IMGN - Earnings call transcript Q4 2019

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Operator

Good morning, and welcome to ImmunoGen’s Fourth Quarter and Full Year 2019 Financial and Operating Results Conference Call. Today's conference is being recorded.

At this time, I would 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 full and financial issued of a year we results. recent our fourth today, press includes release summary XXXX Earlier quarter and found of release our of immunogen.com. call web press at Investors stream This can Media and website be under section the & this

will With are Quality; Chief President Vice of our Affairs and Mark join President Anna our CEO; and also Senior me our Wingrove, Chief Q&A. Officer, our Dave for today and Accounting Foster, Berkenblit, Medical Enyedy, and Officer. us Theresa Regulatory

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

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

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

Mark Enyedy

and XX morning, comments recap for Thanks, year last the this everyone, then for ahead. we a Anna productive anticipate us our our and morning, Courtney. thank I will highlight the months today. over In milestones you Good and progress joining

challenging was us. XXXX for year a

ovarian in reduce reported our to lead then, accelerated meet and programs focus FDA define have to study our with Since to cancer. for in business primary the mirvetuximab, prioritized an did path we As not Phase program, for the the restructured promising most we our endpoint. March, cost, to III our on portfolio mirvetuximab worked closely approval

of move benefit these emerged strong we into the With as we've for with prospects steps, XXXX. ImmunoGen

of us our positive how This, identify outcomes. from produce give us patients. the in to the which we’ve with will view from mirvetuximab III next the those turn, Phase study today, business In mirvetuximab clear most best of that gives mirvetuximab patients benefit at confidence studies data particular, looking and a generated

mid-XXXX, approval. support To treated folate a first FDA top expect who Avastin alpha could submission been potential study we by XXXX with the previously have aligned called followed have XXXX. with women in this this ovarian SORAYA and We a anticipated receptor that quarter, platinum-resistant the this of to with enroll accelerated BLA and with single-arm study in a in high cancer approval half end, patient in line data second

have first the expand additional mirvetuximab to we this approval, indications ongoing year. the studies Beyond with potential data for

Our targeting range and portfolio tumor malignancies with in hematological solid moment. important includes also milestones tumors, a three each additional which year, a programs of this cover both in I'll types

offering recently XXXX on just From upsized an a follow-on in roughly financial $XX million net million in completed we $XXX perspective, that over sheet. balance with ended generated We cash the proceeds.

provide will later detailed We guidance the call. in

it advance suffice our cash this initial material approval So inflection of say including to us will position points, allow the through portfolio that mirvetuximab. to

execute well to With on of we experienced strategy an value, assets generate term. this combination short are both management positioned significant team, and long our and and

As strategic the a reminder, we priorities business. for have set three

an initial approval cancer monotherapy and look in obtain expand platinum-resistant First, to earlier therapy. as into then lines of for mirvetuximab ovarian

to in our portfolio complementary finally, reach, partnering. capabilities malignancies. And our early-stage accelerate Next, access an strengthen our expand through on gain program with financials and our emphasis hematological

MIRASOL for in and significant made combination quarter, platinum-agnostic this priorities first III continuing momentum our these the XXXX, Trial number studies. of confirmatory a into in with progress enroll from have We data and our Phase These Trial we important as each and head expect presenting year. continued with include to platinum-sensitive SORAYA opening patients of milestones the mirvetuximab,

later AML clinic IMGNXXX advance year. along malignancies, in For to our with this monotherapy in program to we in at combination continue the data expect present AML, hematological BPDCN and and in ASH MRD+ data

ADC, advance we IND ADC, of during into FRα year; ADAMX-targeting the first and preclinical IMGCXXX, expect programs, to targeting development. file for the For half our novel an our preclinical to our next-generation IMGNXXX,

an year exciting So ahead.

financials. so morning, results. are just to a few Turning the our summary this covered in issued release details press The

we million year comprised milestone For cash received $XX.X million million be generated $XX.X fees, of $XX.X $XX.X XXXX, license in of the in royalty million revenue, which from related and full revenues in will of and XXXX. non-cash

