Y-mAbs Therapeutics (YMAB) 11 Aug 232023 Q2 Earnings call transcript

Good morning, and welcome to the Y-mAbs Therapeutics, Inc.’s Earnings Conference Call for the Second Quarter of 2023. At this time, all participants are in a listen-only mode. Instructions for the question-and-answer session will follow after the prepared remarks.

As a reminder, today's conference will be recorded.

I'll now hand it over to Y-mAbs’ Head of IR, Courtney Dugan.

you. Thank

thereof, of marketing, remind considered business development, following the in to, of and statements regulatory our forward-looking Securities are Reform including quickly statements contains DANYELZA and the related statements for cash related anticipated statements expectations that to and include, Litigation guidance XXXX development financial and and estimates are product other beyond timing of statements territory future of to thereto, that collaborations commercialization statements Act about the respect capital you advancement regarding our runway for expectations me not related sufficiency and discussion the reimbursement distribution future of performance, benefits and current potential certain revenues, and SADA, historical and of Private but Let programs, expenses and expectations are Such programs, model limited facts. our XXXX. as including and and requirements our preclinical regulatory, expansion development and cash partnerships and and initiation with submissions, completion clinical for assumptions studies, our and plans, our other approvals, to expenditure not strategic research development resources defined the potential that the

June statements August report filed actual on ended the forward-looking Because the company's forward-looking these in differ may results XX-Q materially including on XXth, and to guarantees SEC with statements XXXX implied the those Form for XXXX. from of performance, by factors, involve risks expressed discussed future and not uncertainties, a they quarterly as quarter of XXth, factors those or variety are due

turn the and to now I'd Thomas Gad. Founder, call President, over that, With like Interim CEO, our to

Dr. our Officer, Vignesh thank Commercial Officer, and and us Sue Officer, Thank our Financial Smith; Today Rajah. Chief with for everyone, joining Courtney, and good Chief Kruse; today. Bo our I morning, have you Medical me you, Chief

well In position as second the providing and a review as will discuss from key I'll full will today's our platform, updates on pretargeted line who by on naxitamab Phase of further year into highlights then, call, our financial ISS by report our Y-PRIT. then additional currently our Smith, XXXX programs overview an SADA up on quarter our of DANYELZA and will on sales underway. product further under DANYELZA Vignesh SADA and insights progress ex Q&A. clinical reiterate and radiopharmaceutical open highlights, study, for the X then our two-step quarter touch our US sales. the second our guidance. cash quarter research Sue I'll an details And Bo update our begin novel provide performance, DANYELZA the US also followed we'll

Let on me update a far. so year the begin high with level

As our this DANYELZA focusing know, and a successfully the earlier on you we pipeline platform implemented strategic year. deprioritization SADA of

several past pediatric mission financials against incredibly the cash Our been and innovative to our first XXXX. to execution I'm our estimated therapeutic cancers. steadfast cancer, of us swift particularly realizing our fight extend the the dedication of resilience months team's half demonstrate, runway providing options our proud has allowing in as into over

end we cash XXXX. and look of in are the of equivalents quarter the we and financial million cash $XX.X rest XXXX of position As to beyond, the a ahead with second in healthy at

time, alike. through SADA and both deliver to which being and focuses have enable that will value strategy in advance at disciplined a on believe clinical long-term R&D to continue the our sales, DANYELZA's platform to place on investors patients our while development firm net spend We us growing we same

to me Let franchise. turn our DANYELZA on the highlights

bone children. and most in patients and relapsed cancer DANYELZA is US demonstrated disease the a for in FDA Neuroblastoma by prior refractory approved third the reminder, of a bone stable therapies. common response treatment who minor to common partial response, for cancer infants or the marrow in high-risk have is most the As neuroblastoma and

quarter in year, than up million net in we second of of $XX.X from XXXX DANYELZA, second we more this sales of the product XXX% what previous our the quarter achieved double, In from X% recorded and up quarter.

across gain significant the in of We have efforts new and our sites accounts. the number Additionally, commercialization made DANYELZA, we on with XX momentum a progress for US continue activated now US. to

