YMAB - Earnings call transcript Q1 2021 | Y-mAbs Therapeutics, Inc.

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Operator

Good day and welcome to the Y-mAbs Therapeutics Incorporated First Quarter 2021 Earnings Conference Call. Today's conference is being recorded.

Let me quickly remind you that the following discussion contains certain statements that are considered forward-looking statements as defined in the Private Security Liquidations Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including the fiscal year ended December 31, 2021 as filed with the SEC on March 1, 2021 and in the Company's subsequently filed SEC reports. At this time, I would like to turn the conference over to Thomas Gad, the Company's Founder, Chairman and President. sir. ahead, go Please

Thomas Gad

Good for and our Tonya. joining you us today first morning, you, thank everyone, for Thank quarter XXXX.

quarter, expanded pillars this our monoclonal antibodies is during we omburtamab. our leading continued So and execution first, strategy our and our on of three DANYELZA all business, which have of

meeting can omburtamab on are able our the for We omburtamab BLA important treatment a continuing also Application treatment impact an this to Authorization gave third developed are for from of patients the We've in with currently tech quarter on working is the We believe of for are which to in the submitted where to week and we a XX no we to liquid hard radiation. to with B towards neuroblastoma Further, being second quarter late update and platform. the here needs metastasis also metastasis our Marketing CNS or on pediatric April we address therefore, omburtamab finally, for the XX. Secondly, last Type that refer FDA in we there under resubmit achievements CNS these omburtamab bispecific substantial And on unmet as therapy standard have a today. the CNN landscape in XXXX year. strong high-risk submit and Europe. the start significant US had compounds -- thrilled the platform, this Y-BiClone and SADA technology as medical potentially March

high-risk neuroblastoma hospitals saw We of last US throughout approval in February from for and you in just the the received primary DANYELZA year. DANYELZA As November US. know, refractory beginning relapsed in demand started delivering we

exciting. very is this So

million, first to are The commercial net and these sales sales months we of report first pleased $X.X numbers. represents less revenue two of than quarter

not and I'm COVID-XX partial reach forcing launch mode, DANYELZA note us provided revenues have that. pleased on few both virtual with expectations these months more internal sales, we for Although a we pleased into not first to be could exceeded guidance our that despite and

continues and on Going positive the construct on package GDX very IND our of feedback in to SADA FDA year. fourth an had on look file quarter our -- to recently expect SADA pre-IND promising. had from technology the we the this We

and at addition radio of that April, model in GPAXX-SADA XXX expressed against colon the XX hours xenograft GPAXX is cancers IND high for of showing bispecific in year, of uptake In cancer very therapeutic ratio a demonstrated advance. programs colorectal so injection. AACR after targeted favorable the we to platform a is pre-targeted continue reported measure a for all the index, The Y-BiClone next under to immunotherapy on tissue radioactivity tumor XX% exciting. GPAXX

to in Our are ready IND cleared we dose was our getting this and year lung the cell nivatrotamab first patients cancer study small last for quarter.

are year. X Phase for later neuroblastoma In expansion in addition, we planning osteosarcoma and this

large the and for most strategic note pleased Y-mAbs waiver this Our in be of trial March, our serving malignancies China. and clinical unmet pediatric in CDXX-bispecific children. Pharmaceuticals, XXXX unmet received which for as into China view needs challenging clinic DANYELZA to should time AML potentially late is as that hematological significant Kong, our important and opportunity medical will partner medical the Hong AML for remains I'm need pediatric a market accelerate continue to Mainland potentially enter we SciClone a addressing to to scheduled in an for one for

Israel. far I this so in progress note for our Takeda a with China. pleased can very filed that year also of in BLA in are We March naxitamab

