YMAB - Earnings call transcript Q4 2020 | Y-mAbs Therapeutics, Inc.

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Operator

Greetings, and welcome to Y-mAbs Fourth Quarter and Full Year 2020 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 reminder, this conference is being recorded. It is now my pleasure to introduce your host, Thomas Gad, Chairman of Y-mAbs. sir. you, Thank

begin. You may

Thomas Gad

and you thank morning you, everyone. you, joining us thank for and today. Thank Good

So XXXX business. stage was transformational the our our year that we significantly expanded as significant on on became strategy made and for pillars believe we a We’ve commercial of company. three progress executing Y-mAbs was truly

Technology under tech platform; and First, our and DANYELZA Y-BiClone antibodies, omburtamab; second the the SADA platform. leading monoclonal our bispecific compounds finally,

relapsed high-risk DANYELZA February, As and U.S. you not in U.S. And but XXXX. the for we we’ve MSK, hospitals to DANYELZA, of on know, primary neuroblastoma from received approval delivering only beginning XX, to throughout November refractory the been

presenting So from the agency, and possible. had soon Type XXXX, FDA, that’s the focus with believe as third to hard the and FDA multiple the with the the Omburtamab, now XX, receiving interactions for now we’ve BLA address March us from second will likely our B on will continue the refuse-to-file aiming where the finalized or as near-term meeting FDA, work After quarter what additional very request end we’ve by be have letter efforts quarter. in resubmission on a scheduled exciting. we and we the data very to resubmitting the be of we

tumors clinic We unmet this are in large the brain lutetium-conjugated BX-HX-positive for very a pediatric here into pleased addressing and enter adult brain excited and to need. generation see our quarter omburtamab-DTPA next medical very metastases XXXX, for

to payment additional milestones. Pharmaceuticals for approval a which for entered $XXX a and agreement SciClone million and of an $XX and DANYELZA in omburtamab, included we’ve approval with China, DANYELZA, up into the million upfront commercial Following Greater licensing

three Here China for this BLA year. at the we in end of January submitted DANYELZA our package

Eastern a agreement entered licensing as Takeda a with distribution in BLA scheduled I’m and now a international and for to ex-EU continue patients. into to also quarter covering well. have Israel We the to ex-U.S. Israel, local and Europe signed BioPharmaceuticals add submit package We of Russia, omburtamab agreement this pediatric we’ll availability DANYELZA aim with Swixx optimize and more both to and territories to

under Our Y-BiClone continue well. programs the to tech as advance bispecific platform

and nivatrotamab the to ready was first expansions a cleared planning patient in Our getting cell And we last and study Phase this in year, on year. IND in X/X we are soon are later osteosarcoma for Phase dose lung cancer. in neuroblastoma addition, small X/X

approximately The late this package very for plan thus for or after IND, CDX-bispecific ended disclosed week, later earlier again, received closed Voucher of our work the enter planned. the need same In and submitted potential pre-IND keep advance Review scheduled nicely. sharing and later pediatric time, clinic clinical in to $XXX our a option platforms lab unmet we of to addressing which, nivatrotamab and on At submit year, to have of shares launch Morgan We in advance medical CDXX, with pediatric the next Bank support development. with SADA XX% Our over-allotment common $XXX enable got patients. the AML for enabled million to cash into $XXX continues and exercise us oversubscribed offering This book and strengthens MSK proceeds. addition, by our this two progressing quality XXXX, at compounds, four million. investors a of share DANYELZA we in Technology million balance led secondary stage commercialization our sheet JPMorgan XXXX progressing full sale and this to for first sold America. X.X IND that’s to We but with our us our million to to Of and Priority generation Y-BiClone very net the not we tech feedback as high of completed We only including $XX year. positive very our the approximately the further the approximately Stanley of both and omburtamab important far that earlier is XX% of and targets look we compounds $XX SADA We’ve omburtamab, an million continue subsequently a and and promising. DANYELZA stock,

very medical financial are Y-mAbs our Taking which we balance call. very on believe very, expand while that. activities to will do Bo And it addressing pipeline clearly we with to elaborate hand consideration, positioned and XXXX point, we sheet So into this with very, to overall we have at commercial needs advancing this are our you. like our solid to I’d continue Dr. pleased well very that, Thank to more unmet our into in excited very Moller. large achievements over very

