YMAB - Earnings call transcript Q4 2019 | Y-mAbs Therapeutics, Inc.

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Operator

Greetings and welcome to the Y-mAbs Full Year 2019 Earnings Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a remainder this conference is being recorded.

It is now my pleasure to introduce your host Thomas Gad, Chairman and President. ahead. go Please

Thomas Gad

Good us Ashley. and you thank Thank this afternoon particular joining on day. for you, everyone

So XXXX to activities. that was significant the submissions, our we year that we clinical two complete launches, our well XXXX BLA and while work very expanding to progress prepare believe strategy took product us steps for position and for as potential on we made significantly

cash. offering And we We by as to know, of further million ended proceeds XXXX Morgan October, secondary with XXX strengthened These in which approximately JP completed Stanley, in a same for both without in we and launch led XXX of pipeline sales the Morgan late to million BofA, net company. our later should revenue. you naxitamab and the raised carry sheet potential us this consideration end into potential or that's advancing at And time any of XXXX. partnership through our omburtamab balance product the any the taking and year, while proceeds

we rare pediatric it and previously was December, rare is vaccine both financial as omburtamab designation from have very today. received position as our pleased So disease FDA. And Naxitamab designations granted the in with well. disease pediatric our are

have in the these for shown addressing reproduce paves we read out neuroblastoma that third clear for to voucher. priority encouraging trials. we able results unmet review now and that So way And patients. data, omburtamab potential are Naxitamab continued to multicenter medical needs

We a everywhere. very our major Europe who in and a global 'XX. is believe is Hong our result for we to to in trials and Y-mAbs. both Kong. XX million this naxitamab clinical naxitamab are making including the highly Today children direct available spending omburtamab are and dedicated operations we of And spent think US, Canada, treating teams omburtamab committed worldwide children outreach approximately achievement And on

clear antibodies are DIPG, addressing ongoing working exist for pediatric these patients. both activities clinical where osteosarcoma unmet our We medical expanding and for hard needs on

XXXX, also add access We're to global in a in naxitamab as an opening vaccine here worldwide. provide on hard on to working up to children trial for order

are about. Going plus we excited low advancing our beyond which affinity omburtamab, are and bispecific CDX bivalent very platform, naxitamab one we two

Our first escalation dose validating and potentially trial centre in currently MSK. CDX I study platform very see indications product partners. this is It'll GDX into bivalent in data expand with future clinical Phase be larger interesting to at from our single

focusing on need we IND hard We're working our an the bispecific, focusing announced CDXX this also year – on have and CDX, filing again bivalent AML, another which on potentially unmet children. second for

we filed announced, our an last with As into get next conjugated omburtamab omburtamab to year the late clinic. generational IND in order lutetium for

on patients with two from clear and primary that part medical Here metastasizes tumors to face we second need a a are unmet strategy that neuroblastoma up brain. trials; multicenter working the for pediatric one opening trial a BX-HX the the

to the And achievements Taking and stay believe clear work children XXXX. company all continue will we are of us positioned consideration, our into the forward very needs Y-mAbs with position oncology well in a pediatric is to bring excited focus rare to true as living and very a hard these advancing reach lives always therapies addressing unmet we to company cancers. in to leader our as on medical we

you to you Dr. And CEO. with Moller, very I'm that, Thank Claus pleased our introduce to

Claus Moller

the of submitted continued and we Therapeutics to the candidates pleased earnings November first chosen from Thank to we submission XXXX within the be their portion BLA fourth respective naxitamab We couple ensure the of call. that advanced today to XXXX expected to lead of naxitamab that completed and omburtamab and to quarter, BLA join the Y-mAbs have us weeks. rolling Thomas completion submissions. and our in next hard work welcome during product you've to you, We're

meeting omburtamab recently to have very we and the FDA, our pleased a plans were pre-BLA with agency. the had For we confirmed by

We that projected are timelines rolling commercialization meaning in our complete BLA unchanged. expect May, overall submission our to omburtamab

on to We to ability have the progress. We commercialization our continue execute continued keep our this will you believe we year. – plans the posted of to our that through quarter first on demonstrate year

