Provention Bio (PRVB) 12 Mar 202019 Q4 Earnings call transcript

Good morning. My name is Andria 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 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 from Ergo Martin Partners. Sam

and for Financial Thank Provention you you thank Andria, all Quarter Full Call. Bio's and joining Year Conference XXXX Results Fourth on us

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

will review provide will PRV-XXX today's corporate provide open with the with of Ashleigh then Andrew the on commercial PRV-XXXX Francisco Jason positive for the On focus for or teplizumab. then will steps up call for review the update a then discuss review the a teplizumab. call, and next financial data questions. will program. and landscape will recent then we

remind statements our me our safe of purposes make time Litigation Reform product XXXX. the statements and matters success regulatory various projections our prospects. Act the Securities candidates, lines, that plans clinical the forward-looking constitute and the you and of Private about remarks potential of today future include let expectations, we'll developments for and harbor financial under provisions First, These

these Any in today future. and filings of that other the in Actual statements we the of various views from is SEC with Form materially may indicated the statements which recent make annual discussed those most of the our results with XX-K, SEC file a as Risk on result represent important by those only. differ including may section factors, forward-looking in Factors as on forward-looking report our

any our change. the point statements forward-looking so, even these future, if update some views to elect do may we disclaim specifically to we in obligation While at

carefully. under complete Provention's not files statements documents any the regarding are on our Provention should website in reports available we www.proventionbio.com, information on as more documents forward-looking Investors with review today. to as encourage section, you you These the the and of representing There risks statements, uncertainties at forward-looking to is rely and Therefore, date subsequent these views these SEC.

call Executive update I Ashleigh Provention's business Co-Founder achievements. turn Chief to provide an and corporate who development clinical will the Palmer, on now and over Officer will

Ashleigh?

to Thank all them. progress for the and compelling you, era are At paradigm made pioneering Provention, remarkable us diseases have we options plans development today Sam, commercialization thank fundamentally our the of shifting and new going for autoimmune review potential and available joining patients you forward. and a to in the we with therapeutic the

organ have or organ endure prior otherwise preventing support of of end-stage the By dysfunction, or world, the tissue improve for chronic treatment lives lifetime the a and autoimmunity, patients potential we intercepting to thousands would damage failure significantly who hundreds to irreversible around transplantation. of and of

broad agents a We spectrum excellent clinical-stage diversified life-threatening our diseases, progress life-impacting lupus are making type immunomodulatory including portfolio targeting immune-mediated of celiac X disease. diabetes, of and advancing and

track the the first potential and rolling complete teplizumab our for in four year or on are groundwork our lead diligently We to in commercialization PRV-XXX BLA program this laying its quarter for of submission TXD. of

focused potential strategic prevention its with immune-mediated landscape transform our the program flagship to extraordinary treatment on diseases. TXD, This intent validates interception of of or the

this later candidate of has scaffold exciting treatment B-cell diseases. a will ready bi-specific potential of X call. case PRV-XXXX, wide Francisco also state-of-the-art Phase the for in and this CDXXB, we targeting CDXXB variety for teplizumab, which data Today, our Like detail transformative reported in mediated our

that of treated late my comments is diagnosed me than is autoimmune TXD. X better too and Let unacceptably no disease There type an teplizumab. focus diabetes on today example or

DKA, a with present TXD condition. life-threatening diabetic fact, than ketoacidosis of XX% In more patients or first

healthcare a responsible hospitalizations States, and creating system. on a United a medical significant year for is and our than every placing In emergency cost the XXX,XXX total, DKA more in burden necessary

know the close like forging JDRF well patient type We with we collaborations X. from and are beyond groups, and the partnerships advocacy very

their changed. patients leading the patients diagnosed, therapy, TXD are will their families once to poorly life long insulin in forever term. of the of with Despite disease continue rigorous and lives throughout serious XX% controlled, So both short TXD and complications intensive glucose daily and monitoring

XX-year One children expectancy. sobering most their will of statistics on the with TXD the average life XX the have age is under diagnosed of in a reduction

known XXXX as Bio pre-symptomatic changing and published treat presented New the Data teplizumab and Journal landscape England stage study last autoimmunity the highlighted of of at the community. onset prevent year, in study, the TNXX Diabetes was TrialNet transformational June TXD year and the clinical patients delay to in disease. the in TXD of Medicine for Provention Conference potential the Association a from American or at-risk of also