Brazil with significant approval for DANYELZA partnered in making been by marked In Tecnofarma outside received marketing the in US, of the where in progress regulatory the Adium, We've have also recent we we approval Brazil. May, region.

in Additionally, further you believe the late potential early pose firmly progress over launches an on market important driver Asian SciClone revenue that and the Asian updating these to the market. coming our China, Greater in We DANYELZA, we great June, for solidifying the July, DANYELZA look a launched presence quarters. forward of as

pharmaceuticals, progress Eastern Swixx our Israel Europe. Takeda see to in through program in WEP Central partnerships our We and with Europe and through in distribution also continue

aiming to We even is patient continue it. commercial to to global access to further, our to who This families in their may fight backbone beat of support cancer. the any and Y-mAbs, seek mission enable benefit expand at children our footprint partnerships to from DANYELZA

further the already our two of year in guidance. continue share ability net commercial XXXX footprint revenue with of We more our DANYELZA creating meet sales market full shortly. We couldn't confident quarters sales DANYELZA, gaining product pleased grow provide to for than and be in in US. $XX XXXX will the our remain more quarter million to on DANYELZA our Sue and color net first market

Kettering leading Sloan Memorial Cancer partnering Beat on MD DANYELZA. our to studies for expansions update collaborate efficiently KOLs Cancer we University sponsored and provide continue clinical leaders will to with opportunities Ohio Research Center. ongoing with forward DANYELZA, at Anderson an potential Cancer advance trials State to label for the In investigator Childhood Vignesh clinical Consortium, our strategy Center, on addition and

side we any from bloodstream, radiopharmaceutical that a offers insignificantly we on with potentially development Now working of radioactive highly substantially We pre-targeted on clearance followed SADA, licensed let's turn potential to this two-step tissue radioactive Sloan to Memorial rapid dose resolving in by while April by on-targeted pre-target payload limiting XXXX. the uptake off-target are efficacy to payload. the mechanism from of in we to are on and amount tumor MIT indices while increase onbound protein the the with normal maximizing -- SADA to and minimizing a differentiated believe only thus simultaneously Kettering platform SADA, protein higher effects. working therapeutic delivered novel With and tumors,

making simplify payload the facilitate This in not approved. from chain could dose centers of and DOTATATE-lutetium if it Further, The dose. our our supply two-step dosing patient heart separates protein use SADA is institution the payload specific, large the the Platform SADA same believe drive different supply if use to potentially has Y-PRIT SADA payload significant and accessibility SADA patients approved improvements. constructs, our different increasing the Theranostic possible potential for efficiency. We and chain platform's to

(ph). constructs the first, this targeting our [Month] entered GDX hopefully, Our SADA clinic many

We I we data report dosing we closed currently administering now and cohorts that have kilo. we at signals seen R&D say and have cohort GDX-SADA. imaging Day at and pain further December. not PK milligram our to a dose and are have X XXX-milligram per that doses We annual X in when administered X anticipate sharing can therapeutic pleased X any in we are

platform this from derived program development is the second construct. CDXX Our

FDA, this with our submitting this anticipate have the for of third pre-ID We IND meeting program contacted we application already the and in an quarter year.

BXHX Day Additionally, free and our on an year. on constructs, R&D advancing clinical have plan both progress we this our made later HERX we a good to provide on number are of and SADA targets, which update

short activities. a on Lastly, our business update development

mentioned, and strategies. commercial of DANYELZA we to the expanding As footprint dedicated remain potential through partnerships ISS global

our outlicense to some advance approach constructs SADA at parallel aim We is seeking Regarding in multi-faceted. targets. internally Phase of other least to current SADA the X, while to Y-PRIT,

to seek potential opportunity introduce Additionally, targets we explore we as maximize and platform our targets to the the unsuccessful third previously of party their platform. to Phase see to collaborate Xs to with an and SADA from important

like Rajah. to And with call that, this I would Dr. Vignesh Thank turn over you. to

the everyone. first ongoing an I'll platform. morning, of and sponsored our good SADA discuss provide investigator updates our studies, and Thomas, will overview latest you, ISS, then I Thank naxitamab on

frontline Beat diagnosed high-risk newly a multicenter Childhood with X are naxitamab for Research trial in the patients evaluating we in So Consortium setting, Phase combination collaboration with Cancer neuroblastoma for with neuroblastoma. our excited about standard therapy high-risk induction

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Moving to osteosarcoma.

