IMGN - Earnings call transcript Q4 2017

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Operator

Good day and welcome everyone to the ImmunoGen Fourth Quarter 2017 and Yearend Results Conference Call. Today’s call is being recorded. And at this time, for opening remarks and introductions, I would like to turn the call over to Sarah Kiely, Investor Relations and Corporate Communications. Please go ahead.

Sarah Kiely

Good morning. you. thank And thank and joining call. today’s Good you morning for press includes and a Earlier operating today, of that a issued progress we summary release our results. XXXX recent the under This can our recording and press immunogen.com. of release website at be Investors the found section of a call

Anna Gregory, team call Officer, our Officer join are the Chief the Chief today CFO, Q&A our the CEO, Mark Scientific and On our Dave for session. Enyedy, our Medical Berkenblit; Johnston. Rich will

from call, XXXX, anticipated lead guidance an mirvetuximab financial we our will programs, today’s soravtansine, and XXXX events accomplishments development key During year ahead. on provide highlight key outline for the XXXX our update including asset, for results our and review

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

Mark Enyedy

Good business thank you to Sarah. everyone we in with progress made we XXXX. productive you, and the another XXXX be joining the and to with you us We're look why to review morning, year Thank in today. pleased forward for

strategic a ImmunoGen priorities. at with Our efforts focus commitment start with four

for First, by women XXXX. the the and complete launch with development mirvetuximab of treatment ovarian cancer

accelerate pipeline IGN of programs. novel Second, our

strategy made enrolling platinum-resistant of Phase Since more fully Throughout we before XXXX, the end FORWARD reach expand study Third, of innovation means build Operationally, which our advanced at I we consecutive cancer. XXX XXXX we've on these in our At X sites enrollment patient a patients of company. on progress for priorities accrued have are June, and than ASCO in mirvetuximab roughly our four end through strong in of supporting leadership through the we the continued track first execution to the of quarters across complete January we our with XXX analysis of XXXX, of FORWARD ovarian the resistant in and partnering. monotherapy XXX patient financial platinum mirvetuximab pooled registration position And fourth, will towards ADCs I innovation. in maintain activated disease. presented months. as XX each strength significant in

support multiple efficacy of of mirvetuximab in data Avastin, with combination these to from combined including Keytruda be with of demonstrated full carboplatin. doses with expanded we of dose FORWARD safety of mirvetuximab and stage no the data mirvetuximab also addition regimen agents These therapy, that In outcomes. full X lines and benefit encouraging the evaluating trial earlier escalation new our presented doses signals could

mirvetuximab have platinum-resistant a and FORWARD together, to initiate Keytruda Taken Avastin of the X from X these with expansion have FORWARD patients. accrual mirvetuximab data investigators, interest plus and which enabled supported degree IN generated us high cohort in rapid plus

In and in a addition, platinum with quarter the we've this triplet Avastin sensitive started combination mirvetuximab plus carboplatin setting.

commercialization Pharmaceuticals, which the for at capabilities advance time, substantial partnership August. offers ImmunoGen we scale, first to generates provides to commercial our strategic accelerated we Moving alkylating Jazz clinical and are XXX supported integrate call collaboration to XXX portfolio, ADCs DNA with of IGN. and development established partners This with funding and novel in by and for global two these earlier proprietary our access stage our that payloads, development we substantial XXX XXX a which program. the programs rights

collaboration in off is With start. a progress made strong in XXXX, both the to the programs

first go month, Phase will blood patients balance sheet as aggressive stage we of in and BPDCN. the ASH activities $XXX follow-on clinical than in of Anna the AML our through our began with dose in December, on each to our those AML. more part X activity business a Phase million reported we XXX data patients well into As moment. and efforts leukemia trial in came development in in dosing patients offering. escalation or acute as rare trial patients clinical a antileukemia more we and with these safety X XXX myeloid from with successful $XXX Financially, at a $XXX million referred added detail XXXX, cancer studies of as million to through Last

on In sheet addition, million the These year. our to of $XXX we converted equity the almost as $XXX position little significantly end million $X of outstanding in strengthened into and debt our very around financial million. have with almost debt the debt balance reducing of cash efforts

from momentum a year. we the of catalysts with a important the expected of With in strength generated during months, XXXX number position enter the we XX last

