YMAB - Earnings call transcript Q2 2022 | Y-mAbs Therapeutics, Inc.

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Operator

Good morning and welcome to the Y-mAbs Therapeutics, Inc., Earnings Conference Call for the Second Quarter 2022. Today's conference is being recorded.

Let me quickly remind you that the following discussion contains certain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Because forward-looking statements involve risks and uncertainties, they are not guarantees of future performance and actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of factors, including those risk factors discussed in the company's quarterly report on Form 10-K for the fiscal second quarter ended June 30, 2022, as filed with the SEC on August 8, 2022. At this time, I would like to turn the conference over to Thomas Gad, the Company's Founder, Interim CEO and President. sir. ahead, go Please

Thomas Gad

Chief morning, compliments me thank CFO, today Commercial XXXX. review and our Good very Rajah. us to the pleased Bo for second today. Chief briefly our Smith; Sue With we you Officer, Officer, everybody, you. Vignesh you I'm our and with joining Kruse; Medical throughout Thank have of our quarter

FDA the and of our patient We first progress a anticipate Lutetium in ITM from and resubmission the Technologies our with with review obtained non-carried CDXX BLA in by omburtamab date the construct, Isotope priority foremost, after the Munich. was quarter treated GDX-SADA decision in and we for accepted a which we PDUFA continue secured the in for First XXX pediatric our and for the IND upcoming isotope bispecific AML clearance first XXXX. November antibody supply clinical

development We have GDX-SADA fourth for through expect Phase of and in I secured III supply treat first XXXX. GDX-SADA patient of quarter we the with our to the clinical Phase

Pharmaceuticals to approval firmly while generate positioned unlock benefit our with We believe platform creating that In further to Y-mAbs value Greater diligently with Our is to milestones, the decision DANYELZA's SciClone data patients we year. have partnership meaningful advance our worked to past on expected shareholders. provide well to an and China deliver multiple the later of expansion continue for this on quarter, potential well.

the and patients neuroblastoma and the was launched high-risk our in relapsed me FDA's with following with which commercial commercial refractory the first product let franchise, turning ago for with DANYELZA marrow. bone treatment accelerated approval our bone begin to Now of XX-months first

positive a response, stable demonstrated therapies. have minor to for prior disease response We

offer of U.S. DANYELZA's at look Y-mAbs expansion of outside nationwide to being date to and here the the able potential us we forward proud truly to launch DANYELZA are to children of All and

product in XXXX DANYELZA's previous launched, in revenue they came X% quarter While since corresponds quarter. of decrease the quarter-to-quarter which a million we $X.X second at to have increased the from

the June see early in However, in QX $X.X consensus are was new included the encouraged and rebound partially revenues in $XX.X second rebound which DANYELZA approximately patients. two by we analyst in decrease offset continuing a through below came million to slightly decline that quarter, was the consensus meaning million corresponding to July. our patients a

royalty in to income Our a international sales, decrease due from offset increased volume revenue orders. partner of benefited by from partner timing

Officer, implemented changes, leading actually and successful and and new very to changes are several and are and we to track. management confident Commercial has recent markets. in by Sue. her and leveraging have DANYELZA see the are delivering operational call She on highlight starting launches our other differentiate you. now global that you a so And has Thank including over changes we Chief development Sue I'm pleased today, experience to on implemented potentially U.S. positive Sue. we the product right With Smith been to efficiencies campaigns the

Sue Smith

DCC launched We through to DANYELZA appropriate journey Facebook initiative, an Community patient much, helps thank goals, focus leadership paid the today expect align team In with adoption made. very and progress resources to and caregiver you us first half a with to finding DANYELZA and point, team place targeting to journey. support and they DANYELZA strategies, supported created focused with need families and patients clinicians neuroblastoma DANYELZA's with we That and DCC care. to called support might support the anticipate the in using to new they and life At in we caregivers everyone. operationalizing the be of the rare others company receive others the treatment second year customer improve gained disease when targeted reach by can In now experiences on community families like to how connection information. to first experiences, target process. the benefit their to DANYELZA is a approval and sharing empower the centers caregivers connect In quarter, journey. caregivers This our they relapsed the of patient managers on journey and with our community. DANYELZA in strategic with patients strategic stakeholders a variety the The this our good the their the they commercial the and efforts also can with identify along active and also This right provide on helps team plan drive firsthand of our parents the in rare I'm what to effort neuroblastoma Thomas, to all the the understand quarter, the disease are time. to from is marketing been will a or time refractory educate high-risk roadmap. this we've child. or and they knowledge appropriate opportunity putting joined would the you Thank our hyper entrusting and catalyze over from it their the where who've use new for DCC. also the way, morning, allows we parents, company's Great. efforts account about supporting talk This families earlier leads. have their real commercial real new who in to child's happy to need media also pleased Caregiver us

