IMGN - Earnings call transcript Q2 2020

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Operator

Good morning, and welcome to ImmunoGen's Second Quarter 2020 Financial and Operating Results Conference Call. Today's conference is being recorded. 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 can website at This of Investors a and immunogen.com. Media be call & our press the found of web section under release this stream Chief Financial today our Officer. Mark Anna are Susan and me our President Officer; With CEO; Altschuller, and Enyedy, Berkenblit, Medical our Chief

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

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

Mark Enyedy

morning, by for in Thanks, data execution, the COVID-XX everyone. today. Despite in you marked of performance presentations environment, important our milestones. And was us sound thank challenges quarter joining operating the regulatory key and second Courtney. the Good

top and of an MIRASOL on longer time, of BLA. the business in remains and Our SORAYA studies actively already both previous data highest in slower-than-anticipated expect given portions priority for approval we earlier companies, QX are enrolling patients XXXX. a experienced we in is readout second the submission mirvetuximab both however, and for start from of Like BLA are other mid-XXXX. continue pivotal MIRASOL. the completion the site second we conditions particularly for limited complete, and mirvetuximab now That said, quarter. Europe, guidance to during half studies be improving, and reporting supplemental a versus our XXXX initiation large of week anticipate six we results With estimate With of delay of eight accelerated for a track to SORAYA these in to in lead line that for filing line the top

serve ASCO. as and These data a the to FORWARD for choice virtual at of agent thereby label mirvetuximab end, in cohort of presented II ovarian broader for from status needs a patient recurrent approval expansion. are Avastin combination considering regardless oral mirvetuximab, the the we of initial encouraging the this meet To demonstrate data expansion the Beyond potential we population within presentation cancer. of multiple options platinum

MacroGenics programs, Moving share pleased to for IMGCXXX, ADC, accepted BPDCN that and which our we has application what codevelopment drug XX/XX earlier has morning a when Orphan the the Koenig are in MacroGenics. positive codeveloping thank IND Scott looks you quarter. treatment study in Committee the a great forward this IMGNXXX designation programs. team fourth opinion Medicinal is ADAMX-Targeting patient grant enrolling with look We are the to the stage good FDA for partnership to we example first adopted with and first-in-class EMA's to for Products delivering it orphan then our I comes in I like of IND. entire the of for Phase the their This to

in In presented AACR receptor various support its cover this into FRα more preclinical our program compelling generation addition, in alpha exploration advanced next tumor data a moment. at will ADC We further preclinical IMGNXXX, Anna that detail types. positive anti-folate in development.

Susan ImmunoGen to most cc our Stacy and are to welcomed Altschuller Chief Officer. Business we as our Financial Officer have Finally, Coen Chief recently pleased as

and a Susan our commercial transition experience strengthen with addition to and management to business. Stacy team to support energy, great skills In our invaluable

to like ASH. ImmunoGen to that, earnings carboplatin in to and back combination the to cohort her over cohorts year, for with I'd evaluating combination be half BPDCN in the and With our our mirvetuximab we at platinum-sensitive monotherapy with we mature discussion As from AML look turn disease at will the Susan? in financials. and Avastin her to from the data ESMO on progress Susan this and welcome cohort presenting IMGNXXX first data triplet review of expansion

Susan Altschuller

Thank I'm stage the joining the biotechnology company's the with look time forward and ImmunoGen company. be novel as I the evolution. advance team an commercial ADCs. next in at ImmunoGen transitioning important continue to generation such excited cusp to of working a to our you, rest into portfolio Mark of Mark. is of we on

Moving in second were release quarter details of included press this to our financial morning. which the results, our issued

all of quarter revenue, second which $XX royalty nearly the revenue. For generated from of in we million non-cash came XXXX,

were lower due XXXX to our quarter to the costs the and second greater $XX.X for for of compared for second the at related studies. of mirvetuximab, SORAYA administrative million in fees second expenses year. $XXX.X lower increased advancing Second partially allocation quarter, $X.X to charge. offset by office decrease personnel This million were million million we quarter R&D in $X.X the cash. million clinical restructuring to quarter increased higher million and $XX.X quarter restructuring prior the trial partially the compared Operating XXXX a quarter the offset facility-related to laboratory and expenses After for for second a expenses. second from $X.X of expenses was to XXXX $XX.X and million space, have quarter XXX access million expenses professional General expenses second of the operating of expenses $XX.X compared of $XX.X This XXXX. the of end by million. resulting business was driven by included the