Enrollment We the interim and are on X positioning by brisk first a in for the which on for track in FORWARD we only. reminder, the in first a futility accrual is complete midyear, readout to analysis endpoint should the conduct trial XXXX. us quarter, topline primary as the half

more than These cohort XXX and study. Avastin cohort efficacy X In cohort this escalation will in Keytruda begin our combination combination for from report by the addition, course SGL, will over the at with readouts the patients Keytruda submit for year, of with data expansion in expected ASMO as an we data from FORWARD expansion October. which abstract followed in dose March we the for ASCO will

early and end, in and of efficiency with with review recently delivery functions late contract an to resources external our and oversee production Phase manufacturing and our and on regularly to ASH. strategic needs. immunogen our an clinical to to Finally, in program. pipeline include high-quality we X testing developing and XXX data manufacturing operating capabilities we and assessment, priority that to in-depth determined commercialization development in-house Through we a focus manufacturing quality XXX model support our conducted could benefit access that can both drug that goal and this of this of effectively transitions network Consistent the materials. quality model long-term analysis both we the gaining from substance with upon expertise, our building our external objectives, highest moving our benefits are for drug capacity timely, studies advancing that These of operations levering advances anticipated stage our CMO ensure from and will partners. programs improve Based product

in considerations located in Norwood from will XXXX eliminating be currently early XX these Massachusetts the and functions mind, closing positions facility With approximately there. we our

in facility of generate any and five over next year, the as affect continue decommissioning will Combined, the development our during that facility slight Over for XXX not will we of other in to later this also call, increase and quality years. for to in add with business consistent in a the the partner from Norwood areas and for support to partners testing will been years. expected without million XX timelines model staffing than as I patients revisions the next guidance and programs. year. are interruption savings the we well the the staple of operating end result and manufacturing by this long-standing net anticipated and and programs should ImmunoGen's decision of has manufacturing XXX of these the $XX to is products provide in a more business, high-quality the growth delivering

employees all evolution We the are of contributions ImmunoGen. growth of have our to made for grateful and Norwood-based the that

support and With in goals the patients XXXX to the We mind, now will in productive the catalysts to new advance XX and norms those we therapies next forward upcoming line for bring stage more create pipeline in we value our more Anna program progress data events our clinical in and shareholders. review detail. benefits industry severance look months, will comprehensive in as in multiple retention year to With this employees the decision. to provide affected by with another

Anna Berkenblit

Phase Thanks registration am women with FORWARD X designed to Mark. I going to study, related our start is cancer. which by off platinum ovarian approval support mirvetuximab full X reviewing to updates resistant of mirvetuximab and for

across U.S., are have Canada on enrollment and As sites XXX to by opened Mark midyear. mentioned, track Europe we the than we complete now more and

We continue X pleased very progressing. be FORWARD how is with to

in FORWARD in to expressers alpha patients the X and the intent reminder, a includes of that both PFS both subset As high levels the primary folate in survival high with of medium of progression-free expression. population FR-alpha treat is and receptor endpoint

believe has safety observed potential With the agent and displace setting. activity far, single as profile the to chemotherapy we in platinum resistant mirvetuximab the consistent a encouraging so and

update to reminder the which than complete to ratio alpha If greater subset This greater analysis, for the will one, for reach intent you. than XX events trial PFS interim for a the of monitoring ratio the we pre-specified quarter, would we one for data hazard is independent and the trial is population is only. stop. the Otherwise then recommendation analysis expect the folate treat high futility as is we receptor and Once required committee, hazard the the the continues.

we combination, date, earlier X, shown we disease. positioning expand to X and Avastin, Expansion it can in expanding the with platinum-sensitive the expected To into FORWARD three FORWARD are full full trial are conducting the mirvetuximab cohorts year. safely that and throughout of potential dose an doses the Keytruda. mirvetuximab combination therapy be of Keytruda line data as and Beyond with ongoing have readouts combined both carboplatin Avastin

Women's an by We ASMO abstract Keytruda cohort. at will dose data reporting also Avastin from on the an Meeting in featured which We're on on expansion presentation combination patients June, for expansion submitting ASCO the in Cancer SGOs at followed XX Annual a from cohort, March, have provide the update poster plans escalation to the patients from on October. XX in the patient XX cohort includes with

due carboplatin study expanded Avastin look sharing evaluate to enrolled triplet have first recurrent details and cancer. of forward am to platinum-sensitive X more In plus in our I in announce week addition, pleased we a the this ovarian mirvetuximab patient FORWARD we that to and course. combination

as at with gemcitabine Network National several Beyond types is other in patients other the studies are receptor gynecologic in are the breast also to evaluating third expressing the the folate studies mirvetuximab mirvetuximab investigating This that mirvetuximab malignancies. NCCN, in and Cancer in and alpha in looking cancer our Comprehensive includes with three internally triple investigator-sponsored trials combination combination. negative monotherapy sponsored with there mirvetuximab tumor

