IMGN - Earnings call transcript Q1 2020

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Operator

Good morning, and welcome to the ImmunoGen's First Quarter 2020 Financial and Operating Results 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 first today, press includes release summary Earlier quarter XXXX can website at This of Investor a and immunogen.com. Media be call and our press the found of web section under release this stream

our Accounting today Berkenblit, Officer, join for Mark Q&A. will and are Dave Officer. me our President also Medical With CEO; Foster, and Enyedy, Anna Chief our Chief us

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

the actual discussion, in included risks investment from Descriptions we and During an will use are the results such our statements, forward-looking SEC of and our with ImmunoGen materially uncertainties filings. associated may differ in statements.

And with turn to that, I'll the call Mark. over

Mark Enyedy

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

milestones our the quarter, for the SORAYA we of programs the maintain our while cohort top programs for opened time first platinum-agnostic we And studies both for MIRASOL to advanced portfolio line evolving with parallel, expansion In are lines quarter the quarter. potential ovarian our and Despite preclinical meet during track and expanded forward moved challenges to of will expect describe registration in this Anna our key results the as COVID-XX. for hurdles in adapting have earlier-stage activated and sites presentation Avastin moment, from remain mirvetuximab cancer remotely, detail studies. pleased selected During operating at oral a to a data May. virtual we ASCO for in late for more in on

follow-on in $XX strengthened our at the upsized January, generated which net of balance and million the proceeds. in we an approximately on XXXX, building momentum Finally, raised sheet with offering oversubscribed close

of the a effectively terms Boston, half here In indications virtual in our These environment and COVID-XX's rapidly us to core implemented of ongoing of functions to plans in impact adapt our in early operate the allowed we business in developments. first to March. plans have response pandemic, with continuity benefit response new the working of

ongoing want with with X parameters: supply have than drug year hand I to date expansion a programs, execution. we any all development for transport. enough ample of in key trial product upcoming entered to have our and perspective, of From IMGCXXX. I at in our experience and our our to sites activated trials, stock Furthermore, drug Almac that chain partners clinical the potential more our monotherapy prospective disruptions mirvetuximab taken combination IMGNXXX sufficient you on share complete interactions Phase have to safety trial weather supply, to studies inventory and regulatory ensure currently on drug Focusing measures the on

remain have Finally, the the first and FDA, we've place. beyond regulatory planned the no national perspective, we fourth slots for in runs quarter year, quarters EMA and reserved a of of and we've covering CTAs. From timely our received manufacturing to reviews during submissions competent X authorities production the our the

incorporated personnel. virtual encounter during patient and recent sufficient our monitoring, ensuring that clinical to study issues order to integrity. data and clinic approaches innovative site such safety patient accrual the efforts have engagement These as pandemic, oversight digital of transportation while patient investigative with included and remote services, we've visits risk going studies. yet early regard mitigate In still regulatory significant to start-up we've execution, With it's with ongoing forward, days, while guidance enables

material as A impact time of expected meetings. the of experiencing clinics see where availability our we key in is limited timing the not aggregate, and staffing to other institutional individual site adjustments do of activation, these such IRB focus lines. and constraints, testing us resulted In area challenges PPE for have a

accordance with and trial global IRBs activation to data our with pace practice. contact clinical sites CROs, and monitor to scale ensure good on in a close enrollment, continue We and progress collection maintain keep

So active and engagement in and complex evolving environment. effective a

now I'll release morning. covered are issued financials, the press which our the this of in details turn to

the $XX.X million partially clinical of XXXX, we This $XX.X compared expenses in in lower the all expenses resulting decrease and for MIRASOL, million, advancing driven quarter by trial million XXXX. approximately was came SORAYA by with at first comprised our the generated revenue, first of of second to of were For quarter combination expenses greater related $XX.X the million the business IMGNXXX from of $XX $XX.X costs R&D from royalty noncash of nearly quarter of million XXXX, the restructuring revenues. Operating end studies. offset which

of partially to offset quarter expenses XXXX, $XX.X the primarily allocation by million expenses resulting in lower $X.X from and compared office for to expenses laboratory of space. higher excess G&A due first personnel million were restructuring, the facility-related

In restructuring in charge quarter. addition, $XXX,XXX an we the incurred

As offering in net proceeds million mentioned was our earlier, upsized cash I which balance position with we added sheet. that an strengthened January, in completed approximately $XX follow-on our to

$XXX.X With ended the million addition of this we cash. with the of first quarter raise,

remains financial guidance XXXX Our unchanged.

