IMGN - Earnings call transcript Q2 2021

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Operator

Good morning, and welcome to the ImmunoGen Second Quarter 2021 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Courtney O’Konek

Good morning, and thank you for joining today's call. a progress that financial and issued of a results. we recent our second today, press includes release summary Earlier quarter XXXX be at immunogen.com. This this & a and section found can Media website press Investors under our recording of the release call of Medical are Chief and me Berkenblit, today and Anna our Enyedy, Mark With Susan President Altschuller, our CEO; our Officer; CFO.

months, anticipated will the business last X During events. for over upcoming and accomplishments today's our review call, results key we financial the

forward-looking uncertainties statements, SEC materially ImmunoGen use our an During actual Descriptions turn differ the will in filings. discussion, in may and from I'll that, of the results we our investment with included are the associated call statements. And Mark. such over risks and with to

Mark Enyedy

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

the past fully on preparations potential for With on on commercial next objectives our accelerated we've products novel continued our to Over months, pivotal top quarter, to track oncology BLA strategic for innovative a submission the integrated we study mirvetuximab. our from company execute advance for transition market launch ADC and the the pipeline and SORAYA X to X candidates prepare data release line as we year. of with of next

with the largely of over targeted the U.S. inhibitors. novel the that as analyst near-term continued catalysts, project billion U.S. Starting we launch in market in from reports opportune Given data and the driven these briefly and industry $X.X the PARP like see an growth, with dynamics to today cancer increase cancer. by mirvetuximab ovarian uptake agents you this other review moment market $X and ovarian opportunity approximately billion in XXXX will to of

X,XXX cancer. establish from with chemotherapy. quality alpha and limited of of indication FR Treatment tested SORAYA, landscape, for that data Against which fourth-line platinum-resistant the tumors roughly cover levels one We for our in ovarian standard on the disease. approximately data women with second- of discouraging who've to in in just for are with label a poor having also anticipate survival X-year this to positive options diminished suggests and as as mirvetuximab's expand we cancer FR Looking more patients mirvetuximab the majority deadliest receptor express clinical are of the the settings XX,XXX is and XX% cancers to the of our these maintenance, XX,XXX alpha, more Avastin. would care our epidemiology, life. today. With diagnosed patient believe at U.S. our goal is rate, With Based data will outcomes be than die initial as eligible. advances high the from advanced impacting high population platinum-based cancer year high women is patients represents with each experience from been than resistant cancer relapse ovarian ovarian to X,XXX XX% this become folate with X,XXX patients earlier-line would Avastin-naive previously Despite inhibitors over confirmatory PARP treated patient patients MIRASOL, patients samples, alpha target ovarian of ovarian With mirvetuximab. ovarian U.S., will

share aligned Beyond displacing single-agent of FR in that mirvetuximab recurrent Anna trial support we're more strategy study a in alpha platinum-resistant that on single-arm with initiating data high ovarian monotherapy a minute. details generate the mirvetuximab platinum-sensitive setting, later-line to cancer chemotherapy. PICCOLO, will our

presentation Avastin pleased demonstrated plus cancer. These last ASCO. these ovarian to We alpha expansion recurrent become of choice data, were generate at the initial status. of supporting highly this XXXX, the cohort in an We approval publication continue to to of for formal FR ovarian in combination for data month platinum ahead antitumor to believe for the support compendia the the mirvetuximab doublet cancer monotherapy also from regardless with our of high We together in activity final plus label published proximity data close listing mirvetuximab share patients could agent with data mirvetuximab compelling of potential Avastin encouraging mirvetuximab oral in combination.

the first with Given place, and this potential, and to of the launch submit second awareness we data robust receptor call, already the the with top commercial medical To on generated folate targeted selection the for alpha to in plans accelerated mirvetuximab. cancer with to we in mirvetuximab of patient our increase as are the half continue ovarian end, work a therapy. the accelerated BLA I BLA to mentioned at inventory of up as preparation for for parallel, submission distribution. biomarker the potential educate community promising XXXX we've of year. commercial this sets engage finalizing support of gearing for to In quarter in are in we approval And the

progress we're So on being in also data advancing through potential and is we've the in year. updated And IND of next as codeveloping escalation. BPDCN with IMGNXXX, an our our innovative antifolate potential receptor the of got we next combinations for also portfolio has AML forward ASH remainder of studied mirvetuximab year-end. track lot a launch submission at approach ADCs going progressing. IMGNXXX, next-generation in from ADC you quarter. IMGCXXX, CDXXX-targeting is XXXX ADAMX-targeting with ADC, our expected to an cohort ADC launch dose to The on by MacroGenics, look also keeping on alpha is our and AML in our that is

and our I'll over to that, initiatives. clinical education on the call with Anna? turn provide insight additional to Anna medical some programs our So into more