DNA mirvetuximab with develop of who highly benefit ImmunoGen We as evaluating guide made Clovis, that ADC earlier mirvetuximab with agents treatment. damage, anti-tumor to combination CDXX a double-stranded by use cancer. which in DNA XXXX, are our are that instead Data novel progress relative co-sponsoring stage Rubraca help payloads, study patients will malignancies. IMGNXXX is were further retaining of reach a IGN programs from activity we positive designed significant with healthy IMGNXXX and studies with patients potent IGN these ovarian sparing as hematologic we potent we refractory CDXX strand which as cells. in IMGNXXX with in novel and relapsed causing evaluate alkylates one DNA Both how of targeted from our will also In possible acting may many AML. in

in including ASH with that study the has an from at and dose schedule study observed with at CDXX patients ongoing portion X pharmacodynamic December. biweekly the XXX which dose from with both saturation exposure anti-leukemia AML in with Data updated Phase of prognostic and tolerated Pharmacokinetic we has escalation been We been presented dosing weekly in looking and activity patients have demonstrates those well no limiting dose toxicities. poor features. increased data

biweekly with schedule. we dose XXX Phase submit fourth the X the to escalate expect continuing both are We ASH quarter. and year study the at establish dose for to additional and Phase data for recommended presentation in weekly X This the from

increase preclinical which standard three we December, as a additional prolonged safety levels, and survival novel agents tolerability and At DNA escalation, AML it apoptosis hypomethylating cytarabine, well cytotoxic for flip forward no presented and agents, used with and damage, with as as with in include As as in NbClX in-vitro to arrest preclinical data ASH dose increased issues toward remissions well models. vivo we inhibitors. showed therapy models, evaluate XXX XXX's in in CDXX chemotherapeutic continue in numbers we combination AML. efficacy as data well These combining look the using may growth combination enhanced commonly complete as of in human

MD to XXX on ASH lymphoblastic selective preclinical December, At data of is ALL. models of of vitro, blasts BALL IMGNXXX that a in at with promising potent out our which CDXXX IGN of BALL demonstrated patient AML Moving the samples. acute ALL. collaborators preclinical that in subtypes B-cell elimination IMGNXXX leukemia six ALL. XX% in targeting patient activity and than safety of expression presented our and activity we second activity of program demonstrated or of is Anderson, and and ADC We samples in has CDXXX models of promising lines T-cell prevalent demonstrated eight and in both more nearly including cell ALL in including XX% reported across preclinical half

we We're end, patients including study for with neoplasm. not therapeutic across window. dose believe have encouraged very hematologic first followed dosing positive suggesting of we recently X preclinical or reported were used there study announced a dose cells BPDCN, at cell malignancies. normal affected hematologic Importantly finding strong our in positive by higher the be range the XXX To by in Phase The dendritic expansion in will stage. to-date XXX-fold that the BPDCN is results for the with concentrations, an three-week malignancies, in CDXXX AML, increased cohorts its potential other selective patient XXX every potential plasmacytoid CDXXX The while once evaluating IMGNXXX malignancies. AML and blastic patients dosing and ALL in then and schedule

present from in ASH this expect data We initial the at to quarter. study fourth

updates to robust potential of extremely heard, encouraged milestones the by set the ahead. year. and look sharing year forward leading are As you our the have we of in throughout a pipeline We

over call to turn the Now Dave. I'll

Dave Johnston

Anna. Thanks

we of approximately release, driven focused executed revenue, breadth of amendment license year. $XX morning's due with and related partner discipline expenses results included our of million to non-cash our license on license In for clinical million related Our fee development we collaboration on operated guidance million paid-up operating just $XX.X milestone XXXX, advancing spending, related full XXXX. financial this Throughout the activities revenues XXXX, in the year detailed $XXX million an last to trials. recorded to of and mirvetuximab CytomX million amortization by in and $XX.X $XX.X highlights a this is I'll in IMGNXXXX Sanofi, to our business were sale a financial agreement million our transfer with agreement with development $XXX press fee million [indiscernible] updated Debiopharm, review so lastly, $X our research of non-cash royalty and sales. the in reflected million to heavily and in and largely payments, Revenues approximately $XXX approximately and

from our in balance sheet. XX.X This over into the the heard Mark we done debt up cleaned course million XXXX, earlier, As $XX you was substantially of of through conversion roughly of strengthened our and million debt part of a about $XXX that stock, shares proceeds about outstanding $X to we raised shares October of reducing public In net closed XXXX, offering today. just XX.X common of of million successfully million. million

the to $XXX the enabling million $XXX end approximately over in with cash equivalents. added balance to and throughout sheet So, us million XXXX year, cash

million We expenses and million million million and expect and with revenues of anticipate $XXX cash we and equivalents. XXXX XXXX and between ending of ahead Looking $XX $XXX $XX $XXX operating between $XXX cash million million. between

expected our fourth financial execute evaluate X to our from that collaborators fund expect revenues those including We cash us all current the important results. cash, and to a combined very which mechanisms and we position programs XXXX our with into the topline started of a number quarter to XXXX, milestones strong strength the partners take in through operations will will of continue and on We market. maintain FORWARD to bring will

lineup that, we'll questions. for the with any open So,

Operator

first to we'll And instructions] [Operator Michael go Schmidt Sir. you, Thank with Leerink.