Claus Moller

spend to Thomas, with thank you, us. everybody Thank deciding the to for and – morning choose you

work the while omburtamab the have advances market to our to quarter, hard BLA. same DANYELZA fourth making FDA, time the progress by the continued pipeline approved the resubmission our at that what having During we of including at to and ensure in progress

the initiated we addition, nivatrotamab studies. one in in in metastases one cancer two our and CNS in Phase our lung initiated study Phase CNS/leptomeningeal under ongoing and In small own have with a medulloblastoma X/X in X advanced patients cell adult BX-HX-positive IND studies,

patients country bone the who marrow, older, of have demonstrated is in DANYELZA in one of the first on treatment also to constructs commercial our GM-CSF vials earlier This of overall The out approval approval the response. rate came we send approval the us minor in XX, advance of granted including continuing work a a centers, to month. and regulation bone Naxitamab, of are are as treatment age combination partial as for FDA few days PDUFA November indication and high-risk disease vaccine. the to We and and this on response or or DANYELZA. programs and GDX, accelerated stable date, or our response well GDX the the therapy. MSK the indicated neuroblastoma across with on the year on the refractory adult response, is approved to thrilled bispecific prior based relapsed duration with SADA new patients pediatric

really achievement for team. that So a was major the

been Let effort through the staff employees, possible and supporting tireless the and United to for X.X product that registration. and credit made has less in me efforts years the acknowledge antibody commercial pause investigators, development in for deserve in applicable available take and team our total, agreement XXXX. patients signing XXXX August it a shelf licensing their site February consultants, in this highest States to becoming all than and second MSK in a It the advancing from on the the DANYELZA authorities to

treat of the of As universe we you we organization the neuroblastoma have pediatric cancer of a commercial believe And know, a lean built launch. targeted majority that ahead centers, patients. and small highly

clinical neuroblastoma chemo the we DANYELZA, ongoing maintenance in neuroblastoma have well and refractory approval treatment, to as DANYELZA addition of Barcelona, combination patients. in trials In for as for MSK in trials at with York first-line New

We treatments. are in X Phase chemo working in frontline to initiate naxitamab an combination for both multicenter international and trial

trials letter patients lead BLA CNS/leptomeningeal with the its at And neuroblastoma. part X compound; now We been context. and clinical a U.S. refusal-to-file omburtamab from also CMC BLA the three of that clinical trial further additional refusal-to-file additional metastases for that second Upon have to FDA noted no from received the And non-clinical of patients determined in requested the a FDA ongoing our the module the should omburtamab, module preliminary certain in turning osteosarcoma or are the detail. regarding additional required of be or also was required. October, pediatric a review, for in No we Phase of data requested it sites recruitment have treatment

patients agreement a of to variable regarding of the omburtamab from close raised have can the and we a XXX, a resubmission where FDA study. details the dialogue the remain we in that providing We month, before the included or with among We our resubmission B remaining response the omburtamab data reach Type with from FDA, by include including with the hope very our supplementary BLA. on will have initiating BLA agency enrolling requested meeting all disease next address scheduled which final maintained this data tumor Study confident patients points

the few prepared the with this in been omburtamab the or by XXXX. of maybe BLA the end we plan And quarter months. to the omburtamab to year second of staffing for resubmit next marketing quarter, our submit beginning U.S. of begin to late in operations BLA. has the authorization third within application parallel in expect April The and We European European marketing commercial EMEA application

X study and known to disclosed, we pontine DIPG As as are shortly. previously planning patients intrinsic diffuse developing are at X/X multicenter DIPG omburtamab for a Phase open study also MSK, glioma in a Phase for we

potential In quarter. start to and the intracerebroventricular international a with omburtamab-DTPA FDA in cleared we its omburtamab cord. patients to For of potentially called is unlike on establish the are anticipate X/X using the opened of in make lutetium-XXX safety tumors at the construct. construct. this this omburtamab determine locations of IND dose tumors the the trial X rapidly this iodinated leverage primary for be we Phase using Phase lutetium year, our with tumors, omburtamab Catheter known XXX patients in clinical BX-HX-positive our and treatment maximum And for study medulloblastoma brain the metastasize in iodine-XXX cerebrospinal in approval the omburtamab-DTPA drug with which experience one the metastasize most chelate of patients different screening desmoplastic growing along lutetium that labeled deem excited brain Furthermore, have is catheter brain, treating for as are The construct, embodies in brain they the XXX lutetium see radioisotope obviously finding U.S. small the to radiolabeled of common Ommaya and MSK. cell the omburtamab-DTPA year, to the XXX delivery tolerated will per the Reservoir. the we regulatory antibody. based we to also XX lutetium round surface of our fluid October this way XXX indwelling spinal medulloblastoma, clinical medulloblastoma profile types later clinic tumors, approximately multicenter our for DSRCT, and antibody through last recently DTPA most omburtamab-DTPA the hope construct spread for pathway frequently to advantageous the invasive, our naked again, Medulloblastomas and on from children. with a our experience study, incidents medulloblastoma molecule to to once We lutetium to

omburtamab. the cancers our leverage to in prior cleared our adults iodinated a basket XX In FDA the more BX-HX-positive for addition in from we adult experience FDA, trial with also than the hope IND where iodine-XXX separate to has CNS/leptomeningeal recently patients, treating

the for lutetium quarter be screened our study this with leads omburtamab-DTPA year. the it initiate during treat first adult the to indications. XXX include to are widen this patients And expect we We to these to adult and first clinical thrilled of