By symptomatic more stage have binding not to to has progressed teplizumab reset system of but yet immune X co-receptor, clear, by to To two clinical or autoantibodies. patients the disease. the TXD having type the these patients pre-symptomatic have diabetes, CDX identified potential be

TXD Teplizumab works insulin TNXX which T-cells, are dependent precious dysfunction ultimately to TXD. that course showed study relevant for the beta which the clinically of pathogenic destruction and by the responsible leads organ diagnosis the The study two the eliminating of single clinical this disease cells, significant insulin autoreactive XX-day results and producing of of teplizumab median statistically years. a highly highly clinically therapy dependent are least type The patients from at of X at can risk delay diabetes insulin relevant. by autoimmune onset in of

chronic data complications of The cannot in and who breakthrough or loved from resulting the diabetic or Any insulin importance therapeutic ketoacidosis understated. challenges is child cares control. family, and of and fear with nerve TXD well damage this poor eye, heart therapy. events longer-term be aware glucose corresponding hypoglycemic of kidney, the parent ones of of importance their the for blood The

all progression delay first TXD the teplizumab the and with potential prevent for Now end-stage intercept disease. the pre-symptomatic timely time, dependent we redosing with definitely insulin therapy or of to to have

laser is TXD generating enthusiasm tremendous focused rapidly and excitement bringing modifying as As ever responsibly as on market the within teplizumab therapy to remain you expect, and potential the first possible. we for would and this community,

Designation Regulatory has teplizumab FDA granted of Europe. and Designation therapeutic recognized Breakthrough potential. States both PRIME awarded in the sides The the agencies Atlantic in has Therapy validated and on United EMA transformative have teplizumabs'

of by began Therapy emphasized the submission. of data represents we our for data XXXX, diagnosed as successful sufficient regarding a FDA teplizumab a taking BLA study patients, set forward submission, confirmation XXX Breakthrough TNXX the Type conjunction requirements meeting B including Provention with regulatory newly in that the our and basis conducting for Designee granted clinical existing dialogue advantage a over meeting full of the discuss from clinical were module enhanced of path teplizumab. November we This In rolling our the alignment FDA to

of therefore this followed by rolling in with proceed will by quarter three. in submission We quarter module clinical non-clinical module our year, our filing our two

have partner As scale the scale, our manufacturing Seattle. from will Lilly stated in manufacturing the Previously, we -- that development AGC filing or now controls path commercial completion we at transferred successfully process Lilly's have process partnered our MacroGenics Biologics Eli contract previously, be completed chemistry, and commercial manufacturing to and manufacturing in and CMC sites Ireland our rolling with critical to of submission of module. have

GMP run. purposes And of our At XXXX, has for set against us run. FDA a successful our to submit first comparability the teplizumab asked run. analytical analytical both prior data brands quarter, IND this And complete of our a the to end completed the engineering Lilly assessment from data will we we from

summer feedback batches. we then favorable commercial performance, this will qualification FDA, Assuming PPQ scale the from proceed with process, three or

quarter us stability, for will be validation, used PPQ filing enabling of four by submission BLA and module year. process These in to CMC qualification this our rolling runs complete our

a in Breakthrough two Designation, mid-XXXX. assuming an we Following period review we priority decision month Therapy reasonably the could customary FDA expect and acceptance file under

the efforts, kick-off We as our EMA with procedural a part relevant a with of regulatory experts with our committee we parallel rapporteur, multi-disciplinary in and of assessment engaging Designation met EMA forward to for U.S. our PRIME recently EMA their team meeting Europe. group bring representatives. and are meeting, the In PRIME teplizumab the with

marketing U.S. nine be We to months. application submission kick-off followed the submission This currently at-risk authorization approximately Scientific discuss the BLA indication for our MAA. months potential or expect the follow XX meeting to will of MAA meetings Advice by will teplizumab's by

for of we submission. So second half targeting that XXXX are the

are Following study from the PROTECT the of by behind not newly remain We the To-date end on patients. any indication, TXD advancing our this track have diagnosed study we in impact closely at-risk enrollment in COVID-XX we XXXX. complete to pandemic. seen