financial XXXX unchanged. remains guidance Our

$XX be platinum-resistant We be is commercial year-end between and launch. to at and continue related ovarian and $XXX XXXX and increased support for revenues potential $XX ImmunoGen accelerated million, in cash investment and million for our million million. preparing to potential to $XXX and manufacturing mirvetuximab for is planning $XXX for expect approval cancer in between operating $XXX to our to million, expenses be million between

more will With the addition I'll second in progress anticipated quarter the Anna operations turn XXXX. review Anna? our to call the of current into these cash detail. With its company expects fund that of and partners investments, receipts from to clinical over cash the that,

Anna Berkenblit

and trial the latest we with I'll our have Thanks, for by regulatory nimble to mentioning clinical our IMGNXXX and consistent and program. enroll in guidances sites our registration approach to activate mirvetuximab Susan. begin that continuing execution, in trials a patients maintained

Regarding mirvetuximab, aligned our pathway alpha received Avastin. monotherapy women SORAYA, we you'll an who scoring for XXX platinum-resistant as PSX+ single FDA have cancer via evaluating whose high with that, in approval in approximately accelerated ovarian arm on are mirvetuximab measured receptor with late pivotal of study the method and XXXX, by mirvetuximab folate previously tumors recall

are six As anticipated week site enrollment result the in a activation COVID-XX to Mark delays mentioned, to eight delay. related

are QX US that we confident support potential this in the quarter momentum both Europe in XXXX. and we and However, approval top to gain will data in XXXX sufficient line

continuing sites of Phase MIRASOL, in patients mirvetuximab, additional open We enroll our to and year. launched are confirmatory which in last III December study

patients randomized XXX one a receive alpha been who ovarian will one MIRASOL treated with to As folate-receptor will Patients have reminder, with up to to cancer, regimens. enroll be high platinum-resistant three approximately choice response and investigator's primary and pegylated the mirvetuximab liposomal are overall rate, patient namely secondary topotecan. or endpoints or an reported chemotherapy, The progression free overall doxorubicin outcomes. of paclitaxel, survival survival endpoint is prior

this support to of We in continue for top XXXX. anticipate XXXX study the to first in approval full half line data

regardless presentation, this and in platinum virtual given folate-receptor and FORWARD patients evaluating II ASCO date At were compendia efficacy status. carboplatin high doublet of choice data initial for in longer bevacizumab encouraging rate combination combination. oral pursuing with combination with highlighted of and combination durations currently Turning bevacizumab in we triplet support of to treatment listing, are with therapy, and of expansion cancer lines mirvetuximab cohorts observed and with in serve overall our in expression, earlier expand alpha ovarian the tolerability ovarian recurrent an mirvetuximab, meeting data as demonstrating of provide response to The cancer. into and in in responses label generated favorable profile, the an May, formal we order are safety opportunities to a XX% studies could evaluating

we present ESMO trial, Looking randomized to combination mature data of of the platinum-sensitive September bevacizumab look platinum-sensitive triplet disease second and Phase in at initiation plan mirvetuximab ahead II evaluating from to the with FORWARD II mirvetuximab half combination in a cohort, in the sponsored supporting investigator carboplatin and fall, in the evaluating forward in carboplatin year. with to

continued stage solid types tumors. in we and hematological to to range our malignancies target of that both programs tumor earlier a advance Moving portfolio,

monotherapy therapy the look December. progress and induction progress We with BPDCN in at in AML cohorts and patients. combinations positive the combination on cohorts BPDCN frontline cohort forward to continued from in and including and expansion We relapsed IMGNXXX, expansion with venetoclax monotherapy presenting AML minimal multiple data monotherapy IMGNXXX following ASH azacitidine residual AML and disease refractory to

of development. our also to We a alpha tumors broad target designed folate-receptor ADC range with moved expression into preclinical IMGNXXX, next-generation

highly back on including increased of independent epithelial peptide enhanced enhanced derivative, demonstrating tumor potent high, half-life virtual in the bivalent, to biparatopic for I'll expect a reminder, ovarian, in a file with vivo FRα, an As and activity. by endometrial, asymmetric, FRα XXXX. linked in AACR in low IMGNXXX, longer a FRα xenograft half to antibody that, anti-tumor human the cancer, negative epitopes models the induced forward lung levels in linker Based models With two data we these the clinic of and call meeting of vitro activity IMGNXXX complete IND cell breast second bystander preclinical triple both non-small to and Mark. and DMXX, the in cleavable IMGNXXX positive and At targeting turn regression in stability, we on June, to IMGNXXX malignancies, presented with of in comprises exploring with multiple those medium expression. data, look maytansinoid

