the facing clinical teplizumab for and to been a blood the nurse to preparing has alongside potential pathway scientific the attention this at-risk committee physicians, insulin opportunity by working as term burden disruptive well dependence. now, community We focus continuous other of concentrated disease-modifying potential for very committee. meeting, therapy. risks

our momentum However, like with programs. pipeline few providing throughout moments an you not that a impressive organization and of is our that to the taking progress now ProventionBio would And other with spend on update certainly place therapeutic immunology I is all that about.

Beginning guidance Phase three previous newly in programs remains PROTECT respect our with patients. our teplizumab diagnosed of our on to Importantly, track. trial with

you was As randomization know, due year for paused this COVID-XX. last to into trial some time

has steadily second half the increased. randomization, of complete are we come sites However, enrollment and track countries on year. trial The various this now resuming in online to upon have back this enrollment and of

Importantly, in mid-XXXX. top-line available this will results position us to have

CDXXB and antibody inhibit both receptors, Now causing turning to and depletion. function targeting designed cell our B-cell suppress humanized, to CDXXB production auto This PRV-XXXX. is without platelet scaffold bi-specific B or

quarter preclinical commercialization data half the in therapy results continuous collaboration toward expect XXXX. Also Medicine, in gene this In Huadong a the with year our the reducing in anti-IL-XX of trial development from line top showing XB with enrollment efficiency XA results the we Pohnpei with China, progress we greater second immunogenicity model the reported and improved program, a proactive addition Phase in human we disease, respect PRV-XXXX trial to to first antibody our continue of preparations partnered, PREVAIL its of of in product agreement strategic to surrogate. PRV-XXXX, initiation and fully for PRV-XXX, by this lupus a year. and Phase transfection announced monoclonal of of we

after would of XB At commercialization. we and royalty to Phase receive completed, take trial for subsequent asset an has payment. if Amgen three milestone payment option $XXX Phase this is a exercised, which back million with As along point, a development reminder, the and

vaccine are excited for enrollment Phase the trial to Coxsackievirus one inhuman we Lastly, have our B. healthy that against in we first volunteer completed announce PRV-XXX,

We top-line have trial in quarter results for this the expect to four year. of this

commercialization gastrointestinal beta make progress auto Coxsackievirus that one it discussed to gluten in is significant As disease. triggers and cell of cascade type advancing in results that previously, immune on all with at immunity call first immune while pancreatic we continue exposure financial auto in is one closing going and the questions. potential our to to turn Overall, main celiac B on details I'm the the the quarter, provide preparation. and disease for to now programs, Andy time, remarks same over concentrating our results returning teplizumab therapeutic you for before pathway diabetes destruction believed the of driven of the Andy. regulatory

and Ashleigh morning Thanks, good everyone.

of as prior begin, well to financial to I would our read encourage Before press and financial to factors, the also which was would XX-Q release, that call. our to your as this earnings I filed was discussion you condition. issued XX-Q analysis like risk management's includes statements, today. call attention our I

Let generated our net $X.XX the first to XXXX, in position and and administrative of expenses. costs in trial We of Checking primarily regulatory general increase me activities, of first pre-commercial the XXXX $XXX.X share. awareness, research which nine start one an XXXX teplizumab, PROTECT well and quarter of $XX.X programs. program, X.X our loss was for in development infrastructure The as costs as three of in loss million from to the Stage manufacturing type medical or includes increase with quarter cash, and million. including a the by as also XX, a and of P&L. million is education resulted for net The affairs March basic support screening of driven diluted now cash compared our which in expenses net of XX.X the increases million, teplizumab build-out state per increase diabetes, loss includes million, disease to result

Our operating net cash ended expenses were XXXX. the first million March quarter, for $XX.X XX, base

