YMAB - Earnings call 3 2023 | Y-mAbs Therapeutics, Inc.

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Operator

Good morning, and welcome to Y-mAbs Therapeutics Third Quarter 2023 Earnings Conference Call. Please note that today's event is being recorded. At this time, all participants are in a listen-only mode. Instructions for the question-and-answer session will follow the prepared remarks. I would now like to turn the conference call over to Courtney Dugan, Vice President, Investor Relations. ahead. go Please

Courtney Dugan

press and website. quarter operator, press everyone. to Relations close. Welcome with available slides Thank the on Earnings good Conference third Investor The market at XXXX results of a and Call. our accompanying our are our you, section yesterday morning, release We release issued

development Vice include, Private the that potential forward-looking early statements expectations territory statements timing as statements submissions, Let cash strategic me the anticipated are and that potential may that benefits programs; advanced of these guarantees regulatory thereof; XXXX. those including considered by with results including and those call the statements you but Reform to of there and east, XX, they to are September initiation XXXX, quarterly of future to Board as other the uncertainties, following Founder, regarding estimates discussion with of by our potential discussed variety programs, coorefficiency Business revenues, statements SEC cash Chairman clinical collaboration a for product of development would differ marketing future performance, to not beyond current respect implied completion related our to, expressed are our Form XX-Q the the Subsidies and materially the plans, and other requirements filed now or and involve our future risk over XXXX. limited and quickly performance, company's factors approvals, remind turn statements ended for XX, Gad. from expenses of Because financial to contains regulatory and Litigation forward-looking the Act to really assumptions capital Directors quarter expectations of Chief and Thomas of related certain I development, and our guidance expectations with data, on and the XXXX the development historical respect like statements statements due DANYELZA model expectations not November business of our resources not from defined reimbursement our report distribution and actual and including forward-looking risks and partnerships commercialization Such on and in preclinical and and expenditure trial factors, research expansion about or Officer, and facts. and studies for to are

Thomas Gad

third begin reviewing quarter updates our Chief Mike in On highlights Executive our updates call, clinical our Chief Daniels SADA today's Rossi. will have newly Kruse, will by the sales. Sue Officer, Commercial Chief global DANYELZA Good I'm Smith; and And you today me morning, our Officer, appointed to excited you, Lisby. and with today. President sales welcome Thank our into report and U.S. everybody, Financial further our on thank Bo high-level Steen around then insights Officer, Dr. I and program. Courtney. necitumab third joining very on quarter. ongoing Chief Scientific our for Michael us trials also Sue Officer,

performance, of I the which for on U.S. our SADA CDXX clearance for Then by we guidance thing and full recently overview provide on XXXX IND updates DDII resources third our our the details will open our further to quarter currently our cash Phase Bo Q&A. before Next addition we year in program, an lines trial provide we'll received underway SADA FDA. financial

Michael welcome of X. officially Y-mAbs President behalf the quarter CEO, results, we to November a third of team, Rossi, I and the new to and Before our Directors extend leadership Board warm get started senior on want who into our on very

Mike Advanced and President as industry. experience, the of very Accelerated spent a the company in and joins led our for Healthcare, has in XX radiopharmaceutical dedicated radiopharmaceutical the careful the Jubilant and and career, over Group. the experience a a GE that, better at Head Earlier vertical in Novartis with a also of he where of brings Prior Board in the right over of radiopharmaceutical And Radioligand served have leader was found he's certified AAA growth pleased that, nuclear years into He are pharmacists. Medical decade conducted to deep as radiopharm we from Imaging Michael known Mike. us to that leader. search he before his of company. Applications Technologies, Mike integrated Our commercial Merian

of as first efforts team potential I'm paradigm. positioned proof ahead, to Board with value of to advance of new initiatives its is SADA about our sufficient of and Vice rated call further Chairman very treatment a excited are continue unlock incredibly mission in over of the quarter this in the I excited the companies cancer to our novel better the that, also to Business SADA our resources continued role the utility much reach and biotech our financial the and Mike. bring we radioimmunotherapy of commercial independent pretargeted to year, the Mike to right very we reorg Officer, a with This Mike. entire with few and maximize transition one therapeutics turn cancer time concept. look pharmaceuticals forward known through our the expansion to to DANYELZA for platform, and of to Y-mAbs me and to X-step on closely novel Chief geographic to stage expand And patients. working As After indication Y-mAbs been the as has this therapy, Go