Michael Schmidt

of what line patients XXXX regarding How on remind help us example get how study. the middle mirvetuximab-Avastin get made. and update of question characteristics that you'll folate the all biomarkers might those the the terrific year, efficacy in just and provide on probably if a receptor can sense Congrats we conference you you combination I at these of the study, had patient benchmark Avastin of before? guys. maybe progress are one What that ASCO said received this have for the us alpha Hey The the data you thanks? wondering could and about many in in? to

Anna Berkenblit

you question. thank Michael, for your Hi

in data two is the population that initial patients at from plan data prior trial. who patients escalation the as what therapy expansion one pretreated remember to may dose mirvetuximab-Avastin of we've when naïve, data So, last Subsequently, are that and same from and we benchmark in the presented who have Avastin combination designed at we year. against and heavily we AURELIA you the expanded cohorts; had intent present ASCO to lines to cohort one ASCO, our we two

idea enroll an cohort who prior and to expansion Avastin group more second have heavily the patients The are pretreated and there pretreated. is Avastin is received

allowing up lines therapy. to we five So, prior of are

platinum-resistant that the we will all Avastin that the patients, disease, AURELIA at since in cohort analyses the to that ASCO recurrent been patients study, of subsets. Avastin critical Europe. while will in in are in there of that the had providing So, designed subset these setting be from U.S. be we've been that caution for cohorts course of already want the naïve as has small the appropriate data Avastin and presenting the do platinum-sensitive gotten in approved it expansion approval enrolled we has with observe however, of I

going of we we be Avastin was that And we'll The that's folate ASCO used medium therapy triplet. started lines patients that and low, be the included at and believe so, one more have question high. earlier presenting in again, the and reasons with we of had the alpha to FR alpha presentation. receptor data And is in subset last you detail

Michael Schmidt

the maybe in or the for retrial efficacy next do this i.e. do information. you think position And compelling be Thanks guess, something XXXX? you steps how be a should Phase to is considered wondering enough, signal year I think another it X added start Thank potentially in I Great. you’re was should you. that about

Anna Berkenblit

Yeah.

of year another start with the of triplet carboplatin, confidence in do And down platinum lines continue recurrent consider up this mirvetuximab and not the earlier with very the platinum-resistant expanded Avastin in will be specifically the provides move We Phase therapy road. X of to to it use Avastin that if into the trial expect strategy settings. really, down setting hold road data data up. to supportive our the I So, the in

Michael Schmidt

much. Thank you very Great.

Operator

with Debjit next Chattopadhyay And to Wainwright. we’ll H.C. go

Debjit Chattopadhyay

Hey, hear good morning. you Can me?

Mark Enyedy

well. Very Yeah. Thanks.

Debjit Chattopadhyay

Michael here. Actually, have I I asked a when questions kind take heading more was But deal Thanks. what at. XX,XXX-foot

So, share landscape, opportunities the as is I the largely think oncology you mine see for ADCs broadly? you survey Where do immune-oncology.

Mark Enyedy

Sure.

So, to they then think adjuvant hematologic malignancies. progress, of management if a ultimately in about with let’s tumors have them which Most present the of start surgery solid And reflects unmet most chemotherapy. then need with you particular, move in we will and undergo I bit space. can disease, little patients think the later-stage

ADCs targeting example, an for multiple very mirvetuximab so, to of with And of tolerability benefit particularly single potent is profile, see addition profile agent a look the when and anti-tumor to with opportunity having at we the the what we given favorable combine efficacy. agent ability compelling agents highly in

in And so platinum classically rapid clinical of with is single initial case progression the patients patients, us enables in to relapsed find head-to-head therapy, therapy typically a survival. ovarian platinum-resistant a market strategy relevant to pursue ourselves progressed endpoint in in after cancer free this which development, we receiving case population a that agents who against

and move and how So, question earlier you chemotherapy. will up lines do then typically is the into therapy, that of involve

we we important look an agents forward, oncology role. moving course the that at increasingly And of landscape observe so, immuno-oncology taking are as

we part a are March with strategy, from disease. again at interesting cohort in As collaborating share we and our platinum-resistant and results dose of Merck, escalation will which with Keytruda see SGO

an early expansion moved those of results, basis the into On cohort. we've

ADCs to for that treatment and partners. for in single example broader chemotherapy as displace the and partner. again agents preferred landscape, So, with have we example also mirvetuximab, profile we single paradigm a in think combination both of as we the And as as we the a potential preferred again agents agent combination see as with an see we increasing think role four the those about