As neuroblastoma cancer the treatment October and in will happened now an recall, granted to announced quarter the you rare XXXX. has X the nivatrotamab, our a of the also antibody, leading for We IND FDA designation study that IND bispecific designation pediatric XXXX disease drug we in Phase submitted small orphan lung had in and for cleared. fourth of that cell

are patients. adult to to cancer leads excited So widen clinical lung we nivatrotamab’s include

excited Technology, we at plan neuroblastoma SADA good SADA and of two And osteosarcoma. X on we and are the nivatrotamab our one are progress targets separate ongoing into clinical study making this Phase to in arms, addition, turning for preparing one we very expand development. prospects the of technology, In the about to MSK

tumors and potential potential tumors cancer in GDX-positive include or file GPAXX-SADA for negative cancer; SADA targets and year. that use cancer, in use these breast the solid have is for agents SADA in to Technology. Technology breast use we responses the lung the constructs expect radiolabeled versus melanoma, announced potentially not in for therapeutics the we cell this colorectal radiolabeled intended meaningful historically of in We also cancer believe the cancer. treatment truly And SADA demonstrated Our for cancer; potential small eventually BX-HX-SADA triple efficacy gastric use can or which of excited to quarter IND first GDX-SADA prostate the in about improve GDX-SADA the HERX-SADA first fourth are for the

plan omburtamab with up antibody DANYELZA our of multiple antibodies. and to we the and the build up, across launch we and and through leading are omburtamab-DTPA Y-mAbs plate patients resubmission our positioned advancing development radiolabeled other to a BLA the continued fuels deliveries next to company. on we that the to planned In centers we So widen SADA well we a work. country have for that the constructs treatment of coming pipeline already Concurrently, as the development the to business to the our the a continue stage bispecifics sum the commercial clinic, approval our of excited constructs, lot words, deepen by move and predominantly generation with are and and helps forward believe XXXX,

financials. the Now, let me share to his invite XXXX remarks Bo on

Bo Kruse

the expense share XXXX. reported December diluted December incurred revenues first million XXXX Thank report in to Claus. loss for of the no December revenues a reported of XXXX. related in ended ended We the year XX, and a in million year Takeda. There per the and basic We Israel our December you, the were There share XXXX net net in royalty compared revenue. ended reported SciClone revenues We the expenses December full We basic and diluted XXXX reported related $XXX.X net year XX, of in XX, $X.X of with were loss ended December XX, XX, the the royalty year XXXX. to or happy such no for $X.XX licensing or XX, per ended year in licensing for for $XX of XXXX. China million to million history $X.XX to were ended year arrangements our with Y-mAbs $XX.X

a was $X.X cash for expenses December of million $X.X Technology million expenses take launch the the and marketing a XXXX increase $XX.X business increase acquisition the our by and $XX.X at infrastructure million professional ended year in million related services increase the we per by $XX.X related SADA note operating to million insurance, MSK, increased $X.X related in activities as outsourced ended commercial a for for used $XX.X increase attributable million primarily our December fees. year ended from increase and with ended for XXXX to a $XX.X million period. caused cash the million $XXX.X XXXX $X.X XXXX. million we for a million look $XX.X and million from XX, million. compared increased that loss increase $XX.X expenses, and $XXX.X December show by in million it to XXXX. G&A XXXX. by increase ended As in for expenses from year million loss by the XX, sales personnel XXXX and commercial increase the $XX.X the the and consulting to year And million $XX.X ended XXXX, XX, DANYELZA, the offset December year net year-end for in of fees. year XX, $X.X have personnel to costs, related million We professional ended and by the full license primarily Cash increased stock-based partially million closer increased ended from itself increase $XX.X The increase The the million December million position XXXX the supplies, burn million was primarily The year This the December in position costs, in in $XX.X the for that G&A non-cash R&D to for XX, milestones in operating cash $XX.X $XX.X of XX, the the primarily costs, XXXX of December increase for $XX.X expenses for to the compensation an year with for including in was net XX, increase and increase XXXX. depreciation million. expenses, of December

the of burn has we on has quarter and As through commercial fourth nivatrotamab seen we’ve our work up the resubmission our to have launches approved, ramp continued BLA DANYELZA accelerate for increase. progressed cash the and omburtamab the

operating remain the We the to expenses of the line roughly cash expect in where with XXXX burn was XXXX, of operating our from quarter for to mid-XXs. spending rate continue in fourth the

of offering after sale in of race financial a together and with secondary to which million $XX have of expenses. that XX-XX cash PRV with $XXX terms extended $XXX.X the total completed get January $XXX with now to In and XXXX closed and year-end company This million position before DANYELZA million means the rate, recently keep we that we commission the so run and an MSK, of our run rate. of far million was sharing we

in continue very to now the remain Thomas. So call I’ll believe concludes over and healthy Y-mAbs a we position. financial This financial turn update, the to