During generated $XXX.X which proceeds. approximately offering, the completed a net follow-on of we first quarter million

development payment to during next accounting from contemplated Huadong on million expect conduct upfront proportional in the from $X other also this perspective, the over upfront China. and the PRV-XXXX recognize years, payment by basis D our performance an as that to agreement. funding strategic develop we note commercialize related a we Please the the three a agreement and received quarter, collaboration with Greater In addition, and we R to activities

to expect XXXX. $XX for of use cash we and million of between Finally, in second the million $XX quarter operations

all sufficient will projected one for We operating We expect of fund on type our teplizumab. for for for Ashleigh diabetes, develop additional enable that, as provide least lupus, the toward to celiac, with launch to call we closing PRV-XXX plan regulatory will next securities for and be me marketable actively programs our And requirements current guidance cash, over and PRV-XXX, the progress to of cash to Coxsackievirus us that turn equivalents approval and comments. continue XX-months. PRV-XXXX to four call B teplizumab quarterly cash potential vaccine. the commercial With the at each let

Ashleigh.

Thank you, Andy.

deep Before hard work, dedication. we here appreciation up you for call may all I any our colleagues the share to for Provention have, questions at address and open to Bio their want my expertise,

You to tenacity, reviewers with of changing and challenges day, officers the to and we of and collaboration the There the also our becoming commitment, option to innovation at set industry together, of pioneer disease to as the of a one company we type level closer and two strive patients change. the their for for path team four shown they've bring our stage am as of demonstrate highest every each teplizumab be always modifying fulfill FDA will diabetes. professionalism levels out years ago. becoming mission create I game disruptive, catalytic, thankful we along

confidence. shareholders, who especially from However, have thank to want with and those been witnessed both with new, us and optimism our to us date I we the very the provides beginning. cooperation have

diseases. forward your inspires worthy is serious and and needs and and every cause believe deserving, type and to four to impacted mission ago. to patient auto clinicians, one create and us enables beyond your make compelled Bio significant over thank their in other XX-months. and propels want acknowledge, support patients, members you. have our years Provention courage the each day. And your by past immune continue strides organizations, essential the finally, We us family that it's fact, found we witnessed to and and us I Your has goes advocacy Sincerely, It the progress diabetes

with from question Your first Alethia comes Young Cantor.

for a us exist, effectively, on the was so And of of this one you guess, hypothesis this pretty did Do puts kind a now pre-specified was why just these comparability you bit just place? more the question, significant us then area you Just like on little I panel. third maybe kind background panel, XXX% your in the now? known, the seems that a And significance then the why specified, couple, XX% it first what's happen issues basically maybe kind bit consideration it give it a another -- so panel or kind did of to how just a become through to it of focus because kind on FDA? there'll this it just And if under the obviously sort positive on more how walk can little range, curve have be trying out? think of

Alethia. the for you questions, Thank

context question and is this Francisco on at range understand now the Let positive me the significance and together solution the to typical the a answer agency moot what hand support is issue meeting this the advisory committee to and then a breakthrough why. last important community advisory question and comparability as over committee to find answer very if And a exceptionally is committee a address quickly A as company possible. the as designation comparability in will will regarding I positive, not to under juncture. point. therapy becomes very the Yes, one create work a which advisory essentially then the

there. could to as the range why? any correct So speak comparability and you're you thoughts XX/XXX to exactly Francisco,

Even XXX% our though a as was study. that an the so we XX% innovative obviously a in typically we for is is to used as Alethia, it the are target required target bioequivalents. product, are biosimilar, well not

you and don't single which are the healthy also and that study toward why think honest might answer was that ameliorate there's And do know. is toward we intended As higher a it working low still when so working data cetera, clinical that to dose questions volunteers. doses if believe in target, relevance, pharmacodynamic we we trying to were understand concerns. inputs, FDA's multiple this below especially no and we providing of et additional our analysis, is use, in patients, But

follow-up. a is This

guess I'm how So I the it's or so think months would on, be couple out perhaps months, it something together it eight kind past that focused new FDA the didn't ago. guess you now like of all focus guys be effectively, this maybe that of figure I of versus in to would low-dose trying the was kind that came