Review sale. the DANYELZA the of of or $XXX with closed $XXX received quarter that DANYELZA sale We million in after million. we million we with continued are with our MSK, and Priority XX% interest proceeds globally. both cash agreement overall, approximately first having Under for in omburtamab ended $XX Voucher of So pleased our very the

oversubscribed In the of which common an the $X.X $XX approximately offering by sold in addition, full million. Stanley million and we of we including Bank our a completed resulting led approximately exercise stock, option net Morgan proceeds secondary shares JP of share, $XXX over-allotment America, at in Morgan, of

nivatrotamab more So, development. late-stage talk platform. is advance support Moller, continue later launch potential into on the Y-mAbs very also advance and achievements expand to medical we the conversation two well activities excited same to our while position SADA to pleased call only Dr. construct advancing very consideration, balance pipeline believe unmet address to but and Lutetium to sheet that are needs DANYELZA current and At Y-BiClone continued into financial we in our our to you. Officer. our we Executive conjugated our this platform have our positioned And not to the Chief with continue clinical to to very we call. omburtamab, Thank our to do and hand platforms commercial time a time, over the strong of believe about the We're omburtamab-DTPA of so. we'll I'm same continue and we at Taking pleased

Claus Moller

pleased Thomas, you, to join welcome today. Y-mAbs quarter XXXX that Therapeutics' earnings you to have Thank call. first us very and We're chosen

ensure the first market. our the have worked pipeline we to hard that advances quarter, towards During

alluded submitting application of sales just making BLA as and the Thomas commercial DANYELZA the the we're the omburtamab initiating with of in authorization included resubmission marketing the while at to time US, progress omburtamab. efforts European Our same

we initiated adult two patients, and IND DTPA advanced and BX-HX in metastasis a positive studies CNS lung omburtamab medulloblastoma studies other with X-X tumors in in ongoing In cell X our lutetium-XXX our with small in initiated own leptomeningeal Phase addition, under Phase have nivatrotamab study areas. in and cancer

work constructs our We are continuing to also on bispecific in SADA programs. new

high-risk to minor refractory response neuroblastoma turn a stable or indication or of bone let GM-CSF in year older, patients patients with partial rate the prior based with were naxitamab. FDA as approved sales bone treatment have response, disease duration in DANYELZA This Now the who one early country or for to to accelerated of the $X.X of centers is adult demonstrated therapy. the response. in net just indicated or thrilled miles with million was combination pediatric me pleased relapsed mentioned, age are and February. by first and of launch. response across the to under approval total We The out overall the MSK Thomas commercial very treatment including send on we regulations marrow,

largest educating but highly other DANYELZA. with As about very cancer targeted had customer and believe have affairs than now their treatment expect, have our our Many been organization MSK generally nurses gone the has experience across and physicians medical you to done first an would whilst shipped date, commercial country have XX outstanding centers and in more we DANYELZA to and treatments is well. centers job the

of to addition, we BLA quarter we had meetings launch China hopefully the to in China. year, In have and will pre-BLA third expect in submit we approval a lead together Chinese which in SciClone, this and XXXX

clinical are naxitamab as neuroblastoma Our Spain maintenance and our for MSK York DANYELZA nicely. ongoing chemotherapy treatment with as Barcelona, for patients New refractory at also in progressing well combination first with in trials line neuroblastoma

have and Phase We both for osteosarcoma to with also multicenter a multicenter and ongoing. X and Phase international are we initiate trials chemo X trial frontline working combination treatments an DANYELZA

omburtamab of towards meeting Now the with patients turning treatment resubmission discuss Type March BLA we with road of the US omburtamab. On the from FDA metastases of for CNS/leptomeningeal to XX, a B neuroblastoma. pediatric to had

XX resubmit in rolling marketing form statistical submitted we FDA plan, was We the data to our of June control B still agency with and prepared reach of and quarter data April. BLA end to US to dialog or EMA omburtamab European quarter by FDA the was historical The is third to remaining the the are last was the additional to resubmission scheduled of April the groups granularity meeting valuation would omburtamab open of in a the this European hope parallel the close maintaining XXX with Type We work from XXXX. and where the on X, a second application very with Medicines late application the days. of In concerning for agreement regarding of have BLA order the BLA forward our final how in with week the granularity second the Agency, this and we scheduled in and for on submitted details identified this. agree aim analysis on