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quarter data then Phase X/X positive, Phase to this from X of expect trial if begin And XXXX. in for trial. three hope pivotal a recruitment we We

presented with the of INRC response GM-CSF per with on was percent bone residual in in combination neuroblastoma rate a overall and naxitamab and/or as The this bone marrow. relapsed criteria. refractory patients or of with clinical XX% limited we ASCO June At high-risk interim response data to pre-specified rate disease year, complete in XX%

were Scores, rates XX% in XX subset patients clinically There and the the of relapse XX% disease, up were meaningful response disease in with and respectively. minus reductions ranging baseline to patients the regardless Curie status. For of overall refractory

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the to with potential strategy to humans proof-of-concept could establish and breast strategic in we significant solid a naxitamab the of and opportunity cancers We partnerships. medical a with large Our of generate unmet data plan build franchise of aim is worldwide. of in needs, naxitamab tumor treatment and attract in cancer both firmly and to commercial execute to cancers, that the variety in adult upon aid pediatric the potentially believe

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followed the using in based patient X, shared cohorts progressing dose therapeutic our classic study have given news The cohorts the to days design. recruitment is advanced XXX optimal X+X now by we we lutetium-DOTA is animal escalation point that six sites coming well. Particularly to the patients We based a two have Dose active exciting that is two on have five and is XXX and currently studies. dosing today the of interval of ongoing. timing millicurie through X on we from

this forward far still looking an we have R&D with are at early seen but in We that are what interim so noting update we days, later are day our data to providing pleased year.

Y-PRIT Additionally, quarter lymphoma the an exists altering our SADA a become in we treatment focusing this the landscape to third SADA potential unmet in the potentially non-Hodgkin's variety of lymphoma platform of the to file We the in FDA believe CDXX on track targeted in for year. cancers. of program where on with across if remain delivery the for choice IND future medical an T-cell radiopharmaceuticals need approved,

call to the Smith DANYELZA to continued on Sue I'll color now growth. hand over provide further our

and progress of be Thank everyone. speaking I'm you DANYELZA. commercial about pleased Vignesh, with our morning, this you, good to morning

Our feedback revenues mentioned and plan on is their in remarkable. And we execution the are the physicians benefits patients. second The team's earlier, we strategic quarter truly of expand gaining as the as and we for experience and seeing more the see pleased to reflect footprint. action our and from Thomas market further with receive physicians very centers more DANYELZA new commercialization

and I'll each in plan speak commercialization to we strategic The have put includes one. key three place initiatives,

do. we the at keep the First, we of everything patient center

place year of the further continued and the effective educate to in strong market from about built initiatives the use quarter DANYELZA. this first has and the put team of safe Our to momentum upon

quarter, new in using the and DANYELZA quarter. have a three have and build DANYELZA hub. our as and XX new the new We second consecutive our three in treatment than to identify upon had second patients added during prescribed more result, During continued the to physicians XX quarter. we work XX second months patients started accounts patients, of support

stream of out initiative parent a launched specifically which the and Instagram age as noteworthy new launch with steady we typically in to social a The of in been or a XXs. we roll our a caregivers. informative of to their average Additionally, parent has XXs media content strategic particular child neuroblastoma, is target

we demonstrate Second, account teamwork. focused

the in we've a XXth of delivered our realigned since June centers US, announced And seen year, increase the to Following can the across team this quarter. sequential versus centers launch DANYELZA initial our in we've of earlier as restructuring really what the accomplish. XX X% the of year, last number and

in quarter, the of consistent with quarter Kettering, XX% vials XXXX. were our sold the of the During sold outside in split second Sloan Memorial US of first

team continues demonstrate professionalism making mission DANYELZA and to of patients. to Our to commitment our accessible