Michael Rossi

our great be YmAbs all Thank joining to introduction. for third you, you Thomas, for today that earnings quarter call. It's

focus radioimmunotherapy a a SADA in care radiopharmaceuticals. enable I pretargeted is truly has out Y-mAbs. in highly SADA As platform is that stands joining SADA precise about driver Thomas designed X-step of delivery. XX-plus as key Y-mAbs pretargeted the the potential differentiated, of personal my own platform, specific paradigm which treatment the built radioisotope mentioned, is on a radiotherapy. believe I've to shift career health with pioneer with a technology year a excitement to that

In addition, stream radiopharma we our DANYELZA have franchise, revenue our development support growing with of product SADA to where to we with independently work promising a development expanding With clinical DANYELZA several a trial market. pipeline SADA in have commercial initiate the believe rapidly underway CDXX next targets in GDX-SADA anticipated currently I additional clinical have year our ahead. Phase our a to Phase I highly preclinical and promising we and expect trial we exciting

highlights quarter, into dive let's the for the Now key with starting DANYELZA.

disease net relapsed in achieved FDA most prior this the in and treatment marrow in $XX response of a of by high-risk million in of third have approved or neuroblastoma year, XX% therapies. for with demonstrated the partial or U.S. third quarter is sales cancer common refractory the is recorded DANYELZA reminder, or a DANYELZA, As bone most the common the bone infants Neuroblastoma minor third patients the we response, stable up from we XXXX. in of the cancer In product quarter children. the what

accounts. are in launch XXXX. U.S. U.S. commercialization in with significant DANYELZA, a of We XX X continue DANYELZA's the new efforts new now we and across and We make activated momentum the have sites gaining so for far with our in progress number to accounts

in recently regulatory received expand marking through regulatory partnerships with approval footprint DANYELZA America our to and Latin Adium. approval global our continue Mexico, our We of commercial partner, second in

our In year. as June in quarter, DANYELZA this addition, launched or last successfully discussed of partner [indiscerninble] China in

has in the aisles used, terms the quarter. the in of approximately the been launch during vials commercial the first in in of China number usage used In U.S. quarter of since XX% full the China,

in over and the coming as the still providing it's update a sales see we region DANYELZA, to we months. region early, seeing look We the the While an forward to in key for coming look quarters. forward progress and trends China

footprint $XX and meet relapsed/refractory guidance months for by We revenue XXXX patients our very first market in we to with global full continue of WEP of than broad Sue program expand million. in in color further the the net across neuroblastoma. step important geographic shortly. DANYELZA regions on commercial our and treated with global sales We these DANYELZA accumulating of further expansion XXXX of remain pleased physicians net $XX to product continue in Europe in encouraged as access be million remain XX patients the expansion traction mission prescribing quarter year more an global confident for between end the continue DANYELZA million with provide $XX with to DANYELZA, our gain DANYELZA's The DANYELZA. X DANYELZA our sales continued We through will of to the is QX. with ability of high-risk enable to

our on clinical comment briefly Now let me naxitamab trials. ongoing

which to the single-arm naxinimab We is and from with a efficiently high-risk clinical Childhood with expected trial diagnosed initiated for randomized or induction continue current partnering therapy, The high-risk the standard for neuroblastoma. plus chemotherapy treatment control To we combination BCC trials Cancer the standard with on inhibitor of expansion make neuroblastoma dosed. progress naxitamab a an added frontline ALK been in II evaluating X are X IND. be Phase study we in have KOLs arm to with Consortium date, BEAT for care file transition induction study the advance plan label investigator-sponsored induction potential have is for for opportunities current will collaboration to setting, our where patients which DANYELZA. and Research been to In an newly standard therapy multicenter to minus study sites leading patients to with or

recruitment projected total patient size anticipated years of is an the the reminder, a approximately a X patients. sample of XXX As with span for trial trial over

naxitamab of to demonstrate standard arm superiority the trial a for aim Our in versus care. is

Sloan Center, I/II anticipate next improvement M&A for We the begin III a MSK in second osteosarcoma, work to multicenter And Phase trial data its a if investigator-sponsored Phase then Cancer quarter to to hope trial new this study the on readout pivotal of we quarter XXXX. fourth in expect of we're with We provide randomized an In positive, for year. Kettering trial. naxitamab. randomized Memorial from initiate to continuing potentially or