Thomas Gad

the Thank like operator you, remarks you today’s Thank prepared end very of I’d thank you. and Claus. much, Bo, This questions marks call open to up the and for the now. our

Operator

Thank you.

a be conducting session. you. [Operator Instructions] question-and-answer We will now Thank

with the Bank line proceed from Alec America. your of with comes question of question. Stranahan first Our Please

Alec Stranahan

Thanks congrats XXXX. closing on out and for questions, a guys. the Hey, solid

me asset how cancer following that the So this I results up. small the approaching these first both And study may osteosarcoma were year follow lung from how reach year first? given and the on of I’ve last given on the see And nivatrotamab, from DANYELZA modifications neuroblastoma in got cell indications you actually past sort various proposed paradigm approval the slotting are trial? do you that into treatment a guess

Claus Moller

I’m not you progress. cancer is small patients get to are small your second the come sure treatments also And for nivatrotamab. before on – potentially in came the also likely chemotherapy cell additional of in they have most know and then lung PD-X, PD-LXs the treated line sure but meaning to lung seen these cancer cancer oncology lines, take also approved some as are or the would mostly to patients, can got in for frontline after being that. I the to patients lung you But have continue idea second cell patients are that that back study, part, last relapsed

weekly subcutaneous idea to sorry. administration side effect combination side potential release. reduce further from product or with – cytokine basis the side And giving that corticosteroids is biweekly We effects are of give activation T basis, should on cell a systemically, risk in the effects, the

answer was to other think. So nivatrotamab, the What I was the that the question?

Alec Stranahan

Yes. And going it slotting see similar a maybe then do how similar indications and given behind they’re after just you in DANYELZA target?

Claus Moller

the unmet XXX still neuroblastoma based at leaving are a the XX% you you of exposed from rate you that setting, there’s also, responding, data treating we Study, need been third Well, ORR setting. say DANYELZA. can medical overall in in as the can the XX% evaluation response look so an in to had when see on patients And not line patients we the and investigators, definitely have neuroblastoma

So don’t DANYELZA. And market I in to early is this a stage I going anyway think for very also, it’s cannibalize said the neuroblastoma study setting. in as

So a think it’s too and to commercial shelf. substitute the on is don’t other way and it’s available market think whether early on it’s one. going discussing – the start One one to would I I the product

get The program other it approval. that’s one a is to the of years several before BLA it potentially ahead could development

Alec Stranahan

the Okay. could of the And as first preclinical the time definitely year? where’s one your you the confine may, target to excreted? That’s product models tissue I on clinic the its but SADA And this other the patients date be of in encouraging, to very question, organs helpful. as residency to radiation Yes, done sort in this speak is maybe actually more platform. sort if manage in will ability what and

Claus Moller

Yes. a anyway. in actual problem is per construct it’s toxic course se because The not of not

is to the binding the tissue tissue there is Then So normal the of the of of it. construct may target, out if expression have some construct. you binding course, binding tumor – of part and normal

issue definitely a side radiolabeled patients now MSK, doses about profiles first we in side that that concerned the we terms don’t given is planning know eventually to and think of GD-X on the in that no GD-X, working of they for there’s doses at effects. since we’re the we’re The to effect from an to GD-X with antibody very up high the radiation have And past. one

the higher SADA. are use expect substantially doses that we the So to with than

from say, DOTA DOTA lutetium-XXX, the and Then when bound caged to end that’s you the normal tiny with about but So molecule what tissue toxicity in the the to lutetium tumor. a of we shoot DOTA the molecules molecules can that’s construct bind in very into that’s were then a little the SADA supposed molecule.

molecule course, water spread the typically body, less bit thing woman. of which male of adult patient’s bladder. going to pass of a will the is the And entire through it for body to is it’s XX% phase adult every the through going and the passes time half an But through, an So, of is the that in this kidneys and kidneys circulation. DOTA through leave it the into

is bladder and radiation radiation very bladder bladder. make of from Now in the cystitis you course the comfortable not

there, a you patient If the put make only sure circulating construct in is think continuously that’s while the and my catheter the don’t radiation DOTA it drain in you having I bladder but we the toxicity. of terms either. in in it real utterly to seem they with the about had clinical topic of to pre-IND side don’t focus on have agency, concerned And discussions be that

