YMAB - Earnings call transcript Q3 2020 | Y-mAbs Therapeutics, Inc.

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Operator

Good morning and welcome to the Y-mAbs Therapeutics Incorporated Third Quarter 2020 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 Securities Litigation Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they're are not guarantees of future performance and actual results, they differ materially from those expressed or implied by these forward-looking statements due to a variety of factors including those risk factors discussed in the company's annual report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 12, 2020, and in the company's subsequently filed SEC reports. At this time, I'd like to turn the conference over to Thomas Gad, the company's Founder, Chairman and President. sir. ahead, go Please

Thomas Gad

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

quarter has date executing of Y-mAbs. third know review the So XXXX as FDA up we've BLA currently you significant later with Naxitamab month. the We the been made progress coming strategy. on PDUFA our and is under is believe for strong this

a is pediatric has designation, which receiving a approved. are naxitamab if rare disease priority naxitamab voucher Additionally, we review means

the omburtamab beginning resubmit late We XXXX the are to also in BLA of or expecting XXXX.

next-generation also patients. two the In of omburtamab addition, BX-HX positive ended cleared exciting the has expect We the into in quarter XXXX compound the but end the year, $XXX we brain FDA metastasis targeting with INDs clinic our for to approximately by enter both the lutetium-labeled pediatric adult cash. million and this patients, on in medulloblastoma

balance launches while support same of we a to advance the pipeline. the believe our omburtamab, and sheet naxitamab remainder development commercial strong potential at continue both to have we time So the of

later which carry will that any sales should without income, cash potential position taking the in on product through call. We also partnership of believe into end on our consideration elaborate this us or XXXX, Bo

go on Phase see a very with of focusing with very our such it's We're anticipate remarks Dr. which a Executive GDX, Officer later to provide lung also BX-HX our living in into plan CDXX, our advancing Officer And bispecific self-assembly in cancers liquid both true to Thank results maturing will Concurrently, X technology and patients platform pediatric and our or Kruse, oncology AML our Chief the pleased patients adult have to next As SADA you'll also like also cancer company, we from to year. where platform, to as cell our who of CDXX we medical third populations, Claus to from Moller, referred Financial into Y-BICLONE of year. work disease. position adult as clinic Chief the study and omburtamab bispecific our pediatric and bispecific, Bo Today continue overview; progress we radiopharmaceutical lutetium-labeled small that. this business pipeline therapies stay the -- quarter our hand enter radiation call a to on to as I field platforms Claus unmet CDX exciting positive our we that. hard to hear to for needs disassembly pleased a addressing I'm for the over financial you. lives rare clear will call namely think reach our

Claus Moller

Thomas that chosen welcome call. spend us. to morning Thank have you with and very this Y-mAbs you very third XXXX quarter much, We're pleased earnings Therapeutics to

the quarter, pipeline we including have During candidates to our third market. hard lead omburtamab work and continued our advance that to the toward ensure naxitamab

rate that based filing on an approved response. PDUFA treatment hold to If overall date to the and meeting agency not relapsed/refractory As discuss BLA in indicated FDA it letter for of be committee we priority accepted XX, a approved accelerated FDA the The approval the high-risk and you currently that duration under communication BLA advisory for review. neuroblastoma patients is on also back in expect application. naxitamab indication for with June planning the know this our set response the of November XXXX has that will

contingent and be this for clinical approval in post indication verification upon description then a benefit of marketing commitment. may Continued

of and is ORR Naxitamab of already orphan progression-free The Study survival. ongoing. in measure received breakthrough more the total has benefit from enroll and study. trial XX follow-up. drug ORR XX% endpoints upon rate survival naxitamab Barcelona be priority will At overall XXX, XX% treatment the company's of independent and of for Children's will than the central with FDA. from XX potential XXX SJD a had and a breakthrough pivotal historically otherwise this in the is refractory survival We responses the be of expect are much therapy long-term verify and survival The primary that Pediatric SIOP, And secondary study. showed year of designations and International Dr. needed October pediatric the which as approval patients to Hospital Congress disease any the evaluation an was rates, then data for clinical believe The confirmatory post-marketing to we response multicenter Society the Virtual review overall the approved Mora endpoint relapsed presented. XXX have patients progression-free complete required who Study rate known from Oncology the presented overall rare have neuroblastoma, available. overall will clinical response patients not the describe

seven marrow complete duration long-term was nine patients, had in bone at the the median for addition, marrow The at was of of time XX bone start. conference observed with responses trial clearance response In positive follow-up of who weeks.