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

our expect anticipated will from cash fund that cash receipts partners of second the operations and We XXXX. half into current

review our details. With more progress I'll turn call Anna? to that, programs the with over to Anna in

Anna Berkenblit

across program, due and reiterating monitoring essentially regulatory converted consistent with allows flexible across sites our clinical more patients unmet large trials. have our our to possible, model part that approach remote recent to by remain Wherever clinical that us trial to execution, IMGNXXX studies start SORAYA, to activating we high a populations to and patient continue our all enrolling to studies guidance. I'll of all for MIRASOL on a track, and clinical need our rapid the in due pivot Mark. Thanks,

to receptor the have and rate response folate received available therapy duration accelerated time of late who best Recall previously single-arm mirvetuximab. mirvetuximab, study SORAYA, approval and scoring Avastin. overall that SORAYA approximately mirvetuximab ovarian to PSX+ via provided Turning our response of women year, accelerated support of monotherapy of by approval measured mirvetuximab XXX the for tumors we surpassed with regulatory evaluating as with FDA high closely the action. could platinum-resistant last alpha pathway whose those worked at that define an in for cancer, pivotal are

As previously a who therapy rate. have rate patients overall reminder, in mirvetuximab criteria available we our program response key for enrolled area were benchmark for in would currently XX.X% met XX XX%, is response eligibility for the relevant SORAYA, the whereas demonstrated a and have

regimens. endpoints randomized study ovarian of The chemotherapy, X survival overall track, and choice outcomes. X:X response the we share on and or in progression-free this secondary a top mirvetuximab in first XXXX remain BLA XXXX. III study, which potential confirmatory and MIRASOL to patient-reported SORAYA will that receptor or December. in we paclitaxel, quarter, Phase cancer primary who sites namely submission of began high I'm to and the MIRASOL, line opened be our open parallel, track, half in data will endpoint up survival in In pleased with rate, receive MIRASOL for we half in an pegylated report patients on have enroll line the prior overall XXXX. Patients to in continue platinum-resistant mid-XXXX, XXX topotecan. is enroll been of treated to to investigator's are data second approval first folate doxorubicin and patients alpha top expecting liposomal expect the remains and time a with additional Recall on approximately

and and pursuing studies, carboplatin to with Regarding earlier order treatment treatment. lines we our bevacizumab are expand mirvetuximab cohorts longer duration in combination doublet of triplet into and of provide

Lucy May XX overall platinum-resistant data the in previously year, considering and chemotherapy. progression-free which both will at we from we forward later studies X.X mirv, and II the on bevacizumab We XX% median doublet, patients. in from combinations, efficacy presentation survival These At overall. both to data with of Dr. reported give XX, year. last compelling oral the presenting activity a continue for plus response data build virtual safety and Gilbert on and ASCO for evaluating separate measures an to Friday, follow look with of in durable subset our patients the upcoming And outcomes initial bev enrolled in platinum-agnostic observed where when of rate encouraging meeting an in showed presented cohort this generated mirvetuximab combination bevacizumab will the months, efficacy are we data particular, FORWARD a ASCO AURELIA-matched

follow-up bevacizumab in and to We data platinum-sensitive the updated the in carboplatin expect also longer triplet with from fall. cohort, present with evaluating combination mirvetuximab

carboplatin, Lastly, maintenance in This platinum-sensitive carboplatin. followed we to investigator-sponsored delighted plus to are mirvetuximab is by a trial, disease. by therapy, trial recurrent of with new II followed a in maintenance support platinum-based patients standard-of-care standard evaluating mirvetuximab comparing combination Phase over XXX randomized mirvetuximab

and Looking early-stage in a targeting X both progressed our portfolio, programs we range types tumor of malignancies have additional tumors. solid hematological to

a with we monotherapy, positive I frontline in AML and IMGNXXX focus residual BPDCN therapy. enrollment cohorts continued disease minimal following patient on expansion induction Phase For

also AML patients advancing azacitidine, forward before of combination relapsed/refractory with studies and venetoclax, the IMGNXXX studies each in and year. of data the look with these to from a presenting end are We triplet, as

MacroGenics. We ADC IND have for our anticipate quarter. activities with this progressed further We filed IMGCXXX, co-development will IND-enabling novel in the for XXX ADAMX-targeting be

designed AACR In enhanced which, a models, preclinical XXX receptor with incorporates are FR along We types. linker, and forward shows we the preclinical in next-generation the improved that a to X biparatopic June. data ADC, and for improved with tumor on expressing Finally, DMXX, at and alpha killing. alpha our IMGNXXX look protease-cleavable unmet advancing low more virtual alpha the binding, longer IMGNXXX, medium to of half-life several the next-generation enhance sharing activity antibody bystander to maytansinoid in design XXX folate key tumors. linker expressing lower FR full meeting a recognizes needs including innovations, fully epitopes address stability provides

back that, I'll turn the With Mark. to over call

Mark Enyedy

Thanks, Anna.