Debjit Chattopadhyay

literally on a a got forward your move things, ratios, that competitive you so actually drug full what's drive partnerships think and is And where to given payloads Great. three evolving antibody Thanks platform say really do more around the ADC versus from space? three ImmunoGen linkers, viewpoint, then, much. things, it’s to needs in with you system to can four you've obviously, but multi-component

Mark Enyedy

that we Rich the to as positions think industry going I ask overall, questions well. tackle I’ll in got some around address think responses. mean, we’ve you're to immunological think I comprehensive and platform to most of that Rich I'm But So, ask question. the I asking the

Rich Gregory

Yeah.

data all, it's years think of been moved ADCs the the advancements if but to the say have in patients tend us, that remarkable. technology it strong first six is the who number have last So certainly look diagrams have that years some in the such will a patients into the oncology. ADC's. some which of who Venn area from hopefully at does I overlap just to will suggests. sort you there IO I they'll a And future respond as have of of that from five this lot field I respond see generally burgeoning patient and for at a of over as the to And populations synergy, in where not be to competitors the to clinic, targeted of our sure, reflects therapies well, pretty look we'll which optimism And as preclinical place then

in where the agents comprehensive those terms think Pieris to ability targeting about such So, We that you toolbox might Ablynx as like our space. are small as companies or be most could antibodies, in from or I and positioned? companies scaffolds we see other of Mark think have, discussed

think our of think payload of science tumor any us a to I very adapt payloads type. about to set that allow we specific have, particular how needs We diverse the

well-positioned So, way. think I really going we in to, participate meaningful in this extremely are a field forward

question Now, about us about approach we more that plays strategic you to a how that's think for asked want and of partnerships I how into partnerships.

of approach this as collaborative we’ll have, I about forward. most great the think be think pursuing for that way way and technology, I we is going modified value can be and have, out-licensing which think opposed value in to strategy our We drugs who the we gain drugs simply our partnership targets complementary people, that or work to with co-development example, limited our great our by the more might working with would thinking

Mark Enyedy

complementary As technology. looking to part gain that access to of

with that we a masking So, where a addressing probody in would be terms thought example CytomX of for that targets. the we wider did good of is swap helpful array technology the example technology

has deploy target And antibody or development deploying moving they forward so, a in a payload technology. and Abcam that program that look have link and the put an our CytomX we’ve to probody against or the clinical

Debjit Chattopadhyay

added the for Thanks luck. color. Good

Mark Enyedy

Thanks.

Operator

Kennen to with go We'll MacKay RBC.

Kennen MacKay

just morning for first. quick can the to help good Maybe $XX for and that sort question come? what thanks us housekeeping milestones question. David, real guidance In $XX Hey, and XXXX, those with revenue taking when you for the of could of million million implies

Rich Gregory

that you now reflected anticipate morning, It license and guidance business right kind and activity that of to compare predict. Good at revenue in or happen Kennen. because implies if don’t that it’s hard that’s the it development in to those XXXX milestone we happen are amount don’t not where We extraordinary matching our that of had. the the things least XXXX,

a milestone revenue. So, to business to related development modest and about it be license half relatively And is royalties. reflects of of amount Kadcyla revenue non-cash going actually

relatively in expect on milestones generally out first of whole we our control secondly, minor updates it’s all it’s when of we things. because the don’t and provide So, of scheme

Kennen MacKay

help level? interactions level night you you. Thank you. guess mERV specifically within relating sort conversations of understand manufacturing bit or Got this response then the more at a how GMP board help the spurred just FDA I okay. with us or understand, the Okay. and to idea us in came maybe up you just to this facility the what at or And for board sort can of Mark, these decision one and little announced And last checks

Mark Enyedy

just the me question. last with start let of so Yeah, part that

GMP as the this of the do whatsoever, no So, are with sits manufacturers to there there so material from to mirvetuximab, of production at continuing issues it relates currently all plant was time. contract we mirvetuximab remainder we'll throughout and XXXX. with the And produce

but about let on back here. So, aperture now and talk pull me the what's going

regularly look that all operations. So, our we sound requires of review management

broad-based Novartis the XXXX from time, in and of put Our away that with that programs our that particular requirements Norwood the in in some was back we of shift the declining a we capacity as to for really planning. place, as our Rich Roche focus on in portfolio. did partnerships in with and over changes others just strategy emphasize developing And and to we fall proprietary had mapping these mentioned business has effect own were our net so that facility the our long-range particularly evolved

to In to we the to and quality expanding who need there a to the commercial quality were And contract network put going was for managing do approach that, pivotal pivotal produce the testing contract in-place we comprehensive of testing both manufacturers. addition to manufacturers, and programs out a then there the moving material. and more a were finally,

for that of was conducted and our developments, And benefit given our goal we support those and conclusion manufacturing external analysis a model both we’d would with model manufacturing so, operations And assessment of on testing. a long-term the aspirations. that the comprehensive our that that developing we rely quality the sources the a a of growth would from move to

