Provention Bio (PRVB) 25 Feb 212020 Q4 Earnings call transcript

Good morning. My name is Elisa and I will be your conference operator today. At this time I would like to welcome everyone to the Provention Bio call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request. to call like to now would turn over the Mr. I Relations Vice Bio. President Doody, for of Robert Investor Provention

Thank you, year operator, us conference on and thank you Bio's call. quarter all fourth and full XXXX results Provention financial for joining

today's and Ashleigh Chief is Chief Jason Andy Chief Hoitt, Executive Bio Leon, Francisco Officer. and Palmer, Financial Co-Founder our call Officer, from and Chief Joining Provention Drechsler, team the Officer Scientific Commercial Officer;

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

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

XXXX. stage team momentum like throughout you, progress into for to us market across presented you at global that state good our both by driven Bob Provention autoimmunology bring clinical individuals, today. to emerged XXXX remains and made in X pipeline To execution made The beginning still tremendous and last progress in to diabetes morning the be of forward of Type all here as joining I logistical with, or prevention enormous to of was today. of at-risk the candidate. our clinical the to and teplizumab at COVID-XX XXXX that would which entire this as we And our Thank begin delay despite well efforts drug continues operational accelerated advancing challenges pandemic the year,

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across of the to our would being priorities. progress like I business However, before doing other some made so, highlight

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is be from in line we position top a will that to results the this study expectation mid-XXXX. in Our report

the years work of including to patients at-risk below population important eight the In and in other teplizumab's teplizumab, other safety re-dosing PROTECT, on initiatives pediatric of demonstrating support evaluating combination therapies. addition development to we in with age the continue to

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a our of the of teplizumab call, Therapy at FDA reminder, this designation. this review outset is As PDUFA previously as priority Breakthrough noted And July granted Xnd the year. I date

tentatively May XX. is announced meeting also the planning advisory an have FDA for that scheduled to We committee conduct

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preparing committee for upcoming so advisory Our and months. the currently coming team throughout doing is continue the we'll meeting

disclosures further, Before earlier made address to regulatory year. like of a this I progressing would couple

The FDA companion to the require first at-risk being, considered for in tests the population. autoantibody TXD teplizumab will diagnostics be whether

belief, you clinicians remains definitive antibody have result should teplizumab. may share prescribed the will ongoing ultimately will possible this diagnostic is not a constructive some as approvability not it be determine, considering today, Our of therapy. open by the with What the that of currently required a we factor is the that do risk tool, companion is agency FDA, commitment, be which post-marketing patients bridging, which towards we diagnostic if auto still while dialogue as believe be method, shared our with and we at gating a testing can is that teplizumab with it FDA,

physiochemical drug the to that Biologics. and products, we PD produced Lilly substance of in FDA which be second the product two from supported previously produced believe to also I current our we assessment drug comparability PK/PD We bridging evaluated these consideration study comparability by of year. partner, Eli between drug submitted assessment is conducted pertains module, our like our analysis products would in demonstrates CMC AGC This the drug The in to to last address volunteers regulatory manufacturing the from comparable. healthy in the parameters,

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to with you this As and discuss to meeting FDA points the share review mid-cycle conducting of we the The PK our we still interpretation view, the own topic PK/PD we for regarding month. validate bridging conclusion. earlier many and the is BLA its an had we'll know, modeling the have our our And evaluating time had submitted. study first data opportunity of of FDA this be

later and look dialogue to we continuing BLA the innovative May. review this review designation frequent preparations able and all to support the agency patients TXD this therapy this its a our of our over forward our for agency And breakthrough their with be that result these of therapeutic bring mind, to in of with to patients in represents disease-modifying enjoy to of the on and Considering substantial families, of year. constructive proceeds. to Therapy Commercial advisory commercialization prelaunch meeting I'm now As benefit valuable committee BLA the as FDA's advance the at-risk discuss first activities, continue continued our for our teplizumab for in the execution century aspects the Breakthrough to and the to unmet call Jason the Jason? potentially a remains going turn filing over Hoitt, advancement Officer Chief that indication, need and in given for to planning we of the our

morning good Thanks, Ashleigh, and everyone.