questions. we open call closing remarks the few a Just to before

To end, of contingency COVID-XX look to volatile forward for to by effort in we patients created implemented days instability. strength we've am, a risk for and As encouraged the business more our moving the year business concerted the and people plans position good to to a the no our uncertainty and success manage with environment. however, determination ahead, I continue cancer. in that deliver doubt of has

providing is well Our to and with sheet priorities. our cash continue XXXX, strategic strong, on into runway we will execute balance us

a number the of of our have throughout and We you XXXX, to on in remainder updating I progress the look year. important milestones forward

call we'll that, With open questions. for Operator? the

Operator

[Operator Instructions].

John Newman Our first comes question Canaccord. with from

John Newman

it about like to steps previously have regarding you've definitely and that got, II to perhaps on of that centers? But the smoothly. just are sounds curious ASCO, First build And you you Avastin. some on MIRASOL, would for date could we you've any I've for to protocol, then the proceed wondered ensure if received of patients some taken those been just able the at able SORAYA if studies could flexibility dosing example, into Maybe at FORWARD question any exact scans allow see CT that data an take would any perhaps flexibility you alternate infusion? on the talk

Mark Enyedy

Anna?

Anna Berkenblit

Thanks, John.

getting SORAYA consistent have here regarding out that and employing guidances as we're studies running, MIRASOL and So we are up across pond. flexibility and both both fully these of we been we can, have the regulatory the taken measures, put and the with that as

that implement possible, initial patients we consent where the things include, receptor prescreening to for for allowing have Specifically, remotely folate started to alpha.

their to FR with consent need don't into site remotely inform have and be tissue You have for -- so site come the alpha, the form. the IRBs. policies they the paperwork and and done the and may conversation to to procedures along patients sign need the can for recall, necessarily sent That tumor

us that's to momentum. think allow up a will I step So keep that the

CT some at days. really More protocol. than allow or We the had have holidays dates into for by more do need scans, documented make sites. will scheduling the be like That the We easily that, dosed shift and windows and done deviations occur, scans, always we could being regarding if a said, Certainly for dosing things local, integrity to to they for flexibility lower-risk accessible really data not they few trial. have a appropriately. protocol of be CT other

that. building are those in, for we're the are and monitoring closely we things So that

requirement new is a received Pivoting regarding FORWARD in question be and for at some of to XX platinum-agnostic enrollment ASCO, prior expected them a patients, receiving bevacizumab. the are cohort mirvetuximab your bevacizumab, all the this and that was cohort. of whom but toward of II data Certainly, second not have

Operator

Our next from Debjit question H.C. with Wainwright. comes Chattopadhya

Earl DeSouza

hear Debjit. DeSouza Can Earl me? is This for you in

Mark Enyedy

Yes.

little speak a If little your just faint. up you is could a voice bit,

Earl DeSouza

it. now? Got me you hear Can

Mark Enyedy

Perfect.

Earl DeSouza

Okay.

couple front. a questions So on up of

continue program? observing to ones that you new you second expression As opportunity receptor in you And question will cohorts, you later the changes compared the Or explore in the fully to are score for use an bev, assay? we have, platinum-agnostic line who So PARPs, taxanes would patients? any basically, H the marked have expression? altered consider alpha the PSX

Mark Enyedy

Yes.

So I'll you jump color, have Anna, in. if this additional and then any a give please shot,

So of has expression the of lines level irrespective prior alpha over of therapy, folate markedly been receptor uniform treatment.

we then have is have low levels of levels, And vary And patients over in negligible therapy. levels. it the folate express that measured seen, talking screened prior I XX% alpha late-line of So X,XXX what another the about earlier-line patients, at well samples XX% receptor another say, levels true and at expression. by as is now the XX% PSX+ we remaining assay, that of doesn't whether high you're medium about at cancer patients, ovarian XX% in program, terms with

will using identify we for screening And So a purposes very of scoring the across to method the for on program, basis, PSX+ the patients. the go-forward consistent be board.