We study. conducted of the inclusion in the our AGC study bridge to originated drug to PKPD product specifically the PROTECT

analyses, chemical BLA that assays, Biologics physical All showed by of the submitted into were and assays, conducted potency that includes so AGC the comparability. and on ourselves and

of of itself. available at reason that PKPD of As beginning the did many the as is BLA the it year. studies became the results other parameters time same study PKPD reviewed the because appeared The that has is the at being

in And discuss can't the we has disclose and indicated the cycle opportunity our at to first review to which And that own were time and not today. study, us BLA. the this that that they at at that mid our submitted results with we're so IND month, indicated time had And it they while be were agency last they was February. conclusions, had We to that an as April, had to agency the And in that evaluating their the comparability. only where with the you meetings doing know, we modeling. their that's not comfortable to

Capital. comes from question Renza with next Your Gregory RBC

to well have on of mention XXX analytical build them Ashleigh, additional any curious to helpful. on freezer as methods be filing you those to some could one be put or of to to maybe the issued resolved would today, your comment up. decision which findings of as to on I'm a have on prior methods present Thank required you. there be in you the commentary would like little sounds just AGC, on to the call reliability of bit just the Any just form some the release if question. analytical

certainly. Yes,

then reported asked So with site pre-approval life. an in to will we be product that other them. of the These the relatively inspection, has as of satisfactory observations biologics. will shelf in that agency, are that's answer, its It part We're assess they able order was and establish answer believe These in has of a to some to stability part questions the in answer you'll as And used an to questions of AGC for that do those, XXX. agency a the as manner to biologics assay AGC appreciate, done and be finalizing review for products priority can we regarding working they inspection exploration to well. and And sponsors straightforward. able to process that. be inspection we appear of believe the

just unblinding? the the would maybe spoken as using the to protocol I'm trial or analysis And some that be data, more from great. conduct curious just comparability the what the such tactical steps about data without question, the additional more, to PROTECT and helpful. about possibility thinking some That's leveraging one in address Maybe of fulfill you've the best to order of would an be voids study of

Thanks, Greg. Yes.

discussed to So, we in parallel how collecting present are review. we to protect the do in that to PKPD integrity we we way specifics And ensure can not its get a with I the useful we assist intend and with the data can their of of them able of in a discussion being agency the have to make its we input, that them the that of available. anticipation believe outcome, you data the evaluate study have without tell data can to from in that. we preparations them undermining study. And that's do that protect it to continuing the

may, side. and on appreciate, one I for just I'll sneak great. That's perhaps commercial more if Jason, I maybe in the

issue, comparability Ashleigh. how the potentially Thanks certainly winding sort along now. just some raised should docs road of proceedings what hour XXth some now about think of that the any and the been we issues has of impacting of, could for but with also at again, So view commercial how receptivity a are

Yes. Thanks Ashleigh? I'm sorry, --

or the clinical other we impact potential I'll on say, timelines benefits, going we, would any but considerations please assessment, commercialization was answer on you has but Jason. any carry risk the I think compatibility than that that, the issue drive or that let benefit don't market the

question, for Thanks Ashleigh. thanks Yes, the Greg.

think many physicians see during a we the I haven't it drugs if issue heard an come and we approved, for boards, advisory being single this don't time recent yet. up

obviously tracking an issue. being approval, we don't but under it, see we're So an it

comes Wainwright. question next Ram Selvaraju from Your H.C. with

Ad-Comm I will on at firstly, a but could vote not comparability just to something no the list touch So part even there's discussion all or the Ad-Comm come the the wanted discussion, items of is to that render issue, supposed clarify, it's in possibility it's official that of that up on.