So, this that comfortable towards we be to year. the this first we in clinic able the move quarter are quite of will

Alec Stranahan

congrats Thank Perfect. you, the on progress. again and

Claus Moller

Alec. much, very you Thank

Operator

comes question Please proceed Burns the next question. Wainwright. Robert Our your with with H.C. line of from

Robert Burns

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

a few from me, Just may. I if

FDA. wanted release around my package And the be resubmission on the my That’s just what the with question with remains completing one. to first of to Type first a I intend does issuing results to Y-mAbs B resubmission. press regard meeting? So a to get the that omburtamab sense on the done is meeting,

Claus Moller

all Yes. Okay. Well, data we have. putting I together we’re the mean,

available December they published. that register central Pediatric has all there than some that that there a in relapsed published was Oncology happened patients from and gave that survival the shared there cancer things and XX European details German from was data for is been here The granularity thing rodent. the And the more from initially CNS/leptomeningeal of the is are by data precisely paper that neuroblastoma other for as was good new where us database. SIOPE, with studies as One all database Organization,

historical of sets two have we controls. now So

make give to gotten they SIOPE very and be with have to study, from data and January that we in access which them to the We access sure that, us FDA would that about. the to have worked seems with agree happy

also have search as now historical second that dataset So panel. control we used

So When minutes together end for at meeting the had we we the received the meeting submitted the been Type have in from that has next of that the and to FDA put to typically after we what X days in that and happens was what guide will the mean meeting XX outcome of course then meeting, the we that resubmission. of of expect to terms the and the preparation B come and month. meeting

Robert Burns

free Thanks, so frontline Claus. setting second color And provide Awesome. design I trial any a going event it’s into assume in survival the Okay. my DANYELZA primary in the be with the against arm of the endpoint. question, For naxitamab this exclusion explicitly? around could But that you ASCT trial begin additional writing non-inferiority the you being to are protocol, for neuroblastoma to year? the instance, sleigh DANYELZA

Claus Moller

you bone the also still, not, we’re are come can in bone then previously, but patients, And Mora patients treating doesn’t transplant, have the requiring because marrow transplant received is them have we give if in not seen marrow as they marrow Dr. bone setting. No, frontline he transplant. when

it’s the separate do marrow analysis protocol So, the the that bone it bone that, we of section patients but put we and analysis would into marrow. of with without not will

Robert Burns

some data setting? interim accelerated for the DANYELZA in you potentially you since go request considering to frontline FDA the at believe with point time neuroblastoma, data date to totality of what the Okay. and could the do approval And potentially

Claus Moller

FDA say, year I’m us hoping in we of can construct little for in the that It’s We to the neuroblastoma. Type but for a breakthrough early designation second a to with this discuss have B meeting too this. a still this have half

we datasets patients’ that would I meetings. But as we the most additional MSK. have of with they together that. study, MSK, But study frontline that the Dr. why from patients may are we was for mean, approved data the study for that and in now, enrollment to that indication I eligible frontline. And frontline not collected likely would meeting. continue asking as be naxitamab. showing me reasonably Type as at from I’ve patients that putting XX – patients let they of we Mora – an a in B are we’re see recall, And yet, we So at said that the would you I completed and mean, soon have And some before, are, actually as not it’s treat course, treating definitely with

Robert Burns

sense. the complete Thank quarter. makes Claus, on much, and you again so that Yes, congrats

Claus Moller

Thank you very Rob. much. care, Take

Operator

Next question Darout Please from your with comes the with Etzer line question. of proceed Guggenheim.

Paul Jeng

Paul questions. Hi, for this Thanks is on taking for our Etzer.

Thanks. license Europe. for partners distribution in opportunity partnered with you might recently For nivatrotamab comments on us in and out months context the help anticipate Israel, Eastern how shape trajectory DANYELZA, maybe also get hoping to some in DANYELZA current to look? understand launch regions coming And and and the China, additional you’ve dynamics. Can you in the of these particular and how COVID applications

Claus Moller

Yes.