Anna Berkenblit

may I a if color. So little add

for tissue is trials the tissue. archival based So tumor on our

have folate come XX% have receptor data over and of as therapy additional between from so fresh archival that well showed concordance and stability time And as the data tissue that that of our other reported biopsies. groups retrospective showing greater biopsy than alpha cohort lines we

expression FR is time. do believe we alpha over So stable

we would a score versus PSX+ Regarding the with based level the But percent the -- H agree that totally the understand score, with of please say, PSX+ on what that that pathologists I and moving of I methodology. forward the intensity. self-positive Mark methodology are

So the they H about go score. the similar quite scoring is way to

of intensity at IHC at cells moving XX% for forward. in validated the by of having staining inclusion We have X-plus trials just least our cutoff PSX+ least

Operator

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

Kennen MacKay

on progress global pandemic Congrats here. the this operational despite

folate I forward could you the at the of a more hoping But the Looking here epitopes to on the AACR a hearing well quite bit and maybe and protease-cleavable the release linker, bit into to mirvetuximab, as actually more XXX talk on stability again. deliver was payload conference. now little importance virtual receptor from cell cancer Congrats, really it as differs being and of relates before as potential the binding release how to that especially early payload. the brought about

Mark Enyedy

Anna? Thanks.

Anna Berkenblit

Yes. Sure.

So is it we next-generation biparatopic, ADC. that as on a it heard, X receptor that key incorporated alpha. of epitopes folate And XXX innovations is that have receptor folate you the one our is binds that alpha-targeted so means

internalize. and that So more gives bind therefore, drug more FR antibody conjugate opportunities the basically alpha opportunities to to

for lower have particularly FR showing is that alpha this of we approach So data effective, preclinical with quite patients' levels expression. tumors

are key, stability. innovation hydrophobic, attractive is linker better then but medium or positive remaining address in So XXX. to in protease-cleavable key more specifically that need maytansinoid with unmet that for intent has next-generation also FR is a a is And allowing the payload bystander alpha The some features very of terms that really bit improved itself of again, the positive low levels tumors, in expression. at killing, the

at be middle of I be May, virtual what can in AACR meeting. the released and will that's then mid-June poster of will the think, So share next the abstract I May XX And tranche now.

Kennen MacKay

Anna, just elaborate that. to on maybe

potentially bind antibodies the biparatopic to being of is level to enable a Or there despite same this competitive X receptor? some inhibition that? like does So

Anna Berkenblit

have No, different you could two Kennen. it would two ADCs inhibition, bind Rather, have in one ADC locations or two be locations. competitive you bind construct also different in could

be the wouldn't molecules more competitive internalization. there and both binding is, are there active, So the more because really inhibition

internalization. for is more So better binding

Operator

comes from William question Blair. next Our Andy with Hsieh

Tsan-Yu Hsieh

up following of on Kind question. Kennen's

probably a just receptors just and wondering a smaller right this safety target. Is select about of with a population an the that? about expect of the cleaner here, bivalent think cell having With thinking to that to I'm binding, way logic for you profile? do kind logic, potentially I'm logic

Anna Berkenblit

patients on tissue alpha XXX with address of in expression to sparing designed features their FR the retaining So of tumor tumors, levels lower all of we've normal and ADCs desirable really terms targeting tissue.

safety The target a ocular. are related these really we're mind, cause rather doing unique of So be when not can any features in itself file safety in that with that related Mirvetuximab the are that payload very the of but studies in has of will the of IND. nice payloads the tubulin-directed in process needed ocular terms certainly terms we profile. the it of required

a there's early stack we'll up. safety alpha really ADC on the of just expression. to population tox to clinical target well-tolerated be is lower a data think be potential think for safe, But I able levels days. once it nonclinical, then I data, our the the it's really, profile have And once FR So but focus we we improved, and creating that another can broader with have

Tsan-Yu Hsieh

Okay. And the XXX -- terms carboplatin. outlined, patients combination sense. of in guess, you makes with I That IST that targeting in

maintenance the is And that. for pretty phase, is Or to of duration duration? flexible? related set treatment kind Just a the there

the they for that the patients So "induction for continue phase," who again discontinue phase in maintenance trial? could in

Anna Berkenblit

led an trial by So and it Philipp in Germany, disease. investigator-sponsored is this Harter is in platinum-sensitive recurrent

So these cured. patients maintenance be we this it's generally in going given to not know until And are progression. when given setting, is

according both so given the to standard-of-care And of will arms trial, really maintenance practice. for be

overall the long are as So as from patients benefiting therapy.