Anna Berkenblit

Mark. Thanks,

mirvetuximab and final overall nonplatinum-based expressing each Just with median agent. response including survival with progression-free study high oral and the were of session during rate a ASCO II a profiles of combination of months, medium XX.X an our were FORWARD from in adverse in confirmed recurrent of June. with of FR demonstrated activity that appropriate. Avastin events the at median These FR a presented details evaluating with where cancer is alpha XX.X The on patients robust alpha antitumor combination combination treatment consistent with in patients duration data data high side regimen with more ovarian in XX%, few manageable a months effect expression, response a

are mirvetuximab's highly support as in use these potential to by We we of they its and as believe lines combination serve therapy. in of encouraged cancer reinforce agent a findings choice ovarian earlier

underway, randomized a approximately cancer care carboplatin investigator-sponsored standard now patients. Additionally, XXX mirvetuximab Phase along Dr. These forward inform in plus recurrent ongoing mirvetuximab to in by platinum-sensitive expansion with led is with of data, II we Harter Philipp neoadjuvant study Germany the XX-patient compared UAB, evaluating our Arend our Rebecca for label as combination consider with IST path Dr. carboplatin. from in at options the will outcomes ovarian further

MIRASOL. and Turning to monotherapy mirvetuximab beyond SORAYA

to the of of patient our of response single-arm and response. primary we mirvetuximab initiate point new quarter, ovarian study rate enrollment cancer monotherapy in secondary end third-line-plus platinum-sensitive patients This PICCOLO, of recurrent in confirmed FR with high plan a alpha overall duration point end

exposure the for but because therapy. well months, cumulative repeated as to suitable is potential platinum-free platinum-based reactions X platinum in incorporation relapse, patients ovarian With a greater is and with be with the related maintenance with another cancer that technically may first platinum-sensitive risk as to inhibitors other patients of PARP more in toxicities frontline these still platinum-sensitive of of of as recurring than interval later-line hypersensitivity are not platinum. This disease

option to after have designed inhibitor PICCOLO under of to maintenance as in The as a pressure maintenance the In may later address therapy. addition, increasing nonplatinum effective need recur in those be patients for been additional is tumors not trial platinum-sensitive who disease. unmet selective recur sensitive lines from their platinum of who PARP absence this an

working Roche Corporation moves with congresses. important the with presentations biomarker alpha. receptor medical biomarker establishing symposia and Tissue and community we education diagnostics in pathologists the folate As upcoming as commercialize an include boards and to closer to on continue oncologists, to companion at importance at ovarian medical congresses cancer. the mirvetuximab and Roche of and efforts alpha advisory potential receptor approval, Diagnostics folate educate develop Diagnostics for These workshops We're

receptor the expression are physicians part decision following diagnostic. With the their mirvetuximab expect assess companion treatment diagnosis as of standard folate process, alpha of approval we we and and groundwork to laying,

Moving pivotal program. to our second

relapsed/refractory and the study dose-escalation first and to expect with of line AML. azacitidine in venetoclax a next XXX as in is enroll relapsed/refractory Ib/II BPDCN and combination and look We IMGNXXX ASH initial venetoclax a at December. with Phase Recall data in AML and in half our MRD+ We top presenting study II azacitidine AML that patients year. also for Phase with patients in with of in frontline in IMGNXXX to continue patients combination data forward advancing monotherapy

these forward and call Susan ADCs. to are excited about As turn advancement the also I'll with and both that, progress cover of Mark on we over IMGNXXX financials. you our look updating of mentioned, Susan? With to to the IMGCXXX the