in we've course capabilities organization. XXXX, the commercial Over of an made as building significant progress our

discussed As our industry. biotech core infrastructure be the has relatively previous this across time. in all could calls, I've built a not from short commercial more proud with of we've And talent amazing of in that accomplished period I team

services planning understanding distribution our the also insights patient strategy. to pediatric the of and key understanding two laying from and advances pediatricians, educators', market and a mid-level the and acquisition, The substantially extensive this providers, disproportionate deployment have X patients, gleaned talent and research, for have in ever Through TXD market our their efforts, our screening and disease importance including of research launch stakeholder launch caregivers addition of well Type by we launch XXX at-risk participants as the go-to-market our far to early deeper infrastructure of options. readiness national as campaigns, market certified including our individuals, of model groups, increase tested, led we've testing advanced market the caregivers connected endocrinologists', TXD TXD design the before. adult and disease, the from families comprehensive our over company-wide. this program, learnings being In the and diabetes from The than development research stages planning informed awareness of early of available groundwork and patients, and their risk

screening As through offers in spot the TXDetect TXD in program to testing autoantibodies its been the only December, blood for JDRF's sponsors also proud for early we dry of screening option is of initiative. the have This program announced we're TXD groundbreaking founding in-home technology. first and that kind the

with and healthcare to increasing awareness, In payers. addition also patient discussions we've advance continued to provider our

other. million engagement excess of we that payer anticipated directors database representing million a conducted Since medical numerous our from our recall, time, mix, with we've began approximately These that across anticipate with covered ad an in first may to analysis payers payers claims we've which for requests be You May, XX dive date also payer included that increase medical cover commercial, X% has last share I'm board approximately XX% XX% meetings we individual XX are data from lives. a meetings lives. consistent affairs the the further team BLA And and we been can teplizumab to pleased since generally our report assigned. positive. Medicaid those from and both into that seen feedback deeper was that in from filed and PDUFA a a

XX we Beyond along specialty single infusion of limited and model in pharmacies our specialty all plans payer have anticipate network engagement, home a finalized our states, a distributor. capabilities that with distribution

are you With no period. This that potential time that program only exhaustive. preparations at be prepare validation journey adult to and to at endocrinologists, and sessions, but process believe discuss later and patients. design call physician We've provides we Finally, I a design are a address launch, on the co-creation managers, need of brief to healthcare the for concerns We this calls, needs providers not and potential it the that forward important with offer based a now we the a of the Andy? patients into update, very look our hopefully will to taken moments and future assistance services going here bring program pediatric their I'll patients by hosting the updating us the two final second this Andy over staff, year. and to high-level to launch, of process, we've this we points we that taken financials approach plan approach way patients look a medicine one are that office of for to separate as the some initiatives the but caregivers. practitioners a in that nurse are turn the the to potential it, our in believe our this with pain create that overview purposeful of on patient approach help and and of patient and our differentiated also and to finalizing the in to meaningful identification will work matter a serve.

good Thanks, morning, Jason, and everyone.

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

projection. current cash me with and Let start position our cash

position completed exercise cash generated net $XXX.X recently of of approximately including December million offering additional a follow-on XX, proceeds, XXXX, shares. our to which $XXX.X We option underwriter's the was As purchase million. a of partial

expect marketable to XX current and enable all PRV-XXXX equivalents months, be Teplizumab, will We celiac of to operating for for at for cash and vaccine. projected cash, fund our develop type least coxsackievirus diabetes; lupus, sufficient securities PRV-XXX our us next for programs: a requirements four actively one which will PRV-XXX the

cash fourth operations quarter net for XX, in December the million. XXXX, ended was used Our $XX.X

XXXX XXXX We and share. a and million for The attributable to compensation loss to quarter of net million of to BLA for net commercial or compensation $X.X loss costs achieved. administrative in the to research loss each teplizumab guidance compared for progress and several the in XXXX in a $XX continue was well share expense, development XXXX perspective, was as XXXX costs, We million Net on $X that preparation included of XXXX potential in costs, we million increase teplizumab. $XX.X $X.XX affairs loss were stock-based share $XX expenses and million the noncash to the $X.X With expect loss million for expense. generated fourth net three for launch of is to diluted million. regulatory over $XX.X CMC XXXX. quarterly related to milestones BLA first noncash III costs, study of while compared we general $XX.X a of per call call, included to year use the loss an loss or provide Phase expenses. the quarter increases as fourth and additional to the vesting as and commercial The approval $XX.X the year From $X.XX basic increase turn of between and for as quarter net net teplizumab stock-based of and basic towards to closing compensation of plan $XX.X non-cash cash The compared for included million net P&L comments. of stock-based million or increase quarter related loss medical per XXXX PROTECT cash the XXXX. full million in for net basic of The costs full diluted fourth let per for in as me $X.XX of Ashleigh diluted the operations attributable

Ashleigh?