capabilities. capacity and to is to so, that expertise same so to that at world make finally, in And sure resources And portfolio. ultimately take and had we to centralized and the on and the and access evolving own respect we increased oversight is and technology, the an that testing wanted our capability things increase focus rapidly our of do CMO building the with which to commercialization time development we our in-house own best, advantages

our facility XXXX. on decision those Norwood to based the considerations, in early taken So, de-commission we've

of partner well going as timelines top, I couple have case This as it’s As this will IMGNXXX no mentioned of and we're impact and a on to our the at means to programs. that decision in continue IMGNXXX, product produce programs. the these

has save XX the but of highly XXXX, years. on have of our grateful facility, the about We're $XX on stress about through a looking And employees. think a part result term This our an organization. those in comprehensive five severance that. to thank a FTEs. we're impact for their reduction net staple we This And of as packages. we of we of result I will long-term does longer course And a productive a important that, the been accounting business. then efforts. it's next been expect employees, to This over the the in of them facility retention with be decommissioning million providing they've will

Kennen MacKay

PARP they even frontline of go potentially was sort one for the their that them lines data them potentially and XX sensitized of color you, a inhibitors of Got really whether about so I this any the little maintenance standard I then, from caring changed just -- there would of into changed with the hadn't knew some potentially appreciate know thinking standard two, that or line sort it. activity more makes of take I cancer, patients we the given turned could later one of sort sort care AstraZeneca, investors meant in And helpful? temperate ovarian getting about Mark. in market therapies it question into off your potentially what whether or I had you if and comment a That and make maintenance? be therapy the guess and as that with added you. that anything last combinations I post that you lot inhibitors final plus clarity. of Thank early was that radar how of more PARP think on, the one altering suggesting resistant to or many the changing treatment Avastin. this PARP how Thank of setting whether Clovis saw earlier mirve, But has of strategic years with a mirvetuximab of any guess sense. outside And that activity collaboration outside bit there even

Mark Enyedy

raised Sure, to on I'm you touch to Anna the points there. going ask that

Anna Berkenblit

Thanks, Kennen.

resistant the landscape have platinum no rates. about So response In single disease PARP have PARP for negligible platinum digit transformed that. basically sensitive There's activity doubt disease. inhibitors

And the And future platinum-based have patients sensitive combined as cytotoxic once that's therapy, recurrent a number the less are not paclitaxel does, strategy mirvetuximab that’s because become chemotherapy as them PARP, platinum but hair we're undertaken. is maintenance, neuropathy. second mirvetuximab two platinum There in mirvetuximab. so, they least then number so the certainly in and is with where that least of not the in tubulin the this That's safety it with it the physicians to quarter before triplet that's integral because preferred patients associated potential our why chemotherapy. near so therapy. about to setting, seems frontline initial have regimens so profile that are will use at platinum platinum-based at our monotherapy because ones be have approved so part of having tolerability currently become mirvetuximab, well Point indicated is started and profile the the for in sensitive and one. cytotoxic but remain it is loss their you carboplatin, of targets and the excited de-bulk resistant to an And will doublet And cannot does combination setting the point. regimen Avastin, agent indication with of point like maintenance know

third PARP. and are The significant there demonstrated is for recurrent have is platinum-sensitive which in Avastin point benefit two with patients that that setting, currently disease the strategies maintenance

if point, standard you many one will then get with some initial me of disease, with back surprise if will at it of and platinum-sensitive do they out would of they frontline therapy. than chemotherapy and patients do not will most maintenance have the chemotherapy combination frontline But them after round care them another them better is currently So, of will they'll used relapse, other and recurrent when therapy. relapse still of

will least currently because patients first, be PARP setting, But hope do cured the cured, the relapse. at know some some or other are you most of flip-flop way patients benefit benefit I frontline our then preferred around. this there are of second the majority certainly, answer not So, right in will potential may them initial more think has patients mirvetuximab And platinum-sensitive is that now platinum-resistant space. And Avastin at your is patients indication. as our the disease the again, combination agents be from with initially, why question, to patients in up Kennen? who but still point, the moving platinum-resistant chemotherapy the That in setting –

Kennen MacKay

does. Yeah. Sure, it

Anna Berkenblit

other what your about activity me Okay. question Great MERV reminded after was Mark, part.

in the that BRCA the of indications So, what on the in And that's you frequency we we have expect mutations analysis presented and showed have the And analyses, monotherapy based at PARP I about ASCO significant would prior demonstrated, for of does inhibitors percentage whether holds regardless a tell XX%, activity a enrolling for study. whether of PARPs same what exactly at demographic table they last is puled patients higher patients we or inhibitor. mirvetuximab that we the XX%. year, looked at the you were time can true got subset had not having a The or not Avastin. prior PARP

Kennen MacKay

I SGO. this very conversations up and incredibly follow much to on there thorough forward an was some you and the Thank looking additional for you. at Got

Anna Berkenblit

Great.