recorded quarter. effective the as product of for in first quarter XXXX the Our refined DANYELZA to of approach million we revenues $XX.X appeared be first

of leverage delivering continue patients. and We first to continue to from them XXXX use experiences quarter DANYELZA the to

quarter, caused came but quarter, new earlier offset XXXX, again by previous the revenues the and DANYELZA a rebound a in in in through million continued patients the in by X% quarter July. slight mentioned, our $X.X partially Thomas decrease second as second at from the However, June decrease, in U.S. of

focus teams' implementing disease spring. was over Our initiated to April rare due the on soft in and the new May strategies

the be of centers with Second prior are U.S. can the XX but of steady at quarter not the compared but half the over patients, have plan currently launch, DANYELZA provides treatment roadmap the our the DANYELZA's up the interaction disease education network that encouraged from the infusion, we drive revenues. benefits our disease for rapid million across options, DANYELZA take of upon adoption most the X% we're by our foundation leaders occur. including physical half we're the hospitalization guidance footprint great With the team which our across its track. July we're in summarize, peer-to-peer with help course. to to days in international having stay an We community. experience with administered growth fewer setting. rare will with centers our million convinced future launch. seeing and These signs And accounts we treatment of notable to that our We're benefit rare We're with to we revenue XXXX, of and the evolved DANYELZA our key and very remain programs DANYELZA than launch, across we're continues the building which And feedback, new commercial showing with multiple expand practices number the the clinicians' We're accounts of re-challenged the to of ever and at as to end centers into things using opinion the quarter, inclusions DANYELZA formulary available gained XX the see. of encouraged featuring the outpatient prospects DANYELZA. its comfortable end solid being these addition growing higher time added now and new patients hub expansion administered by about which disease was Year $XX was experience also which and quarter. includes formulary to the based in groundwork U.S. quarter. measured about $XX To on first the commercial second best second foundational more in two seeing by this the see And other patients on since potential the rare having is foundation. with underscored flexibility starting time, of reiterate long-term with centers for since geographic right We're increase for to incremental patients, are confident laid, in

conducting expansion we and on core to broaden ahead further educational look focus site Our engagement additional activation. to accelerated continued market remains

Thomas Gad

Sue. Thank you,

and pre-treated treatment was to the label pleased in Irinotecan, by achieved. potential opportunity neuroblastoma. needs. ASCO pediatric revenue excited introducing look has the everybody, work can The combination a with combination hear also into going forward XX no is This achieving while are to II demonstrates evaluated adult And its time neuroblastoma. with DANYELZA expanding been you expansion. Phase the partner any and potentially As that additional opportunity. trial a indications we're of continuing rate high-risk patient about we forward, address medical the patients antibody of with greater complete presentations unmet This studied commercial to patients further a we have of anti-GDX rates and XX% is discussions growing in grade this heavily toxicities. ongoing supported two safe topline the Temozolomide, towards GM-CSF possibilities capturing results further and the response. DANYELZA in from committed very and DANYELZA XX% recent The high-risk with such Sargramostim's our is This with very of first larger chemo-resistant than DANYELZA the of Y-mAbs the population potential overall endpoint response primary reached response we

omburtamab. to over moving Now

meeting FDA thrilled take BLA are recent and XX, for XXXX. omburtamab's priority name of XXXX We The and a in for that PDUFA a report guided to to advisory accepted November date submission OMBLASTYS. committee October date the brand place our review has

leverage if approval significant indication that any Currently, we for a CNS potential are here. there need are rates address the major fit portfolio no hope about to and additional on the without as overall approved, infrastructure line investments. metastases this further approved Omburtamab very to with medical would our commercial our unmet into commercial omburtamab neuroblastoma. enable patients from DANYELZA, well us We in extension survival therapies efficacy will meaningful improvement based unparalleled FDA optimistic and in

present if significant we believe targeting would opportunities diseases drug into would pediatric needs with an -- and BX-HX. within label rare unmet mature opportunities approved, medical over several expansion medical omburtamab, indication that larger important Additionally,

its extend our FDA, Given priority the that PRV, by agency MSK from from the review generated are sale the to cash that we voucher such approval. a receive of non-dilutive granted run been proceeds upon company eligible designation rare the pediatric is further cash omburtamab disease potential receive to contribution a have a of net the XX% securing omburtamab rate. would to potentially entitled