Thanks Andy.

I'm start. that to And you is an XXXX updated out to and spotlight well as Provention year. off good see our TXD dive our you the for a throughout Investor expansion Day and for So with product take translated a autoimmune will a serious program to mission to we'd details our into on company our keeping to shine with opportunities. autoimmunology conduct progress and an intersecting The sent need questions. forward as exceptional impacting our serious we are on April at debilitating franchise to our to also of operator like really event And life progress Bio unmet in ambitious associated life-threatening for deeper that and aimed a teplizumab end That can of life-threatening in soon. the stage pleased and Analyst be any planning into as both that provide this progress with represented clinical continued other diseases. which We look candidates you XXXX to year has fundamentally substantial address the pipeline conditions.

[Operator Please from Cantor. question go ahead. first today Young Instructions] comes The Alethia with

you Congrats question. dialogue my Jason. of taking active can talk X. think at that progress. would I the since Maybe maybe a us can with of dig the you for on that I maximizing that? that the question how you -- into a second the consideration can have an FDA, One with remarks. kind speak longer know thanks referenced be guys, for of the curious, just think have and panel? payers? median you perspective just seeing -- I prepared to bit about the some is you you're kind you price to the been with of I'm think a prepared can feedback kind you're just about little if But Then just price Hey help on you now a more in be kind But what couple things of not granularity. think the much has about some

very you Alethia much Thank for the question.

So the therapeutic there being that nature we've an patients respect a but just in such therapy, presymptomatic respect and with disease a modifying one stage identifying shift how a is would type to administering diabetes is at to with this considered, ADCOM that by only fundamental intervention. a always anticipated not paradigm be

is here understand the from the in they chronically the dosing I will typical advocacy, and in of guidance a to groups that be need opinion also consider I that experts is we're believe resets with to we're better the confident you a with that delay therapeutic discuss when patient with that patients, suppresses that and an in the think median they three-year themselves. risk-benefit respect dealing advisory as system in the opportunity not order to the system. immune XX-day in that that review. an discrete the with we're and So leaders, will relationship. And for the and dealing therapeutic field onset speak data now And fact regimen with immune the in results think then welcome their the unmet key seeking agency going committee to context appreciate

safety context. in to And intersection be good profile that's very an so considering a

at details not looking signal database be we'll Jason, the address functional previous safety XXX diagnosed and we digging could that an from of experts of over evidence cell study, TNXX into but with for pricing? the deep to studies patient question the prepared only the and FDA have C-peptide beta So regarding the respect newly you in now as please consistent preserving mass. Alethia's

absolutely. hi, the Alethia. Yes, And, Thanks for question.

So board the payers we've meeting to feedback remarks before ADA in where was hearing reassuring XXXX as about three think year of in payer we're is Type the that last a May our mentioned with advisory engagement, with team in our payers is really that TNXX June respect one X has are that done a job how phenomenal think year of our previously than prepared began which more the diabetes ramping data the was announced, the of payers the delay. is year, access two thinking discussed market understanding Type I over for course from thing of favorable of I I that our which obviously up X us diabetes, educating consistency because

And ultimately so they we the unmet we autoimmune how anticipate in Type what respect between to the diabetes understanding reassuring a direct of appreciative heard I payer think drug what need covering X the consistency in the and are can of teplizumab nature of like the Type space. enhanced an teplizumab, X the how address and they board from that advisory with heard is engagement

research that kicked are they're about how on with research type launch. we part are commercial for our of within with of initiated But how last that at about go it next ultimately process Type think thinking encouraged just we we we process come the off again to one that months anticipate around both would to just couple about now the announcing which HCPs we're physicians and time engage really X final So pricing where both couple and as and price of be the payers profile to teplizumab, going a going I as will payers thinking -- decision we're the into teplizumab. thinking of a pricing will now how diabetes which or a both

think that financial cost to the maybe how a of kind all them -- that. look lifetime delaying like Like the of follow-up insulin? Just value a about on of insulin what's -- do the of on foregone cost and of opportunity they a like year of