This the these being With at facilities. in what our our line be the naxitamab necessary to believe deemed coronavirus I omburtamab contingency in the of to to to with mentioned. contamination we plan company submission mind enable that BLA stress the want we has timelines sites precautions on everyone's includes days, taken I minimize that all US and just ensure all will and us the risk

with to in addition relapsed/refractory XX clinical exciting also high-risk both from Let the Data our naxitamab Hospital, dinutuximab, with neuroblastoma Barcelona's naxitamab, some we This event free XX% XX a neuroblastoma osteosarcoma, frontline to anti-GDX naxitamab showed ever a months. me complete frontline patients osteosarcoma. in in four presented. in presented this remission, first rolling data in and significant study first from antibody experience stage sponsored at frontline investigator At day had patients news data the naxitamab BLA treating has antibodies. for naxitamab competing is both survival from rate Children's turn December Mora R&D Dr. who have in

significantly event related to Mora's dinutuximab less free morphine with required first morphica with less with the dose required XX by required opioids for anti-GDX infusion competing used treating was anti-GDX pain months declined of significantly only associated XX tolerated naxitamab antibody finding XX% study, than and And antibody. The The competing antibody than well survivable by frontline This be the compared antibody. in patients treatment of the Dr. naxitamab that the the in the favorably generally anti-GDX XX% cycle. treatment published naxitamab Dr. data Mora. of the appeared after use generally

the published later with start to a study, year. City, later this be substantial we the encouraging provided exposure presentations International Oncology Study ongoing total to last highlights MSK Pediatric and in year. data. XX-XXX. naxitamab at primary planning currently frontline frontline was SIOP Among which France, At we New Society We're Conference this second study of this a refractory from also A from data data by expect naxitamab October to study or patients MSK the in of expect in neuroblastoma high-risk is six multicenter clinical York

one patients, who received prior chemotherapy, than patients patients, two salvage came were In of XX refractory a antibody These of than to patients patients chemotherapy. and we and were outcome intensive patients patients In XX% demonstrated more had also third and more are the second refractory the this GDX overall a induction XX% in response therapy neruroblastoma were line including analysis, another saw addition, to half subset the subset XX better rate. on expected we have resistant relapses valuable or with they also relapsed these before naxitamab. previously to

response progression benefit on had These a a XX% at overall survival to population. in months, to rate XX% and treat this XX next naxitamab two rate the free or indicates difficult clinical years patients coming which

keep therapy had the patient observed. had naxitamab two-year therapy survival also A neuroblastoma of received of of before patients anti-GDX second therapy data rate progression-free or XX% previously lines presented receiving XX% from population in and of this two and naxitamab. anti-GDX XX% disease or more In remission. received evidence patients with We later in GM-CSF high-risk XX treated them maintenance complete with were to as remission. no was

are these one-year encouraging lasting XX%. typically responses We believe progression-free known of have patients to these survival are data about very short since with

has the clearing with We as of been trial. have ever disease bone investigators also the I for XXX% in that interesting patients be very compartment before assess this to population. in any marrow bone data restricted patient which believe seen will don't neuroblastoma marrow

small let developing and this for previously to is a neuroblastoma, known compound Omburtamab as DSRCT. we also diffuse round cell also as and tumors are DIPG pontine omburtamab, Now, compound. me lead glioma for our CNS/leptomeningeal turn Iodine-XXX disclosed but for regulated antibody known intrinsic as second metastases desmoplastic

see March omburtamab outstanding in of FDA BLA before shortly of naxitamab reflect BX-HX plan BLA May. for the to for year. the plans the compute the We thereafter team, tumors positive. of All In compounds confirmed to by meeting expect submission submission our which our late for FDA, hope those end Completing for performance we omburtamab. and rolling a the a we February, filing and had with in these an pre-BLA approved we aim

December, to our agreed EMA Pediatric In proposed Investigational for omburtamab. Plan

process in of An for a that the in And marketing omburtamab in is of medicines, the omburtamab As pediatric registration to is Europe, market. step to year. Europe. authorization a CNS/leptomeningeal efforts provide the new strategy authorities. it European regulatory plan their of is European patients constructive with application the product for we in a this for any registration regulatory fourth in now investigation are believe the marketing with treatment omburtamab required pediatric and clear submit prerequisite to and our quarter bring to a a from path of vital new forward establish the application interactions for part filing approved demonstrates PIP authorization of We of companies that PIP manage outlining for European new products This a close populations. we of metastases to

small with in round Tokyo, young patients omburtamab, DSRCT Society each males. year the the is presented or typically limited XXX Tissue a year, and sarcomatosis that poor to in patients data year Connective at diagnosed in intraabdominal have generated DSRCT very desmoplastic the CTOS XXXX data Japan. malignancy survival. in US, turning the with cell presents last annual prognosis November tumor five as meeting Less are than Now, with Oncology was

population. it's year abdominalpelvic gross approximately do on radiotherapy tumor to need be advisable to can resected. Even where So there's DSRCT be medical possible XX%. more the be from those this a whole may clear for based observations MSK total fortunate in survival whose patient appears resection intensity-modulated unmet patients the And five