In had XX% during same versus further response treatment. study and versus trial, results of HIS naxitamab the superior pleased addition, neuroblastoma patients treatment naxitamab-based chemoimmunotherapy who this survival early the induction supported XX% XX% of course journal we chemo-resistant received the estimated In XX% combination overall compared the chemo-resistant patients neuroblastoma. in publication high-risk who of rates, are the in with with course cancers. in regimen after of the utilization those high-risk later the trial X-year These of higher a received for immediately with patients with HIS

for cancers value to treatment in adult believe gaps much We truly patients are and both naxitamab potential continuing to worldwide. needed its work a to of pediatric in unlock further fill and

moving SADA. Now on to

technology SADA numerous had to novel driver win a Our key roles, this development privilege personal of extensive From my excitement breakthrough in various own joining radiopharma career about Y-mAbs. of I've platform is my platforms. technological leadership the

in later However, wide where BIMAS potentially will our SADA SADA overview differentiated, in the potential with fight radiotherapy impactful the XXXX a of pretargeted X-step to cancers. Massachusetts by We platforms on of stands shift delivery. today's has variety specific we that high-level Steve provide of our but treatment call, which further precise is be out from MSK pipeline. as in and let a provide me are a paradigm color truly enable platform against radioisotope currently SADA the highly to that is Technology and designed licensed Institute believe the

with December. Our dosing progress elected proof Despite day share first seeing, date, R&D or and meeting sample of on I we've doses have so this to have early development are size a the focus date, cohorts next far, Due currently our to Phase we we're event this readout data of year PK platform more major have lieu we for progress seen in program, SADA earlier a administering limited and an to to and at To call. we the completed during to X. X, X mature medical the patient pleased Phase concept GDX-SADA year. in we began decided positive very cohorts I

CDXX received this our CDXX multicenter advances. trial from development FDA deep SADA exploring partnership the We're clearance single-arm recently drug open-label, opportunities clinical enter Phase dose anticipate program The targeted I about IND U.S. potential Our team's as evaluating We escalation, to given development. particularly anticipated program experience. second to program and excited refractory SADA program, T-cell the our patients advances. forward to a relapsed as safety CDXX updates next We unmet remains of believe of in and patients and look with year. both further providing lymphoma tolerability significant is or origin, need the there non-Hodgkin's we for medical these B-cell begin

and on multiple are targets made we HERX addition, advance progress, BX-HX In continuing encouraging constructs. SADA and our especially have to preclinical

bring clinical through we're delivering thrilled into over in Smith, am to this year, who our rest need in to of to value management cash during which our development our quarter sales Sue ahead propel XXXX. working we use additional financial a extend lead was effective and the well look let novel which in currently with and to in our are this sales this now further discuss will equivalents patients as strategy SADA the positioned and reorganization DANYELZA We earlier in of $X.X forward a of further we planned them, will detail. at of to Of action of only at right With I with believe beyond, support of we As who with X technology We team. the we believe call to third time, here turn the the now position XXXX quarter Sue? business me growth, believe DANYELZA capital million to end the third time be note, shareholders. cash runway as U.S. and serves our the drive cash following that, forward while same direct result therapeutics year. our strategy operations to entire great have cancer exciting place to programs. foundation long-term to XXXX, million Y-mAbs this our $XX.X believe cash look as

Sue Smith

quarter-over-quarter morning, XX% year. increased unevenness year-over-year the commercial commercial We third last particularly everyone. the Thank pleased the surprising indications, to you, disease to good quarter -- DANYELZA indication considering DANYELZA. rare Despite not is DANYELZA compared of I'm a be this and the Mike, to with of share the from ultra-rare progress U.S. the sales of in standpoint, in

sales to initial growth upward We in of launch trend an see XXXX. continue since back the

growth at And is XX% versus percent have for launch, where was we continued launch since XX% Our well growth. performing Unituxin above post X-year believe we room growth.

the in recorded mentioned, As million Mike sales DANYELZA of X XXXX. we first months $XX in

million year our and in to expect million XXXX of full We guidance $XX meet DANYELZA sales $XX between sales.