customer most the team believe This two our having part associating has or high XX% our led consistent earlier XX has to a against being we recognized on executing in pharmaceutical to experience that commitment XX% Consistently experience a mentioned ongoing company physicians. demonstrating due launch. strategy treating DANYELZA the of with our patients based is with to among DANYELZA committed the and clear our high-risk support. neuroblastoma to Y-mAbs recent place. level XX survey the on since space, of put led the is has in and the -- more had as in a true US, Third pediatric conducted excellence Y-mAbs commitment We administration physician neuroblastoma increase disease with to I a to accounts in of physicians in

this have progress look of quarter of this our a I'm of year. to this highly quarters. team, market I in of second are and we anti-GDX forward of proud the US and sharing We as commercial in a leader continued cancer, future XX% important the pediatric area share very

to me in our detail. discuss now Let Bo, the pass who results more second ball quarter will financial

and Thank morning, good you, everyone. Sue,

the of revenues Our $XX.X of net WEP first increased DANYELZA quarter to has this product second months US increases and 'XX number quarter by markets. patients primarily and the quarter DANYELZA net [Technical incremental for increases in $X.X and comparable XXXX. in XXXX, from X% which million of product The sequentially expanding million quarter and the an million ended $XX.X Difficulty] million year. XXX%, six the million and XX, benefit the $XX respectively, by revenues an over represented of in international million 'XX of first of the increase driven $XX the respective of in were $XX.X June of new reported million compared $XX.X and XXX% periods

operating to expenses. Moving

outsourced ended research resulted to decreased increase respectively, same plan supplies, outsourced to and deprioritized in spending periods six was and development and last XXXX, costs. $XX.X $XX.X personnel due and the quarter $XX.X related Our million XX, $XX.X restructuring research by net decrease with connection The on and which year. second to our the the manufacturing, primarily clinical decreased months expenses in in million for trials, programs million and million June compared

were by XXXX. -- June million general the former Chief ended and primarily and and XXXX, decreased to million and of six June periods $XX.X XX, three expenses for last for six decreases Executive the for $XX.X administrative the in $XX $XX.X QX, attributable XX, the $XX.X quarter million a Selling, ended the compared The related months million Officer the year. the company's in and respectively XXXX to million second SG&A same to to months charge departure six

recorded six restructuring plan. Additionally, a during SG&A restructuring XXXX months with charge million connection we ended June of $X.X in the the XX,

our net the to of and decrease loss loss costs, $X.XX or was [Technical ended of corresponding diluted lower the compared in restructuring. The ended basic to expenses, of XX, to share product June net period inclusive we million six XXXX driven loss net XXXX. the basic reported of months and Difficulty] departure impact for Additionally, diluted related related ended primarily quarter per Personnel million six in decreased ended decrease former stock-based a inclusive the XX, for the months the XXXX, for per compensation, R&D three June CEO. the a recorded of in compared XX, net million XXXX expenses, June the months $X.XX for of share We $XX.X or a $XX.X the revenue, SG&A charge by to net $XX.X due loss the lower higher

second the The ‘XX. decrease compared quarter $XX.X $XXX.X was million ended million we year-to-date. $XX.X with cash to of year-end million As cash equivalents Thomas at mentioned, and

or the XXXX during to XX% from used reduced quarter our million Importantly, cash the first second $X million quarter. by compared to $XX we of

We full expected burn will sufficient commercial equivalents 'XX $XX for into be be continue the market operations is pipeline along planned And responsible our XXXX. million. cash demonstrate to our year cash with million cash DANYELZA. to support $XX currently and total cash expansion and programs management to for We our believe between and that’s

As are are this understand. business previous new calls, important assumptions. income or new underlying other in development the to assumptions partnerships guidance the for included in we No noted

in increase a assumed year to adoption. by of product this as refined indeed the purpose we DANYELZA only, hope that indications could revenues see For We I runway data to execute DANYELZA strategy physician guess, for clinical work each new and higher and growth rate to the and to expanded commercial XX% ‘XX. greater analysis, are our deliver lead the potentially ’XX

terms for have no this purposes assumed not our I be point new debt equity program been the own that omburtamab In activities, assumed assumed assume and offerings expense our development for development the have of has programs that purpose we any borrowings. No at this the analysis. would of we prioritized enhanced or programs. estimate, and of or further of