Mark Enyedy

with And that, Thanks, Anna. open the Operator? for call questions. we'll

Operator

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

open. is line Your

John Newman

SORAYA for just the in Hi. much taking some study past several any the Good Anna, they've question, in curious for morning, and accommodations question. months. due know allowed has that maybe issued guidance guys. to FDA if Mark the Thanks my We very COVID. this

we just have For drop patient be perhaps to if COVID? for which then, for in just have and triple explore able a beforehand? think question, out additional you terms an in regimen should that Thanks. the enroll as if two you carboplatin is or might frontline to more or you have combination frontline example, mirvetuximab an about And someone would likely curious be that ultimately additional of the would mirvetuximab, it

Anna Berkenblit

Thanks, John.

could and because XXX combinations terms are some patients for find on turns and are we cancer COVID, trial So, and To who with way cannot combination, really ovarian designed, FDA. need out have patients. activity that primary comply potentially it is platinum And efficacy point platinum-sensitive is patients evaluability exciting we the we ensuring FDA protocol-related saw of follow-up If in would is anticipate ill for potential mirvetuximab/bevacizumab amending baseline second a XXX with analysis. in evaluable approximately based patients this discussing But we COVID that will recurrent the combination the regarding scan. ovarian quite protocol the both SORAYA, of typically, and/or cancer. to your resistant have evaluable procedures, we there have and the in because

So, about the be this doublet. it platinum-sensitive certainly platinum could in frontline outback of resistant development in disease, an setting as even doublet, also disease, maintenance thinking in

it this and we're figure really potential is out form now a of lot hard label that to strategy of why doublet. the So, for has working expansion

on are In gathering data more mirvetuximab based doublet for that an be I encouraging the really Phase addition, platinum-sensitive from for disease. appropriate again, we data – escalation, for certainly and recurrent could plus dose upfront carboplatin

Our focus IST this doublet running colleagues year. get with that and is our later in the Germany to right now for up

Mark Enyedy

ESMO have potentially just that we go recurrent think in think to the looking evaluating so, to follow-up even the the about neoadjuvant And triplet, the setting. we'll setting your and data we'll would upfront at at approaches different I maybe question the practically in where and and on about be

with from discussions the key as ongoing those that at our the advisors. I initial cohort. will data are So, ESMO say, triplet are have And mature

John Newman

you Okay, great. Thank very much.

Operator

Instructions]. [Operator you. Thank

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

is line Your open.

Kennen MacKay

country Wondering does taking the majority slowdown QX least to so in shut if in of you back guidance being seem for the what us is into impacted. question country geographies here. various but little like you're the much. opened But was here opportunity are of while. file at Maybe enrollment really that now to Hi. COVID-XX are hearing giving enrollment, for questions unprecedented new just time with or in on up, really is slowdowns Thanks on a timelines the building it in down several still technically and stay. the so obviously, sort much Thanks geographies the work an

Mark Enyedy

March. a Thanks, the we strong Yeah. high of started because late initial Kennen. At level, onset heavy in approaches lot the site part place a filings to before and took the mid to in

what But they to terms in like. observed was access personnel we of the bit the we as responsiveness, so, at slowdown than a site essential were people ahead level, particularly were closing And other a the curve. during little the sites the quarter and of

particularly course we quarter. US. the we mind We And so, site, around that approaches Europe at is the that's the paperwork keep basis implemented many over see and in sites what the enroll the that which, all particular, turn second – in a as like. in of and in could do some People really we reopening administrators, patient on innovative expect studies patients on in access. these the we screening, are of in saw go-forward the in Correspondingly, Europe terms least as what around to of

factored to have the timelines a in and we've is and acceleration so, particularly of we've the looked Europe, what relates the as at in as that's activity, of of And we it impact study study here. seen resurgence what late

And see week eight about a this so, really delay is point. we to six at what

Kennen MacKay

the Thank you it. Got for questions. taking

Mark Enyedy

Sure.