as BLA, In trials neuroblastoma trials refractory patients. for we as naxitamab BLA relapsed/refractory in ongoing neuroblastoma, in Kettering chemo Memorial New Barcelona combination for first-line at have York the addition in well Sloan for neuroblastoma and to

file metastases treatment lead the second regarding CNS/leptomeningeal In turning FDA refusal a October, with omburtamab from pediatric for received from of to BLA neuroblastoma. Now the letter patients, for omburtamab a compound. to we our the

detail. disease refuse additional should also FDA FDA, requested including data evaluable with points non-clinical required August was requested Study include it certain the from that Upon the data from will required. XXX, in is And the originally been Protocol additional all clinical confident patients No supplementary among Our the address additional the it be or file the BLA information clinical included in module later. have of that patients to determined XXXX. of in raised trials and are XXX. requested parts CMC was the review its response CMC data no providing patients noted which by that BLA the Y-mAbs can preliminary additional of and submitted further module

from SIOP, This XX In very which study addition, an the presented the rate median an results patients almost multicenter oral pivotal favorably The with Study MSK interim data Kramer company's to compares OS and of to Memorial enrolled study survival follow-up appears study. preliminary approximately a are of in group. Sloan survival of conducted XX overall XX% The multicenter presentation Kettering. control encouraging for XX% of at identical weeks. the Kim XX-month XXX in from a Dr. a showed results XX-XXX, was overall the historical results XXX at

very data neuroblastoma. to to appears that preliminary conclusions survival metastases We are multicenter omburtamab MSK CNS we support setting is the see similar data. from the news believe in pleased and MSK the leptomeningeal data ongoing, still is curves recruitment for good with While to the original preliminary this the very children the are from

omburtamab a previously glioma, planning also study developing for intrinsic are Phase multicenter at for as Phase we and diffused a we DIPG known to As DIPG are in disclosed, patients study year. II open pontine MSK, I this

round small Sloan at we tumors Memorial desmoplastic study opened Phase a II recently For DSRCT, Kettering. as cell known

of profile omburtamab leverage XX the Ommaya the DTPA locations cord. the common tumors to metastasized cerebrospinal of lutetium of unlike that in to known embodies fluid through catheter. for naked patients medulloblastoma Lutetium study, tumors In the positive opening excited the the clinic of from experience, XXX with catheters XXX medulloblastoma, medulloblastoma and In to the turn XXX the lutetium brain and dose IND XXX most during types Medulloblastomas different for that I/II these brain this be Phase October, determine screening subsequently omburtamab treatment most are radioisotope brain spread IND. using FDA-cleared, primary the along of in of our brain clinical construct the metastasis, Iodine hope for Let's clinical to international antibody. way for cancer labeled chelate lutetium radio tolerated surface the experience, lutetium omburtamab treating initiated which delivery DTPA, omburtamab. rapidly to and are quarter, maximum now is growing based the XXX with children. a into one using the the spinal DTPA the with safety on company's we antibody labeled omburtamab make the anticipate potentially trial indwelling see with BX-HX Iodine drug an our again pediatric We also XXX, multi-center to will patients our to lutetium for And its intracerebroventricular the obviously clinical after patients. to omburtamab, this as we invasive establish