is we're question, of the Yes. insulin around the It's Alethia. big cost of a not It's with year budget one CGMS. And on or frame it payers for right on of pumps a their a and the mind associated the two. pump the for admission frankly, And with diabetes. insulin the into conversation that payers along of the factored having goes cost isn't hospital great of or ketoacidosis It's of it's a now therapeutic $XX,XXX single insulin like direct a diabetic about presenting from diabetic can be need of that XX% just discussion like totality right? is things because the cost that supplies top necessarily that to cost aren't with part the really cost when Those they diabetes equation. to the of diabetes, a anywhere patients So to budget of the in and the think $XX,XXX. ketoacidosis. XX% healthcare X Type know just costs of not We that type

would associated type that in that a avoiding context with totality mistake. of conversation holistically more pricing because the having be we cost disease that just thinking about of think one them So this so insulin the around them are the

Thank you. Great.

go Renza Capital RBC Gregory from Please is question Markets. next with The ahead.

Hi, congratulations Thanks. progress. and Thanks on team, Ashleigh for the taking my question.

really just interactions in Ashleigh, I to-date? the regards And to I those appreciate. on review, mid-cycle just which color to bit the wanted a FDA follow-up on

comparability to positioning your their use in that there. about Just at curious, if FDA comparability? your into Thank expectations its you is And of elements do sort the what arrive engaging do own you. you layer to timelines could current work the perhaps around just

Thanks Greg. Good morning.

see specification from are and so Biologics a side the So, release that the We couldn't product with at to situation recall assessment. comprehensive validated Biologics healthy dose analyses terms comparing manufactured we panel is new low that obviously -- wanted the substance now study as process single-dose of as Lilly yes And our our administer what to material we're AGC obviously believe may belief at the study. physiochemical did we with a agency with transition and to products manufacturer where individuals. Lilly we and a and you also. PROTECT is ago. full to within manufactured the a of therapeutic dealing because That in we the from the to we dose comparability decade AGC then to is specification the the very had that started a healthy the that product. regard a to study have And in product And in volunteers That a our context PROTECT that XX-day comparable. will bridge in

As study a a bridging parameters the PK/PD indicative area fell indicating of little parameters which were within the PD with PK Biologics And the and dose the the again the cleared anticipated the the AUC curve. that safety target it this AGC result of under efficacy below that of all more especially faster. target exception single that are of slightly

products that from in a the result And when in and in area the the done in that be not typical have you consequence therapeutic we would take in agency the in efficacy curve will to modeling which that teplizumab. at two modeling, analysis is from of under what made the to clinically the we've internally very industry behave how we what account very do that difference believe days the difference is So, evaluating of extensive submissions XX the the safety and show relevant into dose?

the to agency the meeting had whether their had order will have modeling they And we've and enable do was are results in same their in our that. us to indicated in to modeling that them. that week confident own a time the make and coming information obviously to we the so out have to our And will decision they our and we do they the they at mid-cycle -- and coming at the that arrive to that only weeks requests and submitted do. we've a conclusion we comparison very make laid we date anticipate in to going to meeting interpretation We they the first we them that modeling between submitted not discuss review interpretation. were And that

that Got potential you. the it, Thank of diagnostics companion for potential. maybe just how on could early post-marketing patients physicians as though. you Jason about any as concerned more curious just maybe with engagement be could that knowing conceptually look that's And Thank think the very patient mention much, interrogation more one helpful. may the I'm you far that and shape what that like around it's journey thoughts as and and

screening The of the when pathway. auto the and I one primary regulatory antibodies, will should that that two glucose you a the of they're indication And stressed patient show thing that that first two a ability the then an obviously confirmation of test that dysglycemia status. by just indicates to stage screening. will patient. patient a don't clinician workup. then for is part do has to manage endocrinologist think full is the the tolerance on auto autoantibody agency of briefed glucose a antibodies patient the first whether levels, refer the workup the the administers consideration And full have a So component, teplizumab. and has there we that include which a That sort patient two It's a test

the exercise as this that in done the much agency to autoantibody post-marketing believe a And are or TNXX do historically were them here. to to and at indicated themselves whether be a that applies to respect to exercise that testing approvability we will -- that look the study commitment tests for really determinant available preparing today those that. bridging be a that opinion a But differs in post-marketing will are to not with for able definitive get very that If we're so very itself. reasons And patient to reason is bridge the type that of comfortable companion scenario hurdle the it they've the and obviously and tests autoantibody don't the tests diagnostic the not teplizumab.