XXX However, authority cluster regulatory respond questions up any the and the any revenue side. the once from without we European we responses only basis posed whenever to our by so the responses, FDA, resumes have submitted our clock the

commercial have European addition, product excited staffing our In for this prepare launch. and organization begun our first for are we European to we quarter

and MSK multicenter Glioma study in study developing we previously omburtamab open As patients year. to a DIPG Phase planning DIPG we known as Phase for Pontine later X at disclosed also Intrinsic are this X for are an Diffuse

a is ongoing BX-HX common In of different locations we small For IND round XXX brain rapidly brain our spinal the cord. firm cerebrospinal primary unlike most through surface the desmoplastic have labeled turning October Then Phase omburtamab DSRCT, omburtamab-DTPA cell the X lutetium known tumors the at for of XXXX, study treatment the cleared antibody. our portion to lutetium FDA MSK. as medulloblastoma, in brain tumors cancer to fluid frequently the the of most metastasize along spread invasive and that tumors which of growing children. and type the are Medulloblastoma the

our for open clinical with medulloblastoma from Phase treating with multicenter with XX based X/X international pediatric medulloblastoma experience omburtamab Our our and on is patients patients construct. Iodine-XXX trial

construct about We mode to get to Ommaya the of using Iodine-XXX started again clinic giving trial leverage known the and study and safety in clinical maximum our are the omburtamab on omburtamab this very through doses moving Catheter giving XXX, Reservoir. this experience and establishing tolerated antibody. new hope once prior see profiles to infusion -- the determine the this In once we enthusiastic this to as into from

our study treated are to with of reach adults the our to Phase open In include also experience excited Study CNS/leptomeningeal include subcutaneous bispecifics, in to to in now with thrilled cancer we more treating of XX our to first cancers patients XXX version from iodinated X known patients our adult adults trial where we screened be the administration hope indications. omburtamab to lutetium nivatrotamab's positive leverage XXX BX-HX with adult are addition, omburtamab-DTPA the clinical and widen for widen reach we and bispecific. On is in than prior basket the clinical our adult as

We also osteosarcoma. separate expand and arms, at plan in MSK the Phase one ongoing in X one neuroblastoma to into nivatrotamab

next is year we IND the scheduled the and pediatric QX IND CDXX the antibody for -- our on for are AML is the line bispecific treat of this second generated platform an which for Y-BiClone quarter the addition, In for preparing quarter. in bispecific

our Now technology. SADA turning to

targets SADA excited the for clinical a XXX are are GPAXX for progress we technology the XX% peritoneal about IND we know cancers for year. ratios showed April, our blood preparing is to very fourth we good prospects for the xenograft this we in uptake GPAXX-SADA. making are tumor Meeting XX you presented expressed all the slow hours At and colorectal a on Annual after an development. first data In As measured AACR our and GPAXX-SADA model carcinomatosis. radioactivity on injection. favorable of GPAXX colorectal targeting of of next annual

in for quarter Our to positive in use other potential first IND we of publicly the expect which tumors our announced solid submit for targets includes first GDX-SADA XXXX. GDX

of HERX-SADA in the technology. cancer the radiolabeled liquid responses about and a can we treatment SADA have radiation potential are have in technology potentially that excited also truly We our we tumors use technology BX-HX-SADA demonstrated agents efficacy believe cancer. in have breast radiolabeled SADA of to therapies We and on use intended historically improve meaningful for not prostate the for

and treatment Company. believe launch we well-positioned internationally country and deepen centers already of to the to the resubmission plan Concurrently, the of we widen development to BLA a planned as that across DANYELZA, of through are our we development. antibodies. and pipeline busy to up, our that elevates multiple very we words, next omburtamab commercial-stage remain continued leading Y-mAbs forward With deliveries continue excited radiolabeled a constructs our and the constructs In coming by move the are omburtamab predominantly the SADA advancing and patients we to bispecific and helps clinic generation build the DTPA antibody business other the the and

his on Now, financials. let remarks this me his quarter's invite Bo to share --

Bo Kruse

quarter $XX.X a and XXXX income Thank basic Claus. per to reported million net March main revenues We March This basis. million was were net representing ended XXst, other income reported XXst, you, share XXst, loses per XXXX. for a the March corresponding go the on net $XX.X quarter $X.XX no $X.XX is for compares the XXXX. We in $X.XX The for of of reported March of Okay. revenues net ended million reasons to quarter revenues quarter XXst, income. ended sales diluted the and basic of $X.X fully or ended and up to the there the loss for share DANYELZA XXXX

$XX XXXX, whereas also of quarter monetization the XX income recognized as XXst, XXst, there ended no the years of other ended We other March March in in the income from million PRV XXXX. quarter was