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

of the reach include to first adult the omburtamab We the are treated and XXXX, expect XXX thrilled we during to indications. to initiate for quarter lutetium clinical our DTPA with study to patients be fourth adult widen

into Now humanized our antibody study multi-center pediatric MSK and other In relapsed let's PDX relapsed the Phase are to We Nivatrotamab orphan in well our the have II lung in Phase treatment therapy. in for collaboration talk one the and neuroblastoma GDX osteosarcoma, designation about arms known tumors CDX positive bispecific neuroblastoma. bispecific anti rare standard clinical of in patients to as a in neuroblastoma is cell separate Nivatrotamab, osteosarcoma PDX solid FDA ongoing as patients and disease leading September, in development antibody well refractory with with separate high-grade designation drug granted plan I/II study previously where or to small expand Nivatrotamab antibody. as initiating a a cancer. one bispecific II Nivatrotamab refracturing Phase two as of

reach fourth widen submit study excited We the include of cancer Nivatrotamab's the are we lung adult XXXX IND for an quarter expect and to also. clinical to during patients to

pediatric targeted we the that We of majority patients. small commercial and aspect, of if ahead organization neuroblastoma both of the that omburtamab and universe of have are a lean treat believe approved. commercial to the built centers cancer launch the naxitamab highly giving the Turning we

place months. team exciting Assuming are European potentially in begin staffing and U.S. our believe our within the few and and commercial approval well our few in approved to to launch in if few SADA then positioned of behind U.S. we omburtamab, naxitamab next the also weeks on for in application commercial marketing is a to we The ready the of the approval U.S. plan for the only launch of naxitamab, we months technology. omburtamab organization is And European a its

Sloan will and tissues has an Memorial agreement been Massachusetts constructs in entered the other for spared. technology agent Technology was shown toxicity while completely eliminate bone SADA April the license to the a delivery the No on We observed. and for platform. into animals, were with tumors in recall, kidneys and collaboration or antibody to exclusive no also rapid thereby shrink compound, research technology were allow significant clearance or immunogenicity. you As in to vivo of in marrow develop believe the setting to maintaining radioimmunotherapy an The Kettering needed Cancer based worldwide SADA Center SADA target while payload high uptake, less we and of clearing two-step tissues Institute in-vitro liver may causing that

payload the be appears therapeutic to any SADA modular possible. any combined with seems addition, antibody technology In radioactive whereby data modified

We the we to and intend for And we newest prospects for treatments. SADA in development. the to SADA IND first use liquid which our SADA have plan treatment SADA, We cancer. far are today's excited four hopes about XXXX, announced preclinical half submit the second prostate we construct radiation have high of construct This BX-HX targets transforms to includes cancer thus in the of see technology. of

a during increased employees of headcount support we more plans, few the total supporting growth by general recruitment comments, the sales a increase to about XX is recent force compared our quarters. to quarter. and functions, to the Due XXX significant Finally, to our of

and and antibodies. bispecifics antibody invite next-generation With the remarks Concurrently, coming and the of to transform widen by clinic. naxitamab our this, our month, Predominantly, the on BLA second planned constructs we the believe resubmission Y-mAbs turn share Bo of date the to now his into omburtamab me pipeline are positioned commercial Bo? we PDUFA over advancing the omburtamab well SADA state to constructs let the plan coming With the this radiolabeled him quarter through up, and that company. financials. to deepen we a later

Bo Kruse

of of net per quarter September ended of reported the for share or of comparing $XXX XXXX basic quarter XXXX. We basic with XX, or share September million, million. a third cash compared and position $X.XX ended the diluted diluted for XXXX, year-end a $XX.X $XX.X million, We Claus. to per you, and loss $X.XX cash quarter with net million, the XX, ended Thank loss the $XXX position

has we cash and on ramp-up commercial the through continued submission quarter our and the of for accelerate omburtamab, as the launches As burn the naxitamab have potential we've to increase. our work BLA progressed seen omburtamab

the that expenses to roughly quarter expect for quarter. line We in operating increase cash slightly, XXXX in but fourth third burn with the remain from the