Dr. XX combination with that not radiation from was just A study The The survival with XX Modak I tumor receive for MSK. but who at no who the overall total nine who resection, months omburtamab and and at omburtamab. received on XX the omburtamab. a months of abdomen received those XX with showed patients of treatment who for in radiation the after Phase data interperitoneal median and abdominal CTOS total did iodine a patients to the those started reported evaluation based omburtamab by administrated patients study

low improved tolerated radio was our indicated iodinated So the that and in to presented opinion, data CTOS survival. standard at adding showed therapy omburtamab

adding Kaplan rate historically to the XX%. of to Furthermore, from survival year XX% the approximately Meier approximately five overall estimated omburtamab resection the reported improved

these means survival very see we're the in patients. is only endpoint of these to evaluable disease So data. pleased Lack survival relevant that

use compartmental approach we antibody which this where the may has applied regulated this help resection, with patients not that be not may of believe patients strengths. is compartmental achieve to its data cross width tumor help that other believe peritoneal exactly which it microscopic illustrate the who potentially While of omburtamab, could do malignancy. or diseases, We

are CNS/leptomeningeal patients group to XX-XXX final XX.X months, from patients, recently II for patients in cancer and the MSK omburtamab. of we study this reported a doses reached. open study. readout when evaluable we the to small updated received patients. initiated both that survival yet also months two gastric with had the trial with radiolabeled Phase XX.X Study DSRCT showed XX the not and from for increased cancer data of XXX in MSK patients neuroblastoma median ovarian SIOP presented planning median We This metastases the to compared previously Data had and At a we omburtamab where exploratory at at

survival this with approximately update. median patients for pleased we're months. Remember, six these the historical So is

including cancers who different administrated sarcoma, included with patients omburtamab. nine primarily cancers, in In with total CNS eight melanoma. had metastatic included five XX of primary patients XX with Injections patients received cancers, XXX nine addition, ependymoma, outpatient patient's tumors and CNS patients with diagnosis including primary we for settings a from were other with diagnosed injections had including different patients medulloblastoma, metastatic with the routinely and tumors,

highly patents of As in for with XX from diagnosis lutetium results December. lethal our of construct today, labeled filed we XX omburtamab These IND have are patients fueled these these an which alive. still

that medulloblastoma XX we the The previously patients experienced first from iodinated construct. study had in will be with

of we separate our with BX-HX a treating addition, submit positive XX CNS/leptomeningeal in to than for plan in trial more experience iodinated cancers adults, the omburtamab. adults of And the basket our delivered the IND from

the the these potential keen labeled the include the the commercial we're our to the ramping to for The widen team is constructs the support half expect in employees omburtamab. our XXXX. our of indications. and with by second we increased lutetium plan first approximately headcounts trails aim And treat up to We launch of a XX% total XX in on To primarily fourth the during team quarter. and development to adults adults due growth of increase to naxitamab

well in to concurrently for the stage next positioned We omburtamab. mentioned, indications we are omburtamab candidate, the move focus omburtamab-DTPA both I the as believe as naxitamab that line and GDX-GDX to XXXX, construct, our commercialization approval earlier continue and including our bispecific as to in to and labeled and the well programs pipeline vaccine, FDA the and lutetium increase naxitamab

me share to invite remarks the his results. year XXXX let Bo? Bo on full Now, financial

Bo Kruse

the Thank you, Claus. $XX basic XX.X net compared $X.X for basic loss reported and share, XX, million a million the for per XX, or per diluted December of into year to ended diluted or net We $X.X loss year December XXXX. a XXXX and of share

$XX the quarter's The million primarily roughly offering to due compared XXX expenditures. $XXX of XXXX ending our of was increase ended November proceeds million XXXX in secondary offset XXX We from of position of cash the our million. million net quarter the to fourth cash position third net

lead on the cash we've first work ramp burn and omburtamab the the launch up the our from BLA operating XXXX. for the expect two to seen XXXX of compounds, potential line roughly of submissions expenses As cash burn accelerate from remain our and in with the we quarter commercial we increase for naxitamab progresses and

This by XX, two our expenses. and XX outsourced trial increase ended from XXXX clinical support increase costs naxitamab XX, increase primarily in ended $XX to for the million and months million increased expanding expenses the for XX was XX $X.X in December and development attributable billion development million in a candidates XX December leads activities, for and omburtamab, XX supplies to to product million manufacturing Research $X million million months increase $X increase a outsource in research personnel XXXX.