Operator

And with we'll Boris Peaker to move next Cowen.

Boris Peaker

morning. Good

and probably if close that one. as in particularly to X kind Anna to sense enrollment it a keep folate I'm group stop the efficacy comers safety specific of seems first ratio happens standpoint separately a if just wouldn't be question to that make even happens X, so hazard for you're my all above or hazard analyzing there as group to to that curious one well enrolling have plans And is ratio are or So, from above FORWARD for me expressers. and high group?

Anna Berkenblit

Thanks, Boris.

certainly, So, let's than currently hazard the the in population is be what you is a We is if in one. the because tumor just you you're I benefit for hives, most And greater we of is monitoring greater why shrinkage one describing, our way have reason, example, medium is adaptive may, the ratio But continue hazard as say hazard about less interim demonstrated the is all one. would ITT the ratio it probably analysis say significant patients have the than likely that we it's remember. is That's that designed stop. monotherapy and pre-specified both, the risk. scenarios will as unlikely well the we if in an case, this will. But committee independent study data do design as that is ratio the than data not in in because that

also hives, and review recommendations will the safety the hazard approximately, patients it in the look their in the benefit they and we at find are ratio we hard So, would would do such which then have that of other accordingly. on though and two-thirds will imagine negative to looking I but at be will it direction. population the minority swing the mediums who they are impact the a efficacy, then make have decision a that somehow

Boris Peaker

you. far? generally these or patients could line? is primarily BPDCN And And the IMGNXXX are so and frontline curious specifically actually describe on second second you question many Got BPDCN you Are you So, find my finding have to they it patients? in patients? BPDCN. just difficult how I'm enrolled

Anna Berkenblit

are patients, So, so, we as and patients. AML imagine just AML in there we've opened patients are thus far and as the the study patients enrolling in are they dose can January enrolled since And more AML we come. BPDCN escalation you

who be they the their dose have with investigators trial experienced escalation hold However, patients have but And certainly, would they clinic. other the are in in when enrollment who for not for those priority them they are will participating come, agents for given we up BPDCN

Boris Peaker

So, enrolled not? or a least single at have patient BPDCN you

Anna Berkenblit

No.

Boris Peaker

you. Got

Okay. Thank you.

Mark Enyedy

Yeah.

escalation. standard X+X So, a keep in is dose mind Boris, this

who for next three soon, first the and three will safety open up the have it review patients. sometime So, we’ve patients cohort enrolled of a then

to surprising AML it’s start. got it’s you three we’ve that So, not patients know, going to

Boris Peaker

you. much my you questions. for taking Got very Thank

Operator

Fye go to We’ll Jessica JPMorgan. next with

Jessica Fye

I higher my it you that a we just like hear start with weekly with guess, other than question. go when expect are seems forward Great. year, on to able been dose you to a should identified? go the taking has escalation week, likely dose the every have forward Thanks that given to for within there are IMGNXXX did and you I dosing,

Anna Berkenblit

week So, are point, schedule. weekly at escalating and we the Jessica every this other still

is Our goal dose. for recommended to excuse year me, the identify, X this Phase

to in and and our Phase that X able predict recommended a have We at limiting dose see ground stick I because can't will we really when the we require haven’t yet. ASH. have say data any dose we put would toxicity would be

Jessica Fye

Okay. Thank you.

Operator

Blair. We'll go Hsieh with Andy to William

Andy Hsieh

Thanks Hi. and a again for productive congratulations question taking on my very XXXX.

earlier. So, Jessica's questions and two it's bit I a related question little to have

I you the for an the disclosed has folate remind that detect higher could I, other publicly for – a And at you over receptor X X.X I have So, can can sorry have during call that last update months is disclosed? the the to quarterly believe benefit that intent us secondly, if high benefit, you guys you you the of powering you. months, treat the you population cohorts? or to us assumption been on FORWARD Thank this dose X, population the for potentially the cohort progress for maybe believe assumptions give about with the were progressed Anna said IMGNXXX,

Anna Berkenblit

IMGNXXX. around Your first dose question for level Andy was the

So, we week are the other still every escalating schedule.

rather up and dose a can. at we as quickly we’re to lot we X Remember the cohort due fill ASH I think, as the and escalate disclosed enthusiasm trial So, there's to of to for level quickly. continuing

We arm. statistical in high don't months question IGT the experimental be free in which your subset. powering, the in the different arm testing improvement to as corresponds months same we're the in progression We well the two. as second population would that six assumptions X.X have the statistical For for of so actually regarding ratio from X.XX, testing control hazard the a assumptions to survival

Andy Hsieh

very you Thank it. much. Got

Operator

with We'll go Amin Instructions] [Operator Jefferies. to Biren

Biren Amin

my taking questions. for Thanks Yeah.