we the stats patient stats brings key me since Let XXX. sales close DANYELZA's total third of of quarter in had XX in a highlights total review the third from of launch U.S. This of the the patient quarter. to new XXXX, At new year-to-date.

of getting using third with this We DANYELZA accounts grow the we in DANYELZA more during physicians continue XX of patients started to HCPs demand vial patients first with total outside X of year. them used XX including providers the all this XX more are now doctors X care X X or the the the have have year, XX X X launch, accounts year. comfortable seen and MSK DANYELZA health Since of U.S., DANYELZA non-MSK of sold, of first in or months prescribed prescribed With having months XX representing in have XX, treatment XX% patients first or on XXXX. We of as U.S. more having DANYELZA of quarter. in September X a believe more the this treat starting months around

of launched sales through X,XXX team this HCP the in commercial months since first over customer DANYELZA interactions X positive X,XXX interactions feedback U.S. on has in over increasingly Our and received are year XXXX.

has a highly XX anti-GDX months total important We pediatric year, X area a added leader institutional formularies. YmAbs launch DANYELZA, formularies the in U.S. of rare hospital disease bringing incidence is market see cancer of to this the in of also -- since hospital market, in remains a a with rate. X to the to flat continue first which adoption which been

which on efforts this Looking high-risk in and beyond, interim more who DANYELZA ahead also prespecified are is versus with characteristics induction an DANYELZA's neuroblastoma data patients patients our relapsed, have we of in elaborates rolling therapy response regarding response repositions market patients their our a to and of for in the are data, year patients Utilizing marrow. in detailed team process for analysis campaign the our and The differentiating DANYELZA's campaign. performance induction fourth quarter data consistent of who bone was new share relapsed intensifying campaign refractory us label, the commercial incomplete groups. to providing to with therapy the incomplete X our and treatment our experienced to enables which are out bone patient separately, and brand-new different

hard therapy. year. been the new rollout campaign addition, we year-over-year In of DANYELZA's see of in addition growth. They to from new children preparation the work achieving to next proud campaign it sales begin this am in as very after demonstrates traction meaningful the have believe starting will at anti-GDX in prior response team. and I We

discuss to our SADA platform detail. Let me call the now pass the of will in Steen, who further latest progress

Steen Lisby

and Thank SADA. with good our I'm morning, an you programs, with provide SADA pleased you, GDX on Sue, update the beginning to everyone.

administration A [indiscernible]. Phase GDX-SADA modified we signs evaluates explores B X escalation safety by efficacy cell cohort dosing. data days on in of X dosing dose and and in will safety dose the tumors, and year. sarcomas March the X initial this multicenter This followed I the trial intervals the it's small X-week dose and of toxicity malignant limit of the data A, SADA cancer, including each to testing the lutetium of is lutetium has Phase still dose finding C cohort, using trial X in lung the be payload. optimal repeat tolerability molecule X, And or single-arm and Part emphasize Dose solid a the Currently, and parts. got will patients very based melanoma, Our of self important away evaluated dose observed between in study escalation that so-called Part the and progressing after of is DLT period. well. I determine GDX-positive period treatment Part the in X patients Part safety of are to and a in protein

have And active during to present, X of expected in be year. quarter this activated sites We patients at with fourth we quarter. presite dosed X further the the third have

therapeutic first cohort of dose investigate patients the advanced still emphasize dosing I now data. patients which through more lutetium X determine XXX-[indiscernible] receiving the that cohorts in have now and of profile of to this We to the drug. like X. safety would part We to are protein the is are often we the in to essential the lutetium trial, A the and administer timing have

serious are of SADA tires visualized not as that success concept are are molecules and binds the and experienced to We so ready find scans not to we of severe to note early with indicative that note, any announce of data demonstrated have event experienced program. Furthermore, full by necessarily dose adverse that seeing pain that signals adverse spec events. important serious No proof are And the patients demonstrating have SADA no detected. tumors ultimate SADA severe with what target to or dose-limiting or patients can on also we city results we far. toxicities of of start can we believe or pleased and any Today, date. the the development no approaching for nuclide these the have GDX-SADA can related It's count. complete

the a X each those here being dosed groups, are opinion in The the patient blue, as the patients supported are X protein in expected. represents an milligram As total. X next data patients purple exposure The exposure patient milligram and patients in represented used dosed with in in so slide, of the -- seen of comparable but X.X X X here on so as intervals treatment of the with to a that includes we per X days and look protein kilogram per far. in

spec conducted first was This demonstrating scan, tumor scan dose are the slide, CT an only. sharing a of On XX the one imaging uptake next time, in after millikilli for we, patient.