Susan Altschuller

ended compared $XXX.X $X.X expenses balance compared our in Anna. XXXX. Starting the consisted primarily expenses generated quarter R&D to XXXX, of G&A million $XX.X were million $X.X million of XXXX. Thanks, equivalents revenues. second of in cash expenses $XX.X million on $XX.X the results Operating royalty with in We with in of the cash comprised quarter million million, for sheet. million $XX.X We with revenue, and second of noncash which

for Our financial guidance XXXX unchanged. remains

be and expenses to between year-end $XXX be cash million revenues million expect operating $XXX cash $XXX million. $XX million, and $XX at between and million and We to and between $XXX million equivalents

continues be sufficient to half runway of questions. the call that, Operator? operations to second for we'll cash fund current XXXX. the open Our into With

Operator

John our question first Instructions]. [Operator And comes Canaccord. with Newman from

John Newman

you if rationale talk in that could more your strategy approval. curious Just could study. about therapy forward will going of if you the after lines talk mirvetuximab the expanding about for bit with PICCOLO mesh other wondering Also a behind how

Mark Enyedy

Yes.

medical to talk rationale that increasing of and about little about what Anna ask can patients I And the population seeing talk broader I'll then terms might of maybe more an these be in the the strategy. case. why we're bit So a and

Anna Berkenblit

Yes.

line agent than we patients, disease. line a platinum-free you for there's been X months, ovarian patients platinum, returns, in and know shorter survival will, recur of unfortunately, shorter. that And and And at their historically another gets disease-free point, develop if greater law they diminishing platinum their platinum. if is therapy, has they platinum-based when the progression-free typically therefore, of cancer. active interval platinum-resistant some after most So with of or And get each

treated inhibitors a achieving with are and more or this therapy, PARP more platinum-free being interval. in as platinum-based extending CR their after maintenance PR is patients from However,

still if artificially have tumor. And interval, putting and so patients the pressure that have PARP inhibitor may disease, maintenance selective but that, their recurrent the been technically -- on platinum-free you has by will, platinum-sensitive now has been extended

in nothing the may XX emerging patients same a will, tumors who you if of the days, platinum-free months as this olden X interim. patients So but not their the population saw to had of be in interval

on But there data active. receive patients with so that as are can now you anecdotal And part in out guide this recurrent earlier further right of becoming what benchmark in is. mirvetuximab is patients this more monotherapy, there, more what we will tell program anticipate is, data will mirvetuximab population where I the the understanding quite that based disease be did mirvetuximab platinum-sensitive from category,

And profile quarter, efficacy the so in unmet will and study that's recurrent understand later-line that this PICCOLO help why increasing beginning growing population with this we're for that the an is mirvetuximab platinum-sensitive us need. further

Mark Enyedy

development broader this context just the -- broader and So maybe John, expected to the labels for in product. of the in frame the plan

the Single-agent specifically in so generally range goal that. to initial is chemo chemotherapy. there, So space of in comes supplant platinum-resistant And platinum-resistant market we're disease. combinations, The disease label a of half today the platinum-resistance chemo the single-agent Avastin-based to looking is is with remainder about combinations. our treated displace

really as to was indication. patients, think at followed June we look in that at or first-line with treated and are compelling by carbo-pac therapy, their And PARP there, support as a we data with a carbo-gem platinum-sensitive listing combinations Anna triplet the you space, so as talking got When for Avastin often the maintenance. about, published data speaks compendia the opportunity ASCO to we've that

third-line imagine. When Although about be of the receiving might see get -- to than maintenance platinum-based platinum, chemo. what patients is getting are therapy, you you patients however, smaller of or third-line might is share XX% one only

fit that mirv-bev in. ASCO, had this data so rate But had is think a we in in where And with terms is population there's gap, of of at response again, really either some could could combo with the a third-line a the gap a the big mirv-bev the target little terms in combo a data, patients. sketchy we we that of patient numbers, monotherapy XX% and platinum-sensitive we The platinum-sensitive. remainder of

on patients XX% get in said, of DRG those about regimen. as based estimate, platinum-based a and some And about X,XXX Our physician best are chemo patients there surveys, I is third-line.

that leaves after. go the remainder us of that So to population

Operator

Our Guggenheim with next question Schmidt from comes Securities. Michael

Yige Guo

This is Yige for on Michael.

a have one how I of with mirv a combo various evaluated, with Do on combo mirvetuximab. think so, combo being be quick retreatment of possible I other sequenced? regimens therapies? regimen mirv And some you with is backbones think each could if currently