Turning show now is that target radiopharmaceuticals to of our portfolio to to in the effects, in targeted minimal platform development key great increase promise indices. SADA a WiMAX delivery technology. off significantly opportunities tumor innovative with to proving sites SADA therapeutic the continues

to GDX-SADA expect filed year. become the community. the positive continue the the encouraged of to was potential it year, technology, last this the fourth we in we the treat tumors at optimize July, The SADA represents quarter last the construct for first IND the And IND advancement clearance patients for late for we've during year. GDX solid medical As after more scientific company even about first our

lung to while treat cell are potential that We on efforts pediatric in adults two-pronged indications. focused with on to GDX GDX-SADA small the here working cancer strategy validate

is Our focus indications. indications here on while pediatric time over we to medical larger strategy out-license unmet

quarter binding We a tumor are approach. fourth while able indications. first we we where here our pediatric approach the in use therapeutic the treat to we'll proprietary as focusing to options expect being explore development partnership to strategy data and the forward positioned plan the adult to SADA well tumor leverage by followed platform our seek indications based on to and imaging is on potentially SADA to demonstrate binding our We to for believe share to partnership in look is XXXX theragnostic patients

these late-stage have that been believe the as enhance further agents. that PK not targets them implementing We repurpose could into also safe proven SADA optimize plan by previously to we clinical potentially failed targets SADA potentially a and construct in platform have already therapeutic SADA humans radiopharmaceuticals unlock the responses tumors pre-targeted the significantly any meaningful of to demonstrated indices and historically by the of in attributes therapeutic as potential evidenced

remains and important progress for CDXX partners this one for as launch the focus Y-BiClone decided of unfolds. has promising to pediatric can to patient as and close Moving pediatric AML study we bispecific first asset a hematologically need preserve order the to AML look unmet our of to out in and attention believe cleared We address promising of AML challenging the nivatrotamab an GDX-SADA June platform. DANYELZA been it capital commercial The forward our potentially to as so malignancies reporting our this and is omburtamab. in the treatment IND that clinic the -- treated children. is licensing We've with we seek our potential to the on most

we established especially you which will expected SciClone excited potential $XX have expansion trigger the DANYELZA approval Greater China, we As this and to partnership know, a later place and Pharmaceuticals take a million with year, omburtamab about milestone. are for DANYELZA regulatory in

for to this an Asian see driver an uptick patients continued pilot treated revenue sale. in market have expect in We in DANYELZA's important the zones and China be to

DANYELZA continue call have support on additional of reprioritized our have With internal through execution pipeline continue in a in the omburtamab XXXX making we commercial second rate we unlock track we advanced effort the entered previous if pipeline, DANYELZA in continued well Eastern constructs. cash. work work We on the sure believe including footprint Recall, Israel our LatAm, $XXX.X conference have omburtamab, first near-term the the an partnerships. and and partnerships deliver as the early-stage we into our launch clinical for robust mentioned we and Europe value programs many footprint. external to of with We programs, focused a quarter and approved, and run to to as are potential to cash this and global of strong potential support will SADA to and technology of and widening million covering XXXX that ended quarter a the and of our commercialization more milestones,

Bo. pleased Bo We our Chief to current you. our with will Officer, Kruse, which Thank elaborate Over position in are you, minute. very on financial Financial a

Bo Kruse

you, Thank Thomas. morning, And everyone. good

and a of revenues June and million six the million net XXXX, XXXX. in of ended in $XX.X $XX was $X of respectively ended million million corresponding DANYELZA's XX, the $XX.X the $XX.X months worth of $XX.X of the the includes corresponding revenues and respectively, over million comparable for compared X% $X represented in XXXX. license six and revenue June to decrease million periods periods X% XXXX, revenues license and $X.X represented months and increases which of XXXX, of product and revenue million for Our June six worth of XXXX. the increase XX, quarter and Net million over months quarter ended of an XX% respectively periods XX% XX, quarter