This offset increase increase million in itself look commercial from drug naxitamab increased XX, late the of a in $XX.X to consulting ended September for $X.X We've entered $XX.X million increase engagement PRV reflected and $X partially million the monetizing for the The expenses receive per September receive in increased XXXX G&A personnel lead $X.X closer September G&A expect in the the and candidates were ended million If increase our will and $X.X loss $XX.X that was the operating two million September potential fees. thereof the we agreement, was building approval XX, third million. by attributable The expenses for quarter, partially Cash increase launch used terms rare by to also $XX.X by million the that with million is and PRV. an increase of period. development XX, net fees. insurance million the caused a assuming trials million It's the or net from the costs and XXXX. These non-cash a The beginning of proceeds GDX obliged $X.X from Nivatrotamab omburtamab, share stock-based in XX, to FDA quarter that in increase remaining to the of increases if of to the we from net XX% with professional in decrease million quarter the net ended million quarter license $XX.X increase approval we burn XX, we monetize XXXX. ended manufacturing receives in the million will outsourced period received $X.X for a expenses the XXXX. the GDX, noting by million cash of the take naxitamab proceeds expenses and XXXX business disease primarily to for complete a XXXX XX, nine period million XXXX. period and field professional the compensation our omburtamab going an in at XX% are increased offset vaccine. was as million have increased in level any MSK institution research in expenses million expenses loss for PRVs a including our XXXX show worth of either for in the us. $X.X first costs. clinical $X.X As designations quarter personnel and who of for $XX.X primarily the and $XX.X September $X.X depreciation by months ended $XX operating XX, XXXX we for and increase infrastructure-related to leading naxitamab million by activities XXXX to transaction September into $X.X of increase ended September the pediatric for have and for the primarily ended the Under note by September the and MSK FDA, costs, for

point another in coming. our compounds will So these potential have PRVs three of approval

financial take naxitamab does does revenues and hand the fourth our the net but account may take cash of secondary any receive potential last not we've may quarter from PRVs, receive expenditures into on capital partnerships. of upon we the XXXX. that would cover the into year, future account In potential guidance, the proceeds This omburtamab operating terms proceeds of offering omburtamab expenses and said naxitamab either we since or the approval the of monetization any commercialization from potential all through from

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

Thomas Gad

Bo. you, Thank

concludes prepared -- This remarks the Okay. remarks our of today.

for Jerry we this let's you. any call to at Q&A the Thank have think open right over and I we let session go now. questions will time, up

Operator

ahead is Thank Wainwright. question The Please [Operator Instructions] from go you. first sir. H.C. Burns, Robert

Robert Burns

Hi, right if question guys. the congrats taking quarter. from I Thanks for my Three on me and may. now

cited one rate with proceeding the data for the So of activity the FDA evidence reasons first response file by filing. one, they the the refusal i.e. are to I for requesting was mean anti-tumor that to before letter of

we any study see color level seen in that unfortunately, you presented of response data any point. Can we've is to trial? not X FDA SIOP, specific at despite it for Phase secondary response of the Now provide response here? level from a rate minimum did being end looking a omburtamab And the the multicenter

Claus Moller

of that many will FDA has patient responses the be comfortable definitely we're disease, are. able to look seeing disease the all satisfactory level refiling. will be you replying say, on to yes, the how Well let can wants patients that much just have that not disease to about assure what in tumor early now we and still are this. to patients. able responses. be maybe and and agree me But we details little And right seeing but we to and to yet the showing definitely for like that of these of data eventual So we measurable how are a are measurable check presented of to XX% the looks will a I group when are I'm we discussing the we see. feeling having responses start responses present we're that measurable the FDA the level It

Robert Burns

Okay. Thanks.

much how you lutetium Iodine considering -- as is What lutetium see patients? sizes in relatively lower tumors the my medulloblastoma XXX efficacy omburtamab. that XXX XXX look XXX, than particle that omburtamab, reasonable market do the doesn't not maximum believe labeled XXX's as these may beta around energy now So -- is the the similar like you BX-HX that second benefit does it labeled adult mets BX-HX seem a is to the CNS between Iodine compared positive omburtamab label well one as question for

Claus Moller

the about it electrons mean lutetium XX% about an energy is of Iodine. energy off electrons of I in correctly, thrown the the lutetium is off of of that the XX% thrown of are Well has

also the pretty the days maybe days pretty similar. isotopes Iodine. lutetium two for to six they're seven So five Half-life similar for and of the

also Iodine so about to that like the it's elated in a penetration it's should a up versus almost difficult, tissues the the antibody maybe little XXX versus tells about the is for is with on Big be to of a also the label of dose the therefore, but be possible kids medulloblastoma lutetium pediatrics, with the ballpark is construct. you in XX% retro And And that adults damaging the that Size in that Iodine. it per we market, believe benefit lutetium same lutetium penetration XXX. bit in XX%, for I the U.S. DTPA the the -- easier mean, lot very year

size with ballpark positive year of cancers. the dying of tens indication, per the at medulloblastoma BX-HX metastasis that's So we're adult patients but leptomeningeal thousands CNS the of from looking indication,