see But that, sites to commenting managed on I’m ship the ahead of first quarter naxitamab. the on shortly first to MSK report we sales number in come been reporting. and positive have our order. that But In launch, the of we to two use first next seen a what’s of course only very quarter also. when of will I MSK hospitals outside able just can of we to get terms accepting place the of line to have a I to to we say mean, the happy

we our way first report quarter with four the when weeks, looking quarter to forward to So conference have much has panned three the the very out on very first comfortable call. in this

patients. In China for in obviously, to we hopefully based the treatment what year what submit the neuroblastoma, approval if we hopefully is here X,XXX the then submitted grant filed terms now, in part the very Chinese partnering, of diagnosis with And received will BLA file the on these as of of pre-BLA market, Chinese us a China and interesting of size then package the FDA. is the can consisting that of And naxitamab. for primarily that’s most we available package, year, each the Chinese about to speak quarter patients that’s limited this for third because BLA partnering case, we have that’s approval

mean, U.S. Now, but a you’re more of also I U.S. pricing It’s very a market, big the from wise, the XX% price, than to XX% to market. to with be going as able probably market not perspective. still interesting that’s get financial threefold as a

sales In have can to see I mean, the financial. a see a it’s able our hope medical tourism. Israel don’t is you sales blip in small Israel the think as they very do you’ll on terms – country, but anything but I of – of also bit that I Israel, Israel, quite else, a in be hopefully

agreement Now with where, distribution allocated pursuing a of system oncology the And in hundreds a collaboration pediatric to millions your is addressing get Russia, And of Swixx there’s new that to try euro particular, Etzer? under of up sizable of program. set Did in that there answer significant market. amount to is we a relatively course, treatments. and are question,

Paul Jeng

That’s perfect. That’s very helpful. Thanks so much.

Operator

question next from your David the of Please with Stanley. question. Our comes Lebovitz with proceed Morgan line

David Lebovitz

taking my much question. very you Thank for

that – and to had be? transitioned IND just trial was BX-HX the about And little IND that were the earlier Could nature indications. because just adult for a again, for – targeting mentioned, you confused I-omburtamab You the is through I run going what filed then initially you Lu-omburtamab. when talking the to you omburtamab, and that of was

Claus Moller

Yes.

say said, adults, antibody. have the construct. we as the is to of on we put radiolabel way therefore, quick three the of more, to to a needed patients easy thing DTPA with iodinated We antibody. data XX going version omburtamab adult I are can the you a and being that the able key if we So And address

having is of side I some the we for lutetium. taking binding the thing put the elevate, and the the to a recheck the The antibody. the then to and and radioactive wash antibody pipe entity process close of and have off XXX it omburtamab-DTPA, like XX amount up instead iodinate column a construct determining do So of ends need Well, minutes. tyrosine iodine inside on only to to to whole between to the and the because resetting of and binds

the antibody, and put else. be radiolabel isotope antibody. everything amount to the don’t because seconds so And lutetium, excess bound will of nowhere with you XX only the will titrate, me takes it bind so you on So DTPA

with that So separate than able that And year we dies to of millicurie CNS/leptomeningeal the the and maybe we omburtamab that, put of of adults that patients we construct. and XX metastasis be get put of CNS changed We the that higher because be we’ve the it the radioactive up dose why also XX get have per the address heads we used XX may patients. iodine clear? BX-HX even for from able or to the that the to existing treated we of tens kids why are that’s isotope so XXX into able every may that making now to the we opened that’s for a positive. adult into maybe be created thousands millicurie Was IND

David Lebovitz

patients? it be would any I why there in Is adults pediatric be than in different guess, reason would efficacy the

Claus Moller

only simply, for we is the the felt with the study iodinated labeling if more the rather efficacious level after DTPA get it we a think it short have a delay dose for reason going I lutetium-XXX X/X reason conjugation going to can and and construct. would in a higher that was off patients. since to anyway, we But up key adult are a we – than escalation Phase with radiation to antibody the of go version, anyway, it staying the relatively dose patients why adult be start

easier existing exactly the radiolabel. a different to antibody, So faster the antibody cheaper it’s and radiolabeled and with isotope binds much as and it’s just

David Lebovitz

that. is possibility with sounds checked need I there the like the guess, off the you for of you part. question have the with it FDA is Thank meeting, check? to this other most upcoming guess, boxes, meeting a that come to boxes respect you more could I for you out

Claus Moller

with your such on FDA What’s topics? experience the

David Lebovitz

haven’t… I

Claus Moller

it fingers it, and approved You never these as to get them as hope and treatment see as see need know. this quickly it I that possible. they crossed for they that my we need kids

we the seen certainly that do if on us boxes will are an among just tumor And up it patients. approval we first that need have hope to based commitments they I accelerated post-marketing they check. and give responses not So new with that the that, will that, XX coming they be

David Lebovitz

for you Thank that.