However, to closely. monitor we situation will continue the

commercial To are for preparing strategy to regulatory efforts, also the of lifesaving potential our support introduced drug ago. approved nearly first disease XXX the teplizumab, clinical which insulin therapy years modifying TXD as launch complement since our and we

specialty Jason team. our demonstrates a planning, diseases Hoitt in execution commercial preparation at previous Chief building launches Our including recent has Vertex rare Sciences. positions success leadership experienced Officer appointment Jason competent Sarepta, in biologics as Gilead had and of markets, of Insmed, and commitment the Dova, and to proven and nascent Commercial

In significant preparations. a made has of already our and planning short period commercial progress advancing time, he relatively

diagnosed the Access had We strategy our Blumstein, to who and our both to Dr. lead Jessica years and experience bring commercial of nearly have and forward. patients our with going of subsequently clinical dependent and of insulin work at critical XX newly team our teplizumab two patients are Jason diligently we addition team, experienced the to as Jessica expanded also disease. has TXD, Efforts, recently to progressing Market sector, will to of her thrilled with Distribution we components join in risk biotechnology our stage

Jason? let turn the commercial detail. more to me With landscape discuss to in over this, Jason the call

Ashleigh. Thanks,

a given has Let January, juncture joining say organization. Bio. me that productive, be amazing can begin both at the and exciting been part in team by am this saying Provention it I critical to incredibly I we're of thrilled how at an early as Since

Provention with a the to opportunity novel has teplizumab, unique product bring transformative forward With potential.

publications confidence our to our beginning recent have strategy, our and are reinforced approach. execute We commercial in

the paper U.S. TXD that Last helped Fund the reached approximately published current to commercial and TXD JDRF estimated discussion. provided the a the billion lay in $XX on insight white groundwork global According that of alone. billion, $XX costs landscape our for paper, an the TXD with month,

dependent screen available also on simple, more the XXX,XXX our reinforced autoantibodies are the patients, using or commercially currently There two in a who research patients size U.S. at-risk estimates for positive and of U.S., own test. as blood Their inexpensive and the intervention. asymptomatic believe defined we market. by TXD end-stage dysglycemia progress an tests ultimately are U.S. the without will oral or insulin more Within positive patients test. in have there two group, this XXX,XXX way that tolerance of to individuals for glucose These autoantibodies

the also a our TXD insulin-dependent X and over XX% based Society Stage without these We American published of antibodies chance patient, specifically, X At the Provention, Diabetes have paper and patients five-year to are intervention Stage a direct Association familial have subset Endocrine Stage of commercialization believe that a XX,XXX up to with JDRF XX,XXX X two by alone. progressing on and roughly effort of a on initial XX% of X will known type to dysglycemia, diabetes. relatives focus patients that patients, two individuals at-risk amounts This period. and autoantibodies who

this for of developing type size, ideal is screening people date. X our countries as looking X.X screened of globally initiatives diagnosis and already stage particularly for various to effort. in company blood million tests marketing disease standard initial known to morbidity, a diabetes, are we There way For been help already diabetic Existing our reduce available, believe represents under TXD suspected focus an ketoacidosis. have are early over patient

with already members family commercial accessible targeting familiar believe of infrastructure. market these into this TXD, By readily TXD XXX patients, caring tap motivated easily focusing with immediately pediatric for are endocrinologist the a roughly of upon who and we life-changing we patients, on can the highly modest and impact approval the

As a initial a alone opportunity. that reminder, we believe billion could represent market this $X

risk we In encourage the collaboration initiative, to months, be with in an launch and at screened. advocacy awareness to intend coming ideally partners, screening to those

to way with is patients. Medical In We TXD out this screening importance to screening for general but and disease of of this a pre-symptomatic proactively no screening into such evidenced expense campaign expand an well gaining as enable to TXD study further HCP-targeted encourage roll also disease the screening by The effort, the we that of at broader population in already strategies for working intend parallel, highlighting intended a be screening reduce screening published burden offer patients. them public will population of is American in as to and recent to value suggesting moment, as of agent, TXD the awareness members in stages family severity, the Association health teplizumab. may and as interception Journal novel of

the efforts. diseases, unmet an In therapeutic is with many is addition, likely screening rare drive address case surveillance availability to and potential the to expanded of as a first-ever need