you Makes much, very Ashleigh. Great. sense. Thank

Smith with Leerink. from ahead. SVB Your go next question Please comes Thomas

is Dylan filing. sitting very Dupuis guys on much. Thank BLA Great. the you Tom. in for This Congratulations

to way, to to question how to products. questions full autoantibodies them or where on dysglycemia? patients in any present at follow-up the of And AGC TXD? the Greg's you start us two can as remind that you evidence on work couple for maybe if opposed reach the them of as regarding of for a and getting a point showing as two see with two PK/PD of Just And pathway history they second interview natural Kind generally approval and says kind waiting questions. it the use to do diagnostic in this long And patients what companion teplizumab to stage then present autoantibodies? could whether takes soon more you around the with just

the are Just of planning this Eli kind with that dose any on you and with already into round second ahead Thank or product the study, you. product are product you their PROTECT study? of just the dosing reserving have line incorporating of them go patients dosing? you second anticipate guys would for of the AGC entered going And to Lilly for

Yes.

me first quickly. take question your let over second the question hand but Francisco, to So

giving AGC dose about don't the enrolling time this anticipate This the product. a we So regimen is about dose the of for product. two AGC second the is first patients on using

saying that issues. that and we Again, believe We Lilly then would up derived their clean. any material we And patients it result material. that we from of believe were second first would that clinical profile we're nice would those therapeutic What if And in deviation so -- will And not if AUC comparable. was therapy -- and target is. didn't we isn't and a to we're that introducing sub-analysis do dose. again is when then would have a study given not the it's single that it be can it not and saying them with keep itself the comparable, we change that transitioning, was modeled there the the dosing dose versus or low have the a patients efficacy did or they necessary safety

And foremost, in them. changes There They're anyway. biologics, small not they're so and molecules. with first as are overdosed greatly often very as often simple

to be agency done in result but is this so a to comparability, assessed of and the by as And new we material PROTECT the modeling that something and are regularly study. is has very comfortable the transitioning

And is regards two one because two plus I'd autoantibodies to type X that is dysglycemia. stage two question Francisco stage answer the the two to it's autoantibodies like on really with you alone diabetes. autoantibodies,

of to it's and so evaluation to bring And would stage use one stage you a the versus different be the probably expansion discuss indication would two. best to population the to teplizumab forward what have label Francisco? done

question. the Yeah. Thanks for

them autoantibodies to autoantibodies, faster developing So net or when because years. study. is It the dysglycemia of takes develop first why XX%. two XX% TNXX because TXD. more in it's just to enrolled of dysglycemia you go have the study eventually through clinical stage. one stage five a Once these The patients have It's will is at that you conversion. in And to trial TXD longer you you clinical probability have easier

of the the we the the is As same same. mechanism beta disease, cells. destroying continuum mentioned, same disease the cells T It's of TXD the

teplizumab near-term, potentially we them, So regards in with we cetera longer years that combinations. will well. old, opportunity materials studying under cycle expanding we be the help study, feel to we should have these that life which have this And expectation our do mindful But of et to a have have an we patients as larger age indicated better study. eight be in

an an something to So is eye don't undertake. that have we plan keep on, immediate it but

one quick then Jason. question for And last real Great.

affect and the Just timing commercial a needing around do in your rollout recruiting of you anticipate in is educating terms what force, sales large good team? sales and of how a order to

It's Yeah. we're think more still at Dylan. guidance that I Thanks rare our somewhere in sales XX good of neighborhood reps. to hold disease And a looking XX I type of the question. a size. original force

Investor to of the additional in more ongoing XX around I to planning lot course we're over and that details that think preparedness or the April commercial in our a the insights planning into market XX during the give and so, been somewhere go-to-market efforts last Analyst neighborhood we're have XX. strategy but Day months the of going

much. Yeah. you it. Appreciate very Thank

You bet.

ahead. The next with is Kim Oppenheimer from Please question Company. & Justin go

how and Hi, modeling well? wondering as building we as sort terms for for just build much good approval? potential Maybe wondering the a potential commercial has And in of been see question. that, might things follow-up, how a Thanks launch the of, morning. Just of already just much taking purchases of timing for ahead maybe the of done?