Robert Burns

the then Clause. I'll me Thanks Last one Okay. that and for queue. back hop for in

the viewing now, regulatory to an in label protocol? as discuss proximity time and how expansion the for well could line the more given for setting path frontline as a for in relapsed/refractory detail approval the currently little neuroblastoma, FDA So, you're into HITS naxitamab you potential

Claus Møller

then a said idea approve Yes. let the and back what saying still have and what I'm B along we meeting to Well, what do is, go for is naxitamab, Type frontline we ask the ongoing But, we a B line they discuss I FDA and think, And for that study. let's the have after have studies approval. meeting front the Type see center so to already. two know, as you have agency gotten then -- with need single all

to about presented is study the already months have set supposed MSK study data Dr. patients. enroll Mora's from XX ago. of enrolled. first And almost the We It's completely XX frontline

so, have we soon should for very also And data that.

studies with be able about in go of we II. FDA, for Because the And like discussion I do have two to need with as frontline a study that then, for chemo ask But Spain data And there. we would -- both study what a get investigator-sponsored irinotecan-temozolomide frontline in and find the the study multicenter to single a FDA, Phase for we potential we them line. label to setting let's are to GM-CSF MSK from at the in as by into the goes when approval also expand out also said, combination, additional again and you we'll we combination bring separate they combination, and know, naxitamab chemo and the have planning needed. So also. And that's Dr. for to them phase clinical design center naxitamab studies a second see. same in what a Mora the is more more

data So rather that's meet to we guidance get are second-guessing side, talk where we their definitely are the now. We they from regulatory need have clear to that. and actually But we need. get what planning than FDA, and to us

Robert Burns

you, Thank hop I’ll back and congrats the in again. queue Awesome. Clause.

Claus Møller

Thanks.

Operator

The is go Morgan David ahead, next question sir. Stanley. Lebowitz, Please from

David Lebowitz

questions. Thank you my taking for

look I at the sales the launch? point? see? revenue like that organization for naxitamab first launched this on could What growth to what initial is side. could smaller soon, clearly your And market type should mean, of, in us you through, is run Given we opportunity an be I very guess, looks I just guess, what potentially we going

Claus Møller

mean, Sure. a most launching sales companies new cautious I on predicting David, product. you on as know, very are when

any have what therapy. so, XXX said that refractory know are now that, approved -- and about right patients secondary year And they a kids there's we neuroblastoma primary or we having don't

So are making will the very let's ones customers. how into many and our digging we start going definitely are approved, the in reach? develops Let's And it product But how we we launch. that to see But get excited. year. will those are the we first

have very expectations. strong We

reference have still, as everything you paragraph from it, both MSK. frontline And strong very collaborations monotherapy and patients second very for using last was and using Kettering I various Sloan with We to in as neuroblastoma they combinations think, with in that, almost the had years. third-line can the Memorial to for using also a naxitamab one I hear are every have second-line committed five collaboration been or and

doing product, a So a even rather clinical if commercial that, becomes than naxitamab development they continue obviously program. would

So sales visiting we organization in people terms all of They the team, XX sales that those are the for in in have actually responsible place. doctors. our are

science have And, team, this We medical are set course, et with liaisons research ready of organization also and and and nurse the and market our All up cetera. the also access and go. go. marketing to ready to up support additional been co-pay, has set whole

and So, for we that is excited to these confident final close development. and naxitamab. any are for continuously And potential a very days I'm everybody extremely new authorization we're marketing monitoring very

David Lebowitz

by, you just, being dynamic Thank that over discuss at the a pharmacies the prescribed between the version? therapy omburtamab and radio the how to could And that. guess, hospitals for of lutetium looking such having I differ franchise, I challenges iodine could and you guess, the