included by partners in $XX.X rebound patients and international by sales the wealth the the the decrease partially from to increased offset Our decline DANYELZA income volume in due while orders. to $XX.X offset net million timing second quarter revenues The from million. partner first benefited of decrease second a of a of revenues quarter in product X% quarter, compared revenues June July, in of decreased U.S. new a XXXX, in slight earlier

and severance were million the $XX.X Moving the These increased operating million our that net by R&D to of reflected and inclusive by to compared million million increases share months manufacturing SG&A six constructs. a on second inclusive $X.X expenses, reported Executive $XX.X $XX.X six million in and launch of quarter loss commercial by for and use during $X.XX particular net months XX, quarter to trial diluted June And basic basic loss million and naxitamab the share-based expenses which diluted expenses compensation-related compensation for $X ended expense, inventory June the XXXX. of focus million per ended SG&A per June increased clinical and $X.X the June which Officer increased $XX.X DANYELZA, designated a former and net us reflects increased related million ended increases The million with DANYELZA, of million to to XX, quarter employee-related Officer, decrease non-cash XX, or $X.XX in and $XX.X and outsourced omburtamab, June and respectively. benefits quarter former Chief $XX.X to the XXXX, $X.X six and of XXXX, June million contractual Chief ended include the of months three XXXX, for share XX, our the in of earnings XX, the charge for related million primarily XX, the quarter $XX.X and We activity clinical were related SADA were million XXXX. XXXX the periods for and months The of extent, six our lesser of the $X.X in unfavorable contractual Executive commercialization ended a severance expenses. impacts and both expenses related in the $X.X R&D result XXXX. increased as benefits noted. the charge of million $XX.X or $XX.X expenses quarter the and, and for costs of ended to accruals for million

of to and license from of the above, we related the contractual as months for the impact of months increased We XXXX, share DANYELZA's per noted ended share expenses, offset revenues. growing unfavorable included $XX.X months net income for the agreement. Officer, ended our by favorable the quarter June diluted with decrease compared Priority June compared six in Executive former related XXXX, XX, of in the of XXXX, year-to-date the our six ended cash $XX of a as Voucher, second million XX, in to six-months DANYELZA MSK severance Chief per the was decrease of Additionally, XXXX year-end earnings balance from the R&D partially charge million net The to of share basic ended X% with June per also reported sale of sharing million XXXX. at gain benefits XXXX. The a impact or million net after the by the quarter compared the the million XX, XXXX. position during cash quarter of decrease reflects the and Review ended The $X.XX $XX $XXX.X to proceeds June the burn a $XX.X sale million about cash reduced XX% $X.XX per diluted $XX.X million basic or loss six second for that $X.XX net and $XXX.X a and reflects XX, the was first income

mid-XXXX. is with our the our We support used cash a position mentioned. into cash our financial we quarter, current by Consistent prior of cash in believe that of sufficient operating provides Our as is commercial our driven current million the fund reprioritized solid activities. position operations $XXX.X June cash burn initiatives and as believe our our programs to pipeline runway Thomas XXth, to

noted include upon net anticipated which PRV, quarter, to the in this are we understand assumption the underlying received not and for any could the we we the omburtamab. As of from approval prior for potential assumptions did important guidance the proceeds sell

growth hope entirely indications to the data to rate and to of addition, the partnerships upon To revenues continue sources come other by are could see deliver to year clear, related are that each approval physician DANYELZA potentially commercial purpose clinical be the adoption. we this lead income and potential our or excluded, strategy different assumptions, for included refined to BD analysis in the omburtamab XX% and assumed greater expanded only new modestly also years of for are no In of in increase execute runway. as DANYELZA we revenues an

cash benefits trials, expense activities of point. us In no our current behind and that regulatory Also financial programs related million package not impact from post-marketing unchanged million for we million at disclosed, million be assumed we include are net $XXX full expenses continue the the do to the point. the total and do are this assumed operating at terms to not forecast quarter. -- would advanced projections, are expect expenses, operating programs related the to cash pivotal most a and previously this first of runway at $XX burn which new to expenses commitments severance of from XXXX. fact $XX estimated own This but development the have activities, of accruals $XXX The increased year cash to

purpose any of we debt believe of milestones. execute multiple to the priorities the borrowings. healthy or mission, offerings guidance, remains position not assumed our of Y-mAbs equity a have the financial strategic and in delivery For We support

turn the Now, now and this call to concludes back updates I'll financial Thomas. the

Thomas Gad

end you, of Thank prepared the marks Bo. remarks. today's This

remind questions So you let's open your and we for perhaps Thank of you. can now ask up procedures the this line to the time. at the submitting operator

Operator

Thank you.