G&A XX.X X from increase from and to primarily for million costs, December to by for a ramp million the personnel commercial launch in XX, expense increased year year up The of in ended omburtamab expenses XX.X expenses for the potential reflect XX, XXXX. upon ended million naxitamab. G&A million XXXX of December related increase million $X.X our $X infrastructure the

that million XX, million XX, in operating for by caused XX cash was December net XX by the burn year flows the Cash from the primarily year. the activities ended to December XXXX. increased from the increase loss the million XXXX XX increase year show for ended The for

partially the The and net including loss increase itself XXXX XX, expenses, an on by in year accounts leap X.X increased increase and increased by a $XX.X offset ended $X.X million. million accrued stock non-cash December million was and operations of in for based payable liabilities, which saw compensation

cash in increased activities of to the in the lab purchase due addition, investing XXXX. million X by spending for X.X New to in primarily from XXXX In million Jersey equipment

quarter related where XXXX. closed of increased from proceeds XX the XXX of by first to common follow The public from XX the stock offering million in net million XXXX issuance million that to in secondary went we on our

In secondary from offering from future still the capital that the operating account proceeds the cash the and from terms the commercialization naxitamab plus of this cover XXXX. into revenues all through net any financial guidance, of And quarter proceeds and of potential activities not omburtamab offering does our partnerships. and we potential on any hand would fourth said take expenditures since

believe do remains So financial we healthy position. very in a Y-mAbs

turn now financial the update, Thomas. call This and I'll concludes to the over

Thomas Gad

Bo. Thank you,

I think we'll questions. take some now

Operator

a question Instructions] The of of Alec go be Please now Certainly, [Operator we America. conducting Bank ahead. will from question-and-answer Stranahan is first session.

Alec Stranahan

meeting completed 'XX Congrats questions. taking guys. the Hey, Thanks pre-BLA for omburtamab. on and my for the

studies, BLA the it's with omburtamab? done launch for then needs a BLA following for if you a commercial give of And just with And a to the end that interactions by clear FDA, picture any, rolling So to sense could do on the of of the now you timelines, submission additional your be think reasonable I've year? up. follow still us assume got the first, that

Claus Moller

study opened Claus. for requirement is study is have just the have the we additional not we now. for FDA is Okay, and be so the almost XX Yeah, What a thanks to about actually, the patients approval. or as patients requiring Alex. studies in they multicenter the where any FDA I XX we from This that requiring mean, are omburtamab and clear,

followed a the be and supporting to three patients historical is BLA of that of The giving come is patients will study, estimated the where oral in significantly any years which not additional survival FDA about means with cohort we what first completed commitment. approval, The cohort XX%. call three data is of requiring should a post commitment May. will they the will is which marketing the one-on-one that year approval part be in be to be it there first that us requires that up And is data, an post be marketing than for study first the patients have the better accelerated

patients of ready are I number about to those that to follow pretty three we patients. year or and the XX to XX be the now we have study already XX the is close So up think And in for need face patients. having

we're a actual So as that. not said, requirement pretty the to it's close filing. I And for

filing. information And of We everything for have May. to getting end the before we the all ready submit are need we the

we we of believe launch can do still terms time, yes, In that that.

to FDA launch this May the diseases, filed and products get complete the in naxitamab, likely For or life date the end most How XXXX. launch the and early. of we soon addresses small from BLA one year? we approval BLAs as will have months this of two get date BLA in PDUFA we believe ready likely means January We Well, there's month, before the we these kinds to omburtamab rolling most to we expect can as November the a which threatening we're a the typically approve typically in for they that PDUFA chance should then FDA.

their potentially typical questions? So to time, omburtamab if definitely could use on approval, the minus FDA answer we that the one US early year. naxitamab, months your for this Did market also have standard the two seen