Thanks Justin.

tracks So that, the approach the alignment good has strategically our been the with scale-up regulatory approach of, in a gated and and sort to one derisking of is pathway that. of

he this to and comfortable launch been Jason be at efficient going that effective to of to the on preparations the very the specifics Jason? for to give and the some on very Jason But do same is we're all So done job experienced the can, approval leadership team and necessary you core in time, at is hand a has I'll but over manner. you time and that intent the with very reasons. not obvious has great as as our to boots now ground, much until put a

And Justin. access Like the looking approach the associated Thanks gated monitoring we're very a we prudent situation about absolutely. to particular, physicians team. that taking think Yes, with and deploying Ashleigh spend current what in in with we're pandemic, the I team. deploying like the a said, as think to field is field

a space. experience a collectively and first third job of Bio And of disease recruiting the that both and diabetes. last a the Barley rare got to having talent directors rare across of that it example got been the bring diabetes the So of great three type now, Vice the of from and X of passion from coming biotech potential we're when could direct actively of Provention and the as both having wealth of two regional diabetes type Sales, lined on for teplizumab disease since wealth along type the and launch we've the and in individuals identified goes proportion with X Chris the a those that to from interviewed, X to top board our looking together for have with quarter and that decide And has of connection done talent significant sales being that right up we patients. our that mean year. perfect pull what across trigger, He's the space stands that time type we've both President talent so are a comes them

rationale that the the with timing program? on of and the and genesis Got share maybe sort the how in Thanks. of you terms And Great. of of think Could more or touch wanted Huadong. partnership the your about of on having I the overall to deal maybe collaboration just and currently the for light it. you for sort development development cost

absolutely. Yes,

to industry keep So obviously R&D the partner focusing an we so understand on. a relationships business favor out on to approach We have fundamentally companies and eye with our champions tend certainly regions. technology function. leaders And in that we our for development and with opportunities pioneering

the an excited region. And in significant that to engage is the behind to compensation process And is teplizumab expansion partner from immunology willing so so, is for put continue momentum opportunities. without competing Huadong XXXX subsequent was lupus that an it we and want commercialization that and label that us transaction franchise for in program us a excellent with the just study the to opportunity some conduct. this a the company funding through funds is of about building to wonderful doing In for enables

really R&D the discussions? initiated it believe And it it your and that So -- match. was perfect We're to was pleased. a Huadong a very perfect Francisco? Francisco, was outreach championship I

Yes. Well, to don't the want take glory. we

strong R&D. Always, outreach strong from business lead conversations. start immunology presence to Ashleigh a Huadong presence. to has and coaches our we say, this And us otology As have development and you R&D

have in combination turns sirolimus, with results that very we in seen have the some on might nice press for one Huadong number is You company our China out sirolimus release example. PRV-XXXX

So into this the it's for us money. They a strategic to expand not leverage region. just provide

wondering, there you target an would I it, about immunogenicity just programs. here? -- Is a a potentially be Got on XXXX when to therapy Got maybe good final just question great. of think indication fit the what and/or a think not is utilizing some maybe it. gene had first this agent Just explore think of efficacy? like safety you you sort of that Just you agent programs adequate in achieving might that types would about you wondering, the immunogenicity, currently think issues pursue? issues you of leverage addressing or experiencing how programs And it setting? of are the where what that

Francisco?

Yes.

that issues. don't want right, you're vector, to It's So for Justin. the of runs safety into programs now primarily which push dose the we

of to In of course. goods addition cost

all expression So of allow the the out we in or greater at adeno-associated to the put efficacy they're the greater day PRV-XXXX, the of combining end we immunogenic, an types transaction with vector transgene. so believe press that other of dose That's would release. tissues our allow a what would logically, of factors it combining of because use and lower

side, there block side the also of therapy. because of gene there are immunogencity the allowing benefits safety the redosing the and So benefit the course you are potential on benefits of efficacy on first

delivery broad systemic is of here and don't for potential a the disease. It's therapy any product. So limited specific in gene we're think to we quite

would therapy We're want out do develop and of going intent our that for it developments. But is to avoidance companies to that any go for autoimmune collaborations would those them then gene explore like therapy agent doubt fund for speculatively. or with this indications adjunctive and for to monotherapy negotiate to an the not this lead to

Okay. That’s helpful. it. Got very Thanks.