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

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

Alec Stranahan

Hey our guys, taking thanks for questions.

us. Just a couple from

Just similar do the with roughly in you what sense same preparedness you optimal more SADA you the like adequate question second And omburtamab to A&P? take and through you quickly expectations in you trying you'll might commercial of as just to coverage escalation obtain plan could you the at study this the need potential pretty to be approval And your the the the with have are preclinical you had feel Do have of given level in a a the First what of DANYELZA a your sales should you point on activities maybe how a parts good of ahead how think on follow-up, of dose hospital-centric as studies? in the Do haven't interaction many people design? U.S.? November. to payload think on step to Thanks. a talk launch? given platform, dose EU approach the the be EMA about bit able And FDA?

Thomas Gad

think I first take you Sue, on the Alec. question omburtamab. can you, Thank

Sue Smith

Sure. question. for Yeah, thanks the

of and actually good launch is So the for standing in the omburtamab we're there. U.S. now right team preparations on the engaged very

have more facilities administering. disease, volume given certified this slightly medicine rare this, a to nuclear a higher they administer they want of leptomeningeal the Also a have ability approach nature capability. taking the proficiency CNS in are ultra-orphan hospital-based so because be that to the we of very we'll We that in of see

this that And current taking we are feel hiring be with specifically right the synergy actually approach. of number that launch. and with out people have numbers we that the to we are for people efforts, feel start successful. the And patient some we DANYELZA small do to we So our

continuing we with EU same In expectations, of and engage terms to from agencies. are guidance the EMA

and continuing And should we're for on that that have our to come outcome obviously effort and with so commercializing the the certainly to signs that hoping right now, way prepared thoughts you fruition. best

Thomas Gad

detail Thank do to talk the design, of you, the achieving Vignesh Sue. dose? the go into and not two want maybe mean, of you let's the I timing for first study and -- about the starting what we are cohort injections dose

Vignesh Rajah

so Yes, Vignesh much. well, thank Medical This you here. Chief the very Officer is Rajah,

study this SADA And will escalation this be dose the So that three Part repeated divided A, escalation. the the be trial, Part being three dose Part Phase and designated escalation. GDX into B also looking dose looking A C. the B, at three parts. Part a And Part is dosing Lutetium-XXX at parts will analysis. separate separate XXXX I SADA

will be parts these completing upon part. of each so only initiated And the previous

be the limiting GDX-SADA. completed So in who first example, looking observation just only for Part where the initiated with will at patients is we're of Lutetium-DOTA part, escalation which have dose for toxicity the B, dose

primary to adverse standard occurrence of this a for objective number the details has classical trial is and three a or escalation tolerated dose. the DLTs the is will you establish based it primary as endpoint, can the the So -- design on but maximum imagine, titration stage plus with But specific doses be trial events. and severity of myself, three

this So your I of at part hope answers question. least

Alec Stranahan

Yeah, that's for very helpful. the color. Thanks

Operator

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

Robert Burns

taking thanks guys, for Hey questions. my

if may. two I Just

will able also the with And slowing trial like the recently, are initiate of to to to what that some neuroblastoma? it of question curious this Thank personal, in the we an the for still year? for average of centers this planning you as per of still II year of of that neuroblastoma to. front-line for see the naxitamab are then in and get another given is sort So And IND Phase you're upcoming additional access regard you. trying you're catalysts, number my advance set second contract to seems centers submission patients number

Thomas Gad

will Sue, I the Robert. the question? Thanks, can you second. first take take

Sue Smith

about Robert, terms patients your this disease, Thanks, of nature question. into are of high-risk the XXX those perspective, XXX and relapsed of ultrarare number in diagnosed or neuroblastoma for XXX for Yeah, this patients the so our high-risk neuroblastoma those bone label sort there have the of in again about in are of marrow. Sure. neuroblastoma, putting refractory U.S, of in about bone

the aware we're we in the growth. are of are those where and patients they So focused acutely is And team where see, accounts. the very on sources of

coming So prioritized. that standard. from of well, potential our of enrollments we tremendous and we've into execute at segmented the amount which also accounts we key have a know we've are accounts -- And still can news we priority priority team the the good is XX% our

haystack. to us. disease and launch, that needle We place, post source for in retreatment plus rare growth are efforts second those know patients I patients And of are those we patients the given some of So the put accounts patients, new see of think in will now be XX months third compliantly. a starting both the sort where know following we in of

rare that So lead we'll generation plan. the start disease of I think new see also and to our of growth from the efforts those expect we expansion accounts new