We will will support such known and type type XXX,XXX for Stage time, as children. screening advocacy identify the dramatically. greater to Foundation organizations, broad-based the believe continue beyond proportion Over closely with of of X familial JDRF thus to size allow patients, X this relatives us population also to X more increasing work Helmsley are not market who a X those and direct diabetes, we

are of referral of easily patients' XX,XXX States. population, TXD to Beyond From United approximately clinical will diagnosed successful and if PROTECT insulin patient these endocrinologists the expand registry, that newly each lifesaving approval, allow exchange patients are and found. the or severity Because pediatric TXD the ongoing for in know year patients our in us we X diagnosed trial, the at-risk immediate to Stage resulting into their the population. unfortunately regulatory the conditions therapy,

will consistent with Our profile the to initial eight ages in focus XX patients study. be the PROTECT on

life I term, for seek opportunities throughout TXD management, about for the exploring year. and We're combining and looking the dosing, the our on cycle commercial to community. broaden updating at formulations, ahead progress, planning you Provention the forward teplizumab potential through and to insight of Longer teplizumab look with will age excited many eventually and the remainder therapeutic. we other the for by repeat subcutaneous expanding market groups

our Let PRV-XXXX Francisco data to me exciting call now disclosed turn over Francisco? our to and the discuss program. from recently

the a reported known also scaffold, PREVAIL of to in PRV-XXXX such therapies Thank immunogenicity a lupus, intercept targeting that you, and healthy well volunteers. CDXXB positive Jason. bispecific gene portion associated the therapeutic both PRV-XXXX, from erythematosus autoimmune Xb has as evaluating CDXXB we Study, believe We Cell-mediated as with and the results Today as potential Phase systemic diseases, protein. lupus B

portion support inhibit demonstrated function therapy and forthcoming gene ascending that no PREVAIL tolerated well multiple B binding Xb Pharmacokinetic were the was PRV-XXXX of double-blind, The multiple serious efforts. durable generally the result the durably depletion. data of of our and high was Phase responses. resulted was tolerated dose-proportional, study pharmacodynamic receptor study placebo-controlled, it and in lupus well without study administrations a Cell after The study. dose adverse PRV-XXXX and These our events. parameters with

This lymphocytes circulating immunoglobulin As did PRV-XXXX circulating and and in prolonged pharmacodynamic not was reduction demonstrated B reflected expected, deplete to with Cell the levels. B extensive sustained of effect. binding M

determined both production antibody not levels affect anti-drug pharmacodynamic observed While dose immunogenicity safety to or was was exposure, at tested, parameters.

balance depletion, the PRV-XXXX conjunction and drug, results durably These evidence has A results and our vaccine in with effect hepatitis PRV-XXXX. prior a molecule inhibit in disorders. the of autoimmune our clinical without Cells, data, depletion. Cells activated striking including existing innovative potentially believe teplizumab, rapidly similar that on has B PRV-XXXX these B Cell-mediated which lupus modulation without to lupus in between T efficacy safety increased can other MacroGenics of We for CDXXB and role further and enthusiasm

wide the indications as or role, orphan conditions, as multiple of B such to potential where a variety pemphigus arthritis neuromyelitis such from has PRV-XXXX purpura, optica, thrombocytopenic large sclerosis, gravis. autoimmune myasthenia and to Cells play rheumatoid idiopathic address diseases a

We immune established have in prioritized as given need lupus indication unmet for CDXXB proof-of-mechanism this our the and disease. lead agonism

At failure. to a with patients, and the tissue Cells apparent chronic CDXXB is patients. affect is of gene pathogenesis and organ production characterized damage, of and system, in Cells in of the B in likelihood subsequent The Americans are Mutations an lupus in some overactivation lupus, nearly in Xa every from patient lupus. million study lupus organ least organ in disorder first can inflammation, is with increased are Lupus injury, PREVAIL pathologic lupus B commence auto-antibodies. CDXXB by afflicted that causing expression abnormal Phase the major of autoimmune portion We associated reduced an humans of plan of of XXXX. this half X.X

immunogenicity for prevention the In the exciting the associated backbone has therapy addition, gene to serve and with other of as PRV-XXXX biotherapeutic. potential

animal support currently in conducting of new are studies this We approach.

for financials. now the our call turn to me Let of a over Andy review

everyone. you, Good morning, Thank Francisco.