Alec Stranahan

the gotten helpful. might regulatory very the Have refractory Thanks. neuroblastoma assuming the that's MSK of this be? from relapsed would from on? the you study Thanks. the And Yes, approved end readout one what sense so in expected more neuroblastoma you frontline by year. of me, in think gets FDA, naxitamab do multicenter studies influence timing How a

Claus Moller

discussion. don't First have a of all, we

agency decided with a start second We and until And to haven't about approval line. the had line. the that front discussion discussing I get simply not we the

at We study data be multicenter I and sites that naxitamab interested in that towards will see give we some two happen it's frontline. will individuals from highly also I I be will approval, a And of already form think make will different out after And starting this cannot And we appear can least line. at in in will sure endorsed work that truly have in studies front any it's the year. this approval there. a regulatory that the Whether data using doing guarantees we year. think likely to

Alec Stranahan

thank Great, you.

Operator

of The next Etzer Darout is ahead. question Please go from Guggenheim.

Etzer Darout

then around venue changed Thank maybe question some could the on progress, data Great. my of sort Thank or pivotal the maybe vaccine of as sort just your I maybe dispose of design? by that global maybe thoughts talk guess. as sort disruption not One, a XXXX and sort couple trial what trials data the if for and about the taking the look the given far seeing which venue on disclosures can of of are for we're questions, of you on sort or congrats for of like, whether the you. the and that and what the you you

Claus Moller

our few year. I that Well, to happen happened all make have communities? sure when little right to The as wait are think of an data terms mean, datasets, we Amsterdam, ANR for meeting to what going I the I bit we submit kind and at in now, in a presentation out we of the number meetings very May think we woods make let's planning sure, data in the effort April venue, until in this abstracts the use of are of quickly out as possible. we to various we'll course, in as a for larger get

I'm part other not everybody's about what What have. completely So enlightened question? the of sure. was we your

Etzer Darout

trial for about and for like. that – that trial So what yeah, the around sort look you trial spoke global of vaccine could the

Claus Moller

Yeah. I we're I Well, here. mean, doing is we're that following think what

patients. We have These naxitamab in with them line have we can second a that line put they chemotherapy into become naxitamab combination relapse been are and in initially patients. lot of back And data of alone. front in remission then and remission a patients and remission second of

or disclosed progression-free we poor These numbers so patients X% prognosis. later, are survival progression-free second vaccinating The a XX% than remission in they start a survival. is And and tremendously and that a four-year X% then less have them. one-year we

can vaccine progression-free do second from we bay, are late be then the XX% anything two-year on is we what those something. if So in them to which to doing patients keep to do remission, or are a at with these that able survival seems reverting, prevent to

potentially I think accelerated FDA line first the we a for of commitment and track, the would study. So of go in front uncontrolled, setting the fast an a to with line approval, randomized line propose type vaccination, second

we also the XX% ballpark talking three that and about. you're to up typically it's of of the that's two number and just as that these dramatically naxitamab, time the years hypnosis patients but you're within So patients. completing to take for front relapse patients and relapse XX% decreases disclose data, frontline, in A also get patients about will we in line, with may in some

this a the now. of hard study on frontline to on. the go then in those filed. line what with strategies stud. getting BLA we're with an I for dialogue right need And for agency after second kind we'll randomized setting in do to like naxitamab agency. approval marketing the see could agency the a where they with can uncontrolled do So take But we are try you an post commitment have we have are dialogue And And are working But – we the approval along. be get and to working to we gotten we that that agree the we first imagine the setting honest, a discuss could speculative is and as think

Etzer Darout

Thank you. Good.

Operator

from next of is Burns The question Robert go Wainwright. C. H. ahead. Please

Robert Burns

guys, the Hi, congrats questions have on thanks guys for my all taking progress you and made.

Europe, three me may, update around an what questions the believe from So review you filing Europe. in look naxitamab timeline I like for could period if the be first one and you'll able provide the first as MMA the to when you file That's one. would to my in

Claus Moller

we're the I we in be we 'XX, some we maybe is naxitamab The consider with haven't we give And there probably more of in have be file the precise days PIP this in from then Europe in filing final regulatory in guess time different. definitely to the 'XX, beginning can PIP discussing to Europe, standard late approval do but the is I it saying filing place and can is stuffs to we XXX so Okay, a little situation in guidance. between. the that and study What guidance. a need until not get year. the given EU unlikely another any able will in we're place that Europe, EMA, would