Anna Berkenblit

Yes.

even So there cytotoxic with certainly nontargeted is for precedent retreatment ovarian cancer. in

talked Retreatment for that very in subsequent weekly patients prior with lot as we cancer. with paclitaxel. may just actually QX-week detail. platinum inhibitor. a beneficial nice obviously, retreatment about like mirvetuximab is ovarian also And is showing So data the benefit tubulin-directed tubulin-directed you a received who paclitaxel in inhibitors payload from of There's know, paclitaxel

of treatment target, Switching repeated show who that of our in of the still action couple received based So there ago the express did of with have several we a then now subsequent potential mirvetuximab years patients certainly for mechanism folate alpha. biopsy biopsy the mirvetuximab cycles and a receptor payload. on after to is the cohort mirvetuximab

not would suggest it's that down-regulated So quickly resistance.

Operator

question next comes with Boris Cowen. Our Peaker from

Boris Peaker

kind mirvetuximab on other with you XXX. another some overlaps time any study studies on On just when how question it, it of comment on we'll be and frame and can PICCOLO clinical the from the of one updates ongoing? mirvetuximab, Maybe getting

Anna Berkenblit

Yes.

future to running. data So key regarding the it's we focus too track our the running, PICCOLO to SORAYA once some this a is Certainly, we're is And with unmet certainly guidance on we up now, forward is can BLA population MIRASOL, Boris. to I a say, up we increasing need. provide think think and timing. early study and and at really trial getting and little the And that people look Right start quarter. from because calls, it's

Boris Peaker

the ASH? also you set point? in disease, understand end want on at MRD+ Got just a regulatory some And it. XXX, as so On maybe conversion to what's can from monotherapy the view regulatory MRD+ MRD- to as data expectation perspective, FDA's

Anna Berkenblit

Yes.

the that So and data all XXX for azacitidine we with at ASH, we have presenting anticipate of triplet the venetoclax.

triplet with recall, combining azacitidine into started may with doublet, with out the dose-escalation. we and moved we then venetoclax, You and

data So profile give we will dose-escalating, that robust set I have, venetoclax good the XXX safety at of ASH, would the will of say, and azacitidine a a triplet, with exploring this as at that ultimately further triplet the and the the in of frontline as relapsed/refractory anti-leukemia supports in tolerability the setting. activity the perhaps setting seeing well development we're point that sense

that the regarding MRD yet different where bit benefit III to Moving your in not is question AML the allowed there was Phase survival precedent but MRD+ a was in for then to - conversion, approval for There with subsequent because a data setting, in clearly precedent that is setting. of of ALL a consideration terms a for drug conversion. prior overall approval it the

did note MRD+ at that assume MRD+ would appropriate not premature that I the I maintenance, azacitidine, a well. when also you FDA. ONUREG patients. would that's do a an population in oral subset little in think so for broader point their for in doesn't get subset so just a And to ONUREG, their the look end study data it's it be approval,

And so there. Boris. would I certainly, clarifies, unmet a there that is say, need remaining Hope

Operator

next with comes Ramakanth H.C. Our Wainwright. question Swayampakula from

Swayampakula Ramakanth

from RK H.C. is questions. Wainwright. quick of A couple This

that major at you're enumerate for saying is at? possible that least multiple IMGCXXX have tumors. in Is at the solid it note On press looking release, of to you tumors the a being some looked you

Anna Berkenblit

Sure.

lung It's metalloproteinase and types highly tumor breast it pancreatic expressed tumors, multiple and of cancer. So cancer in expressed in is ADAMX, and a gastroesophageal including IMGCXXX member is solid other disintegrin also cancer, as across the triple-negative cancer, well. targets which matrix family, --

I generated nice already their tumors, in we've preclinical distribution so solid dose-escalation the expression And data very Phase study. inclusion showing of supporting those across the

We at we well given can that are diagnostic we collecting a ADAMX retrospectively, companion tissue it. tumor need comers, so to types. look immunohistochemistry all then the be in the positioned enrolling on and patients selection patient expression by should we'll develop We're all for tumor ADAMX anticipated

Swayampakula Ramakanth

in timing clinic? to can of it data? before Any all XXX, work done a then And also launch terms we on regarding the needs Just that. be what at follow-up into

Anna Berkenblit

Yes.

in escalation, year, which point we'll safety interest. at timing and that for we early II a recommended dose a we're next anticipate IMGCXXX, sense tumor greatest types and of So data dosing of Phase have the are

what doing Moving to perspective. need to and year. a the bits before CMC XXX. of We're the and We're the file from bobs on track tox a of the end to IND we last perspective

Operator

Andy with Our next comes Hsieh William Blair. from question

Andy Hsieh

the Congratulations on all progress.