$XXX.X were $XX cost at clinical end of compared mirvetuximab expenses XXXX, decrease trial trial. quarter resulting closing restructuring of of the million, the of $XXX.X to of by commercial manufacturing Operating Phase year driven in R&D facility was and to comprised lower in and the million driven by the at our in decreased I expenses from XXXX. manufacturing the activity second XXXX million FORWARD the of activity of the $XXX.X due lower the end to clinical validation the expenses This expenses external in million support business prior III lower

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

addition, million XXXX. a In in we incurred restructuring $XX.X charge

in on sheet. balance million cash the ended with We the $XXX.X year

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

we our be guidance between million and $XXX and expect $XX expenses be million $XXX million operating be between $XXX In million between $XXX at revenues million. and our to to for XXXX, to of year-end and terms financial cash $XX million,

of our the anticipated will second fund cash, of We cash inclusive follow-on the expect proceeds and the into current receipts operations that half XXXX. from our partners, offering of

that, Anna? to With call turn I'll progress review over our in detail. the more Anna pipeline to

Anna Berkenblit

Thanks, Mark.

provide on SORAYA we'll review I'll MIRASOL, and ASH. and presentations details then at our First,

MIRASOL. and SORAYA

mirvetuximab, rate of those As action. year, could approval us advised patients duration at part time the overall and regulatory the of surpassed in of single-arm for ovarian new accelerated response cancer FDA of last dialogue platinum-resistant that trial therapy best available response a the provided productive support with

therapy we this of SORAYA rate. for this patients a part begin benchmark As enrolling relevant the FDA advised in this Based guidance, quarter. overall XX% on response feedback, that will currently is available

PSX+ peritoneal been previously or SORAYA fallopian tube scoring, primary mirvetuximab by ovarian, trial XXX bevacizumab. evaluating is high a FRα have pivotal with is platinum-resistant in women cancer who approximately single-arm treated that as measured monotherapy with

have I have PSX+ whom FORWARD has from X the assess We trial SORAYA. XX we our would ovarian post with FRα eligibility analysis X mirvetuximab, prior cancer and method for generated a to our with from of to platinum-resistant hoc received pooled previous including met criteria along patients patients I the for high Phase and Phase tumor expression, including identified key with using reviewed III data believe therapy, Each have trials of samples FRα lines a rescoring prior bevacizumab. expression

to platinum-resistant duration analysis We compare overall response XX response response of the rate a XX.X% Based these believe treated in the XX.X% CORAIL trial naive AURELIA months. in XX.X% bevacizumab. on chemotherapy single-agent cancer, rates which an ovarian and with previously and of these trial, data median with of was favorably of which to X.X with patients, was patients that seen both included the the in

And application from As line in submit Mark of half of mentioned, mid-XXXX. accelerated report if we second positive, these an data SORAYA mirvetuximab the XXXX. top approval based on for expect to data during

MIRASOL. to Moving

You statistical contributed FORWARD may Phase factors III analyses outcome I conducted results recall, to that negative may our exploratory I. we in FORWARD study, have a to the of following assess the

select reverting benefit patients to improve factors, to the believe we to to mirvetuximab. those to what and including of most scoring accordingly MIRASOL method identified success, technical the probability key likely designed original from PSX+ the be We

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

approval accelerated continuing confirmatory to enrollment forward of to serve approval half expect based top and in for receive mirvetuximab of expect that full mirvetuximab. We of data the results MIRASOL MIRASOL trial this to SORAYA, first the line report we we If in as on would look a year support XXXX.

and look combination our drug advance move FORWARD anticipate in combination with carboplatin this to of cohort in combination this Avastin data cohorts our lines doublet from fall. to Avastin from we continue data we II Ib with at parallel, mirvetuximab presenting our We and with mirvetuximab evaluating cohort, in earlier triplet ASCO mirvetuximab therapy. updated platinum-agnostic into evaluating Phase platinum-sensitive year; the as In updated

platinum-sensitive initiate investigator-sponsored randomizing carboplatin-based with them trial an carboplatin. an investigator's to an will in patients, XXX combination to the either choice mirvetuximab over regimen. plan be evaluating in in in This mid-XXXX, combination we additional or study Lastly, disease, mirvetuximab-carboplatin