Claus Moller

David. Thanks,

Operator

the J.P. question. line from proceed with with comes question next of Our Romero Instructions] [Operator your Tessa Morgan. Please

Tessa Romero

Thanks Hey, question. for taking are the how you? Yes. guys,

me help of you’ll in about? about product you we top anything started Is the sense think DANYELZA, Just beginning launch? you a sort beyond one launch quick delivering from that Street I line we’re thinking you providing gauge of kind give guess, the should more there bit on can your of sales the be thinking as the for noted, of February. metrics be the what I a us little to

Claus Moller

started too and patients. sites bit first we also few think total be the outside the probably first of of it’s early would that on sales, that and we centers if I not give into DANYELZA total early what treatment of of and be of have weeks I we you But quarter provide – number surprised a very successful said, vials, course, you how think using results, have that MSK. we a were get But actually I to we’re on, unfortunately able the receiving sites guidance different vials into when will as we we many sold say treating total with. to able few the that’s weeks to – first are also number for I

DANYELZA, to So we little more have give but early with it’s managed are on to where and happy launch. a very we the details excited get very

hear. what recently, you expecting to So were

Tessa Romero

bit question there’ll some broader. no, will that’s beyond DANYELZA, color be And Yes, sounds I is my a be guess, helpful. It no, helpful. second like which

initiations walk could of would key assets, this balance for along a you if for studies. what with here coming for we of the of helpful kind data year, be It ongoing sort should the programs? You expecting year, guys have through key us the flow lot up be your the trial of

Claus Moller

will initiation the mean, the planning look the two of we see I you And be of study additional data and SIOP the naxitamab. should naxitamab, of like Chinese we osteosarcoma are hopefully, submissions updates course, some this submission when year. start in from at we get with providing on Yes. course, if to also we to more studies

the omburtamab, here FDA In terms in of of omburtamab course, BLA hopefully. to the second the resubmission of quarter, the

quarter, but that my cautiously quarter. it looking XX personal would are get guiding on second we the one done the for. that We still to definitely And could in also objective it of is the things into would April key slip clearly the third be submission EMA be to

multicenter would of hopefully, being DIPG the and at other of course, of X/X MSK. be study ongoing at able ASCO the The Phase omburtamab initiation with on also the report things to the DIPG

have the year, end the hopes announce the And the the into the all new some with with we when IND There type for to and We see to file hopefully, a cell get think a talk are the AML nivatrotamab. we hoping the bi-specific happens hopefully, the of available then challenges nice on first quarter. And start and out there. the of and that MSK to gotten giving small the of studies Then CDXX/CDX second in the update to in way that real year, I purified hopefully get in this we study molecules study Was of is way rock IND that December antibody, right bi-specific get this my the And kind as long are quarter CDXX/CDX. right one the CMC the that have the of publication think with course, construct the our in approval the will Day on and start the now nivatrotamab, for always side some in give to of the we then we but be for R&D of usual conduct filing. think able get clinic pediatric what there’s together. let’s of have of – to we acceptance when fourth I XX grams managed the we a stuff need beginning, high shelf overview. preparation can I it cancer second an I an we come status a at but study and speak, manufactured you on you lung status towards oncology the and

Tessa Romero

so great. our thanks Thanks Absolutely. taking That question. and much, was for

Thomas Gad

Have Absolutely. day a good Tessa.

Operator

line question from next Please Our with your the question. of Lawson Barclays. with Peter proceed comes

Peter Lawson

And positive for side of shipments. kind initial things? the product detail negative kind final any taking about physicians the of congrats Can of sites going MSK? the getting to feedback on around of the you perhaps from the that’s you, number Thanks use surprised out initial give and of on either questions you’re or any us beyond

Thomas Gad

been you never Was research have first a probably I’m make we more from The et the to cetera. that I have sites of at number administering of give no they will sites and we issues for nurses that administering surprised that sure have that of can also I it that can support positively that thing when give report and color about there details But first quarter only the back-office tried absolutely team is product decide prepared okay. doses. trained help the are before. and MSLs very strong Peter?

Peter Lawson

around XQ, is kind it look or think, the you Yes. like do shipments be to initial MSK see you it MSK? will you great out That’s just from at the hear. when of of it’s clearly we to predominantly of indicating issues That kind But that the breaking drug.

Thomas Gad

trend it I MSK, continues wait that see. then hope breaking means from out but let’s the and it’s and

Peter Lawson

kind post-marketing resubmission if just they outcomes – of it’s meeting the then could And more of I be want what you commitment of data, you. Thank – for outcomes potential want B the kind omburtamab, know Type what range from the associated refilings? there, they so are the run a and of

Thomas Gad

Yes.

datasets that details I’ve granularity not and sufficient be more to requires with indicated, And a that the mentioned the way for Germany propensity tremendous and had Cancer had of control one us would And also analysis provided The treatments. able we hoped they between the in done with previous us. group on did that they to. two collaborative actually be As which I issues patients amount database. have work and as that possible was came the have FDA that previously from the unfortunately, they they where database, won’t Refusal the that had File. the publication they more you as German a study. individual study historical saw a earlier, their initially with new would central access patients patients granular have We out to not this score us was registered In in in of felt have very SIOP there including that from December granted granularity,