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

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

December XXst, of was As our balance XXXX, cash $XX.X million.

middle sufficient current to fund of the We cash, expect our be requirements operating will XXXX. marketable for and equivalents securities projected cash

We continue PRV-XXXX, to PRV-XXX. operations active programs, will PRV-XXX our fund for four and teplizumab,

for million full million. in cash the to $XX.X $XX for net month use six We in XXst, expect Our operations $XX were year currently XXXX, of ended million first December the operations used to XXXX. approximately

net general the in basic or per to or perspective, for million Net was P&L as basic and period of to for million generated diluted net $X.XX share in year the loss the $X.X per $X.X million $XX.X costs in The of research for $X.XX administrative a to million, of an increase in attributable we From basic per fourth increases compared as and XXXX. share, full $XX.X compared XXXX XXXX and or loss diluted and share. increase year $XX.X same and expenses $X.XX loss of development a is XXXX million. well a quarter of net loss diluted of full the

in is and PROTECT expenses The cost costs the increase due in driven of research primarily development net and by development million. and costs. to $XX.X PRV-XXX -- an development internal personnel costs study, loss increase year-over-year Research were for

by G&A addition, $X.X million expenses increased year-over-year. In

turn let to over Ashleigh. call With that overview, back the me

Andy. you, Thank

to be backers] recognize of up shift year and As Provention. life-threatening life-impacting modifying we of are diseases. a innovative disease paradigm we We XXXX approach therapies development X first the a that other for commercialization the quarter, type [standard this in and diabetes very end autoimmune and for shaping the is exciting of

intercepting focused before program has it tissue damage Our for on or intent strategic disease is provided validation immune-mediated and too organ preventing teplizumab irreversible end-stage before occurs. failure our late,

teplizumab, like pathways targeting other further behind advancing in candidates, our by PRV-XXXX advance closely we than Following intent strategic are autoimmunity.

Before investors expanding patients and questions, trial, to and and experienced all fellow our our investigators participating executives the Provention amazing we support, our thank in open for the continued call partners my would employees, their experts, clinical of and for dedicated team like consultants. I

questions. ready now we're take to Operator,

you. Thank

Instructions] Please now will [Operator ahead. of the Alethia We go come Cantor. session. question-and-answer Young begin from will first Our question

for the and on of congrats of couple my questions, Thanks guys. lot taking a Hey, months. progress over past

couple me. So kind maybe seems you for a EMA got interesting update One, from recently. of it like an the

little So you to meetings detail in want additional U.S. if just perhaps, the the but more sounds compare bit I and little looking steps they're about guess -- process that it's next along there. talk and talk parallel what pretty the a it are just the for bit manufacturing then you that contrast about to I a with can like

The would which on there with no next out consider doses? wanted were I immunogenicity. just that And this be antibodies to data, perspective pursuing morning. in get anti-drug kind of question any the fact the on came the your [indiscernible] lupus potentially Would you

to way? for to last under the what you do and Thanks. of now Xa portion, eight, think Xa maybe nine the the like of half XXXX you get about starting then things is, the have other part next that months the first between And when Phase question

much. very you Thank

one, we regards much additional the get and the Advice scheduled. haven't information meeting to we a meeting, was won't have we yet first So more until the with procedural Scientific EMA, which kickoff

that year, will have we looking don't updating. throughout you're it So the But as information in be we for get regard. we the definitely that

could antigenicity? I'll address over perhaps, this question to Francisco, turn now you And regarding Alethia's if

Yes. Hey, Alethia.

was did did MacroGenics, affecting safety by was prior not to with mentioned, and see So ability pharmacokinetics inhibit that antibody anti-drug was was tested words, parameters. drug any of dose that levels not that trial the pharmacodynamic not the affect of drug the both production In not immunogenicity as known affecting the exposure, biotherapeutics. and X Phase the from other affect at B-cell. we we expected and in done like But

– And then the final part

and regulatory to your the start key regards preparation design trial Xa leaders year. all what Phase comes through study next the the first then of is these digesting question, our a half site standard with going process next second in lupus discussing with -- protocol, And and selection, finalizing opinion going the through of of any data, gearing steps the toward

big make get guess, in just ready to to I XXXX? you you a this And you here. kind of, picture, out hires you to next, Thanks. I about question. of a -- made hires Can think commercial the kind talk to over some little the XXXX out build drug and launch further bit [indiscernible] need

you could Jason us, that answer much. for please. very Thanks

for sure. the Thanks, Alethia, Yes, question.