The the and quarter in in quarter a including stock-based take a employee-related first were salary, by The sale progressed. the the million of $XXX.X PRV in partly it the the million we first in decrease ended to clinical was supplies. the in million increase year. in million March reflects $X.X fetch ended increase selling, our Cash first this that our expenses for in manufacturing XXXX. quarter $X.X personnel. March look of by year-end that offset $X.X $X.X quarter million a $X increase primarily quarter expenses partially have for ended administrative costs, partly compared was expenses and ended the the a in caused operating R&D XXXX. we on by of increase the quarter employee-related to March attributable $XX in expenses, general, million $XXX.XX $X year, for in January conjunction of secondary $XX.X used in operating of this benefits, operating increase $XXX.X $X.X period XXXX costs $XX.X This $X.X outsourced has February. BLA XXXX activities by increase increases increased XXst, increase for $XX.X the million a million increase and million increase and by non-cash to as increased XXst, $XX.X to As million cash by with the cash trials We quarter would DANYELZA note ended from of Selling, from million in million compensation and million and omburtamab completion cash rates the net position The work with show XXst, million for million driven XXst, the was our with XXXX March ended million. for administrative the closer at the expenses the expenses burn primarily position in the offering primarily XXXX. resubmission increased for March outsourced quarter general, research XXst, The

operating We has approved have to accelerate burn activities continued launch to of and DANYELZA the omburtamab if which also cash caused increase. our

from remain the operating the quarter first XXXX. of burn expect in with to We activities for line the roughly of cash XXXX rate

believe call position. update Y-mAbs over I'll to financial Thomas. concludes remain healthy to financial continue the the and We the in This now turn that

Thomas Gad

you. the think Thank we at you, you Tonya Bo thank I up Q&A and open point. can lines this Thank Claus. for

Operator

Our Thank [Operator question you. At Stanley. Instructions] from proceed. this Morgan Please first session. a from time, we question-and-answer comes David Lebowitz will conduct

David Lebowitz

there do any is might the on and see the uptake we question. stocking would as prepare Is my just any taking might the population the given to might that year the be for goes initial Kettering Are largest itself. regarding nice there nature helpful? the you much Memorial lumpiness insight a being on some obviously specific Congrats small there of launch. be launch Sloan from customer? on provide hospitals will that any very there dynamics you the Thank aside My question

Claus Moller

you, absolutely. David. Thank Yes,

converted number see I that but think I special stocking of at compassionate use don't that available the of when think was became from you'll course, commercially use any this. of or product MSK converted there license were a patients was

But have are have reflecting maybe up ramp you up from Monday, per than vials just that doing three foresee four typically that's typically quicker Friday. could sites a cycle using and that definitely don't will that expected. patient can ordering infusion beside be you then seen -- per it's we Wednesday, I intrusion see So, two anything stocking

both can they week, we pattern the the treat the vials that's by the product. and and sites to this to that we so from week. order are planning following they So, it's MSK. And see six MSK because can we they patient get next see next that and And a for week, the basically are on ship - planning have ordered would yesterday if product relatively treat outside They for that we day-to-day a patients of at week. also expensive then

have very the So, -- particular I see don't pleased any now started to a initial as are to sites and them you in said quite as patients new than DANYELZA there's stocking treatment. actually I and think think think very comfortable XX put we I and using bit with issue of treated of it are sites that we a MSK have continuing on more patients some number outside is so launch of

for happy effort. very start the sales us. Very So, teams with good

David Lebowitz

That's helpful.

far As point this expect year or the use that of those license as the is special progresses? at to as should converted convert more patients being we mostly done

Bo Kruse

happened No, in that February.

that's So, done.

had -- already last patients. think existed. more that clinical nobody So, trial patients And I no the

So, there our also patients the that into needed to few trials to was but go that's still a clinical happened first study quarter. in

are Well, have US we access recruitments trial So, patients ongoing additional the don't no clinical trials more think and for more any clinical naxitamab. no I early we in

David Lebowitz

questions very on you my again, first launch. the taking much Thank and congrats for quarter

Bo Kruse

David. much Thank you very

Operator

next Alec Please comes Bank question Our with from of Stranahan America. proceed.