IMGNXXX I'll now efficacy At and briefly early-stage portfolio. relapsed in our from BPDCN. findings and of our expansion progress review escalation updated presented Phase with with or AML and patients study ASH, I safety dose of our the refractory we

and well-tolerated including deploys cycle. across safety up IMGNXXX the activity milligrams all IGN kilogram anti-leukemia tested, that per along doses to at a most profile findings with dose levels those CDXXX and our ADC payload. a activity demonstrated And is updated potent per X.XX targeted

II. dosing short a antitumor favorable of And selected believe that and Phase of infusion ongoing AML BPDCN, the have schedule convenience monotherapy expansion We in reinforce ALL. recommended a and the activity, IMGNXXX the for tolerability

our initiated patients. IMGNXXX XXXX continue AML relapsed ASH. with to as residual And in and sharing venetoclax azacitidine minimal and frontline at IMGNXXX as forward combination data monotherapy as a trials well and we in AML engaging disease-positive Additionally, in look enrollment

to turn back With call closing for over I'll Mark the some that, remarks.

Mark Enyedy

Thanks, Anna.

an our open for to year, We experienced advance productive few challenging with lead earlier-stage our business. to call important team XX for the emerged portfolio prospects position cash strong months. the forward and a we with management business Q&A. a next portfolio to deliver thoughts an for our look a strong catalysts Just the points material to inflection exciting before we've and After near-term program, on accelerating,

And with for questions. the open that, we'll call

Operator

from Our comes Instructions] first John [Operator you. Thank Newman Canaccord. question of

is Your line now open.

John Newman

morning, for question. the Hey. guys. Good Thanks taking

a Mark. question and for Anna So

could doublet Avastin patients rough you Thanks. And patients for that group of wondering a any of FORWARD the as therapy? sense the number would II might prior have we received if to if curious platinum-agnostic Just us within midyear? the that see give

Mark Enyedy

the So - sorry. yes,

right cohort patients is. have yes, a head prior number the can't how that is I patients, So will say Avastin. and top many those at the my of received of XX

John Newman

I'm just have a the wondering might more prior just for on U.S., Avastin a little Okay. has line challenging given in than assuming would one of a the been few more one recently. one? than that until have if with reimbursement SORAYA. question I'm quick SORAYA you bit if line patients have will that, in therapy patients Great. Avastin or then of And getting

Anna Berkenblit

Thanks, John.

as remember, being U.S. well have line SORAYA patients if all. with enrolled And as do of historically, get X only So patients in typically, disease X at to Europe. And with access is really priors. it to they is this one Avastin, in the platinum-resistant

Avastin another the where an with treatment it Avastin that Avastin the setting works is benefit I'm aware that regimen. still MITO/MANGO Avastin data the regimen, after was containing only from recurrent really got platinum-sensitive frontline after that with - So of study, showing shown you

will of anticipate patients we than Avastin. one that So prior very few line had have more

John Newman

great. much. Okay, you Thank very

Mark Enyedy

Sure.

Operator

Thank Jefferies. next you. And our of question from Amin Biren comes

Your is now open. line

Biren Amin

about Hey. just think on presented the Hi, with steps data DOR. trial and study? patients, guys. pivotal rates can the II give are? response XXXX, you us do XX see Anna, the into additional much what Thanks maybe my forward for taking triplet, some I the FORWARD you need saw next there pretty before a to strong in move you data questions. you triplet How in

Anna Berkenblit

Yeah.

will presenting where at mature longer-term year, have triplet we ESMO data from we So likely PFS be this data. the should

or also that there, XX months. year and somewhere out read benchmark XX Carbo-doxil-bev carbo-gem-bev also carbo-pac-bev, median recall to triplets, ESMO before, PFS for around the at the similarly. may so last looking other is year You the