expect during operating in continue burn million be million announced cash for and DANYELZA anticipate million expect the net financial revenues to to year, $XX a to $XXX projected million million. of QX $XX range to continue as $XX between product to our the guidance full to expenses report, achieve the we $XXX we year full and with $XX We of million

execute of delivery strategic milestones. in and our position support healthy Y-mAbs financial to priorities, believe to our multiple We mission, the a remains

to the Now this Thomas. back call And update. now turn concludes I'll the financial

you, Thanks overview. the Bo. for Thank

Let's open for the operator, please. up line questions,

comes proceed At Stranahan first be question question-and-answer conducting this the our line Alec your with And question. of Instructions] a time, Please Bank will with America. session. [Operator of from we

taking questions. Okay, great. for our Hey guys, thanks

therapy XQ? per the you Just you that, give couple coming-off flatline to the of Maybe patients want meet a as this guidance, half you from sort us to million for quarter. $XX therapy coming-on versus of in first back essentially, And look us. or to of need so year, sense just could we a if Sue,

can the So then down a around give Bloomberg, roughly guidance just And on-off I've that? July noticed data you follow-up. month-over-month. sequentially be you. second expectation got on Thank the then, rate any Symphony will is the And that was equal I the it follow-up half? in a from

for Alec, Thanks, Okay. questions. the

In earlier coming looking we patients drive terms to the the of and failure. to are patients on induction off treatment,

and majority hope an terms to -- right in data failure new slightly of based so, relapsed patient, to And earlier rate shift the the induction now, patients our -- we on-off that induction we more of on roll the to anticipate out. are a

hope and to that is we're year. marketing later working of roll that. a we So that out FDA effort that new approval on, pending this and

July seasonality a -- the now really And, second did in data, softening a see little half, we being secondly, we Symphony and the quarter, a in after a spring. of terms the here we're see I for little year think, in

spring bit some have hear on the holidays I really think we the is it is kind tap some treatment June, do that's then and in school what that we truly to what of a customers from in end people that time the softening saw. little brakes I think terms of of the And normalcy.

MSK, that done we our XX% patients per sales now confident at over were a XX% right? a year real plus three outside A growing the I stable of of hub past sales in of ago, months the we've month So ex-MSK MSK. are where a and flip. inflow XX our outside of remain But have

So foundation some we that strong, the I think is to that's really take saw but the seasonality. perspective

million And launch. if China from then, $X.X helpful. one, on [Technical if just of of may, one SciClone, Could of That's sales I a any was give you the Okay. repeatable part any quick that the sense us Difficulty]

the that's second the really why we half. And maintain in guidance. Difficulty] [Technical

it that continue income during product I half, the the expecting total it XX% Of a will but little course, revenues. be of think to say would second too we're maybe bit optimistic at international that,

Okay.

how So it about. comes that's

right. on and congrats Got it. All Thanks, progress. the

you. Thank

of Charles proceed with comes your Please Zhu Guggenheim question. the question next with Securities. from Our line

for Hey, for call and taking good thanks morning, this everyone, our questions. and

you have on XXX clarifying it the you've Regarding you're this, patient to there sounds the and reimaging at are the data or GDX at into you. are of tumor images is therapeutic imaging only One SADA, dose, but subsequently and level SPECT resolution millicuries? at -- millicuries. it XXX at misheard, on positive dosimetry? clear you question -- And insights I like imaging not, imaging a if sufficient correct dosed generate also possibly if hit imaging Thank me dose

Charles. you, thank Yeah,

that, when just and we the protein I'll protocol yeah, a been dose. to patient repeat uptake, see say tumor level a has then move designed the XXX dose high So, to millicurie

happened what color the look Vignesh, to patient, that's over So more the details. you, then would then question and with relay to this I like to but more provide a and little forward

when dosed has Yes. XXX By inference, say the millicurie. [XXX] we patient (ph), been to

the As imaging has on basis, the shown data per as patient protocol. positive uptake

and protein earlier of So per on, as SADA at -- through in X, with now X, higher and you as X dose X cohorts cohort we've gone a are milligrams we mentioned kilo.