Alec Stranahan

to my me. for Two Hey and the offer I congrats taking my well. so as launch guys. from want on question Thanks far

XQ than the to the are posted the expected to abates. back treatment kids for and So, sales fact in Therapeutics come pandemic as starting better Unituxin for that first pointed United they

DANYELZA receiving of for MSK maybe time feedback the dynamics So, great. and I'd treatment then be would are seeing you're be Thanks. whether for DANYELZA that clinical experience first you're hear outside using on and interested similar sites market to any

Bo Kruse

I Thanks, to it's whether last on stable from side is year about and have Alec patients would the back we seem us the are of is of lot. number we patients pretty COVID-XX. the anything was best for changed to and stable doesn't think see coming I which the say difficult course say MSK a know

treatment we product, it's for a median and buy necessitate times so I time of to a and hour that reinforcing a their have it's for now in seen about what in helps to plus and that for things. it's January administering of which think we fact best also the bit, great while Therapeutics my attempt for still XX% two I to report it's may think of a it's increased market in things, supplementary because they see relapse-refractory and are the that doesn't setting made relapsed-refractory number also combination giving we infusion antibody. price clinical abandon you context knowledge continuing their those this get fantastic as is where the us have probably It's trials to to Therapeutics but an stopped always but the the approval just I X.X X, United but that it's have that relapsed-refractory XX a by trials decided as in product increased sales have that setting is United eight hospitalization that the on the size to that the BLA therefore, for the not a setting patients infusion, these opportunity them has auspicious those are XX-XX much the and naxitamab, think COT and days offering minutes sponsoring

Therapeutics of So, setting. for approval BLA that satisfied United with refractory situation, the gave fact supplementary I and up the but also with very think we the getting are things course

Claus Moller

answer your up? Did that question

Alec Stranahan

time maybe that for on DANYELZA experience. feedback their the the Yeah, sites first are clinical just using -- on the

Claus Moller

patients nurses is a comfortable. particular doing I our surprised, also I treated infusion any with mean, I nobody we than making Yeah, know the already. or antibody, that as have always are four having I'm that sites been effects I that the positively but you are have great well but and also product more side not that mentioned a and GDX like any think and sure that job have it's MSLs research very centers saying in gone we issues, have seeing

very been encouraging, been has of that's most So the so experience positive. very

Alec Warren

Okay. Great. the progress. Thanks. on And congrats again

Claus Moller

you, much Alec. Thank very

Operator

from comes Guggenheim. Darout Our with next proceed. Please question Etzer

Etzer Darout

early sort as MSK seeing taking a and have the week early offering for question the beyond data point. Thanks the it's gauge this think maybe Great. And question. enough at guess, first to know DANYELZA. demand questions I up quarter sort as then on and I and to we of of sort launch you I about second second well I guess week the congrats beyond. is, for of are

Claus Moller

Well, I on early too think mean anything. way for us start I its to guiding

quarter. what saw We in the are we first satisfied with

the that you it were say quarter. sales I broadening If early think at to be be certainly but very I hope would first to I would expect stage second it so, beat a now. we able would in quarter

the like sales the of issue So stocking a but that's quarter net the to about of products. also reflection with think what responding was $X.X million kind don't the somebody saw in we I stocking. first

So, sales I that for second us to start I now too right would able to early. to quarter, expect the it's anything predicting exceed be think but number definitely

Etzer Darout

and earlier antibody on. we Great sort then talked this and about of bystander the back effect to sort going drug with think around conjugates questions getting of I

coming its in from we to sort and wondered, of of terms what bystander sort in compare if sort the radio you nucleotide investors given Just of of see could contrast sort point. and maybe this sort just will of if of interest the you on that ability the

Bo Kruse

I the in Yes also interest big construct increasing is from doubt no antibody mean, is there conjugated that pharma. radio

with thing a only they're to to then where a using an I'm our emitter, attention to believer instead preclinical using but our believe data ready with development, presented strong are roasted is just agent We we the formerly a for Proteus and XX start-up clearing we think we alpha for within initiate that in formalized not new at have the basically everybody alpha development. using full antibodies alpha step next months but emitters. also they with of technology. technology that to technology push using the tech three recently a similar I technology use emitter beta-emitter a type point of alpha can our paying The mirrors. our to into I'm be SADA will ready construct just XX and

lot So interest. of a we do see

a potential lot pharma interest also to of this from with see partners work technology. on We us

I out think for the it else partnering. out conjugated that everybody anything looks there SADA also carefully that tech we the stands to question? the that's field compared at and feedback in potential Did that's that the radio start getting from answer

Etzer Darout

Yes.