Claus Møller

issue. Well, are the suggesting it's responsible of that, of and of I Right omburtamab the is radio our what now, are we productivity -- a more as BLA planning for iodine. are think, for the part with we a labeling kind

labeling is our So central happening. radio that that means

product XX ready-to-use the We use within potential hours. are a releasing with

for requirement that thing treating to at has radiopharmacy, any the large and the in definitely And so, U.S. that hospitals have the a the to they hospital need oncology. is hospital, radiopharmacy but all that pediatric do, a hospitals the only need and

the the the contains and control lead from then that pull up out dose to receive So radioactive radioisotope, in thing dose, pharmacy and the syringe they box box the in and the check are a and it radiation prescribed the needs the only vial to and and then ready antibody do iodine radiolabeled department XX the to radiolabeled millicurie send a is, that inject. that to everything little a in with the put antibody different lead

the to the it. to they don't we is no anything that's syringe And lutetium, what of There's it's sure is XX simple. up If millicurie order. antibody. check and very do track it's They be the steps. receiving but amount going And need equivalent to the that what So make exactly they're they at look radioisotope same. tricky total

lutetium company, discussed and label saying lutetium of the XX radiopharmacy amount is a X -- vial. then actively the The it will labeled is with typically labeled it out seconds. and millicurie. off. Whereas antibody the when of us, by hour to for the the will takes radio ship it XX the have and that, millicurie that antibody ready-to-use lutetium this is put lutetium, antibody X radiopharmacy. radio will radio just and and solution dose label if millicurie, vial will of the it vial pack contains about is prescription the one-and-a-half XX contain XX, have exactly the will same. as takes antibody We deliver rest and take Y But They in quality microliters patient check a it we dose and it of vial, in a it labeled And responsible they the maybe the prescribed

Iodine the pretty easier of reasons the affinity much the sitting has to what to is side. Iodine binding need a we seem -- lutetium radio-labeling it's know the is sometimes double check is antibody but that necessary binding it's with the omburtamab that the we least known affinity and of today, it affects until still never it's don't at because So the process the binding antibody to tires challenge the side one for giving close the of -- because, because, good disrupting binding

it Now technically. becomes

radio of can And to patients product. therefore, tens for easier shortly, a label a thousands So It's we stable with every us it's year. to it summarize to lutetium. more out lot ship it's scale definitely construct. per couple a easier and But more. can for lutetium send Whereas up probably just to it much Iodine, of the vials out doable thousand a year it's with you bit of

David Lebowitz

Thank for you that. Appreciate it.

Operator

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

Etzer Darout

for question. Great. the taking Thanks

the from with refiling little could on a to what's And the if your maybe BLA. But takeaways FDA first, the positive question. Just on of me. respect second elaborate for a you interaction with meeting of a A sort have that the bit and couple omburtamab I Type

Claus Møller

additional have clear Sure. I the are are put on to number package. response rates still and we patients terms we from. and some need level a response CMC, issues ready we There resubmission mean, of that discussing are in us, clarification the rates want resolved in to on together they still all have that it's And of pretty requested it. they they issues, see that and

together be a putting to next week. are resubmitted package them for briefing We

we able track, have referring we said put as So, everything A that. meeting. are do to that the and to was Type we the confident That I'm very on be will to get together

Your other question was?

Etzer Darout

Yes.

question sort guess, color on bispecific then when with the I cell was preclinically So the CDXX able any be that on the GDX engager, some are other initial bispecific as And we question, And first, programs? may you potential to the differentiation of see obligatory to there. T maybe programs. seeing data. asking other from the the

Claus Møller

details us early too for to give it's on that. think any I

hold year. company update if have data we I are said present in can that that think science we hope we day we this to to see, December trying on a

data company it, the study. first to update for where the So, the but look December, hold breaths hopefully don't from antibody provide we can your in forward sets bispecific

Etzer Darout

you. Thank Great.