Mark Enyedy

Thank you.

Andy Hsieh

start that just this can achieve trial enrollment clinical you just PICCOLO planning I with and how are of wondering study you network regarding quarter, given much study MIRASOL? to existing optimization the the sites SORAYA So am for your

Anna Berkenblit

a I is XXX lot answer globe. sites mirvetuximab now given well studied sites, think in short closer that the we've around XXX over throughout the to

like So high and high we best SORAYA with did clinical best participate picking population who the here. have we're data site and we're, patient volumes that's and the appropriate GCP the in again, of patient have following MIRASOL, with quality, trials

Mark Enyedy

experience And our with drug.

Anna Berkenblit

Yes.

Andy Hsieh

opine now. Right. ADC taking And or Anna, of In That's Myers going investment future pipeline, should at maybe month. the you also earlier on we a successful folate have the Bristol can collaboration trial, perhaps assets you that announced looking kind R&D this about And Mark event Eisai the X forward? receptor right helpful. and think also how was view SORAYA of macro a the on space, maybe

Mark Enyedy

Sure.

we and going talk let about we're business. I'll Anna maybe So where tackle landscape competitive in can the the then

Anna Berkenblit

Yes.

in receptor folate say alpha is What publicly consider their as in So this treatment MORAb-XXX, do, is validating are, at the of an in really point, for the a data BMS-Eisai that site single limited terms compound, deal would to cancer. target available that of important Japan. we the we recognizing, I them

As cytotoxic for which is naked breast you their failed approved up alpha they eribulin, recall, may that their FR later-line with have farletuzumab linked is antibody cancer.

dose types they And to data in tumor so certainly in known the activity express based escalation in that from folate alpha. have Japan, seen one are on that site receptor

it And for our schedule, in And think sites, a have agreement. and dose from currently They the a clinic chance to at more so will. know alpha, as not to validating handful and soon field really us in yet address mirvetuximab dose-escalating. as excited recommended don't because preclinical really of it the only a that population certainly, get has FR their U.S. their our makes They for designed the that foundation open that broader them. further IMGNXXX think follow from I to II alpha-positive much study, a we'll move formed perspective, even tumors but of FR possible on Phase really but the I are we it's is data than

Mark Enyedy

I'd programs But in business, the in particular, And well. the Andy, X we and the class chose And we may that we a recall that in for to future years, we shelved. So payloads chose new X say, we the XXXX, at have terms you time, been we that have when so last over given of developed. programs restructured had direction forward. of back internally camptothecin progress move

success this and camptothecin will development of to as we so move SORAYA, And some and, the programs the payload. in look with pursue shelf additional be particular, objective off those ahead in

payloads inbound interest interest broadly with ImmunoGen the of in this linkers class. amount platform and fair We terms to new have and specific of respect a in

us an with In would good an identified that folks the approach for continue think we to co-development have antibody be addition they collaborations ADC. they've have we relationship to to akin that where candidate that, a about MacroGenics,

those ongoing are so And well. discussions as

a following antibodies our expect, portfolio, ADCs. outcome expand positive do novel to the levering technology with combine begin to we so ability to generate our in to existing SORAYA, and And

So it's absolutely direction that the we're heading.

Operator

from question Our comes Capital Markets. with Kennen RBC next MacKay

Unidentified Analyst

is Sudan This Loganathan Kennen's on [ph] team. from

then there use to that of population alpha conviction kind target indications. discussed ask for COVID-XX that's kind physicians guys to for for the a that ovarian the the confidence kind of mirvetuximab cancer monotherapy kind and for could the benchmark any kind of a of already where you to study the going of just as FR could there single-arm then the And other then class? other what just is be wanted And into kind what PICCOLO enrollment kind studies monotherapy how some I give headwinds forward? on question first, a determined for large-picture monotherapy? macro physician see comes the So of to kind the of of been or you the secondly, pipeline amongst as grow So would from from on a headwinds that environment some of

Anna Berkenblit

Yes.