Operator

you. Thank

with from Our next question comes Andy Blair. William Hsieh

is line Your open.

Andy Hsieh

taking for Susan well and Thanks question. Stacy. new I Excellent. your hope congratulations my roles, on everybody's and doing

MRD+ kind AML opportunity the of So, interesting. is

in paradigm. my the understanding of XXX in treatment just to where terms want So, check fits

you So, getting patients have induction. basically

patient particular approval. azacitidine gets think MRD recent how where this then he if based the oral about XXX on of that by kind induction, you positivity, has Following fits? it Is followed maintenance

Anna Berkenblit

the and not It's to are although maintenance the also our in a we as just was we're we with option. with given maintenance Certainly, for that well, design trial early ours. maintenance tolerability regimen a outpatient, it disease be combining azacitidine three and too best could the that as paved their than here are be monotherapy but days. It's So, the exploring has we convenience Andy, perspective from that regulatory short tell, as really weeks as azacitidine oral pretreatment, different every a AML. it seen an IMGNXXX clinical excited perspective has And but potential way option option, once a bit think of well. we've MRD+ infusion potentially the IV and early to also patients another a for

the others. days, of the thinking it is So, it one Andy, options you're there, certainly there about early but and way are

Andy Hsieh

as the Got And this a to maintenance it. including clarification. half potential option a of of the lot there's plus moving the Thanks for in parts, back mirv, Avastin second PARP year. of

that in about also, that, forward, of to patients very the think trial incorporating how And of to the captures part trial? treatment kind the well. about kind make option about of could curious future PARP just triplet related current So, to of as change the maintenance paradigm an but Just kind ESMO excited that some design. data, as have for going do sure you

Anna Berkenblit

Yeah.

that So, out Andy, you it. you about let some we're the there, unpack concepts and me just of tell laid how thinking

that with rucaparib is nice looks Avastin. There's mirvetuximab quite So, yes, a performed PARPs pretreated an data patients. we that in and very with the Certainly, being showing have are Avastin IST for data option. also as combine with we maintenance heavily potential good being combined there well

forward So, we more inhibitor. to with a data for do look mirvetuximab gathering PARP

benefit HIV really patients PARP the think evolving then the in think either most terms BRCA those negative as of you the to groups, to and PARP benefit field how patients much HIV+ don't about rapidly from certainly trying to from somatic, is benefit understand broader I patients, benefit inhibitors. inhibitors. PARP when which once sequence the inhibitors Then you or germline that most get mutation the therapies. they quite But well. from patients,

need high So, well. the unmet remains group as in that

out of that because trying therapy dynamic optimistic tolerability the generated the combination in I'm So, combination we've I will the in think integrate landscape. figure lines because to far. how profile best become of of earlier mirvetuximab partner still mirvetuximab to we're choice thus of

to point no are inhibitors. after other that inhibitors that The there work PARP data is PARG note showing

after setting. with to a that, So, the will patients PARPs therapies role And mirvetuximab our maintenance play ovarian for going need cancer. then, additional and large will that sense be used in upfront effective patients are is

Andy Hsieh

That Yeah, makes totally Okay. sense. right.

what's a depending looking come, of segment got ESMO, super the XX% which response to high rates at. last you're glimpse in range for on week, XXs, So, we

What are approach some for things about? as mostly of what excited ESMO So, to kind the things are out conference? you're we that watch the

Anna Berkenblit

Yeah.

No on feasible. of it quite survival and of this So, based year. is data. see and rate, as response mirvetuximab, you and last the so active triplet carboplatin follow-up, active we're response you'll is doubt duration going you is triplet Avastin progression-free saw to duration that this year, show doubt no And longer

get of are and there carbo/DOXIL/Avastin. three think them really out Taxol/carbo/Avastin, And there. do that other there's used, carbo/gem/Avastin I triplets

And how best and our Also, where will patients so, could frontline be settings. the triplets integrated these typically, are it work. triplet in serve additional thinking used about would require

a will be large commitment long for that big ImmunoGen. so, trial, And a

the regulatory But focus role. we yield So, triplet as think about management, perspective. that patients a important from will our for is benefit sooner expansion label lifecycle an strategies for right could now, near-term play

Andy Hsieh

great. questions. taking for Okay, Thanks all my

Operator

Thank you.