company to key it, need, are that the Ad-Comm And reason the Just wanted focus an to the the considerations is clarify. Ad-Comm brief that the on, and and the A they're compartmentalize their documents the - focus typically allow with informed considerations AshleighPalmer will and We can but to to affirmative agency up to agency solution. comparability doing include efficacy find has come the statement never that around, the safety. intend mention the guarantee us in that they in on what a collaborating briefing a discussion of the

significant to efficacy D it profile agency though the would the not such advisable to asked for question the because the fully and a answered consider be comparability the you possible drug, regarding simply whether so Have been questions would and it whether was the is at-risk Ad-Comm, even include TX need? study all approve unmet have compelling they a

of facility is it so and staffed, as advice. the discussed comparability does capable And have comparability to able background issue far specifically related any me technicality of provide to with change with the agency do the expertise panel We wouldn't manufacturing, any agency the formulation, a be qualified to et and that have members addressing as as that. typically not not biosimilar It with agency fully or make not additional in cetera. in the questions and would sense

is the they respect be look data if to the conceivably with With that the point. Okay. and you along be MAA, this for does, regulators European comparability Europe, toward you to the At advisable a same and might apply do consider, lines is information additional as authorization that think the as option? they that could unless to it marketing comparability the furnished, has regulators, or off-course conditional need discuss for, European of the data FDA the until deficient FDA may been that instead, do you filing whether, viable additional asking

are We the the the middle and EMA with in discussions scientific of with our advice NHLA.

non-binding advice and received a number have on guidance subjects. We of

yet, comparability throughout given but it discussed, had to those the the the to that issue way same have yet interact regulatory I in it's comparability will them FDA, fees the we it's have reasonable closely solve now think how assume authorities for agents U.K. will as determined. regulatory this We world we And to to not haven't with we solve the but be or for discussions in have Europe.

also progressing going terms you're just additional it us timeline of on of expected the lastly, to And everything's terms you how and for logistical or there go. is challenges as targeting of as has in Then in just provide if that of that, data trial what an Okay. been any on encountering, absence the with enrollment, smoothly you're some might be just top-line overall, could clarify reporting to reminded, from granularity protect study, wanted now. be to

Ram. Thanks, Yes.

still enrollment. So of And of close. the there guidance then second XX is for the half our completion the year month is this study follow-up an for to

in management the of increase and We've and so top-line available be rates we better the of sites of XXXX. a pandemic seen as the countries anticipate in vaccination. a middle And steady will COVID enrollment result results in

agency to that fact, just track like and the as out regarding summer we, go the into months I the that we encouraged second we're to with so point by in will And be that complete half. discussions would having targeted on we believe and can PKPD than enrollment quickly the data the not but waiting results have more data we study. details, final that results wait from for That until to accessed that be we get much the data. top of shouldn't the yet to PROTECT the line assume study we the in know

question and Co. Kim with next Justin from Your comes Oppenheimer

CVB exposure prevent can of Isabel remind to from Can just reach you before the Justin. the patients on from is regulatory just study, what This and the disease us expect of a perspective? of the strategy we for findings

you're much Francisco, please. that, very that for you Thank think I answer question. best to

want you mention CVB? the prevent Yes. to just question. I clarify Did

that's correct. Yes,

the study? mean proactive you do Or celiac

CVB study. prevent The

Just trying to clarify, --. are we vaccine, talking about the PRV-XXX the or

Yes, the vaccine.

Okay.

Coxsackie encounter eventually, exposure Coxsackie their because virus. disease infants type-X other diabetes, on a to literature the a are vaccine B primary and all celiac viruses in we based We It's and prevention newborns B targeting, diseases. key believe trigger are that first with before

prevent attempting the infection. first to So just

Thomas from Smith next comes Your question SVB with Leerink.

to AdCom, the Now that we're asking around they FDA's the data agency more data? for the from your panel for clinical input? talk TNXX you or and just regarding your the about clinical concern on out areas set where where their can sense the the interactions plan three of comfort weeks What's with