of potential so And pediatric clinical observed look We're very sharing from encouraged development we expansion also GDX-SADA anticipated on and clinical GDX how far. pleased start-up at next updates the data this, further forward based medical of a by to are investigated We choice. is year meeting into to next the progression year.

in our heart are In as addition, excited T-cell we B trier lymphoma, also I and program the our expect by lymphomas FDA for focusing year. next in CDXX IND and to on patient Phase mentioned this Mike earlier, of SADA failure dose the both clearance first

Now the to both call quarter. of have targeted treatment believe for now landscape SADA, with the of SADA platform hematological SADA clinical novel financials phase begin platform [indiscernible].I in choice who We potential of Kruse, tools. sides do in we development and will the technology algin our of the the reached approved, radiopharmaceuticals addition delivery the review future, in over CDXX will the potentially variety platform the hand to our if third for across the Bo the the

Bo Kruse

ended incremental U.S. good for in revenues. benefit XX% and driven the revenues net million X Steen, new of international the an represented an X XX, by September and ended September $XX of increase everyone. you, patients of months $XX.X for expanding million $XX.X reported XXXX. months was from primarily increase Thank The the from morning, XX, an increase DANYELZA product XXXX, million

we XX% compared some quarter represented marginal orders Our after compared to international unevenness the and inventory $XX saw from series DANYELZA third decline third revenues quarter 'XX the in net in a product our of quarters. of in reported a recent 'XX of revenues million of the as of partners international XXXX quarter second increase a as to stocking

sublicensing our authorization September. X marketing license the with and X Mexico in the million accordance achievement ended the recorded September months of for DANYELZA XXXX, XX, of following $X.X in Adium agreement revenue we with During in

expenses. operating to moving Now

in net connection primarily programs spending to decreased to million X by million due with million and the $XX.X decrease a decrease XXXX, XXXX million respectively, $X.X was XX, in $XX.X restructuring to $XX.X was deprioritized and $XX.X the X $XX.X XX, million months to 'XX. SG&A million in The in decrease plan $XX by decrease plan. XXXX, attributable on ended in former September Our the personnel-related respectively, CEO clinical the the in periods was and and our in to charge and in X ended for X compared September XXXX, decrease ended in connection outsourcing, was anticipation ended same X which the launch. R&D for months for to in XXXX, cost SG&A million a The XX, expenses extent, decreased in and by savings million periods XX, of January increase in to to X to technology. our incurred our the in for a clinical departure Selling, September research omburtamab and manufacturing, $X.X commercialization decrease resulted and general XXXX, QX months The million administrative expenses The announced outsourced XXXX, milestones million months same million compared decreased primarily outsourced of September XXXX. a primarily $X.X our the lesser related restructuring potential $X.X driven by expenses and time-based trials a costs. related in accrued supplies, and with partially $XX.X SADA offset

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

ended was due XXXX of the increased quarter reported million The for loss by in compensation XXXX. the net our ended stock-based ended September basic diluted quarter XXXX to the and the of for plan. X of XX, revenues the decreased third compared in a per costs, coupled compared of loss We operating and $XX.X XXXX. However, months or impact and share expenses September a of million DANYELZA the XX, XX, $X.XX share personnel-related period third quarter inclusive to restructuring decreased in in and or per to the improvement net diluted X $X.X driven XXXX the loss of the corresponding September growth net $X.XX with primarily the basic actually

higher ended $X.XX driven XXXX. of share million The revenues, ended diluted XXXX. related million was a expenses, basic per September and a lower loss $XX.X the months the former and months SG&A $XX.X lower September primarily the reported of decrease departure XXXX, loss the or $XX.X X of for of we diluted charge X per share XX, net for XX, CEO $X.XX net loss by product for net R&D compared the and in to inclusive Additionally, decrease or expenses million basic in the to QX

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

Importantly, cash XXXX quarter XX% during to use about $X.X million $X.X million or we to quarterly reduced third our from of the second compared the quarter.