is after question, of no terms in is imaging from millicurie. dose. the therapeutic at also XX millicure planned is But, There therapeutic at coming address your have we the least vital least terms there’s radio the XXX straight this dose sufficient dose, question organs granularity other uptake imaging system. dose of that Part XX A isotope millicurie. the imaging from the and in of In clearance and the for the quality to And

Day. data this we'll all end stages the It's we early as still provide So more more provide at mature again, we're evaluating the information we R&D and forward. of very year this when in go

color questions for our that Friday. and and for Thanks happy taking thanks great. Sounds

Thank you.

proceed line Mike your Morgan Ulz Please with comes the Stanley. with of question. question Our next from

just Hey long to of follow-up you for opportunities market talk over launches relative a guys, US US outside your the on the term? thanks on taking those a could the maybe Maybe the about and the question. bit Thanks. thoughts

Yeah.

partnership our they think, approval late talking got in we early announced June, the have July. December, SciClone, over that -- So, now about product they I there, back the China and in launched

work. a very, going forward. new obviously that's going for be that's market us. how us color on going early it's think to it's that get do But material too we for But to So some to very

to two We campaign forward initially So we look or a three it's XX XX quarters. having with know FTEs. dedicated hospital

And quite new. in is GDX market obviously fairly are So we excited it. about that

the market introduced and I nine think the shortly the GDX ago, thereafter. on second months was first antibody are we

So that's exciting as well.

Thank Okay. you.

very With for for their are in pricing. And Brazil, XX% negotiations also of our And Adium as on [indiscernible] South the Israel settles, I us. pharmaceuticals Eastern think progress that to well currently we launch That Europe patient WEP is in once and forward program, America. and look with our, market we are we name with pleased Takeda an on Swixx in in exciting Europe.

see to momentum. nice sales also US gaining it's So, ex

Thanks. Great.

Our your the Please Genuity. with Canaccord next from Maughan line of Bill question comes with question. proceed

thanks. and morning Good

So looking down the first-line line at DANYELZA a indication for eventually.

line in So consolidation. if there you positive GDXs first different eventually of have induction first and one the if obviously, the versus be study line, the study the two, -- induction label, is a you'll but be will in settings

neuroblastoma? in to you you for treatment, to out line being strategies equal, options for have So for head playing your attacking commentary get first it's just dynamic I the just head that competition see different two two two competitive all drugs a not when want how given of else kind different on

I maybe I can you high then, and Vignesh, follow-up. mean, Thanks. level Yeah. can,

the at is the and GDX time, think looking same So, need currently antibody I introducing upfront market for discussing at transplant. bone the marrow

I So it bit the of is induction. little the maybe trial and think design about front GDX talk will more let the Vignesh I swearing versus, market And positions traditional towards line. a whole how

outcomes of as as the chemo as a I consolidation maximize immunotherapy, end equivalent of to induction, is or induction moving with treatment increasing I current the combination in at or stem the looking which the there been state, be well is definitely alluded that the combination efficacy good positive as at the survival seen chemotherapy clinical potentially landscape consolidation standard may Yes. of a earlier, or And correlated and this both transplant. to towards mean, setting, has anti-GDX plus survival improved cell at consensus partly to is as awareness the of response outcomes.

to both looking the the the at still discussions in profile of are anti-GDX these and into how outcomes I now is entering think early to setting patient but is of see this consolidation and So safety stage, there. order scientific improve definitely induction very that landscape community safety

which far standard recent are standard COG to of and the the specifically the be we definitely development but led as maximizing publication, least to induction as showed and a conclude at in to on now, naxitamab the scores aim survival depend way anti-GDX a that naxitamab event-free forward regimens with prioritizing rate. as combination, agents to looking induction antibody. chemo. complete This on A improvements induction report is, at at they outcome go as survival compares therapy treatments like confirmed And concerned, seems study superior improved a response just And of in randomized how combination will based how course, to well, of plus QE further study, before a on not maximize these of the after. naxitamab chemo combination -- looking setting

in is the definitely trial is that can't COG direction. the the with BCC. So that I and landscape evolving And anything specific discussion yes, ongoing more because still than say

revenue choppy. in the that matches in more Brazil where DANYELZA a seen Is sometimes, as revenue? follow-up, curve very expect launch, what having do government from Brazil, out looking the the are just you And reimbursed quick dynamics, Or volume of given expect and a so, ordering and Understood. that can pay be demand at you of other Brazil? drugs

expect pricing. negotiations No, but any expect, reimbursement. choppy ongoing. Yeah. do c-Met it's not And with pending, successful We still on -- we