Just the around nucleotides specifics of sort maybe to we of bystander effect sort really with radio what compared more see ADCs. with

Bo Kruse

they I circulating organ. the the don't sensitive if is Well, is bone that, most regular your marrow mean rid challenge them the you and your nucleotides of bone get to with keep marrow

You using isotope cates one is the the the with of of and we kidneys drives that that's the in get few and tissues radiation. you the get and the of primary and other of quite bone through the after there you people and within marrow then that also DOTA something tiny. duration amounts damage also two you we course kidneys, and -- choosing from leaks heart to the -- radiation with It but those exposure can blood isotope extensive is can see the -- is is is technology of also the the our out the intensity. that in can are the liver that But And administration. of hours thing because, course circulation limited very hours actually is a what give the typically molecule

but on You given omburtamab. high is may short as having dose we relatively much for peptide four is that's as that relatively time, XXX is giving remember a us Lutathera mCi neuroendocrine mCi XXX that times for tumors circulation a are the

think those data AACR in to will and fold blood as the to the with cancer reflected GPAXX XXX see much got radiation So think with the was presented the I that's as from I we animals. cells that also we at

lose out that But three can cancer antibodies. we show where you is full eliminate what data else is molecule your antibodies. patients discussion. not including The to all for But that circulating their different an step I can would in is show. be think that's animal, like a risk use a time antibodies antitumor nobody the on It procedures can setting. coming an for The optimal of fine works this completely other circulating the antibodies will I all you in dextran cautious exposing but show. see only potential to probably patients all ballpark cancer from losing

Etzer Darout

on you Great congrats the Right. thank progress. and again

Claus Moller

Thank you much. very

Operator

Our Joe proceed. Thome Cowen. Please next from question comes with

Joe Thome

taking good questions. and my thank you Hello, for morning

could have and any how perspective duration associated launch, if get board. us of a on any Just then Thank kind couple process centers from reimbursement of from centers that? the little work to you MSKCC you have any need just of seen time you walk it with you. Is through through will second take And a DANYELZA much is pushbacks committee a a any new bringing the bit that to there there onboard in stabilize order to broadly? approval that's if of sort P&T of outside

Claus Moller

Sure.

pretty Typically, a we actually sites bring all, at we and have getting for help also clear haven't that also have to any a help we can we product the first patient up what incurred hub reimbursement of where getting and commission this that problems registered So hospitals. happens set in getting is place. into

the around etcetera. operating the research administration has and practical assistance about been talking know to in about our getting of practicalities been of Almost smoothly. MSL that in side So everybody terms notice antibody interested that effects the has pretty the potential

into within can get the go course were refused after most not that was smoothly and two that's actually say, reimbursement that four than insurance issues we reimbursement about we with was have quite that of XX% reimbursement place and had the a gave only -- only interested where has had they on. would that more reimbursement was and in naxitamab. process how company that of would the one patients weeks the and they we very patients that in until that So We've I single say been end. time, now the And in had excited accepted the and took patient one have to it no weeks suggest doctor should have that I

So that nice been very successful. very and has

that's So, is in and that. my kids have we asked need of chemo the There of with pointed actually addressing were have dinutuximab refractory that medical an this the that in and cases than through also are doubt unmet the about but possibility were their we naxitamab. heard rather patients with no for they pleased setting parents first mind treating

but we making are I think progress. So good

Joe Thome

very That’s you great much. and helpful. very Thank

Operator

question with proceed. Burns Please from comes next HC Our Wainwright. Robert

Robert Burns

guys. for launch questions taking quarter. congrats Hi, on the well my as as the Thanks and

Just one I from may. me if

just I'm one own Tier to of internal expectations as prescribers, contact able your and make date has So, as contact rate you're team the with being to or affected how pandemic track to many does commercialization it? the of the with curious