that capital $XXX our our reduction full We commercial will XXXX for adjustments, pipeline $XX as support total we impact together continue cash range and expansion $XX projected year XXXX million DANYELZA, a range reduce we along to leads our and full consequential for to cash to year cash in to $XX expected which position demonstrate with operating million working planned to management, with burn million our responsible million, of cash programs we're market June cash million believe a to expenses the $XXX expected from from sufficiently to $XXX the $XX on million. and in is million equivalents believe currently now operations The XXXX. runway to

$XX DANYELZA in of expect We to to the full million. net range $XX be continue product revenues to million year XXXX

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

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

have estimate, activities, advanced the new further delivery turn and program assumed assumed at We purposes at our be our remains assumed and of margins. embertimab development any the prioritized not this concludes call we I'll we to expense own to of believe debt has programs for development This that the back or analysis. of and our will no been purpose well update, support mission, programs No execute have terms the In for now and the positioned financial our of borrowings. assumed Y-mAbs this the strategic point multiple offerings priorities equity to Mike. of

Michael Rossi

for overview you Thank that Bo.

the questions. let's do for any Operator, Now you have line questions. open

Operator

[Operator Instructions].

Stranahan Alec from comes question Bank first of America. Our from

Alec Stranahan

Just a us. from couple

the lever changes the for that could would drive DANYELZA. outlined? say role, And XX% First, commercialization that you year-over-year think the you some And in I settling any what follow-up. is you're does single a probably got Bo outlined Mike, I for still help Sue the that growth And into then I've pull strategy know, but DANYELZA? growth to biggest to compare how --

Michael Rossi

you is for to still question. your a discuss plan our have We thank that expansion will that. Sue? robust to for of Sue. best in DANYELZA I Alec, Well, pass the position

Sue Smith

to to XX% the data refractory to label but has efficacy, our levers patients and current data still Thanks, Alex, we're By who in your induction. for a that together. we label, our with that our -- There to able response is Mike. demonstrate response who parse a question. of able Thanks, actually consistent important can couple a are the really the are out blended relapsed with patient parses are incomplete frontline in partial our campaign. out in rate. ability It efficacy our pull in have to frontline this response This induction

the move to treatment. earlier us journey after the enabled that to really induction conversation that patient in just So

are growth actually an third-line lever. that half after of So the sales anticipate treatment about in setting relapse. Currently, we as important our

anti-GDX we we prior shows benefit this is new significant because also that And a movement and after excited failing data So have therapy. opportunity. our are

of the think have those of a get a able you anti-GDX Unituxin after therapy when go patients response. and still XX% users some prior area response to and we XX% rate important were -- complete Another

that those out to really been important team is are very as So pieces well very rolling of we have resonating X be campaign. customers, to data the excited new and that talk

Alec Stranahan

Great. Okay.

Just one follow-up on CDXX SADA.

dosing one about design any the the pushing there As have you've the clinical thinking study? been molecule GDX-SADA learned lessons been from into this or or clinic, of

Michael Rossi

over it I'm on what to move forward can Steen, next the we've learned who that. appreciate I we pass year. Alec, from as GDX Yes, Steen. to question discuss going

Steen Lisby

also we has as what been program learned SADA in quite -- and alluded I safe until so is and to SADA particular. it it's that a earlier, now, far, think I protein

we events the the serious to that program when grid adverse adverse is see X-plus protein. dose the the that of protein, And have next related seen discuss molecules. starting event we related and to no So bring no I think into we we something

accepted tox program, We a our and and with of CDXX package have bring to TFA happy have the program, now have that course, to we experience OND. to nonclinical were an we that over also use,

little are trial. we such, a part more into So I to administering first we of that now more confident quick think before. we hope were the bit as And escalation protein the use SADA than in dose

Operator

Our from question from Guggenheim. next Zhou comes Charles

Charles Zhou

as if I more Mike, thinking things congratulations day, data see substantial on platform. your the or in tumor also medical for the GDX-SADA, to regarding how you the present? images could to as new that quantity given what we, year-end intent role. meeting put planar organ of Can that very And like you Or opposed On are to the encouraged example, readout, dosimetry as heard in XXXX over a SADA data potentially about your data? additional out that? now whole correctly, excitement R&D note, types body the well

Michael Rossi

what for pass year. medical meeting to able Steen off to going discuss questions. I'm you thank be will at this a your coming to expect this Charles, potentially Steen? we information be available what to to present and