ahead. Please is The Selvaraju Ram next of from Wainwright. go H.C. question

much taking very my Thanks questions. for

the that retreatment comment the do teplizumab to considers few the this going Could upcoming committee feasibility discussed you studying me? and be meeting, a all topic you something really teplizumab that's on retreatment with the question impact be committee to you of not at at with a the to or advisory expect around whether that here. Just anticipate of is

the of ADCOM, the I ADCOM. will observation single enthusiasm likely think that at with disease. from suspect delay or progression the approvability. to given other there was approval item from the to gating redosing, the delay on And a regimen I the don't the the it's will a be achieved potential up extend the immediately that I think what side study to come study TNXX that encouraging to potential indefinitely us a

believe sufficient of of a dose single I and However, median is years itself. – that three I of the and that think in delay the therapy

have retreatment you any setting? in at fact post-marketing juncture you impact the thoughts this example the as Do suggest studied be might in regarding for how

because approved evolving number anticipate the speak that summer it give to one this don't of Yes. dose. be in label by see would Francisco probably you that we the only specify can be can label means. is the best We might to and a

sponsored us from by lot clinicians a demonstrate when of payers on other advising they redosing to But justification you dose, of that Francisco, advising benefit in can or occur to giving for be means doing second initiatives going own have follow-up number is post-marketing our a so. and a that studies how to and driven the So instances, consider need the perhaps to information? provide from to on

Yes, hi, Ram.

do redosing diagnosed with in newly the setting. already So, experience have we

the the As you months know, safely. for we There have X issues. and patients done safety second course were was and first over who after XX are no dosed time this between XXX

that us helping And T could delay quite with understand numbers closely the even with exhausted for correlate cell and T against to of believe another cell that we Ashleigh response clinicaltrials.gov therapeutic absence even a the the pancreas. appear the patients is we those have that be information. for ongoing clinical provide can original convert in they a have be read timing to done to in we We extension for it important. study redosing. eventually to a PROTECT mentioned, biomarker the tractor in exhausted an course who best us course study on indicator because trials give great toned, that toned redosing to the in TNXX we natural yet, in And teplizumab while our some the listed then program numbers progression clinical clinical do know in current to we is as will have safely. would immune which very based that's With the of at an regards So disease, we where good response risk, not

So they redose. into trigger we for be patients, the will in toned using that studying before post-approval would new the then in trial, as read cells those a two stage develop where we exhaustive

comment you there also discussion will very be advocacy the advocacy you patient in present at That's patient representatives of that on helpful. Can of to anticipate engagement of whether be ADCOM what and discussion? context

Yeah.

that the but So with to them yet, we haven't the finalized we absolutely doing and obviously. patient the so agency organization agenda would will contribute the advocacy eager be welcome to outcome

ones. quick very two just then And Okay.

what you talked in the about not that you earlier which some generated sources FDA material says in different a of bioequivalent they're to the PK when you that expediently? be fact are profile and Lilly generated the material in whether where differing ways might these between AGC material can situation sure Firstly, the two address the of

post-marketing study PROTECT in So we I've commitment, It simply mid-cycle range to transparently. could the the agency. the we'll used a evaluating dialogue situation have but with those with reported agency. the discussions the that had following review the have from material not

developing for focused or part and record far sense those rest in so lastly related looks that therapeutics marketing then are potentially target? of And autoimmune like therapeutics. areas the that, their portfolio and of being press disease that release would in Okay. Can disease disease what track think us – their has Huadong the inflammation you anticipate the XXXX constellation experience been they of I XXXX a in what mentioned, of give their

the for Thanks question. Yeah.

please? Francisco some think with color, Francisco, could knows best. Huadong I you Ram provide

market large Yes, XX strength a and their in Huadong's Ram, China, information rejection relatively for excess on to billion immunology, of been in reps. are are drugs $X And In a sales public they X,XXX autoimmune while. that top have this for They products company immunology, oncology. sales all disorders. treat is used transplant is prevent They endocrinology and XX,XXX in employees, some precisely in website. other the have

the to of Prevention with allows on side partnership the be innovative development. more them So

Thank you.