question Debjit Our comes from next from HC Chattopadhyay Wainwright.

is line open. Your

Aaron Welch

guys. morning. on for Debjit. the taking for Aaron question. is Hi, Good This Thanks

once data? the completion clinic we get on So, be are pivotal the becoming patients line you at with the evaluation the expecting how And that patients top follow-up difficult and studies? inability And the ongoing because enrolled, the to complete any the is of either might should from to effects readout data missing from deal to sites? of scans of of

Anna Berkenblit

Yeah.

they that be once their are the will all anticipate will If Mark not protocol enrolling dosing seeing to done. the we they're mentioned, and from arm evaluable. be sites they patients to patients open every open they're sites as suddenly get get enough able can momentum. control mirvetuximab weeks of the point scans don't we're anticipate MIRASOL, on regaining that required or be the And to do arm So, for screen able for the to we them for assessments three that and eligibility patients,

mentioned additional are earlier patients efficacy analysis. the to not primary we in some the adjust call, certainly enroll evaluable, number ensure I As to the options of to patients have that have turns there for if patients that sufficient evaluable who out it are we the protocol

Aaron Welch

Okay, right. great. All

responses to unconfirmed tell can converted have point So, the at at ASCO reported II the you in study, that us [indiscernible]. those if responses FORWARD confirmed this were

Mark Enyedy

don't we to Yeah. clear, responses. unconfirmed I just want be report

are confirmed responses our of All responses.

So, there's This way is we is all it. solid were there. put rock our Those how nothing approach the data to best to update of publications.

Aaron Welch

good know could And last, there said the really great. that That's to taken drops job done Okay, mitigate ongoing have good toxicity pivotal X issues then, I to or the that you guys X and know. grade of steps of are steroids studies. any tell administration you in – the lowering being ocular events. lubricating a

to patients So, are is evaluation there any they have of those given prophylactically of if issues proclivity any see and updates any being for sort ocular there? or

Anna Berkenblit

been mirvetuximab patients. So, has XXX studied in over

We understanding very ocular mirvetuximab. have a for of good profile the

separate the start. events of had almost given development eyedrops any trial we low. discontinuation I, benefit due we blurred fact, We early adverse demonstrate for Phase trial the saw patients all FORWARD ocular to the discontinued grade to lubricating the entirely did, steroid of grade. even low in had that corticosteroid cohort rate And ocular it one is The extremely was patient the therefore, events. ocular with eyedrops III the all did adverse was that, only from to those And vision. a X of that initial who it drug in got our In III in and patients patients. Phase And minority

really continuing ocular on generated we these management are adverse we've same nice far, with the based events. So, the data thus of

if at basically that patient eyedrops lubricating XXX only you of then, discontinued modification. a have for vision steroid a blurred can patients had So, And we requires is handful adjustments, some with a to due dose again, And everyone. having blurred eyedrops, that, vision. of least

Aaron Welch

Thank context. you. the for Thanks great. Okay,

Operator

with question comes Biren from Amin Jefferies. next Our

open. is line Your

Biren Amin

tumor on are Thanks US accepted for types Which in just X the my start announced, has guys. you plus trial? plans you look at? I the XXX, trial? I'm What going assume the Are to Hi, the IND Maybe to as also next you I/II a think, FDA. H-score X would in Phase if just taking by could incorporating I of this be terms design. going questions. been

Anna Berkenblit

Yeah.

target So, is ADAMX antibody metalloproteinase for drug novel a matrix conjugates.

target. we the later into year. Ours planning And, this get it the are yes, is this first addressing clinic to

high now lung be escalation, in will And cell ensure will X folate-receptor we the from learned assessing for includes based XXX on based escalation. or that that deep do X, of gastric, yes, our we levels ADAMX ADAMXThis that solid of drug benefit based cancer. solid we development We preliminary express patient standard antibody triple will anticipating dose patients most these immunohistochemistry. in handful see different more plus cohorts the a selection biomarkers negative one And, lessons in tumors tumor apply by and a this we we'll pancreatic we efficacy that cancer alpha breast experience types will cancer, that our conjugate, of know on dose in on experience, have select those to expansion to of non-small