Steen Lisby

Thank you.

escalation So the dose in for still XXXX, human of the early we are study. the part

this So already, we now definitely, But have as and X patients, enrollment. continue prior. we safety dosed study discussed as a discussed is

data, also data we able which imaging, distribution picture PK tumor both first the initial as share So be we bio will today. shared you to we

So this kind of to information next the be be ready year. shared will during

Charles Zhou

squeeze on I could don't if follow-up And if Yes. mind. you that, one in

that the of color on uptake XXX-mile the -- your So so data be the I the tumor noticed also the appears data just protein looking in initial at administration? any provide maybe you've more can to presented upon bit a that on little PK into injected how you But just granular, some concentration. GDX-SADA, far a but something radioisotope

Michael Rossi

Steen. Charles, you, Thank

Steen Lisby

is days. early This

dosimetry forward. the dose XX-[indiscernible] after uptake now going the have and discussed, Most biodistribution dose, more the therapeutic of I [indiscernible]. patients on we're receiving collected XXX the also As data tumor include is the to scans we but planning

fine. So for it now, looks

scalability We are of still the looking for the program.

only. We multigram X escalated from have dose

of we So the are dose escalation still protein. continuing

think wait So we to and disclose data need I before we more robust protein discuss targeting.

Charles Zhou

Definitely next year. look forward to readout that

Michael Rossi

good. Very

operator? question, Next

Operator

from Ingenuity. Bill next Our from question Canaccord comes Morgan

William Morgan

Mike. Welcome,

a written SADA for be XX any GDX from that and sort set through potentially GDX seamless is of data? to time Or X all to cutoff any there may you And up a platform, the to a out CDXX that to that currently from have right there the prevent trying Are accounts CDXX challenges on read is So read-through who unique DANYELZA, forward targeting. questions to inactive? me. targeting looking question then might targeting DANYELZA? versus to that When read the the cite

Michael Rossi

that, ask I Bill, up for the that take are Sue I'll the DANYELZA. appreciate thank Well, of I'll and question. first the you. part accounts address to set

Sue Smith

question. the for Bill, Thanks,

set So those XX XXX to have in ever use perspective, United any accounts the are give only to States, therapy. And some our you anti-GDX product. accounts used up

also on before, seeing X also over are to So of in we using accounts way we're X/X those with we're the Tier We're patients. penetration accounts. as in or XX who X accounts an repeat DANYELZA. of mentioned And deeper and seeing our accounts the use those well increase more

headway from making good a we're and depth standpoint. breadth So a

Michael Rossi

knowledge I'm to actually goes very which able CDXX to far Bill, receptor. CDXX deep that has as pass makes as domain question us the versus very it going moving second And to target in GDX but a that team forward on interesting Steen, being and our the your understanding for CDXX,

Steen? So

Steen Lisby

on hematological differences there the we order Yes, development that that sales. some bone procedure, part are need the too penta can have use course, entering have marrow protocol cost going involvement is are space. on you. of Thank activity in put make limits to ready much to don't have how we which involvement, much CDXX, some between X-step marrow that the And sure bone directly we a for us the to we not also with of

in are difference of and also else, quite some those lymphoma those most there of exclusion the like the involved solid areas criterias. now patients the slight have as seen development comparable to course, we've compared tumors But protocol lymphos inclusion So we in which reaching is GDX. in

Michael Rossi

next good. Operator, Thank Very questions. your for question. you

Operator

Our Capital next Etzer question from from Markets. comes BMO Darout

Etzer Darout

And Mike, role on CEO. as congrats the here

one of sort XX-Q you me sort go B ultimately optimal the the of think for to you the for going would of into expansion. of in X of Just some to back A moving comments sort the technology days where of -- be interval around an question as Part quick the of X kind dosing dosing sort the to of Part through schedule for potentially GDX forward

Michael Rossi

Etzar, will Steen that work as thank you over joining targeting. on he's pass for your to question, the I and the

Steen Lisby

Mike. you, Thank

concentration. you So you see say. to to I on the in early shift a the was went shared slight think call, up protein What curves this earlier I right there it's you when too could this, with on the

is we the safety likely of X this how precaution. days dose be protein. the a the So longer dose interval high can on will than depending And

we between the spot see in to the absorption will to be we And the free relationship have the this will tesemetry, until tumor dictate uptake XX-milligram tumor, we and also will the best behaves. the drug dose and PK how cohorts blood where see biodistribution, so tumor found. into blood together So with wait sweet the

were can So actually of year likely early than say a the trial, but days. for X good we be now, in least, they longer that the we part would in at