So are benchmarks. those the

PFS we'll registration well option trial. for safety we'll see long our so then and large, there. it and terms that a of from stacks as triplet triplet And up Any in tolerability as how be potential would take

be examining data So closely. the we'll quite

Biren Amin

you going year, you Okay. IND, I on the And are ADAMX into to expression? stratifying And last at this tail? you then AACR, IMGCXXX on of guess, Phase tumor you're think, based preclinical be I what some in given the ADC, ADAM moving line data? at had program types presented, I And are looking

Anna Berkenblit

Yeah.

for needed and levels, poised a be will to selection. we ADAMX we down have diagnostic the road be companion patient assessing if So will

be data. early gathering So we'll on,

X pancreatic, we triple-negative can and then cancer. the lung that Phase tumors based The on do to going some also And in first X cohorts. are There that I initially the tumor solid target we're are gastric, after we dose what include we're certainly ADAMX, types express see study. escalation, expansion going but some in breast other these

Biren Amin

Thank Great. you.

Operator

from Hsieh our Thank from next you. And question Andy comes William Blair.

line open. now Your is

Andy Hsieh

taking Thanks Great. for my question.

Mark. So, one for

company I been quarters. has think X the or for restructuring the past X

of the changed Just accelerated was wondering approval if in that pathway clarified the December that? course

Mark Enyedy

Yeah.

took restructuring were And - half got we question, So of a back call, of in QX. place And headcount. a part thanks of that headcount largest and the of were Andy. terms were nadir took number, folks The I'll transitioning to, over for the there we QX the the we sort the early what and targeting year. in

And as we around SORAYA, with the the FDA begun go heads number of to we've of a very benefit add guidance actually modest forward.

the same for an so going that were range And operating in gave, the XXXX from guidance expenses you'll on see our are in XXXX aggregate to be they for basis. as we

the what bringing then expenses And regulatory reflects XXXX, a the concurrent as particularly significant versus, QX group we reflecting in around XXX year. were that SORAYA thought the later I MIRASOL. with, ramp ultimately, and so in both sort some And in be. And where of where modest leveling from headcount a external execution going are then said, in say, were we of online we of and to the additions, clinical

Andy Hsieh

Excellent. Okay.

terms in investigator-sponsored by I guess, was very a, from randomized FDA of the perspective, I So dialogue - doublet. intrigued

investigator-sponsored about curious in the in kind can mechanism which sort potentially package? that of high-quality of include regulatory you a trial by regulatory Just adding any I if wanted know data to there's just packages.

Theresa Wingrove

FDA there of could is is This ISTs. robustly not efficacy This combination to so be opportunities has but data used though, The data. for trial, Hi. Yes, be include to however, it are evaluation consider support certain a that to monotherapy. the collected, Theresa. would

Andy Hsieh

Okay. Got And I lastly, Anna. think for it.

this is year. that, guess, III running been So that readout I but trial hasn't may used immunotherapy Phase really a Roche in

Phase treated if just IO combination in with Ib did So look or mirv? do guys at population you and monotherapy, FORWARD how any they I, curious

Anna Berkenblit

So I you're the the that study. checkpoint right, And inhibitors really have think large Phase Andy, that referring cancer. moved not to in III needle the you're IMAGINE ovarian is

setting, of us incorporating and the - yes, in frontline terms In atezolizumab. that's

we had patients given honestly, I. sort terms our who've at data looking been of enrolled checkpoint at prior of us, hasn't In set, inhibitors, there looking when them of enough FORWARD

really can't I speak to it. So

and say, modest the I for therapy But cross I checkpoint will the of mirv don't like rates prior checkpoint lack given would themselves, think activity. inhibitor by given impact response single-digit activity, any potential resistance, inhibitors

Andy Hsieh

much. Thank very that’s Got helpful. Great, it. really you

Mark Enyedy

Sure.