Thomas Gad

in we Thank address that just clinic IND GDX while XXXX QX validating about on prior SADA, additional your we you. in submitting question for to INDs to And IND. of an are on planning the focus additional other

Robert Burns

for that. also are that frontline you planning And Thank naxitamab? you neuroblastoma trial for

Thomas Gad

any are then some we we still FDA, will Frontline go data waiting not and I but on -- address neuroblastoma, and gathering study. yeah, head-to-head we are planning the on

discussions We take are to non-inferior see where basis the FDA we that. with have and planning can on

Robert Burns

Awesome. Thanks, Thomas.

Thomas Gad

Robert. you, Thank Yeah.

Operator

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

Charles Zhu

steps our for first taking SIOP the questions. My provide presentations? development you and could data development see of your BXHX-positive And morning, one for label omburtamab. Could CNS -- for metastasis, of opportunity? future steps also could color Good XXXX you as everyone, regarding additional expansion this thoughts upcoming regarding also asset particular thanks Thanks. any potential we the types expectation, provide the specifically around a next

Thomas Gad

to Yeah, Vignesh, first do one? take hi, the you want

Vignesh Rajah

Yes.

just is study was will we a oral analysis. we'll will the also interim And quite be rightly XXX Kramer. a XXXX, later at Dr. as you SIOP So study, Sloan year study this be delivered the by which the center Modak Y-mAbs-led Dr. XX-XXX single alluded, that for giving SIOP another looking This at of presentation have study Kettering. multicenter presentation at

safety around But efficacy the rates the previous terms survival is -- calls, details in as a with you, benefit that have efficacy concludes benefit in headline shared and hear of the a response we profile. clinical manageable So about in with there safety think, those clear of news you'll and more I presentations.

comparisons. months account indirect For in need difference progression-free taking appropriate overall you indirect XX doing survival, survival survival example, comparison actual where, shown looked external we interventional Preliminary and control the know, at the to these are months difference XX-XXX, of control the arm comparator. the survival as to overall an indirect arm roughly with we versus the an serve has an the in albeit in in has a overall comparison the as did XX arm, that data

response to rates. XXX where was endpoint the study, primary the Moving

Here, the look looking primary after months aim at response at at initiation of treatment. to patients, is X individual rate

had measurable those a stable partial XX disease. in Here, Roughly of which level about as well response, is patients with includes as response disease XX patients. we have patients complete shown disease, control, which certainly

treatments, believe that benefit the combined arguments in primarily And is our have clinical and abstract think these in two alternative for these very be have shared we with a poor at clearly really more I presentations. submitting there will of this and been studies, is a signal So patients with clinical relevant BLA who we prognosis. the no detail

you question of think clinical this I added your second Is that right? around further. development

Charles Zhu

Yes, positive the yes. BX-HX for specifically, CNS,

Vignesh Rajah

other be in FDA see benefit able patient get where will looking Yes, if can can specific I theory from be we think populations, PDUFA approval, areas past used who in are this to to this. we omburtamab those

programs precisely study to of the the adults. study, moment, Medulloblastoma, open in at only who but can brain through in looking which have at pediatric like CNS are are neuroectodermal that an we details PBTC Y-mAbs-sponsored But there [indiscernible] So as tumor as be not calls. number indications of we're investigator-led tumor studies. ongoing shared tumors subsequent by BXHX, tumor, the just express run supporting well tumors pediatrics, not Further consortium,

follow, will is balance within details further we tumors. So our but best to certainly, risk omburtamab get can benefit these BXHX it the in of see strategy where

Charles Zhu

taking thanks Great, for questions. the

Operator

Thome proceed the comes next your Cowen. question. Joseph question line Our from of with with Please

Joseph Thome

wait here, treatment a drivers? forward interactions? what look of hopeful just on to site-to-site kind guidelines we Do that one first you discussion of morning and to the key is need kind taking questions. would Anything helpful. for launch inclusion Thank are expected decision? once focus you then on October do Good Maybe the And expect outcome there. omburtamab, Hi, that what how preparing you and it these the you. that more for for to team in thank for maybe my the on of or be kind

Vignesh Rajah

Yes.