So is PICCOLO the benchmark one. question important regarding an

whose and BRCA-mutant the tumors of mutations sensitive are frankly, targeting at later-line if these with platinum-sensitive return. actually, they diminishing exist in and benefit, very again, really So they platinum multiple lines they're disease, get patients BRCA who patients each the we're didn't those patients platinum exquisitely small and are who to ones have or a get and because past did were can to numbers mostly continue

I benchmark a relevant So BRCA BRCA -- incorporated single maintenance XX%. for out that X XX%. but and are over just in second- untargeted is. XX% admittedly, include platinum-sensitive is response I'm is papers now agents appropriate there and rate be to the even there, the the for is that nonplatinum Guardrails-wise, disease in mutation, our say, there that on HRD with less, now, an for firm there benchmark. not where older evidence the are to next admittedly response that benefit And later-line of what who X to later-line populations platinum-sensitive a in also about Level still year light shed would data And fashion, those disease. are priors have I to PARP very third-line that platinum-sensitive the the more support out or from less will are so patients and rates mutations coming data being interested knowledge, in this are, no, will personally are

who've is patients response platinum had prior XX%. in the If XX%, line, doublets just about rate you look at X

why these anecdotal So dropping your first based we're we again, is and each line question. was have, this for about really this of with therapy, we And a high the unmet that potential mirvetuximab for population. it excited there's patients. data believe need quite imagine on in That the

indications. question second Your was other

mirvetuximab, a high-grade monotherapy for are with a is serous in in cancer cancer. So we of endometrial and endometrial pembrolizumab. One couple supporting in trials investigator-sponsored one combination

We suggests have some data endometrial an additional already be for target. cancer that in mirvetuximab that would monotherapy interesting

recent with be ovarian delays surprised treatment. say care I for COVID-XX Delta think we've if to working be mean your think because now already we're also year, the patients lung good frankly, cancer and from during what at impact variant IRB the breast in sites saving necessarily emerging contingencies. are COVID-XX guidance IMGNXXX. But need paperwork those was I our I I it is And really be like I'd wouldn't regarding meetings, triple-negative it's trials hospitals question then we've don't last working and the people with if this cancer recurrent are how there around headwinds. cancer Yes, going patient policies. their headwinds. COVID are, to aspect turnover, CDC But will home. gotten there masking, clinical interesting of contract clinical see, experienced, changing through some over may and past with managing

Operator

with Shi comes next Jefferies. from Kelly Our question

Kelly Shi

and patients? high alpha patients experience, unmet the the platinum-sensitive trial. in that you I a also to are third-line stage, drives include -- alpha large FR there at patients, also, needs mentioned based is area PICCOLO what this given FR intermediate drives question in actually mirv have What on previous the only this for

Anna Berkenblit

higher more the We now studied Yes. alpha over FR patients, expression, shrinkage. well having and tumor deeper in know, mirvetuximab durable the the the XXX

that where patients population. study mirvetuximab that that's of in of FR can want most, It's expression, expression. the medium probably of field and it's archival really based But we So about FR platinum about which are of that's trying the to the to alpha go with with in or the be to the active XX% benefit choice. with move tissue. the absolutely from we potential on the we're irrespective And sensitivity the XX% its is I forward FORWARD resistance. patients really tumor chemotherapy. same activity terms agent alpha high know single-agent right you And and is We have

Operator

comes question next with Sandler. from Our Catanzaro Joe Piper

Joseph Catanzaro

Anna, to experience population patients, and think could with mirvetuximab. commercial any in potentially extent impact reason sensitivity prior launches and whether to cash Phase it I then maintenance exposure potential you that the into specifically mirvetuximab sufficient mentioned And extended half I of the the around there's just guidance in both that PARP PARP wondering subsequent platinum-sensitive is to second with and, the what regards of XXXX, being inclusive of that guess, and mirvetuximab XXX? of just

Anna Berkenblit

Yes.