Operator

We have go a of Bank America. question Please ahead. from Alec Stranahan,

Alec Stranahan

thanks for question. guys, taking for thanks our the Hi update and

Just two me. from

terms XXX expansion administration intracerebroventricular see compelling naxitamab us help do you frontline along types underway, adult omburtamab this expanded omburtamab are And from you larger some studies neuroblastoma, populations the think see study? need unique how First, these for patients in for I delivery adoption? with for physicians for enough do capping patient limitations just guess you of setting the frame, in populations? could for differences patient method the those into lines, tumor Thanks. made in secondly And these pediatric whether clinical for preference removing individual with or there the alone in of And any you standard and in getting can be in the setting? DTPA this ASCT do

Claus Møller

your get can to about start first omburtamab one. let's Alex, with the Then question DTPA. the back we second

efficacy of the study, setting. seen XX medulloblastoma with are are where already said, a where with And also very using omburtamab rather and I to track neuroblastoma as of And we some a very the achieving great efficacy. than patients, the development as And And efficacy we signals in was from perspective go the to DTPA. we're nice where DTPA to for important therefore, have reported medulloblastoma. we we fast the I and the further lutetium the is medulloblastoma. about already kind wanted was this of indications asking were results, earlier at of you seeing there looking population, treated clear a a where it we a an patients omburtamab pass increase So, XX-XXX the already see in on dosing as indication if perfect possibility

We are evidence and the our group we have form to pediatric to we and true oncology an clinical from with iodinated need have of staying unmet compounds. patients a medical develop commitment

going a quite and pediatric of to sense I tumor it's omburtamab interest limiting Ommaya intraventricular bit of expanding this adult think so. clearly that And in don't into is the U.S. patients. be brain yes number lot the the So DTPA in attracting consortiums that conjugated Will setting the increase catheter participate to development. the also with a made factor? of a from the construct, catheter,

run And can and portacath CNS in any a my placing skilled and surgeon think both put the kind perfectly in it's catheters. in U.S. I Europe catheter. a these just an Ommaya opinion And is any can in neurosurgeon like neuro a portacath. of in surge put

a So, placed the vessel under there because the I vial don't foresee never And is skin. any issues issue. almost limiting that being

So, have the risks don't outside. infection you from

had forward was pretty way Then omburtamab also? question. a these constructs. the question possible as safe it's naxitamab So for That clear and you seems, a it about

Alec Stranahan

Right. in Yes, the line this and view. first clinical is adoption ASCT a decision for your whether

Claus Møller

I'm I the question. first-line, not The understand sure

Alec Stranahan

Right.

compelling would So standard removing I first-line setting? neuroblastoma, be need guess for the how ASCT

Claus Møller

of same effect it from of the versus on what show mean to hospitalization morphine use significant in no two use a significant survival show in -- benefit even morphine a take similar would less have can term and know, what number total with time, with clinical call there's I entry goes X.XXx, patients is the naxitamab, And that day in reduction average it's in we that that, which have down of my dinutuximab. if the goes at less compared than we which pain naxitamab when side of that amount goes days morphine five consider treatment you side show hospitalization I per with than of we down naxitamab see for I neuroblastoma frontline X dinutuximab, is that although hospitalization significantly cycle the with IL from days effects think, see side use the on and there's combination that shown profile, we XX have one difference to from the the we pretty have three naxitamab is clear I think lower. frontline X, if we days of this treated profile. the of to and see the with when will patients frontline year the that can if if and we with is dinutuximab effects course And side we treating and to effect also long well-established can indication days have hypertension they giving XX in you we

XX% to event about And event-free Dr. two-year to survival. time dinutuximab, survival of and free XX% significant reduction pretty XX% So compelling? I that said As of is event-free events would morphine XX%. think so Mora's to the the what PDX have far it two-year serious without survival only of and same well-established level seen event-free data same at two-year two-year XX%. survival take for and is with use adverse -- in be we antibody And I hospitalization

his patients. So very first -- was and compelling. that that on And was XX

Alec Stranahan

Thanks.

Claus Møller

you. Thank

Operator

Please We Rama, JPMorgan. have question go from a Anupam ahead sir.

Anupam Rama

Hi, guys. so the and taking congrats progress. the Thanks much question, for on

quick the Just vaccine. GDX-GDX on clarification question a

in supposed the right? gating first in next year, quarter I the missed if in the the much. what Thanks But II this are study? comments is trial neuroblastoma start to this of Phase so but opening Sorry, factors starting to

Claus Møller

Yeah.

combination the the are about we're discussing of need no major We been are beta and using that and there eventual first gating the they ligand beta have also the at the the besides MSK both And looking for that. with -- organization discussing with factors. I CR. where with a that ligand we but patient And patient sourcing looking all also study is at gating vaccine significant besides see other study we're an second to randomize placebo. a clearly There's study vaccine need from the you to in with But a between any and organizations start things in factors. interest frontline that don't of do, participating still the

Anupam Rama

so Thanks for much Great. taking question. our

Operator

is Lawson, go Next ahead Please from question Peter Barclays. sir.