Bo Kruse

I about made that I really product have couple sites them among big naxitamab. there that have say made that in would know two-thirds I that but we Well, don't rate guess can - what of at X contact actually the to with, that Tier started with we contact customers and use started that Tier a is hospitals of have of least trying see I the X to we shipping the can also have terms

Robert Burns

contact average two-thirds additional is DANYELZA? ordering Tier X contact as of seeing What there and well the factors at between Okay. any One and gating seems with it follow-up. as timing and curious these of frequency are prescriber the on sort that you the fair. the prescribers. may patients That's had DANYELZA limited least of that actual completely outside have I'm been of

Bo Kruse

on it's that. Rob elaborating to early too I way that think

a I itself of have as I into up patients we is these clinical of do reality mean where with not but now side XX% not say, truth. especially months. omburtamab the have it X, in three clinical it's Tier if need as come statistics on -- study Unituxin, months an all I heard they a this it's were mean are the output principal they trial not they lot is only has relevant. can on the or But clinical actually investigators and I this trials Tier by gives of for said Of two the Tier course, have any speaking patient everything but said about X, naxitamab that I X attitude for remission. the it's we that this for you that Unituxin not would sometimes the if only

XX% to have more -- particular sales MSK this been but have happy is we have pushing product. we in You has what get happy that to with we I are launch patients sites XX actual there the say are your early and than in a are on in would interest so keep the issue able there very launch been outside into seen we very continued the strong early so process that we very and seeing commercial and out that

Robert Burns

Now. I completely clarity, you agree. Bo. Thank the

Bo Kruse

a Thank you. Have good day.

Operator

Please Our Lawson with next question comes Barclays. Peter from proceed.

Peter Lawson

would and April? have say for then the as the just trended thanks like look last sales and quarter-on-quarter question. into And Hey about the think for going we the,

Claus Moller

I for to it's any early us Well think indications. give very

I foresee we and think I quarter. would able stretched first that far our the myself to certainly when as said I can, I outperform quarter second sales be I've as the of

So the definitely, saw in reflecting but is use no indications we that have real of not first or what the sales product. we quarter

when a the the treat before to the can I sites patient have week. ready are the previous see order they're As said they we patient they week getting the next in end actually of ordering

at data you average clinical look of can or patient if is that and cycle X.X antibody. been is relapsed-refractory number number cycles doses or So up per cycles of nobody average the published in this the trial stocking they can median -- the our you has

one cycles patients takes with into two some patients three that after that typically an drop we consideration give progress -- end and you come say some patients or cycle off drop after so or and after one you we off, and into because cycles up but three cycles. average And remission after that happens four therefore five

the up end three remission you with eight in are cycles up cycles. you if so, And

July. is means March average be that's the clinical February means patients continue in And they on which in based for treatment that will So started average new X.X patients in February expected that the of on data. median finish X.X that will cycles, and trial April to and all their our an in

means for answer patients Did that that number of retreatment question? we so, month. back And that every the right have a that now come

Peter Lawson

more that's had products the so guess, think the discontinuations of the Yeah, citizens Percentage do on or of treating really sites I or just again helpful. for patient you one decisions than had kind use you've not that? this to

Bo Kruse

to and clinical were on and all saw certainly incented trials completed able see we positively bad have I think actually that treatment several launch, a patients you the think is to comfortable have treating time all never experience retreatment reflected yet but yet. as they that's are we typically started to number naxitamab one reported in we not and happen three cycles has patients. any that the have patients whether that I may back talking some and four least I was to think as right, use when such very a very early about but you the at I Yes. or we bit it want I hasn't at hope will clinic. more again, quarters said, of data. be more number happened feeling X.X have sites many quarter also give -- and But that sites average we preliminary going second the you and a said, definitely I don't start that I happened but have details. the call in this happening said cycles that what's before only the But into It are you don't of how

hope that So I Peter. are early and clarification, I some gives think you we very on

Peter Lawson

great. Yes, that's

sites our United you had If any [Indiscernible] from stated? Therapeutics towards converted

Claus Moller

remission don't think using any front-line. because it's but two are Unituxin approved that I outside indications. different Well, stop it's patients in using of in sites are in that MSK the complete Unituxin,

in indication, are we told as an and are so think is of approved the want pursuing treatment. on, don't be front-line come Therapeutics parents kids where our that I for the say, a hey, now some approved for I many to new is my else the get we point supplementary more hopefully data on outpatient with supplementary get the want hospital. patients. with treated very just that to BLA be it but while need I But BLA them and we reported can report those not time So until continue indication us probably that they will early my quarterly kid the in nothing United a for are in the

Peter Lawson

Okay. much. you Congrats. Thank so

Claus Moller

Thank you.