Operator

And of you. question comes Thank Peaker our next Boris Cowen. from

Your open. now line is

Boris Peaker

Great. A questions. couple of

to So anticipate to different regulatory move select trials, first, do just the in best in I'm combo and curious, the on somehow the forward? the combo that strategy several what's combinations Is Or you general? goal parallel? advance

Mark Enyedy

Yeah.

with positive combinations action to the from the combinations. So listing to is at the the the sufficient we compendia have time would support step first outcome that ensure, have on regulatory monotherapy publications a a we around for SORAYA,

so initial goal. our And that's

for to use. - obtain by extent use can that there that is physicians, the So reimbursement that discretionary they

is Yes, an embrace have longer term, particularly the to expanded - patients. platinum-sensitive goal label, to our

a of and combinations patients, these in what evaluating the so there. platinum-agnostic we're segment to And trying define also calling forward path

doing at looking are, [ph] Germany comparing that's is AGO with the us this And for doublet and choice. here Hoarder with investigator's what opportunities the to IST. in large that one, So carbo with

good in would The a guide be ASCO equally strong we in the at a program. terms we for that us with will this might cohort provides us. think go data platinum-agnostic with with of have I June that where signal

to broader cooperative very And of mentioned help on very, groups would studies. those earlier, of we - studies the be as likely think with to about Anna I get we any And the look some large. triplet, think to those as

mirvetuximab new tuned. at So doses doses what of safety The point without with date points everything signals. a full that I first, we've lot can data. tried would combine are, this generating We've to we full of say key is stay gathered of

in the tolerated drug combination. is So well

mirvetuximab with the The efficacy that exceeded have comparable. hit benchmarks we've

apples-to-apples, really, to there. So rate relative look too. some you and low combination our in in benchmarks, response we when at triplets compare very reported, these to at with XX% - Avastin what patients. to triplet data those and was look we favorably if I And favorably The the the got studies of compared mean are XXs. high a we've are

we And the on the by obtain on they think and to the are encouraged reimbursement groups? So what that do in physicians the that the our way, ensuring rely data And want could extent what cooperative will be, the I own, that we the can we're to question encouraged. use drug, early here can along U.S.

Boris Peaker

XXX. My second on Got question is you.

indications you Just path curious having what do see the as shortest to approval?

Mark Enyedy

of Yes. on group, had that BPDCN, a ASH, of X so had all responders X which and reported data received small or of we ELZONRIS. in we cohort previously patients at whom all

in And support we approach that see a in to define as dossier breakthrough patients population so patient to of accelerated a population. like designation FDA to create And collect approval to additional in BPDCN part many goal the whether this relapsed is to would they an therapy sufficient for how order discussion, see data sufficient can for us for this that indication.

that And remember Alzheimer's and around was of think XX, may XX approval the XX. I supporting the so you between number patients

done modest. those what Europe quite from has open and numbers there encouraging investigator response with is XXX patient could the go and so be reasonably and we've accrual been an And And to standpoint. sites,

may with not You to that that Stemline remember Europe go did drug.

the of accrual been to take And from go the a to FDA. need able the accumulate patient perspective, have which think we've data will advantage we so us allow to I conversations that with

Boris Peaker

Got you. rituximab? from does on the Maybe just question IMGNXXX, last differ how that

Mark Enyedy

Yes.

and program, payload engineering So we that to and a the have antibody improve also PK. some we've then linker for new done

more where that reflected about that at in have will we in And April, the so improvements are AACR molecule. embodied in data or we can detail talk

Boris Peaker

you Thank taking for my much very Great. questions.

Mark Enyedy

Sure.

Operator

Fye Jessica of next Thank And question you. JPMorgan. from Instructions] comes [Operator the

line Your is open. now

Jessica Fye

for Good my morning. taking questions. guys. Thanks Hey,

in that the implications 'XX, review at that mid while point fails to the SORAYA BLA 'XX back the meet review what you if and potential half in with data under to FDA? of MIRASOL file that is If have some are

Mark Enyedy

Well, so is based SORAYA surrogate endpoint. on a

we if be surrogate. with that candidly, came out a overall difference then we the showed - based given the full response If that DOR MIRASOL and circumstance approval a I approval for - the if agency. I would statistically in think on think a challenging challenged, be as endpoint, data I would think significant on accelerated no

Jessica Fye

after about could think June just for time XXXX I but yeah, the decision. pointing that lines of to here, half, readout And clinicaltrials.gov MIRASOL, so thinking first is conceivably

that possible that the Is after on that, SORAYA MIRASOL has the a play it lines get call approval of the in readsout accelerated FDA where out you of way, time kind time kind line? made

Mark Enyedy

Yeah.