as ASCO think I I guess, brought which for expect will with discussions I expect for well of we around the FDA. has X, FDA important in the be -- or been the previous areas the the up So points, committee centered as X focus we or as meeting,

trial. Study single course, we XX-XXX know of that a single Firstly, is the arm, center

is So important to always appropriate serve the quantifying risk to know, the show important, data, which statement. has you for and make when be comparator And incremental treatment effect effect control benefit in comparisons the survival a limitations, FDA and to with application external as trying as order on you're improvements. will relies treatment the an outcome the

number the control both the study as So datas, as these arm. the And of be confounding looking well will discussions for at a we the to be from around of or discussion around a have any control estimate MSK assumptions the the we score to lot indirect statistical of And matching we'll there robustness be will comparative selection propensity anticipate effects. bias. relevant treatment taken that

questions confidence small at of discussion study responses be the be anticipate also disease replicated with is in degree will number larger a still is And obviously, in here, -- a this population. rate looking area of other measurable study, patients patient and there the the relatively response XXX. seen around whether at looking the will can The be because the there we

one be area will I that to AdCom So the anticipate look at.

of to points So of are points, I in we I discussion the team number discussions these And been these anticipate all a add I the involved were be. with the the most of should think that ongoing confident. key -- have discussions FDA. the And

with judgments in determining should that of case needs statistical applied we do very the because of looks this rare a will the prognosis, largest guidance, is area provide fact in medical is we not the have, data making the to diseases. of to believe arguments flexibility poor are And these, the where we an think I at confidence given clinical any just an I in that their population. address for high be also study with of are around And largely, risk own course, degree in look FDA a have patient We rare data this -- our benefit need but effectiveness as single flexibility the the arguments, drugs at XX-XXX they they this also allow in disease, assessments. and where AdCom in unmet area statements able

to discussion in what expect really I AdCom. that's go So like the the

Operator

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

Tessa Romero

guys. Hey, our for questions. so Thanks much taking

question for So, a you, I could. if

see achievable? should of the second is more through still the Would new talked expect half question initiatives see you to we you pull strategic other And that year expect do the second roadmap our weighted of You year? this for a from Thanks to rare half company. XXXX? sales Or inflection really about impact in believe so my disease and headcount much. is, to increased the

Sue Smith

and rare Yes, do. people the embracing as disease leveraging do put the the know, Tess. programs in you we the them. feel They're in And by cardiovascular in sales adding not a have right This tools that is are resources. And infrastructure confident place rare they adopted into second and been have I these team. a new more disease Thanks, so We're quarter this drug. we materials and ultra-orphan. I is place.

when and appropriate patient for relapsed some an So when then refractory something, appropriate be our that identify takes they time you you product. it implement may

Not rare between all So the the starts six you something time, in see and you start XX when sensitivity. appropriate these maybe when but diseases seen patient. sometimes often to months

So their think And take time I focused quarter think very into that that are executes see we But -- with signs plan accounts. to some place this We've I that point, refined team new we're performing feel in even I pivoted sources is focused we above more will third growth. confident your forecast We're we some to early targets currently have for footing. very clear the we'll get are, hit of benchmark putting The the our things our year. there. these our to and enrollments on prioritized majority of we approach are our our already marketing that started instance, effectively. coming a on from

strong So, I growth in XXXX. year feel numbers that hit and, see this our to additional that expect the fundamentals the course, and are we growth of

Tessa Romero

could. on follow-up one I that, if just Sue, And

I patients latest your treatment research? line one-third previously been is the type sort third you've second market at of of guess, talked think I have the a about of versus how duration that the more between in treated looking of line. sort two-thirds, Thanks. split

Sue Smith

Sure.

focus that's to strategic looking in developing our that. We're at frankly, the So and midst for of new area some another ways refine just us. messaging, of we're

centers therapy shorter unfortunately before what very on at faster. some that they a of go two of duration excellence see of cycles late stage to think three to is patients I we these is often larger with

that's for disease most what are refractory is in patients our bone really stubborn bone And So label. do the primary have and in compartment. in data earlier we're to who move the journey treatment those looking we great and marrow

really and to approach, earlier to as there. and So we our to think shift we're that looking shine we get really refine I to the enhance look stages

just we better do want communicating So of job even to an that.

Tessa Romero

for Thanks question. so our taking much

Sue Smith

Thank you.