Biren Amin

follow-up BPDCN have on, about a expect? some I just combo monotherapy you identified type I would talk guess a you would the to IMGNXXX, you're how do and – data And have, announce, then, II I cohorts think that in with? move data have as the should you And of announced see forward that we'll many where maybe I signal ASH. just well we going you both expect you guess, in we dose Phase what patients, as Can would cohort at AML. guess, to And

Anna Berkenblit

Yeah.

well. data. has So, to for go monotherapy about really enrollment XXX, we're excited the BPDCN continued That quite

as data progressing. we we're and triplet. the with XXX combining combining are a know, combinations we're all we're The azacytidine, those have combining share combinations, at you with that ASH. And we'll as so, And venetoclax,

but say we made point. I us premature to Phase certainly that progress think at probably will we've the II ASH for we've declared that is dose, that a share recommended

Biren Amin

taking questions. my for Great. Thanks

Operator

you. Thank

Peaker Cowen. Our Boris with question from next comes

line is open. Your

Boris Peaker

morning. Good

about just I and trials. want the ask to SORAYA MIRASOL First,

of in appealing Just Is requirements environment? patient terms differ do another? patient other burdens in than COVID they curious, any of patients follow-up or to the kind how one more

Anna Berkenblit

terms of had in SORAYA prior an that The so follow-up they appropriate SORAYA and are So, are In patients trials prior have difference such the may trial that perspective and only is MIRASOL, Avastin, of for procedures, a burden as MIRASOL clinical have single patients from or may patient identical. between must agent Avastin. mirvetuximab. not had eligibility

other a is The single study. arm difference that SORAYA is key

a to is enrolled getting is So, when so chemotherapy. get patient on SORAYA, trial, mirvetuximab. XX/XX to choice chance one, they one know will randomized investigator a mirvetuximab going patients MIRASOL have they're of a or

Boris Peaker

and Got you like. a of for a question talked kind get boil When is look pivotal down of when you. moving the just think pieces, pivotal leading mirvetuximab to My sense might several what options, combination. the and kind we I of of next study triplet timeline study that about want lot on you certainly combination

Anna Berkenblit

in patients mirvetuximab the working bevacizumab two for expansion that label on cohorts. combination XXX generated options the data through right We're for plus We've now. based

label that is, would lead the expansion. for call, really So, prospects I

triplet, randomized with survival. put such trial for ground high progression-free a rate additional in therapy and know, strategy generating label for our data I with of patient before present the large triplet would was we you type the stick of in of would duration data or imagine the size it our part With for and and ESMO cohort response long the that. we because that. Again, XX any a long And at we'll expansion updated as XX triplets for consider

Boris Peaker

you do Got advanced you just you. you what to the in could study in arm And patients ASH, approval? to lastly, BPDCN it acceptable response need these for for you're mentioned, you kind comment be obviously, show be of study, on presenting single rate going to at a think

Anna Berkenblit

think, essentially of, So, But out relapsed forward in was the CRC, CR and Alzheimer's FDA very disease, what question tell XX can in CRs, label, you discussing year. that it to refractory we I were is that two I patients. there later this look with

the think pretty I low. So, bar is

Boris Peaker

Great. much you Thank taking my questions. very for

Operator

Thank you.

with Our Guggenheim. next from Schmidt comes question Michael

Your line is now open.

Michael Schmidt

I the guess morning. interesting for Good just I to pre-clinical see questions. comparison of IMGNXXX. that and contribution may you have the that the think due to to is mirvetuximab. curious compares I used comparison, one to was It information more was if just on was used some these that how the had improved Thanks how antibody DMXX biparatopic about curious additional on to toxin be I maybe being versus how legacy toxin guys. my toxins Hey, and AACR taking much the different recent in efficacy. the mirvetuximab. type

Mark Enyedy

point bit think little Michael, Yeah. a out tease hard individual it's I this at the to components.

I we're improvements think multiple what into is integrate able were most to proud we that molecule. of that

to more linker tumor payload so drug we So, the more first in stable, get complex is the the instance.

also the We cleaves off DMXX which have effect. bystander improved active design mentioned, binding which the you metabolites, and improves internalization, improves as efficacy. then, around And

of all those really things together. it's So, working

efficacy, data folate-receptor alpha lower we based element was I'm of the key impact particularly experience a from say individual And which cell isolate the lines of to so, criteria could is. the models see an with is But sort levels sure what we those not and here improved with clearly those clinical design in mirvetuximab. expression, what on significantly

And so, that's how it. we're thinking about

levels as so, lower at look other also, characterized we But patients And alpha within the folate-receptor expression. what a we look tumor of at of to here, picture is expression. lower levels are address obviously, those cancer, general see gives we with with in us ovarian types when big chance, it

separate to an effectively more us those gives address this So, opportunity indications.