time. believe Excellent P study and peptides encouraged that that's the the We're and We and the studies, evidence the by very modest breakthrough data We delay as continuing two invitation data years and and now newly that which understanding designation, significance that of years is TNXX delay of the this database with the indicating from signal set very and a a C agency Stage then the disease X, of significant is the of be that the committee of from of Stage with clinical strength the of panel safety a X protection the to Tom. evaluating powerful a efficacy study, and has determined the it on three the statistical from the the worthy a median of fact supporting cells of advisory therapy committee beta that the follow-up published by value historic and need from meeting. the believe will diagnosed the question, in focus in TNXX has pining. data an unmet that very progression advisory study, an although find but they they'll the which therapy, finally of approximately first the disease therapy It that's context risks set and conversion relevance might to beta in risk a the we're the and out is of over immunosuppression modifying we're in Then therapy advocacy key very to safety chronic believe autoreactive cells for and resetting system. a opportunistic potential expecting of is and that, therefore we A T will also from in the of that and regulatory that reduces and is a profile not forward the safety a diabetes the or to immune infections context It delay. or the that course keen exposure. chronic destroyed point potentially we profile. cells, immunomodulatory attacked of from be T three malignancies the concentrating again with support after that opinion patients this the we're and of really rebooting lot the the and cells patient therapy discussion have looking That's conversion type-X exhausted immunomodulatory weeks' on that a of of immunosuppression. prospect coming up associated groups, leaders discrete is be

issues on describe date? and are you specific confidence and for of it, current form PDUFA were what July issues level these issues Xnd ahead be what's related the specifically the resolved cited the AGC Can Teplizumab the Actually to okay. Teplizumab? of XXXs that could your Got manufacturing to Biologics, the

that that from its typical XXXs. pre-approval were a response believe observations The AGC they the by site We made inspection. be addressed XXXs will satisfactorily and to

sites. of them matters general pertained to at Some the

the pertained Some considered obstacle. associated we're address the related to of we that or a to but matters approval XXXs pertained mentioned as to I with AGC satisfactorily and with able facility process have the to that an that them agency the as and working few they be those believe earlier, Teplizumab were were to products will for not manufactured

Okay.

you Just received Legacy product new product? study to protect AGC Lilly within versus manufactured the PKPD the have can biologics patients comment as the the comparability, this point how at on many

information We've yet. not that disclosed

Okay. Can study would is just product you level, the or that comment have the at the high received a expectation new legacy in the of patients product? majority your

a enrollment is would at legacy whether blood the for is the a to how and necessarily clears a administered, What's we sub-study evaluate been efficacy, trial, early it appreciate, PKPD much and important placebo in three a study able active blood, be PD sub-study and data isn't simply biomarkers. able we complete new in PKPD received after that their before as requires has we and a completes believe to PKPD ongoing immediately clinical issue taking assist will to and from be example its Phase It the order patients do will trial it's how to and different initiate to them protocol. agency you many the provide the looking between samples considerations. more compared therapy The may trial, regularly, product, that the the versus into about product a bringing

with Your Hoang question from comes SMBC. next David

follow-up. one had a just I and then

still that is First that If to know can you to around? something something give Xnd. revised one you is active an on stands. it July moved, PDUFA be date, that the you're going or that conversation need guidance should have agency to for and wait that the We

indicated a discussions it there comparability. on based on manifest agency's is extension will not that indicated that for be will delay be the delay the a that review of we've response, within to with cycle after how or delay. certainly itself. formal potential Well, our likely Whether understanding We've had on but current we position some the

that obviously the regards material with hope meetings to have review, lot in I will we information. can the will take place, provide the additional that the taken we we agency and concurrently at we completed a the when time the then, appropriate you to clinical the of AdCom will have AdCom and I AdCom. think into has until depend them suspect outcome data consideration wait on update

helpful. that's it, Got Okay.

of Amgen Phase milestone cost they all there you you? the elects back, Just are take on for Amgen option it that development back come assets. I and fee. still you If is still pay disease that to not to in back take would or the three celiac developmental splitting asset involved, costs a are the understand to

The the but full potential decision we asset costs burden in their that to development control development that would means would ongoing if would of that have of interested license that full of asset an mean the after it opportunity with by the have we other parties merited, of benefit would full commercialization that partner and arrangement also an an way of or have celiac. continue we would arms-length

session. I to remarks. to like for any Ashleigh answer Palmer conference and back closing turn would question over our the concludes This

you Thank We'd, you, soon. questions. day that you and we for you Kaylee, like great you will a you to thank for and again your Thank have speaking the thank hope to look time everybody. and again, forward to

conference today’s The Thank now for concluded. presentation. has attending you

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