Register What call based XX wish including be additional the datasets, with granularity So historical the hand, of other control data I MSK say. the have study. But for do that case, multicenter to other response full you XX on response control. for can the not think XX% FDA’s address group they six patients patients to on with from tumor the historical the Should on in is the historical we an for the data the The now have and should tumor approval, tumor we data well supportive follow-up are could XXX and that months data new data they as from Cancer rate study progression-free supportive the possibilities you have with survival, support give data I’ll Is this. the commitment together of German that’s be additional study post-marketing one-on-one have and granularity. response study controlled to supportive continue we to like and and your is a past study original past suggesting from clear. patients would multicenter follow sufficient they and the kind the granularity that with as we more that the two are then additional to provide but they when the

Peter Lawson

around that line with in that’s I be think just mentioned cash remain definitely Yes, OpEx, you and how and then we helpful XX of should the XQ. thinking kind burn the that

Bo Kruse

Yes, so roughly lower XQ a maybe bit the what line quarter. were little in with per we mid-XXs, spending in

Peter Lawson

that account the just does for sales? the vouchers And like

Bo Kruse

cash operating burn. the that’s No,

So to any sort get deducted from would to level. of that net income be a

Peter Lawson

you, Got Bo.

Bo Kruse

partnerships And mobile that the included revenue shares in spending.

Peter Lawson

you. thank Great,

them. Thank clean much. a of you kind so that’s So

Operator

from your Sebastiaan of comes Please line question Kempen the with next proceed with van der Our Company. question. & Schoot

Sebastiaan van der Schoot

Hi those two certainly, was were Claus. questions, I mentioned version. iodine agent experience I the for omburtamab – year have what that Hi, just at first on one you wondering patients. that full the responses that in the with results previous guys, congratulations is on you in XXXX. particular clinical with the

Claus Moller

and this XX% patients. medulloblastoma get lasting and of radiation that had and everybody have we Again patients and MSK top is it seem induction response neuroblastoma, But we a contributing be of to our clearly spinal regimen, these given opinion this the remissions is significantly these kids can patients, of into remission for number but on to chemo the some some In Unfortunately, to is even the that stay crane in investigators remission. the surgery. a of including patients, keeping standard like put able the situation if a to is also in not will remission. like in for within a we survivors it long-term –

a was for in – bit We presentation, at there There XXXX. very has in primarily safety presented been it’s Dr. patients. But a – SIOP huge limited these a forward data have Kramer leap made but little

Sebastiaan van der Schoot

for were about? what’s you And population adult Okay. talking the then

Claus Moller

brain any brain particular another had XX has disappearing for of months that same been meds she had that or a in XX information of else positively, there the been spite in lived cancer. limited months, have is all XX responded after resistant had in adult she number normally ovarian that for for the with the of XX treatment cycle a shrinking receiving, everything impertinent, and XX cancer live first being there to metastasis with don’t available. them from patients that patients patients The recall But that

Sebastiaan van der Schoot

will when great. for then and complete that approval you. regarding think enough, we whether dataset Thank to in… on trial you was accelerated for comment [indiscernible], whether that could wondering could you expect Okay, be And I

Thomas Gad

the patients it Yes, sub have with point as everybody. will But we we say two osteosarcoma we we first particular Day of end to December, we in Day in meds group the we and that’s will patients, least as be as SIOP I XX XX at have of at we that at where too them this R&D should should had continue like looking [indiscernible]. can And present the at the at a sites December. but relapse, the we still we a more at and we we whether or will looking a where we R&D dataset update with hopefully And have are when an i.e., October added early looking continue alternatively, to patients they’re promising the of where is, evaluates in told XX time patient, give look. little will the whether majority year, lung up, would that’s

Sebastiaan van der Schoot

Okay, great. you. Thank

Thomas Gad

first. need BLA for data this, supplementary we formalized the see A to

Sebastiaan van der Schoot

Okay. Thank you.

Thomas Gad

Sebastian. welcome, You’re

Operator

Thank you.

now no further the back over at like for have closing questions time. turn this comments. management I floor to would to We

Thomas Gad

Have today, XXXX, you everyone a a XXXX, hope you thank listening and I great and look Claus. thank you, Bo; thank weekend exciting everyone. and forward Well, we and to agree had very for we you

Claus Moller

Thank Bye. you, care everybody. take

Operator

and conclude teleconference. does today’s Ladies gentlemen, this

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

Y-mAbs Therapeutics (YMAB) 26 Feb 212020 Q4 Earnings call transcript