Michael Schmidt

great. just Okay, on And ovarian one then, Thanks. cancer question competitive landscape.

such with a Just receptor expression other wondering antigens if example. it's known as NaPiXb degree to folate overlaps alpha for what

Anna Berkenblit

And know that the folate for patient question, with expressed they that XX% of in receptor alpha it's of they data ADC any certainly, high XX% was Yeah. XX%, published is patients and aware from folate that the use answers is see of I ovarian I'm alpha that about sufficient did Genentech in not over expression, the also expressed molecule. receptor over of the selection didn't the – that progressing think benefit cancer continue also mirvetuximab. to we in activity really NaPiXb, NaPiXb ovarian who not most cancer. patients ovarian Michael. XX% stopped NaPiXb, development and really strategy cancer But

NaPiXb, with or Mersana's strategy this not with to high they clear it's Now may point me not would patient patients need overlap a and patients. FRα selection whether at those then

Michael Schmidt

FDA Very but about of interactions how just towards I timelines on wondering, sort opportunity. you pathway in BPDCN, if one, think filing fast-to-market on know last the you've specifically, came don't earlier, had type helpful. I if a which that BPDCN, Thanks. and regulatory up the with guess, Then requirements just is very in any there

Mark Enyedy

it see those We Yeah. in terms.

goal for for in population of reasonably tolerability. XXX in discuss efficacy, this data a been has this terms our so, BPDCN to in to profile safety year and generate And sufficient coherent

so, there is data path this a the agency goal the our forward, end be the as before rare the those for to indication. hand of find would with get with which, this year the to And emphasize strategy market goal in you say, to speed to

Michael Schmidt

update. appreciate Thanks. great. And the Okay,

Mark Enyedy

Great. Michael. Thanks,

Operator

[Operator you. Instructions]. Thank

from SVB comes Jonathan question next Leerink. with Chang Our

Your now line is open.

Jonathan Chang

for taking my Good morning. questions. And thanks

for are development business question, mirvetuximab? what your First potential opportunities latest thoughts on

Mark Enyedy

China. interest in As mirvetuximab to had previously, we've inbound terms of in we've discussed rights the Jonathan,

limited that our targets There's indication in launch And so, in competition. pursuing as This would no active that, the market, the expectation in and And profitable and initial beyond that the of be US. concentrated physician highly a focus and first a is products. the is for we is, see we're number position largest We to US foremost, the market. market, those so the label opportunities. most

drugs. they're it's MIRASOL doing drugs chemotherapy, Avastin that is what are we're promotion, And study to design. here superiority can't I generic the in to particularly doing used, directly of terms speak is agent what So, of single demonstrating all And in Roche/Genentech the limited. but

so, investment would think our a within experience. And be that something we commercial here ambit a company the modest with of and well

is than So, as there be opportunities slightly But, that's the the concentrated I think again, forward. And we US. go actually for the US will Europe evaluating market we market. more

X key in effective set Nordics and But example, However, increase and additional investment in again, a particularly of the incremental national have concentration. a very infrastructure that level could Benelux. commercial a launch, limited offsets the to the support focused clusters, for need

speak. we're evaluating we as So, that

the focus principal moment is in China. the at So, around the opportunity

Jonathan Chang

about question as about the Thank second The it. sounded you of yesterday. reasons excitement for this excited target you. an program? MacroGenics And team program on also and ADC promise their Can the Got really for ADAMX IMGCXXX. this talk on call

Anna Berkenblit

Sure multiple So, solid target not novel normal tumors. It's surface issue. expressed It ADAMX is expressed a of particularly the on is matrix a on metalloproteinase cell

and expression normal So, antibody tumor tissues will, for drug standard that and makes normal with makes good and feature well. window, chemotherapy. target the that can multiple ideal tumor therapies solid it – for high target internalized cell expression And an need tumors of non-small it is toxicities target that any on expressed gastric is key then, really cancer, also unmet lung That difference you associated the a is cytotoxic drug tissue if an between even of We cancer. non-targeted, pancreatic another antibody conjugate. cancer, conjugate. have spare that target It like an

That's there in cell then, have them. therapies been there. portion don't cancer, developments cancer. And smaller cancer, available patients any non-small of While has to need unmet a the lung targeted negative breast breast triple but high these remains amazing

proof as have of tumors are So, certainly, achieved well. these are could one that that the tumors I others These another that that concept with express top explore of mentioned. solid opportunity once And ADAMX. just there we really is we

Jonathan Chang

the Got it. taking Thanks for questions.