I think the so going scenario I those segments get we mirvetuximab, previously relates of to more probably and likely And in here. things substantial on. as not preclinical have that's following the change for drafted so the to BLA there way, are it and

So a for looking essentially, we're clinical component what BLA. the is to

the So move got We've SORAYA. from submission to by very our line top supported view this. that of review the is priority data can we readout the for quickly - for

Theresa Wingrove

And we contractors state [ph] have initiating approval... to

Mark Enyedy

Yeah, sorry. you. Thank

my these very treated of around in previously and significant the that FDA, one the agency platinum-resistant sense patients with populations alignment point that there Avastin. was is patient clear particularly where And is need unmet these us so between and

is expectation quite going quickly to on move they're this application. our So

X act this shorter time acted XXXX the application. line a And months data some But is because cases. X frame, that good are in or need so high, a have and we're reasonable they've where time where in - saying they on them in cases in for is to

MIRASOL. we'll see. readout likely on of followed the action a by I regulatory scenario But so think SORAYA, do is And that

Jessica Fye

of XX - they look patient meet enrollment just I'm trying think SORAYA. see Okay. Got had? number a going so kind are like think about kind the background take to when of present you and about the folks it around analysis, we it. can for more those the look nuance we priors who and would group therapies that at to criteria have of And

margins end trials being patients SORAYA? that if going mix to being of those who the given came wondering a ones in than kind from, are up - sicker enrolled might I'm end the up little of on bit the might

Theresa Wingrove

probability with those will XX spadework lot a through have been of patients, the us don't already our Jess. formally really present program confidence did to we to who that who've any plans a understand give have SORAYA treated We details of technical So additional high success. mirvetuximab to on patients looking are

level, by lines to all therapy. cancer. very They've at high X had PSX+. are with FRα So prior some X ovarian at a high all these had They're mirvetuximab. patients to prior all all bevacizumab of And they've point receiving platinum-resistant

from trial. somewhere XX Phase of the I majority vast The from came or them them the and Phase of III around - about XX trial, came

looked be out throughout, ruling will we're that and rate. a we've of response able to in So these data we confident replicate XX% terms

for And The I, one - primary platinum. when of we first-line those may that platinum Subsequently progressed we - that who you of excluded within designed suggested when be disease were last X prior informative nuance be platinum. X talking very of key there, platinum-refractory that within with FORWARD their primary minor the should platinum-refractory those weeks have is really we patients their the enrolled they dose patients of who opinion leaders, months progress patients.

in a enrolling not we on we've both into that SORAYA in impact would the so benchmarking and So trial enrolling SORAYA, MIRASOL randomized as we're not have takes forward. on SORAYA similar much consideration nor probably them well. done not those FORWARD moving In - sorry, the arms, I, are patients for that setting, but

Jessica Fye

it. you. Got Thank

Operator

next And from Chang you. comes question Thank Jonathan Leerink. our of SVB

line Your now open. is

David Ruch

for is questions. our taking This on Thanks Ruch guys. David for Jonathan. Hi,

and ADC. have how of setting thinking the seems guys design using an opportunity you studies for will it where elaborate a bit chemo, on the just down neoadjuvant the road? You KOLs plus about potential receptive Could a be in these mentioned and past, you're combinations mirv little like to

Anna Berkenblit

discussions be going neoadjuvant having trial our And really can right. all a active investigators. to strategy. we're is and for and is I say have get discussions, You're high up the absolutely and with to trial our priority excited trial A investigator-sponsored a in a we're position

David Ruch

would that be an clarify, IST to And or... Great. right. All

Anna Berkenblit

Yes.