So be question. the the they chooses. the option stop of Oh, induction duration on across your I'm it mirvetuximab either maintenance of whatever the blanking, second experimental phase. there if be will arms part in And difference of sorry, terms maintenance Andy, on basis physician or therapy, standard-of-care an no

cycles you and reactions, you So -- typically, bone assuming of X don't carboplatin. when you between enough recurrent generally get have X a hypersensitivity you have healthy you disease, platinum-sensitive have marrow and

gotten across consistent of a And same patients of will the the they again, be on way just then arms standard going be in physicians doublet number as treatment or really how is carboplatin-based arms going care care. with both as manage to take be significant the and is doublet of mirvetuximab. cycles, long the both -- to So patient move the to as has can they

Tsan-Yu Hsieh

that's lastly, Yes, interesting provided a you very don't regarding I contingency mind, so plans, appreciated. much trial. of you lot COVID-XX think commentary Great. if a And and

with assay their obviously, So the Ventana, diagnostic strategy. of of companies in partner are of the development terms corporate refocusing a repurposing and lot kind

regulatory pushing latest with in about Just of of them through preparations. wondering kind dialogue the terms

Anna Berkenblit

we We're ahead on MIRASOL, we've regulatory track that running SORAYA and frequent work requirements with meetings to to Ventana. and assays all They've them very in up plan the so and the got and it done for the with validate commercialization. for have

that remains So track. on

Operator

question with And from comes our next Canaccord. Newman John

John Newman

about folate bit here. experience a comment for Obviously, had could you've you therapies. lot if wondering the alpha of a landscape competitive targeted Just receptor

molecule own faced number your that seen have the second-generation development. companies in have a You challenges. other pretty in We've of past significant some

I you as been recent have some but think about to a could to field. you that but surfaced, just how in envision Obviously, us you're of curious sense wondered you think there's give things here. data rest the the development, late just how quite if as

Mark Enyedy

Yes. I diminish in initial the benefit of of therapy what will just first ask with mean some that I of apart on and But limited then activity there's more the Anna setting, SORAYA earlier-stage competitive And to field. relatively the think to see outcome, platinum-resistant some first is instance the are platinum-resistant recurrent that launch new terms that. talk the mean, from advances a approval by situation, There's broadly open mirvetuximab so a we is mean the don't what number in in into mirvetuximab, the the the of in programs. XXXX predominantly potential terms the competitive in approvals, about I'll and as in time. trials I programs But we with inhibitors, focused disease. near-term in platinum-sensitive to of be which ongoing, frontline PARP in

being of disease. see initial in label competitive platinum-sensitive the in with about mirvetuximab we our expansion, we developments recurrent to comfortable as where lies program. complementary And we're newer is what our So terms positioning think

month. expectation And actually, the combine a at by in so of -- to products date, generated position. we're our data next is that more very we've with ability We ASCO to think you'll our later other see given strong competitive demonstrated is this and that

the some example, these we we've Sutro looked with NaPiXb. of give And at, that will Mersana then from more for the doing as work about think program some programs, is earlier-stage detail, you as also and Anna

along we're let view As with programs. ought what is to further we're from you XXX what those me the you forward. to a seeing say, compared more And earlier-stage a we're lot Anna talk than our doing But be let go about agents little that to ultimately as programs. we bit those

Anna Berkenblit

Yes. Thanks, Mark.

NaPiXb. dosing think for Sutro's some a the There's three; relevant alpha four. targeted probably couple Cuda on a they've The and I antibody has to FR AACR. ADCs. focusing has two; and development. one Azaya at we're naked X in most one; at alpha lintuzumab data selection, has safety, that Sutro, since hooked up some FR number eribulin, yes, just point, looking at are: is really showed their But Mersana efficacy, that preclinical they number So and this ADC points earlier patient also data number schedule, on number

their So grade a seeing out from their X significant seems dosing trying exploring figure recommended dosing some levels that QX the based not dose on going to clear schedule with dosing or is be they're and is. what perspective, II they're if profile week or safety neutropenia, X Phase different They're several schedule the schedule. QX to optimal it and

in really have in with perspective, X features key grade pose they're a combinability. terms dose neutropenia hasn't have mirvetuximab or of profile monotherapy. problem one safety the with. full could that's seeing, we as Mirvetuximab any of resulted that while of it everything to doesn't neutropenia of a And full longer-term that febrile, allowed mirvetuximab plans any dose greater a combine that From the neutropenia us combined for has

our did features, monkeys. any mirvetuximab, see studies, other IND-enabling terms just in not have of we we that would I low-grade And did when adverse ocular ocular note tox In initial events GLP adverse manageable safety we events. the

that me to negative clear is not predictive for So them. how

to around dose some pretty had that there this approval. we as they XXX believe, it's efficacy, activity. patients, selection, benefit Phase is they've from but out sufficient and drops sufficient important. shown early about some of a of have work XXX really to consistent it's for to not But guide really I XX patients point is we've responses patients. a CA clear which And what with antitumor going moving they And And I is and done CA certainly, much that out both figure able one stable what sufficient how thinking really their certainly mirvetuximab PR. data XXX themselves selection some what are in for patient that a have out previously. escalation they've demonstrated just regulatory in to So I I being lot have point disease, number with the by showed also on activity seen one with tumor they're other patient responses program, to that CA a set would shrinkage response, and not than responses is partial seeing they're signs and their be And would