Operator

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

Mike Ulz

thanks DANYELZA. wanted guys, just Maybe question. Yeah. Hey to for taking start the on

think specific Just should weakness sort there about of adds we based that earlier more this or in that of XQ, drove in we sort the some forward on move that patient anything just here? as variability was quarterly is

Sue Smith

I solid, it. full own do did foundation that think disease variability. a frankly mean, use two the I you think We that And very where motivated. it, walk quarterly from in but see you feel year rebound engaged rare -- our are of the and seems up did I team But that's We're I analogy have here, off. that was often was sort will even see the it really accountability. about very a patients we variability. And fundamentals happy just We not stairs, that. I do some

I to as see just year. that and I this hope on to So that blip. a really deliver plan that And deliver on

Mike Ulz

I'm the a Got to AdCom, just yet? quick a FDA be? for set on the it. color you just date That's helpful. And curious omburtamab maybe just thanks sort has expect and on of focus where follow-up all the

Thomas Gad

yet, date Yeah, no, get but disclosed -- not soon. that we we are very are have so we it hoping to

Mike Ulz

you. Thank Great.

Vignesh Rajah

it available. will we becomes And announce it once Yeah.

Thomas Gad

late in Sometimes October.

Operator

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

William Maughan

and morning good thanks. Hi,

on So my first is DANYELZA. question

treat going thought to doctor among in their have DANYELZA, DANYELZA's So these how process these that label. they DANYELZA other treatment access to when a about choose do and than XX through sites that is is a patient patients within

think guess them what factor you that DANYELZA leading choose and process? point their Specifically, do do competitor how to versus decision in you I change is a

Sue Smith

question. you will great take that. I'm need That's assuming Thomas to

Thomas Gad

That can long. a Yeah. be

Sue Smith

Okay. Thanks, Bill.

treatment was all was years the for XX So, through seven we developed been our by has the as COG in and years you the been the on market have and for market developed And anti-GDX at other many of the centers months. over their know, market product Unituxin in Sloan-Kettering.

use nursing at to had they the at and staff product launch, of having sites So experience didn't hundreds know memory the COG how we muscle that launches have did.

data So to and determinants looking And which bone are benefit, marrow on have do flexible. we we is really we there I -- that indicated the including not. and also bone are they and are the highlight think excellent where key

to ability outpatient. We and the inpatient have use

you when these about. one, that And some talk a right talking one areas heading physicians are we lot they with So in with on physicians of the the are those not of direction. are

some of explore. areas are the we're So these to looking that

and boards one of are the advisory some with those fall interactions some at they from we are And look are the have some on flexibility aspect that center areas product. see sense research optimally interested makes COG very also story to of parents that one will that and current know have market areas that telling and in value. really think and We this I of those this physicians very big the that be

something patient So efforts about. there, and we're definitely is community the GCC care doing they I think all that that our

number a to here that the DANYELZA of continuing channel towards working we're speaking story mix we're evolve. factors And frankly omni building we're there's our in So today. as

So stay levers tuned. the of the And on. that areas, some think are we're working I these

Thomas Gad

Yes.

sites So just sites, ago multicenter approximately developed four in Unituxin years XXX sites years versus -- was DANYELZA five ago. adding in six

great we So making -- progress. are but

William Maughan

we CEO update? I how's search, that then to in hear when might check the And going on just an and wanted

Thomas Gad

it's well. attractive think Yeah, an a is Y-mAbs very I going It's foundation. strong company.

in we'll of may talent. but think be year, going attracting be later very you give this terms it's update I well an able So to

William Maughan

you. right. All Thank

Operator

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

Unidentified Participant

for thanks question. taking Hi, is This for [indiscernible] my on Etzer Darout.

third some omburtamab me. for of level DIPG specifically able DSRCT? progress you. clinical might from you Can be updates Thank the and those when trials? And to one we Just touch on in expansion get

Thomas Gad

of it from isotope very, of the will very DSRCT are to So -- trial. XXX DIPG, difficult for the that outcome proper run in indication multicenter year start we changed a small DIPG. very XXX planning later using a to pending mets a we have trial XXX omburtamab instead is we XXX be and CNS to on this

expansion that the to that out see So I as potential we move off will be label a label will hope think future. in we

Unidentified Participant

Thank you.

Operator

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

Thomas Gad

Well, and thank participating day. you a you wish great for everyone today Thanks.

Operator

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

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

Y-mAbs Therapeutics (YMAB) 13 Aug 222022 Q2 Earnings call transcript