in at Just how SGO. expect going SGO. was at on expansion will many for you combo did you expansion what needed in have of of in hurdle terms dose guess patients into I from you efficacy What a of the have Thanks. terms Keytruda that terms you to escalation should before And dose went that ahead we trial? dose

Anna Berkenblit

At present the who for in Biren. the escalation XX were SGO, Keytruda. mirvetuximab data Hi, we plus will patients enrolled from

You patients. data it XX may was only from safety and remember at presented ASCO we

finished hadn't dose escalation. So, quite we

safety the XX not and from expansion. enrolling we'll of present data. data expansion all efficacy was have triggered we're to year. on have expansion just and will did and efficacy of And midst Keytruda from data cohort patients dose in trigger later opening We wait The that cohort So safety. for escalation we'll based this the

Biren Amin

Can behave you’re terms on to split expect And versus expecting the between by enrollment you then midyear. that is Europe? U.S. differently in FORWARD tell it. us the trial X, you complete just what and in of geographic whether distribution patients Got to

Anna Berkenblit

agents in enrollment dramatic differences. this say are both in the you that know Europe. America patients and at looking would and priors the enrolling are we’re we is certainly and I stratification to regions characteristics we we do The brisk point paclitaxel, comparator versus two include of any North monitoring Doxil, three one patients not of see factors etcetera. and baseline at choice So, also

in you I So, look anticipate different will patients different that know don’t very the regions.

Biren Amin

Great. Thank you.

Operator

we’ll Michael And question Leerink. from the take Schmidt with next

Michael Schmidt

program in data X or data expansion and should do And to that early do compelling. you're think is question consider something move Hey our FORWARD you taking cohorts and to I frontline discussions look do for something regarding could desire with next the early understand your cancer all process platinum-sensitive lines? a or the or on own I’m wondering step. from make that next ImmunoGen in into that fast to of or you decision-making internally very have the position prior in thanks launch the just guys, a patients, to you up. ovarian lines on at that something will along setting global do something you you Is that those what partner once I it need like including just a as would had looks follow steps the to as Thanks. in what possible is

Mark Enyedy

Sure.

particularly So, data. as are are they're we we prepared at alluded, available, with see and combinations compelling quickly We the the regularly to programs Forward turn if as review and these X decisions. and take the driven data you so respect look a data

the bar. triplet us rates mid-XXs free to in median therapies. in alone efficacy three year two Their prior see substantial there. we candidates a interested in the the were ESMO in with of platinum-sensitive of the data increments preliminary quite the patients combination and carboplatin interesting know in then which of the with reviewed with the Avastin more with ultimately particular response starting over a Keytruda SGO north carboplatin and we're Obviously, raise to the with ASCO terms and and in and of a those at as then our You'll in survival course bolus the year experience results combination with of ability progression data, expect leading mirvetuximab you and at and patients

be sponsored combination, undertaking patient. that large the move a certainly enrolled think course And you and positive the FORWARD benefit triplet year, of with the I, the stage, a in finance which know of that should for caught positive at so, the our first is attention, Obviously, a position is driving of over the this what's activities from expecting company know of study which said certainly undertaking a benefit our significant a we're I to you we we in those to company which data with readouts first-half XXXX.

do into at interest think, mirvetuximab, in a entering We be beyond four, the anticipate predicate that to relationship currently of juncture, the in that we are study. as way in be a outside expand I the would it. States, we partner this the about which thinking United for down have and company-sponsored us substantially program other would we’ve the could talked would have there enable to in

So, stay course. have are development their business conversations they tuned own and there, these

program, of got is couple this here. terms it's particular pointing saying we've early to which moment in that path is directions this data, of a for way a of in label a commit interesting but long at this some us to very expansion So,

data with program. One breakthrough that evaluating a is things be this doing we're of the from for to potential for comes going therapy – that designation these

have believe expansion we around do the support of of guide are engage interest fundamentally, able with constructively we kinds that inbound the your data, -- that finance those needed company but question be benefit that for studies product, considerations it's and so, we to And said to we'll we will interest. label answer us. to But additional the the

Michael Schmidt

much. so you Thank Great.

Operator

With I'd back over turn the call to like to no management additional closing questions, remarks. for

Mark Enyedy

business you of thanks got today. We've forward got Thanks very progresses. XXXX with XXXX so We of of generated keeping updated a time business a the your year we and position as the and look Great. we we’ve the of we the number entered XXXX strength. a Well, course of the significant catalysts this momentum in from number position from catalysts for of to year over course over much. strength, a

Operator

That our today. call does you participating. sir. you, for Thank Thank conclude

time. this disconnect may at You

Immunogen (IMGN) 9 Feb 182017 Q4 Earnings call transcript