to follow days to continue Certainly, going and were Sutro. developments. early their there, So we're we for

of alpha next-generation FR alpha sort targeting that would our the generation to something FR next benchmark IMGNXXX, targeted I is for of alpha the going agent, about compound. as we think us be really say with biparatopic of FR to

pivoting selecting lots out if -- further well. -- in very, have seen they potent under year, really XX Earlier to with then patients have you that a the selection penetrating some presented lots responses. -- have you figuring partial or having very They issues data Mersana. approach they're They're And activity as an patients. Again, strategy their payloads, they may show hypothesis some patient this trouble that with some to and have continues potential taking DAR. tumors. if a high evidence And of could are

now, excited got and We're tuned, confirmatory will should trial plus we listing. stay a III. at approvals for trials bev we'll share accelerated by data that in We've mirv that compendia set get X up support nice Phase we're hopefully have ASCO mirvetuximab. followed So that about so and

John Newman

one additional quick question. might And if I ask

could stick XXX receptor there that like Given multiple time, we point molecule you tumor Or perhaps know across in would possibility in what some at something targeting the a be types, about tested lung probably folate alpha cancer? to... is

Anna Berkenblit

triple-negative cancer, cancer, Absolutely. breast cancer. Lung endometrial

John. bet, You

Operator

Jefferies. [Operator comes Biren from Instructions]. next And our Amin question with

Biren Amin

carboplatin. on On to in want and ask mirv, bev with I the platinum-sensitive triplet

I last think had data you at year ESMO.

Just trial. as forward your to an when we this are with thoughts in well? given that what on see moving IST also And expect the wanted now update from the can setting doublet

Anna Berkenblit

Yes.

an updated data ESMO So for triplet. the to we're with planning submit abstract to

may first of was the last we reveal for year but rate sufficient data, response we duration. data, didn't the and had have You recall, follow-up

And so we data do, share we that will and now at ESMO.

both would the platinum-agnostic ASCO, about then the to have we clear plans, move with in with say, lines the from cohort will of doublet and So therapy thinking once triplet. durations, forward share able we're several to options it data mirv-bev at future mirv-bev be I the that longer combination do earlier the

Mark, So to add want I think that's anything. if know, where don't I'll leave it I at this you point.

Mark Enyedy

it nicely. covered No, think you've I

Biren Amin

right. IMGCXXX. second question on maybe a And then All

the IND planning an later think I this second you're on filing quarter. in --

plan using is to payload, start year? So later you're DMX. I DMXX And think the I different this the you're using a Phase versus

think the earlier And comments about how solid for a payload? a your ocular and an that on those diagnostic, the using would are gastric then with Phase at expressed, got you in ADAMX given given diagnostic look model Phase And tox, ocular so after for predictive do good going that guess, it's the tumors you've I, the tox not you tumors colorectal? certain I? like you're I where And sino highly panc,

Anna Berkenblit

Yes.

it And think Certainly, keratopathy terms mirvetuximab have a program early learned it's, using of which are should of So lot occur. for days. again, DMXX. in we corneal targets we IMGCXXX, the ADAMX, in I optimizing management

expressed to that we is we'll or But it able it right occur. moving but think we're be does, ADAMX now, patients it the a to expression. occur, member prepared. mentioned, does suggests then So And selection, won't ahead no will patient that get of I it toward if data if relatively need have we select a on variety And potentially, anticipate do based as you wide on It's we of it's family, matrix expressed. XXX and tumors, spared of may cells. normal that metalloproteinase and on

we trial And I to plan so data do support Phase activities we in And to to, trial. to the the and it. early be appropriate Phase should well need selection do types I if are X that, tumor the incorporate patient positioned gather we for efforts we need on, we'll in targeting to

As triple-negative go after follow the and see. demonstrating good nice lung, breast gastric, science, types We'll you going and we'll profile. activity really we'll the be a pancreatic, tumor we'll where safety mentioned, we're then and and after

Operator

Leerink. from comes Jonathan question next with SVB Chang Our

David Ruch

Ruch David on is This for Jonathan.

expect population, the you we but therapy? prior with PARPs? Avastin, about detail Just I of asked prior regard of prior in can do to much someone ASCO population the terms terms on expect in what how know patient previously

Anna Berkenblit

Yes.