David Ruch

Okay.

you. receptor I you are And data that these expression have more FORWARD mature, for type foliate of alpha that Thank in retrospective the next a looks at of bit now little any considered maybe analysis over me, patients time? biomarker the great. presenting longitudinal Okay,

Anna Berkenblit

that require primarily biopsies, initial their not archival based were serial part as patients on the If, protocol, diagnosis. would who tumor mandated So for was whatever from so biopsies of were could enrolled which they to tissue biopsy, a these trial. in available, Phase not patients III participation reason, we have had not archival were fresh during their sequential but tissue the subjecting

we would available not So you're have that the data unfortunately, requesting.

David Ruch

Okay.

Okay. Do you think and that this might Would be something have or... you you biopsies do in pre SORAYA? post-study

Anna Berkenblit

So between X cohort a we after that there have several biomarker we cycles. at ago expansion it in reasonable then tissue. tissue our SGO that I And biopsies showed that was years And we fresh presented did concordance was now. and really, archival did that Phase study

note treatment hard for what's to to perspective. a from on. cohort to progression, At enroll should I'm cohort. to actually we had such I biopsy over tumor had can after allowed who so that what's prefer were an cycles, patients conversation a you that pretty point, engage see at there next to patients that's X is sorry, working, no we'd the saying, drug arm that have shrinkage biopsies to that patient and That a get of also around biopsy that on conversations a bunch a the with they you couldn't investigator going for in like a subject typically imagine longer

David Ruch

Thank much. very All right. you

Mark Enyedy

Sure.

Operator

Capital MacKay our RBC And from comes of next you. Thank Markets. question Kennen

is line now open. Your

Kennen MacKay

question. taking for Thanks the Hi.

area could efficacy that if BPDCN, in is behind you us medical sort highest And need? the bar if the help Just as of of Or of understand wondering sort is ELZONRIS? go at where trial going designation or looking through breakthrough potential in if or Thank regulatory it of that front you. behind? design, you does have could a a here be potentially unmet process you're potentially

Anna Berkenblit

Yeah.

by was responses look then if their worth Certainly, based look but not was ELZONRIS X as the had BPDCN, at out response was somewhere or So the Journal it a safety XX rate of I approved higher. if for Mark you additional patients ELZONRIS in England the XX Alzheimers' XX larger are frontline in of the New for database. And you those setting think considered partial data they around relapsed label patients. - on in setting, were article, mentioned, certainly responses, FDA. But

unmet X is we a high is So think think the I small responders need numbers, perspective, there ELZONRIS. patients from certainly, quite of while And that encouraging. proof-of-concept already for we've X a who've had out had,

We're not the for ELZONRIS. the patients with for them. with also leak, comorbidities capillary challenge with albumin at you pose there not appropriate hearing perhaps handle patient is who cardiovascular And if capillary would that for every patients Certainly, couldn't for label potential renal are or look ELZONRIS. appropriate the low cardiovascular that leak

not That that to where treated be ELZONRIS. been we safety area with another both who supportive might as as activity be able could of well have in be might demonstrate going upfront previously frontline BPDCN patients

heads the we an are informative gathering enrolling patients. data regulators. so the down. our with which set to that data And this We're have point, We're at engage

Kennen MacKay

that at this of Interesting. be then an year? from that Thank see And could update EHA? expansion would you. an we ASH Or later

Anna Berkenblit

duration, I will which data longer important. with have be suspect ASH would that a set bigger would

Kennen MacKay

very Thank you much. Okay.

Operator

ladies for call gentlemen, the question-and-answer back conclude like to you. and over our I session. this any Thank And to does would turn closing Mark now Enyedy remarks.

Mark Enyedy

Thanks, participation Thanks we the throughout to Sonia. and keeping remainder the look of our much good questions progress updated on Great. today, and much. you Very very appreciate forward the year.

Operator

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

now may disconnect. You

Immunogen (IMGN) 14 Feb 202019 Q4 Earnings call transcript