Robert Burns

you're take naxitamab came of of this out the And how setting, Thank out? XXXX? will portion induction that do end at estimate so trial the front long Ferman great. colleagues’ that the My into to read that multicenter year you back the Okay, similar are you. to second you considering the initiating switching incorporating line and treatment that to paper question,

Claus Moller

in actually it the GDX what uncertain does to setting. still antibody It's induction add

to transplant marrow data morrow not we whether marrow marrow that. received transplant that the We're because think get progression-free maintenance the the frontline do at these than for Mora's probably transplantation. had We're anything, have are unnecessary it's bone better facility. or a not We patient good not. of where bone And in put sustainable an studies naxitamab use in you we recommending patients. least do XX% not planning to therapy, you induction setting nevertheless, bone planning a patients transplantation as So as presented and when of and survival if Dr. bone

driven. studies for do of center don't would be data the that we in be sufficient. study, front we with a would sure I for think multicenter what whether two but would terms and until needed potential anything know an ongoing a satisfied approval? So can't we've line had expect I regulatory But FDA single say regulatory would not about would – they be honestly, data the available be agency it it's we that see dialogue willing I with be have. me to data hard that that least hard this. is whatever look, would for would on But objectively so an data at It's Its to enigma. driven, say

take them we well. very, or a and we them one naxitamab other just or have of groups patients progressed large received the the and two my efficacy. then know XX% that, put working of can antibody I I we as into disclosed already of This presentation, give is and hey, mean, very I ask patients remission. Everybody about don't think anybody's we you GDX will going antibodies, to in group

thing dinutuximab key IL-X. giving is mean, be Is I the look earning result. safety. safer will antibody than So up you this Box the can Black

I this. is think driving safety

a patients only I is disease kind I gave And in And – to is issue think have Efficiency IL-X that marrow not marrow clear. the diseases done. bone was safety response rate. they There's morrow. rate data they that response paper like out new a get certified the of The Mora combination came XXX% safety an patients, think older only in get XX% it in by the that Dr. I published and I of gave think patients. humanized efficacy and than a naxitamab the than issue bone more just told presented data. pretty recently than a we you bone anymore. discussion

Robert Burns

Yeah. there. No, you question. I agree with the And last then

Claus Moller

Good.

Robert Burns

supposed all to perspective. you're efficacy question can me for about then 'XX, the the bispecific is, in benchmark relative from thinking you frame be that XQ it's so and an No, Claus. GDX is And good how last data released

Claus Moller

Look yet. the I data haven't seen

I and So tentacle, the unusual haven't this antibody. we escalation say that is for bispecific study throw thing gave we here year a sitting can which one a us had that dose after that can we we're is events a say you started – any,

about wait we to definitely the the and so it's it higher to going – see when can excited And get higher, have like from we We program. I'm dose; get But need we're looks data them. get show. to very time this will

have to still wait. So we it's –

of we can kind of times dose number have dose like week. managed But not now. we it's to a escalate second So escalate every

are service. we in pretty decent So a

then it will but pans the the So ANR meeting And out, happen. abstract we'll talk. get how to hopefully

Robert Burns

Awesome, I it. by very you Thank to forward so Claus. that. well, I'm much intrigued look

Claus Moller

Thanks. lot. a Thanks

Operator

question next JP from go Morgan. Please Anupam ahead. The of Rama is

Tessa Romero

the our questions Hey guys. call for Thank on tonight here. This taking Tessa is for Anupam. you

we is timelines First the seen update? for then up. pipeline, relapsed us think a have efficacy phase And targeting? one there the line safety in Can study, second a And osteosarcoma follow medical II remind you the you're have this Thanks. specific study. of I for data, conference for I

Claus Moller

study, clinical my can XX guarantees year, to this supposed before suitable the find but XX cross as soon we data still hope there's Sure, of in conference. patients trial. I a recruit study in we is and no end all will patients, this as I and the mean, the that fingers present are

hope fingers end the and get year. our study from before So we let's this of data cross the

Tessa Romero

well. you helpful. and that's a commercial helpful. as thank maybe then Yeah, That's Okay, one

sales approval potential year, given year are later approvals, about how you this So initial infrastructure. thinking potential key or Thanks. this