will share this of increasing. demographic patients the we enrolled, percent at data population. look back we time, all as who the is Not have of have PARP cohorts prior a over So from you surprisingly,

versus share with share we'll share sense bev, So we'll the of prior percent are data. is details percent certainly give we'll with cohort, so This of are, patients a they prior And prior platinum-resistant platinum-sensitive. around patients PARP, considered platinum-agnostic who how a platinum-sensitive taxanes. of

a good of population. feel So the you'll get

David Ruch

as studies look like promising does And patient would forward if what Great. for this the encouraging, you setting? regulatory to in central the efficacy the platinum-agnostic or point in are population? And what ASCO path data

Anna Berkenblit

Yes.

median regulatory response is for perspective, underwhelming mirv-bev platinum-resistant versus a in approach us, So of pretty merv-chemo and And from XX% the disease. for PFS rate a certainly, say, conservative could specifically for a trial X.X most randomized months, mirv-chemo. benchmark the be

that a could And into going of patients have includes platinum in sensitivity think dialogue of a lines prior ovarian in with number regardless certainly, broader who've platinum-sensitive suggests require their the would population FDA patients a regard. that in cancer recent productive we conversations approvals with that therapy FDA. of had I

the benchmark been In disease, from non-platinum purposes encouraging. so the wasn't is Doxil in from a having an Phase U.S. beaten for I've That was it there perspective, doublets trabectedin platinum-sensitive sufficient It combination quite a aren't platinum-sensitive our III the at Doxil, single-agent combination in was and the terms lot, is the or for one but in mirv-bev subset European patients. yondelis. approved with But approval perspective efficacy benchmarking from to of for really trial, that in look a starting

should certainly, combination separate the cohorts figuring options most approval their sufficient platinum-resistant so to support the do think, the mirv the monotherapy That are listing. for we've of X us. use terms and will in mirv in have robust or work with compendia in physicians believe initial regulatory enough mirv-bev plus that either around option the data that short U.S. to And mirv monotherapy right the us bev we disease. be more term, to in favorable there's longer that we now available in I which from generated of out So for our is get patients time

David Ruch

later Got year. then regards clarification. it. more that Is And ASH-ed? still you With to update just mentioned this to an XXX, one expected be

Anna Berkenblit

Yes.

David Ruch

far as color okay, the highlighting the of And for what some next be you steps give kind great. most you duration durability, data? on color -- of could the on -- patient most then something And regulatory-wise? expectations -- population what's any as your would for And response that

Anna Berkenblit

Yes.

CDXXX-targeted blastic and also cell induction as our is dendritic with as for disease plasmacytoid developing ADC after And residual patients it potent payload. IMGNXXX frontline IGN neoplasm a therapy. monotherapy we So a AML for our are monotherapy with minimal

combination and those developing a along. azacitidine also We are in and it are currently and in as dose triplet, with moving venetoclax with escalation

approval a have authorities to program to need And also our sufficient with to there's regulatory for for -- in while the So disease we and to from path this on at in MRD-positive allow high combination. BPDCN, data monotherapy we gathering we would progress day engage ASH. continuing there, continue it us on in unmet the are where a focused anticipate we remain sharing all

Operator

Schmidt question comes Guggenheim. Michael from Our with next

Michael Schmidt

I do guess, mirvetuximab question a I XXX mirvetuximab? succeeding balance, are there alternative drugs, is you XXX. guess relevance, how could around there maintain to as just you high-level XXX? where Or both as into replacing investment mean, guess, I -- so or indications XXX see patient longer-term do a maybe you other Just well and eventually those speak? I populations see

Mark Enyedy

Yes.

Michael, get approved. So mirvetuximab is priority one, to

should SORAYA, then Given full pretty earlier securing into on And be in lines terms the adding expanding patient focus we've with the approval approval to of that and populations the based levels of generated, initial data we've on that the of program therapy. high patients got of molecule combinations robust the expand expression. today a

expression. with the securing data come And high so levels an and we data next then of and But to approval, over approval MIRASOL expect focused full out then patients online. first that again, all the readout the alpha -- an unfold of and program to the FR initial half in approval roll those in XXXX, moving on combination to having

about cetera. lower could lung, was goal something engineer of address to broader as of types, so of there ovarian endometrial, segment et the additional also, in as address into pointed that we And think to move but expression out both a earlier tumor to triple-negative, levels questions, the was cancer, XXX, one

going we're from to think then so complementarity by, away potential happen not at the those allow And can our us the whether at that. as ultimately in develop focus to to initial of distinct XXX time here. look tell us them segments point goes opportunity sufficiently very think will addressable mirvetuximab. for nonoverlapping we the long for And that be I what's in or And market a cannibalization potential is the this -- But data XXX I by indications. ways is

Michael Schmidt

on And then choice it. little -- you more just the if of a Got bit just the could maybe just payload. comment on XXX,

you the example, Maybe to, I one that using say think as about is just your for of I maytansinoid opposed talk heard [indiscernible]. the of derivative. choice payload

Mark Enyedy

Yes.