Operator

from as Stanley. Morgan Mike from Our next question comes Ulz

Michael Ulz

on Maybe program. just the follow-up a SADA

some such be program. HERX more from of will of in And the program? advancing curious the some insured potentially process you deciding waiting of data advancing thinking see to before advance programs of programs? You're as about the to CDXX GDX just those But those earlier

Michael Rossi

Mike, I appreciate question. the

some the this, looking and extremely early submit it going do year in an IND are confident in we that we've it As and therapeutic We're radiopharmaceutical every addresses programs and problems the start and to at what advance to on. to market. can continue SADA the that do committed we actually of

look in the order to to Thank invest protocol. going to on are advance SADA continue overall programs you, and to continue early basis Mike. introduce SADA in the annual we So an to

Next question, operator?

Operator

Our next from comes Wainright. Robert from question H.C. Burns

Robert Burns

quarter Congrats appointment congrats, and on Mike, as CEO. your on the

me. maybe questions, X.X X Just for

to what and lutetium. do those seeing you start specifically weren't a that the giving associated received. or point of incremental whether given at get you and the SADA radiation with to would you SADA enable since know put of of of So platform greater get radiation you without SADA? I'm level to would radiation, the toxicities patients level is toxicities doses radiation curious the therapy reduce was level could think platform, the be if to DLTs off trying the what's base essentially dose associated at I

Michael Rossi

for the you thank Robert, question.

pass also As we're to moving to what with looks and to like leveling going targeting, we're Steen? to at is we move and for into efficacy safety patient move we able color. the some goal the tailor But really now our of like. forward platform with and trials. look a Steen be work as responses response looking specific at look clinical these on new the these, that the studies balance forward on these out I'll to it safety individual additional primary as then make some what

Steen Lisby

thank I now of protein that this and to potential administer us free of important because the and much is system. benefit the add is when the more Thank really had nuclear to SADA you it's majority out of platform the you, Mike, the that you. what's radioactive for

will the spare us And data. how whole from we goal nuclear for add eyes on that tumors normal SADA one-step to from see is issue. on on radio in then can differentiate to the we there out much to based there here So order the

Robert Burns

me. follow-up from second A Awesome.

those agents context, multiple myeloma that day? the did a populations? prior think we you [indiscernible] at like new viewing viewing are enabling you look what are also these in about And CDXX SADA, Or DARZALEX then specifically the patient and benchmark looking back you HexaBody CDXX. utilization targeted in as are the DARZALEX you when what So Are in just as the CDXX there? benchmark

Michael Rossi

for to on plans question it are your forward. we for and you pass and that, I'll thank the what Phase Robert, I as over the for Steen move

Steen Lisby

on program I non-Hodgkin earlier Phase call, in discussed this are as So the starting lymphoma. we

competitors. CDXX a quite lot on what create us to benefit And do of there's And mode agree as order completely myeloma of think predominantly we're I we multiple here to the molecule. have actually in Italy. in this of molecule, action competition a myeloma So that the dosing different is space. quickly That's multiple compared is not in but safety for that I do

confident development quite lymphoma. and plan the here space we will later both but TC I'm we will in So non-Hodgkin's the the start to start developing go in there, initially

Michael Rossi

Robert. other Operator, questions? you, are there any Thank

Operator

to concludes to our Rose would Mike floor for question-and-answer like turn session. back over comments. the I This closing

Michael Rossi

and while in and thank you, with and to continuing continued we're strong Thank our of earnings Y-mAbs. operator, milestones we work franchise. We in for quarter drive interest the your you, everyone, to call adoption, as position deliver your a technology believe growth third for on novel participation SADA DANYELZA multiple value-creating today's potential expansion

our with Thank Let everyone, cancer. again, a have you, team to as great me forward fight this patient-first say look working mindset one special be mission it to and I'm company. We day. in a to part thrilled of

Operator

This teleconference. concludes today's

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

Y-mAbs Therapeutics (YMAB) 14 Nov 232023 Q3 Earnings call transcript