a and PARP mirvetuximab. quite that at we've program, certainly So recurrent would that's the ability to reason see interfere a but the PARP or look there is, for PARP with nicely a do mechanism. damage not had with Throughout a surprising mirvetuximab. repair data at, And who've we believe disease no tubulin-directed Joe, anecdotal agent. when our and have there's limited I looked we we cross-resistance inhibitor, prior say, DNA prior platinum-sensitive encouraging. And inhibitor inhibitors nice very patients activity there's very have, are whatever trial patients, in because to our experience, had who

so And seem the prior again, really mirv. PARP of to doesn't efficacy impact use

Susan Altschuller

strong with be I'd then. additional includes positive year-end XXXX, on will and that We've BLA capital We Great. formation been But That we're ATM feel We're a the readout, capital adding looking supplement for that we're on in issue. guidance -- XXX. place. prep of facility. between cash both we a from mirvetuximab commercialization now work the prelaunch our second the filing, now. said, and focus for goes for don't that half spend think that into ways to and an And

Mark Enyedy

what of Susan to just of terms little saying perspective. what Maybe we're a doing from was point an operational Yes. put on some finer in

those sales force medical numbers include buildout includes production So build. function. the launch affairs for of It inventory business, of the additional

the of launch organization that fully into a year. in baked is drug number ready formed to half second the So the

Operator

question comes with next JPMorgan. Our Jessica from Fye

Daniel Wolle

a observed Daniel here is maybe for differentiated AML in you Anna. driving what question could in we've be CDXXX be for outcome two as differentiated frame as benefits Maybe been XXX This Could the and Targeting how AML? a for hasn't Fye. effective BPDCN. us antitumor Jessica in those can settings in

Anna Berkenblit

Yes.

what is expression. CDXXX toxin. has or think SL-XXX, a a the is activity the approved highest I protein level And BPDCN tagraxofusp It's you're of of to with for diphtheria ELZONRIS fusion which referring BPDCN. CDXXX So or

it's going quite if experience going AML to experience disappointing. in appreciable with didn't there. That have their was anywhere, So IMGNXXX. monotherapy to it's They monotherapy work work in contrasts our think activity really with AML. I And

may at the presentations had ASH, highly reasonable couple It You very meet nice of a didn't fast-to-approval our single-arm relapsed/refractory oral showing we've now bar active. IMGNXXX monotherapy actually for CRi. AML quite quite relapsed/refractory in for certainly recall strategy in with activity setting, a but

because is Our have a as AML, frankly. think we active drug monotherapy and a in just highly it's I drug, better

Operator

Our next question with comes from Canaccord. John Newman

John Newman

line current for it in in be a more mirvetuximab, them a and data reasonable Mark timing for line top prior a third could the look will But pathway the accelerated for question that on assume to this top A confidence to in probably about the there's the for but given I quarter the isn't which data SORAYA? on Perhaps little based MIRASOL, at a question XXXX, get the lot for of believe, of calls MIRASOL, difficult and FDA program, approval early approval XXXX give then to able BLA answer. submission Anna, been noisy. is the conversation accelerated

Mark Enyedy

Yes.

there practical question the perspective, ask the E what and overlay So file looking I that. considerations environment have is the that regulatory And and you to deconstruct a from then what ask demonstrate here? But we study, standard under think regulatory benchmark for response about Subpart this -- question, for The which point gave at approval. then over accelerated terms The our the substantial of a is available and primary therapy. the rate, is response. looking duration improvement us secondarily to FDA of end in overall

filing. action to regulatory we And from that SORAYA, basis criteria Subpart E the the generate delay so under those data for the if there's we meet FDA no with on

standards point. those first think data certainly again, the will the think to the meet But that will are applicable decision ability we MIRASOL on are going SORAYA data the basis they and positive, mirvetuximab. regulatory bolster the we're for action. be that's for base make approval, decision we think at with their available to if think here would Yes, what are time I of regulatory yes, positive, and those and the a that criteria I regulatory So accelerated is be

Operator

queue. turn showing to questions the call back Mark like remarks. any other I'm closing Enyedy no And for in the I'd to

Mark Enyedy

much very look much, and to quarter for you and updated also on today, thanks have on very readout keeping a time Thanks Great. our data ASH. to fourth we a XXX your at nice and forward Well, and progress SORAYA weekend. with

Operator

you This concludes Thank participating. for call. conference today's

disconnect. now may You

Immunogen (IMGN) 30 Jul 212021 Q2 Earnings call transcript