One about So points couple but bit this, to talked make here. little of the there's of linker. is, stability we a the a

the So D alanine X made a this isomer. a linker alanine and middle residues of is that's up is

normally find you -- in that's that So nature. don't

our enhanced to so that perspective, from very so gave proteases, And makes it it stability. resistant serum and

payload. engineering In IGN. looked terms at of to the the the We

it of of looked we also a so we therapeutic were the payloads. we DMXX EpCAM the at hallmark where to CytomX So licensed program we're that was using was the with when it and things examine this of index, in going multiple XXX. that the We in to one payload XXX research here used And organization broadly, program. more to -- part as

And some work cleavage improve gave the also done the in around which that's There's really MedChem the better to atoms terms to built adjusting us properties. carbon killing. of exercise improve to the the also in so was DMX lysosome hydrophobicity, here relative bystander the

got a very lower receptor give we've levels and these so attached it, And nice linker alpha a folate to a us is altogether, improvement going significant stable payload expression. which of to we think in

Michael Schmidt

keeping progress on everything up running. and the Congrats and

Mark Enyedy

Thanks.

Operator

with next Fye JPMorgan. comes from Our question Jessica

Jessica Fye

MRD-positive first about this When can two. setting? to that year? XXX. lay out see want data Maybe think have what bar I AML setting, you the in we efficacy you in on is the What later that

side, when is then a the example, on to potential you guidance? any, for partners, cash For receipts the you about think timing And of bit financial size payments? can give a anticipated XXXX of framework from the about talk and into much, those second, how if baked how us

Mark Enyedy

Sure. cover AML? Anna, you to want

Anna Berkenblit

Yes.

Mark Enyedy

Yes.

Okay. Good.

Anna Berkenblit

Yes.

patients they recently The of in randomized the by disease. the and know do, or blast poorly So to know blasts from And Jess, completed patients oral CC-XXX patients. MRD III for we bodes is and because detectable This the either count, or see so taking azacitidine the us. lower a have to positivity marrow. will really, placebo MRD-positive minimal better conversion versus for cohort. benchmark they positivity be trial MRD than that we But residual we less MRD X% want in basically Phase have negativity helpful flow. a who are It's complete PCR response, their

was induction therapy all their slightly took then randomize them. after completion different Now they and of initial patients because it

So focus they cohort, took they the didn't everybody. specifically on MRD-positive

benchmark going for is that so And be a us. to helpful

go, really few this is patients at IMGNXXX. percentage I next data between this looking of like negativity then our oral think we azacitidine MRD is don't percent understanding say, the ready tempo "Oh, who guide point from to criterion." a at see that, us perspective to help and a MRD-positive a of I to the and convert So cycles regarding should think patients from that of But right no-go to would now, reasonable the proof-of-concept we're get of MRD-negative within steps.

AML. to precedent note in engage Just path caution, our in of regulators data conversion the from indication. MRD a a regulatory positivity itself as the if does encouraging, for have are will But not for registration we MRD this obviously, on forward quite negativity

Mark Enyedy

Great.

some of milestone our the components deals, partnering et Jess, it, of piece, earned just really partnering we the deals, are relates cash milestone one and legacy in So Roche, newer from built which into there to element on a whether of the two fact, it's Novartis, payments there. cetera, CytomX,

separate And to then partnering element a there's component so of that. there an active is discussions. related And

for partnership a inbound China. have interest We in

for we XXXX done assumed a get in partnering will deal China. so mirvetuximab have And that in we

don't in over reasons built got strong business, deals the upfront of is we've both that fees track scope we What won't those as what say so in in with partners we record completing those break is as the I forecast. we've here I would certainly guess a a put last potential of the I of components pretty China. years. would separately And negotiating are into competitive cash elements we say about part for -- out think couple

we confidence we deals. so reasonable a that have degree those affect unless numbers of don't put can those And in we

Operator

the questions Enyedy over now back time. turn I'm would this Mark like remarks. closing call not I for at showing any to further to

Mark Enyedy

Great. well. progress, look particular, the continuing you morning. all and and out safe Well, hope to And very AACR you much joining the and us are report to this this thank our ASCO emerging for and I to forward we looking families forward your poster. presentation in from also

much again soon. look So thanks and very to forward talking

Operator

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

disconnect. now may You

Immunogen (IMGN) 1 May 202020 Q1 Earnings call transcript