Peter Lawson

European. I my more become like the I pronunciation of name,

just on it's Lawson, -- apologize missed this. Barclays. well. So And as have I may I Peter

So be be that is what data going R&D like to GDX-CDX Day? patient the bispecific, initial could for potential And would we point? to that responses the your see that

Claus Møller

don't I yet, have treat that it's the can of update seen have December. our -- data we plan how much any in scientific I've our and for available but update out track to database it

Peter Lawson

see FDA point? that data for Okay. we requested criteria And then random omburtamab that well the at would some just on the as

Claus Møller

it it plan disclose definitely before. if update at I present data also we if to we cannot scientific see can

Peter Lawson

your conference be that would Day? R&D a scientific not at And

Claus Møller

No.

interest because have will what think such for I big to try I we know we a there's that -- available.

So at of wait. would be communicate and it to But would can if I I try said don't we think preliminary to see we evaluations that. -- least as probably it's fair

I the try at see So would we we update have if if present said haven't to scientific what available definitely we there. can anything before,

Peter Lawson

Thanks. we about launches And the should and the just then vouchers? of potential cash with how runway think series you. Got of monetization

Claus Møller

question. that answer Bo let I'll

Bo Kruse

Yeah.

your just other making frankly on So was hear financing question. didn't some I Peter, notes I the runway.

Peter Lawson

the how the of the launches should and about just cash On we potential the with runway, then runway? think vouchers, the monetization

Mahiuddin Ahmed

launches funding. happen themselves So course, require some if of would, basically the they

of spite only the cash two current in XXXX including the However the end for -- from we position naxitamab PRVs net good and our omburtamab. through proceeds and on are that, of of monetization

end good we So any potential from excluding partnerships. it's say income when the we're through the that product revenues of and XXXX,

Peter Lawson

Thanks much. so questions. the for taking Thanks

Operator

H.C. We a Please go from sir. Robert Burns, ahead have question Wainwright. follow-up

Robert Burns

for Hi, guys. One me. question more

omburtamab with in So given dosimetry after? allowing envision labeled that replace to which labeled also is the potentially you with omburtamab that have could the with the in that lutetium you do advantages lutetium the the would manner scintigraphy indications omburtamab in asset manufacturing going addition of and XXX potentially a you developing advantage for XXX subsequent guys

Claus Møller

Well, it's I a fair mean, question.

in in leptomeningeal II than more starting and patients year-end or study already to are this study have the Phase the we metastases I we end, study the from start DIPG think where in it's uphill a doing neuroblastoma even a the before on DIPG multicenter new XX year.

you will studies just that. will omburtamab as So well the I have DTPA lutetium foresee foresee now adults that know keep we the I as indications with we're for do DTPA. not for I/II the and we primarily first starting I Phase because do, omburtamab

have are to comes hopefully mean, new world the setters seven now, market market. are we market. looking at omburtamab really the drugs the could we that if in next from So I could record And come we year. developing years to something potentially product six, in the

omburtamab you're doing if And we're planning years. anything the what not know, seven for for know the getting approval iodinated the you me six now. what version from years to to now with in next do know six I because first that doing substitute I'm years seven seven from foresee to So let I indications to six with don't

Robert Burns

again. fair completely the for question That's taking Thanks congrats and Claus.

Claus Møller

Okay. Thanks again.

Operator

like questions There back for are time. conference I'd closing no further over the to at to management this remarks. turn

Thomas Gad

That the call. dialing look And you Y-mAbs great thank have everyone and and Well, you. Thank a for concludes to in weekend. continuing participating. forward

Operator

This concludes today's teleconference.

for and lines thank You time, may disconnect participation. you your your at this

Y-mAbs Therapeutics (YMAB) 8 Nov 202020 Q3 Earnings call transcript