Mark Enyedy

great get addendum been collaborators. team Worked Sure. there, the Thanks, I in. do just hard at thank Jon. really And They've to as the an MacroGenics. IND

are we're improvements site-specific performs made clinic. so the We're fourth so, a really the integrates use to conjugation, in DMXX the now to expecting to position with in first antibody, payload. this in We looking program we're patient excited about and quarter. this because much and our some the this this product how forward And seeing move forward very

Operator

Thank question Piper from we you. have with Joe Sandler. a And Catanzaro

line is open. Your

Joseph Catanzaro

here. much Hey, one for guys. Thanks XXX. so my taking questions Maybe first on

you So, mentioned Elzonris. Anna,

product. market BPDCN via about worth into that five gotten You've insight the quarters of

that thinking maybe you Just wondering around influences what how your approach opportunity how and that it. provides that to learnings

Mark Enyedy

Joe. Mark, that is What we the physicians. profile challenging Elzonris is is This clinical hear for Yeah. quite of

refer in drug And to so, so physicians wanted have course. the into first and for the centers. manage requires larger generally office, patients that foremost, not and first hospitalization That the community patients

the into significant carries that to then, minimum go there other a for six and warning black have leak syndrome. So, drug toxicities hospital of patients are a days. for box And capillary

drug. be a really of setting. drug the profile events, are the in efficacy, a respect that safety to there minutes benign can adverse with of So, profile the XX and this is number at XXX, very administered of what challenges we in look And when we outpatient in terms compelling see

opportunity is we perspective. which what drugs, the different two us there of a difference with in those a so, presents And could very a think profiles I see profound from development

initial we've patients relapsed as previously treated setting. Elzonris respond regimens previously IMGNXXX. focus with as to is What treated seen well chemotherapy Our that intensive who've refractory with is been in the

we that best strategy. could profile, get we we think in and to to like label focused, – through mentioned would And that relapsed patients. the a expansion we with think look allow refractory then us strategy. the that Michael of this on we what that so, an us into initial with frontline speed comments as think effect we positions think are And would earlier Boris, and some patients market to And to

indication, to is a AML important for this the which here to is that of and work a expansion is further the in ongoing is program. on longer have the So, market of goal value look get spade the rare term opportunities, product all then but the we why

Joseph Catanzaro

follow-up, I got Thanks. may. Okay, one if Maybe just it. quick

still that are the large guiding BLA towards you think, you're Mark, second complete. already of So, half chunks noted the filing? BLA XXXX I

be wait? get those need completed readout to Just trial? could Or you and need wondering data you that the are started to would beyond before from from do parts things top line what that SORAYA

Mark Enyedy

Yeah.

of one CMC any So, the section. the big elements filing of is BLA

there And all so, up our vendors the terms of good related in processes. lined of we're and in order

completed. work And been has so, much that of already

The So, well are we'll underway. look do sections preclinical to that.

we're supplement the at would So, really looking be that here. clinical it

Joseph Catanzaro

Thanks it. got Okay, so much for taking my questions.

Mark Enyedy

Sure.

Operator

are Thank to call Mark I'd you. the no for to queue. Enyedy turn in other remarks. there the And closing like questions back

Mark Enyedy

keep you starting was portfolio we of back to us Great. work the as to operating the that we certainly particular team very the the Thanks articulated. year, across that in half today. terms appreciate and the proud previously a on with update forward much. additional your We with of momentum to a the here with timelines work of ESMO. track context I'm of the And through quarter terms time very able in of continuing we in maintain look milestones do we've to in challenging been pandemic. It

thanks So, safe. and very much stay

Operator

this Thank for and Ladies you gentlemen, concludes call. today's participating. conference

You disconnect. now may Everyone, day. great have a

Immunogen (IMGN) 31 Jul 202020 Q2 Earnings call transcript