BLA So the leadership course that really of expansion I before you we're can Blumstein, the think BLA six Jessica right And as we of which gating commercial the going right real on the any hiring. and seven we focus now, as then scale anticipate are submission hire our of, charge would next the broad like with begin -- is at is you acceptance individuals or commercial team, I see more think over lead the couple beyond ultimately looking the factors, quarters. that, to

Thanks lot guys. a Awesome.

Please ahead. comes of question next go Thomas SVB Smith Our from Leerink.

progress would the teplizumab and updated about be just first regulatory pursuing on you and a had XXXX. couple Good thoughts I guys. Europe recent teplizumab, maybe on the on helpful if commercially, some I just morning. give you're this us morning. given data questions Congrats thinking the could around interactions? guess, Hey, of how

Tom. Thanks,

the United pursue do Europe clear, direct to with the is So that team partner to in we United leadership planning States. have moment in work the and a be the to whether in is applicable go and we would doing directly. we consideration is that at his commercialization That commercialization States, absolutely Jason or not intend

for and in actively been So yet Europe, do that, concluded hasn't that decision European to the But we been determined that therefore, has partnership commercialization. we would seeking either. attempt decision are not

levels you maybe like Phase Can it And at Xa? dose the about dose chose you levels sounds here. in of you an in XXXX, translate Phase talk you're a you've doses order levels lupus? do Phase on in how to on about Xb, looked clinical you to what escalation expanding talk And Cell little just for at suppression the bit you think the looked therapeutic going need you can captured threshold efficacious planning window? the Are the the and then, Xa? here And to the you in that B you're Okay. show two benefit think planning then, dose

Thanks, Tom.

So obviously, Francisco, is best to answer that the -- the dose threshold. level, Francisco and then

doses on in-human have Yes. Cell that We dose dose we inhibiting Hi, identified Tom. by done chose highly the for B the and And both efficacious in well-tolerated work Xb function. at escalation the based MacroGenics study. level is first already a

So trial. Xa not requiring Phase dose in anticipate work we additional any finding do the

guys. Appreciate it. Okay. Thanks

comes Ram go of H.C. Wainwright. question from next ahead. Our Selvaraju Please

Rob on a is I've call This for guys. the Hi, got Ram. few questions.

assuming in teplizumab you don't over support on of So, to the about pricing U.S., sort do size force U.S. to goes well the teplizumab switching need sales commercialize of and that the about in in I you Europe, know what front? you was -- how have yourself think for want to Then all curious potential I you're been Europe. the thinking you regulatory

but So of answer a potential those I've partners first. have then you dialogue let licensing in more, few any in teplizumab? begun you got with And distribution two I'll Europe

could and talk in discussions active -- sizing pricing European potential for so commercialization. are with take I'll sales force Jason, and about United we distribution first. the the And partners States? And you one in last yes,

and thanks Yes, for the months sure. a from so or We're Happy question. XX commercialization. potential to, away

Blumstein way I near the nowhere just wealth addition finalizing we're the initial work the building now in health price. experience brings team a that. and the story, of doing the So think around But Jessica under of economic is to

early building cost X start as economic type to the we're the and budget system to So of total and diabetes, out as next effectiveness. is of start and discussing story, to engage models cost plan the quarter impact health what specifically payers

launch. year. would expect a come And closer will I finalizing the research get until this -- we And formal wouldn't to pricing I so later price much us

and at again, targeted to to the Once we And list as maximize finalized lean will a physicians can database them. looking this us, want and claims think drive the we opportunity. come about actively nothing as to data want the workload up approach with we we a sizing, their that sales with We where relative been our either. away force we're there has associated so deciling, ultimately, philosophy of is possibly and analysis,

so, the roughly out And can knowing or and the -- have diabetes patients in educated ballpark be numbers. market. but XXX with to approach our would expect that But XX patients of so, are I the again we're ensure there would I XX to patients, endocrinologist goal But U.S., to to that's their the we XX to range. to all knowledge will. teplizumab with If the do being we force going are those physician is ballpark that type X an there how we sales expect pediatric XX it fewer, committed with of in what may to offer certainly

sounds Okay. got good. more. a I've few It

expect PRV-XXX And -- X expect we thinking you can what then expect for and this testing when that? mid-stage can design can for PRV-XXXX line trial trial initiate on top you of data we PRV-XXX, when sort to for from or there? in updates any we be when year? clinical Phase begin about and you So protocol And the to in that to XXXX, expect the

first the with anti-IL-XX? about question Celiac the XXX, PRV- So

Yes.