Thanks. great. Okay,

question. comes Our with Tessa question proceed Please the Romero Morgan. JP line from of with your next

morning, for so Thanks question. our Good guys. taking much

this to another on seasonality us. follow-up pick see that for we even summer, July Thanks think launch much. you in available Are the kind To is million so what last August? as the to your be you then And ex US, mid-XXs terms here $XX Do should to -- think the of ex $XX clear, any will Symphony up us. was still US current reach of XX% guidance, expectation In down Symphony that the how in million split split here? it to be based you out? And is the this US will your month-over-month in didn't in suggesting data back DANYELZA

the in the those US mid-XXs you Yeah, we comment I from on then if Symphony. in I US who I'll do are one. Bo, comfortable the seeing to know, guess remainder sales. take first don't want and ex think, Sue, I

Yes, this we I is do. Yeah, think, Sue.

it there we back stability think to up. do and is I expect that the pick that

have development also that campaigns in new about. We excited very we're some

I'm this number place. So anticipating this things we will hit we with in year that have the

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

Our question. proceed with the with Please comes Darout Markets. of Etzer BMO your next question line Capital from

for Thanks my question. Hi, for this Luke is Shumway on taking Etzer.

Just me. one for

this PK is year, Looking about and that at are what data thinking should we for later for a about, how you benchmarking program? that SADA no think it and the imaging go go,

Etzer. thanks, So,

are to, achieve dose. the So as isotope with mechanism from PK XX the trying scan we see of bloodstream the SADA having and data, of] clearing at what curves we December, protein proteins we are [lines trying to, tumors the in tumor unbound are of time, to the validate trying by, (ph) terms millicurie meaning imaging the able while and to rapidly platform the same being

think, I be that are internally for what And I for a would at we aiming think us. success, December. that's

thank Okay, you.

our proceed And question of [indiscernible]. line next Please question. comes your the from with

Thanks to questions. can that basis on centers the neuroblastoma. for these How would are annual wondering, treating on clinical everyone. something I'm you enroll frontline and many comment going study trial? the you you. just of taking say data already from Thank you patients are Hi, expect when type centers in if my

don't Hi, Vignesh, why you that? take

repeat Can question please? that clearly. didn't catch Yeah. I that, you

asking about numbers. the potential of centers, patient number was readout He data BCC study, and

Yeah.

earlier, we So study, potentially a study to transition lead to quarter a that to and take we are arm Phase next transition is a which single mentioned current in anticipate that aiming a label as we expansion have could which X, to ongoing year. one I place

So and evaluation what will ongoing current [Technical recruitment of patients the to combination the in study Difficulty] overall of course will contribute happen safety the induction.

which at outside earlier I the about protocol mentioned is in to XXX But in approximately the randomized out moment. They're include study. they very stage randomized of Europe. other are US, this in in draft The patients accelerate currently fifty expand at US affiliated sites the But keen total for also, is also the in sites looking presentation new randomized as are on centers proposed sites have with will in and BCC study. the to be study we part, this recruitment it network, still which to to number internationally Canada, a the of

how take anticipate also we're will anywhere will interim that ability enrollment. complete that and We between five at the well. four of years to data, to impact as on analysis And based looking and the

of discussions in being subject, Does of are yes, all as naxitamab your expand And we hope this to answer data lead coming this I on sufficient that year. course, this subject question? data the treatment. induction which this to FDA, our with positive, to planning will is All mentioned, later we to label through

you Thank very a weekend. much. Great. And have nice Yeah.

You too.

have we the for question-and-answer reached I'll call to back remarks. turn the end closing session. And the management now over of

And Have And happy you weekend. for a Thank joining today. This thank you. call. everyone great Friday. concludes us our

may time. today's your conclude participation. you conference you does this for disconnect Thank And this and lines your at