Please SMBC. ahead. Hoang The question go from next David with is

thanks progress on Hi, the taking the my for guys. past great questions. year. all over And Congrats

missing an has up one, efforts? screening that of the screening going teplizumab is want caregivers screened driving. just point number to which currently teplizumab this in of crisis, terms my My on is, beyond population a of in with goal you specifics has screening going autoantibodies of of able to do individual potentially anything anticipate you'll I on, dysglycemia that just and a Ashleigh revisions possible. of potential -- or be now first monitor the that consequence meaningful that to guidelines terms he a is to the A in goals use question point, ask test. program that patients that this have prelaunch community corporately a kind JDRF to can meaningful. But the fit the believe a that, our acute ecosystem is there Is general to we're we to also getting to fingerstick and And the So the you give. nice is has prior interest once I to bring in is Palmer to change with so which the DKA tests avoid if for around catalyze the JDRF efforts, in has to on Jason What from two to to any the market, of terms primary terms to on and And know coming It that strategically key So, couple. been and we'll of triggering outside closely screening something the get providing intersection. market? approval the to is possibility ramp-up any and screening screening driver been community it in - of patients awareness a the and product feel certain

situation a try we TXDetect initiative our sponsor possibly ecosystem as the paradigm the more screening in can of bring a very details? the disruptor, type being actual and and any and autoantibodies what to able We're opportunity, that its from into first-mover, thinking use to the you pandemic, proud that home. to JDRF is the academic a drive shift during that we JDRF wherever allow just the especially themselves, can an of and goal our as to So do really sponsor COVID ability with change. Jason, and was change of fundamental and do the patients consortium have begin hands at they where of to

would here, includes in-home they drive things getting that components educational I is I JDRF think, nice initiative about add want to a and All Yes. during screening both Ashleigh, make that spot pandemic, program, that, think to I the really possible go blood simple has screening with as a if technology TXDetect for obviously, particularly patients to. to

the hundreds two that, consortia analyses through are, I things even the absence physicians the of in-home thousands add Ashleigh ordered being I to said from think, that that year. and database both in know drive of of claims spot published would think, what's what I tests technology, autoantibody been we by are academic blood

X there And they the have so, if diabetes. risk family there with are are respect gap patients being member screened in, patients out and that that Type there's with also disproportionate a an educational to

They associated lot of create Knowing the two why for to Ashleigh problem. diabetic quality the life. really address we of educational a that disease different through quarter can to ultimately that until number of The those a catalyze is components in are of Ashleigh’s with down suggest They of the digits, approval of teplizumab advance Those which the important. space I that don't all a screened. are noise mentioned, have mechanisms, intervention. of TXDetect. approval second, think obviously end then last should the which be there's thing only want and year to be literature I huge good campaign comments. more should single of would on I as that number for launched XX%, even then be patients at teplizumab can for unbranded reasons. itself a a therapeutic of screened the from to a top patients' in is additions of is, around, screening components there there's people published third and so, think that ketoacidosis reduced And the One awareness this the the And

And authorization factoring maybe does Thanks that of feel curious proposition then, is with to then, the criteria all that's for just just discussions? you something -- on how And much a conversations, I payers, of all Great. that. prior quickly, that on at guess sort is emerging the I'm conversations from in Okay. change are for your whether redosing a the of they're as part payers redosing value thoughts their the the the product? like

Jason?

Yes.

strategic part of objective, authorization seen would which like respect a streamlined to it's respect prior degree the aligned with your we've with is how with fair they are question, first payers label. of thinking consistency our and cover to how product a So, a teplizumab about, to

if in they were control we almost that And it. would would that type profile comment early prior was on that that appeal. label And was expect would at authorization we this to anticipate But of payers surely this the was because additional initial would it would the benefit this with board us gave from to to need advisory they insightful way teplizumab, covering product, price would authorization one of anticipate the medical with deny so, unmet be of that, that, this that what covering be on based was a X thought thought they of the overturned you PA the label. we they they and on prior label. a felt Unless they a then on put out like heard whack

goal a similar policy prior any have would label. at specialty to therapeutic thereafter had authorization a our we a to they've launch that write So, medical is to product chance that, other and streamlined review or shortly once

that their Okay. conversation up And come And just if the any? with what's feedback then redosing? on Is payers?

Yes.

part it's data not have So don't at conversation of a redosing, we're this we not because the yet on really time. --

Got it.

Okay. Great. Thanks so much questions. for taking the

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

with hope and you much your day look you morning. We soon. pleasant have very we very again forward today time Thank you, a all to for speaking this attention and again

for The presentation. conference concluded. you now is attending Thank today's

disconnect. now may You