Operator

[Operator Instructions].

question next Please Our comes Romero, from JPMorgan. Tessa proceed.

Tessa Romero

question from morning, on here. Good initial taking Thanks to upcoming the a the a pipeline our for question guys. progress presentation. actually congrats questions. And on me, Switching ASCO gears

How then Phase us, be be I study. the an steps scenario remind win about giving much. can you should DSRCT are X will think DIPG Thank our and you the for update? what in thinking the we you on indication? so next update this DIPG And

Claus Moller

Yes.

DIPG two from the So by Souweidane. XXXX in is years what presentation an update was Mark ago presented

and data and will see the survival. you patients on So see data follow-up on cohorts will you'll dose additional higher more you a from see

and in As these years than surviving you less that, rarely very, five patients XX% years. patients you two after very is typically survival see may recall the

DIPG, BLA could the that's multi-center that support in of could omburtamab So this for you intention X later a the Phase initiate iodine expect. indication terms a year potentially for it's in And our DIPG. continued planning study to what supplementary

study to in Phase data get CNS the indication need BLA as generate enough listing in get to MSK a neuroblastoma reimbursement together the supplementary support study the from the a setting. we omburtamab iodine first, that minimum can data omburtamab and hopefully but we or X X for then with leptomeningeal Phase the approval from So compendia for with DIP

as as it's year and and in diagnosed a data to in patients saline there XXXX. adults first peer this was XXX also ml young XXX teenagers these a that the Phase maybe tiny recall that's DSRCT, horrible an study omburtamab into X little sarcoma of CTOS give solution the every the we study US in at very the may iodine you and presented nearly On the administration indication with IP where to

where the patients shown have in setting. clear where study a these were the Again, and the We patients now think is and expanded path given into Phase still uncertain X regulatory X safety dose. a two have I of little as I Phase one current only the treatment patients for said, study received dose indication in benefit we

added and just is that As it's to data it would and wait generated have it's but uptick FDA been be I an to ultra-orphan the see to the in the what see also. and definitely comes to sufficient would said, any indication more data market product in that until be published that's data it this, you'll generated the setting to have to

Tessa Romero

it's Okay. know the number turn? Thanks quick. question a year a that -- then by you for you is end sites got Great. lot. clarifying we have just in just this wondering guided and And DANYELZA It's one hopefully of to of

Claus Moller

any all. haven't at We guidance given

expectation I or said for and this media that is have XX the that me sales XX. think is I we what think is remind analyst what is Bo year, that for DANYELZA

Bo Kruse

mid the in XX. It's

Claus Moller

only mid the the thing. and 'XXs in That's

Tessa Romero

sales not just Claus, site.

So site…

Claus Moller

was but point, Yes. And anything about my said -- we that haven't that's sites.

need this naxitamab. see what's well managing -- of this. analysts now, we are well to what We feel are the that definitely out are until positively And this that that by that industry administration median. is we I comfortable learn more also have we -- exceed and reach with can we been happening and to estimation we sales we very also still have most said as But the and about surprised likely in in there said median very very comfortable how cautious how the

job, in not helpful. a definitely but surprised are things about doing been positively are helpful, a I that on good have too this early little they going. with process, very but we So hope how

Tessa Romero

wanted just I thing, you much. Thank That's No. so to clarify.

Claus Moller

Tessa. you, Thank Yeah.

Operator

like to management back would call comments. over the turn I to time, this At for closing

Bo Kruse

launches. thank continuing and to perhaps right. our today and joining for forward All us everyone working pipeline we you at expanding and look Well,

Claus Moller

Well, weekend. thank great you. a you. Have Thank

Operator

Thank you. This today's conclude does teleconference.

have may your you this and a for participation lines day. You thank disconnect at great time your and

Bo Kruse

you. Thank

Y-mAbs Therapeutics (YMAB) 9 May 212021 Q1 Earnings call transcript