Yes. Okay.

a to do few about schedule. PRV-XXX the on Phase say words is you that want So Xb study? Francisco,

commence trial trial XXX Xb track, the the We of quarter on for patients. second Phase will the and in this year XXXX, it's

And the also could XXXX? you answer regarding question

placebo-controlled it will level, single-dose leaders XX key lupus start be will year. trial. for It we first now XX-week be at-risk Phase final are of at opinion design half discussing just trial And least Xa But The the XXXX as with our we mentioned, in obviously, next study. weeks. about will

Okay. Thank you.

Our next of go question SMBC. David comes ahead. Please [indiscernible] from

guys. taking data. for on congrats the a the XXXX have Thanks question, and Hey, couple. morning. I Good

the it expand more period, for of walk and about be just beyond in getting Maybe kind office the anything patient where just of like of we else targeting does through maybe And in might trying launch, first you're is think to What kind journey? payers drug in So maybe initial broadly. on prescribed? the XXK the patients the and patient out to teplizumab. going there in you're If look the the terms screening? allowing look doing us

for yesterday. Jason, David, on you, you initiating you patient talk about thank to Thank the and coverage would journey? us like

Yes.

question. the for thanks David, So,

enrollment XX,XXX study within in initial the criteria New England that the represents TNXX So the in addressable was market the that those published Journal. fall

be So evidence of two that and would patients autoantibodies with Dysglycemia.

And represents autoantibodies. number insulin-dependent patient remarks, progress with X a Ashleigh autoantibodies, that concerned, they soon mentioned far two diabetes. type type as of XX,XXX to his will opening as diabetes. as a It's they matter That when have I as in X think end-stage X as just patients we're two has Stage

can group and organizations approach family X, Screening so struggle know And relatives work motivated insulin we an those levels. highly are easily that and understand partnership advocacy diabetes, glucose beyond of members through of our think of patients. of daily and type target type in a that the that we initial monitoring group is got highly reach who with dependent like JDRF motivated knowing you've those X

X of not go happen beyond familial at risk target diabetes. other XXX,XXX to direct to are in relatives U.S. I that patients think the the type that known know and we be that to XXX,XXX

will to familial and available We things that are population and LabCorp need broad-based relatives. Quest that through commercially now there there out assays payers are for explore reimbursed by We right know screening. like

the societies we JDRF, screening, Helmsley including Association also American in hope to So in Diabetes like X, beyond broad-based society. endocrine physician advocacy working with like the organizations more advance type population

work think at population drive no addressable XX,XXX at advocacy coalition take think those auto even parallel, I and there me it are with of advent happening let teplizumab, families, of broad-based to concerted highly a But the screening so that advocacy organization. effort more broad-based population drive through we that the identify potentially to have antibodies or approval XX,XXX that. in that screening a and therapeutic is known to will -- is familial to longer-term the of direct that in clear a of they be once diagnosis way launch relatives and expense two that

of there increased penetrating type ways And of type probability all other of which know trigger population strategies, ways X are that of risk general the a enrichment screening would that we X population have are coxsackie These which autoimmunity, with we profiles, identify to diabetes, an working we X perhaps of even the type has with potentially virus. identifying be the subgroups think of general higher of genetic could at diabetes, risk diabetes. I that the believe looking

That's then, Got really it. additional Thanks just question that. helpful, that one other for color. XXXX. have I on And

forward As population think consideration? all-comer it want really sort should also that that in after nephritis about, or be it we moving lupus will you under like lupus, that lupus of, you to some go that stuff about kind think is possible an of as maybe maybe something or like

Yes. you. Thank

about talk the going the to So, broad you Francisco, for segmenting want lupus population do population? or

question. the we will clinical a narrow Yes. for Xa steps lupus in standard Phase that of to the the two signal. broad principle, the Thanks get of trial, down better to PRV-XXXX mechanism population. or one action addresses But In as

do typically very which and So to what in dermatitis as is Phase to arthritis on measure. lupus, people and in focus Xa apparent are manifestations, easy

study. with for that define steps discussion those proof-of-concept So will our we our KOLs, in

Okay. Great. lot. Thanks a

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

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