Claus Moller

And months quite team NSL and operating which team you all have the nine and and somewhere together will we most group the already. consistent NSL the NSL separate reps reviews in some but and will likely the the and co-pays, eight, We they'll the between sales have supports, together. company sales team, about organization stuff, an place We commercial heads whole medical started the functions putting sales team under back ago. and an the a put five marketing marketing, office regional XX including other have

about at of looking XX we're I group think people. a

Tessa Romero

our taking for you questions. Okay, great. Thank

Claus Moller

thanks. Sure,

Operator

The Peaker Cowen is Boris next go from Company. and of ahead. question Please

Boris Peaker

questions. Thanks my for Great. taking

about or you on a the line, The with much I'm more in We do first is Would if anticipate line curious have use you strategy to here. just you how the understand talked second your front retreatment in would versus naxitamab. of want approved setting? kind line estimated just front bit a drug one use a just label? line patients of have label front that

Claus Moller

use that you're in Yeah, and see I be second – are getting in treated see And reason. treating, front line. the – then to treatment treated that would are you know line think absolutely. progression-free effect that naxitamab at patients we getting of second front respond or your can survival. no in see the relapse there's you absolutely line, dinutuximab if front maintenance Would we setting, no naxitamab can only have getting increased also can been definitely, naxitamab you a actually experience MSK line in naxitamab in patients have I antibody as so by and line disease are naxitamab in the the from that

line cannibalize of the liners. second any would So not the I think front

Boris Peaker

okay. you, to good That's know. Got

ongoing, what's So the both for maybe timeline which broader – drug. – question, next you slightly studies of for the just – various label obviously, talked both filing for drugs, pipeline and expansion are a about, these lead indications the of for each BLA filing for BLA we have extensive or omburtamab, so maybe beyond naxitamab what

Claus Moller

potential second we the with for think agree discussing what of FDA, on whether other before the depending in think can early naxitamab front additional to we front think little of see indications, those is in year. into And accommodated remission setting, start Well, in data but later I say next line. I end come terms front line it's a line indication DNA, needed could little for to reported or the I naxitamab that line bit ousters that what be we the also is about the patients need I a in on for

induction we therapy prevented thing. For instance, by them and from with treated that chemotherapy, doing them have maintenance

number of that that potential indicates is patients going to a So NAD so there's see. are

I we bit So now. put off to tend think a indication that

the small be first indications round DIPG cell For omburtamab, expansion think the the I tumors. desmoplastic could and

study there. kids for to we're no the months X% DIPG place nothing And to rate and And two-year this kills in these get the now year looking possibility then patients for out we survival. There's five to at group that approval study kids we a later a with of more three survival years the more we mean, to diagnosed are as that a of ongoing touch three ill with get and FDA. DIPG patients the five the treated holiday soon in are get need year, for XX% then – radiation XXX who decease absolutely have we fall and I every five-year. US multicenter we're now. survival. patients it have for from They our and than years arms in agency starting and As the go six talk and And them. again, to bit than and an a there's they

three for We a this than to are multicenter planning study start have we And X% more year. years. DIPG

Boris Peaker

So all have that? would you how of long

Claus Moller

quickly to the I see FDA need and Well, doubt multicenter than that's more these utmost the for would will think there don't to and my no invitation year. good already the to a nothing There's notice But FDA get mean, FET supplementary patients as I for there's for a BLA do cases – possible. absolutely had I question. out to like I the study. a we as a follow

that very I ready. end we these after BLA. But patients. kids. want be so to we the to alternative every help one can commitments we die. their of side. FET So accept years for can help I'm very But marketing have sitting what the but now, next get a are can based – team these And we to that's something also optimistic than There's things, aggressive no to kids, these year, to doing in also going today there's need do and guessing started that much dying and we're towards all just can to five do for deciding from that's here probably could treatments But less always filing need why my get significant to MSK if them. FDA to We on we effort will to in make get single Then post the they data the and disease. a study. in we're multicenter other these

Boris Peaker

answer thank lengthy questions. you Great, the for much to very my

Claus Moller

Thank you, Boris.

Operator

at turn Thomas for back closing time. There comments. further are to questions I would like over the floor Gad, no this to

Thomas Gad

you've on for is a just today Y-mAbs day. with Well, And particular heard, forward position great for excitement. listening this as everyone we're in thank and you, XXXX moving

So hope and you you. have Bo. Claus. evening you, a Thank thank great Thank you,

Operator

concludes This today's teleconference.

this your time. lines for at participation. you your disconnect Thank may You

Y-mAbs Therapeutics (YMAB) 12 Mar 202019 Q4 Earnings call transcript