Immunogen (IMGN) 29 Oct 212021 Q3 Earnings call transcript

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

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

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

our data This to strategy, use candidates, anticipated uncertainties. forward-looking outlook, product to statements and for our and submissions the of the candidates, cash the regulatory During risks we and is benefits EMA financial respect development and projected certain discussion, will the information with to presentation for the business our subject candidates, product product XXXX FDA runway. of of timing clinical our our

differ Our and Mark. that, described factors the to the risk those actual such report call I'll results Form include our annual may statements filings. and over With in other recent SEC on of materially section turn from most our XX-K

Good line to coming Starting that top are our say from quarter Courtney. pleased pipeline ovarian we lead report in advanced everyone, with Thanks, I transform program to continued joining you a our we integrated cancer, mirvetuximab track pivotal ImmunoGen and as the prelaunch am look we our year. activities our this the In into and us data today. quarter. company platinum-resistant for Soravtansine and SORAYA fully in on morning, study third thank oncology to

as of results by of endpoint secondary independent the response these We endpoint believe the comprehensive the the analysis profile will mirvetuximab. the rate as and trial. review, tolerability picture or of provide to duration of expect we assessed a of safety data response include overall and the of key this For on data central sensitivity primary overall investigator, rate by assessed blinded response release

with submitting SORAYA underway end with our the year. of success of of for are end for planning the application of in activities and of launch along that potential the the preparations are next half We second goal well mirvetuximab in BLA before the support to with QX

broad we new as mirvetuximab SORAYA standard patients are of for to establishment ovarian pursuing receptor with alpha a addition program care to In the cancer. positive folate

in past designed a Our we marketing of option importantly single of the continues next mirvetuximab approval confirmatory If and high MIRASOL data trial effective, PICCOLO, quarter non-platinum enroll these expect ovarian the sensitive FRα application need U.S. the increasing of data cancer. study for line support the we quarter authorization also This in top an initiated for EU. platinum positive, arm monotherapy in to recurrent address third enable to and could unmet for an year. full mirvetuximab

with encouraging quarter. mirvetuximab potential we data and combination the generated has enabling Beyond carboplatin. mirvetuximab monotherapy with agent combination next our strategy label mirvetuximab to the cancer to choice combination for in bevacizumab of believe sharing look forward we ovarian and have We become

pleased our I'll to development update very on the bring for whole an rest provide Dr. and Anna? as to deep our to pipeline. mirvetuximab regulatory our near-term of portfolio. call that, to Her look market over we be to As are Board welcome will longer-term With the Directors. team, Anna the turn in we of and both Thackray our expand expertise to invaluable Helen continue we to development

development start I'll targeting Mark. hematological in ADC malignancies. CDXXX for Thanks our IMGNXXX with clinical

designed minimal with BPDCN to monotherapy dimer with evaluated as as being in with is and IMGNXXX indolino-benzodiazepine relapsed/refractory uses frontline or fighting patients top which without a relapsed/refractory for IMGNXXX combination line with a reminder, in DNA our a relapsed/refractory for now venetoclax with minimal positive and disease alkylate combination as patients is and and crosslinking. As novel residual patients as AML for AML. well IGN and azacitidine payload

blasts potent while toxicity highly against normal to are IGNs demonstrating Our marrow less leukemic progenitors.

to we over Susan? December. us We the commencing presentation, targeting through will are financials. refractory the development for a and BPDCN excited ADAM-X escalation pivotal patients receptor tolerability turn in to monotherapy IMGNXXX share tumor data and November separate in response plan de at data relapsed XX% to currently submission cohort. dose enrolling frontline Phase azacitidine patients Previously [indiscernible] of and ASH includes and anti-folate safety Thursday, ADC be at who ADC Phase multiple dose triplet. on treated next novo track IND heavily our IMGNXXX received the overall at our venetoclax anti- The released in AML of recommended activity the activity solid AML advancing demonstrated plan to the rate that to from dose. is X X. including reported we review present we data to to share with year for ASH combination In is combination guide initial Susan IMGCXXX, AML favorable pretreated escalations from prior call generation IMGNXXX, types our alkylate further IMGNXXX end. X With I'll next cohort in the that, leukemia a patients, Abstracts by and

sale of million of with sheet. compared transaction of third million XXXX. and and million non-cash expenses in million the the quarter million primarily $XX.X the quarter the payment quarter a of cash of due our XXXX comprised compared on R&D in XXXX, Thanks in in third expenses third we tranche the in $XX.X XXXX the revenue there and $XX.X with of the million to cash quarter non-cash million Recall completion in We quarter partner Kadcyla of $XX.X results, $XX.X $XXX.X the were milestone third G&A and of million $X.X for expenses forward royalties. to ended Operating revenues balance covering the revenue equivalents under was royalty with $X.X of third fee. of anticipated which reduction royalty a continuing development starting Anna. the consisted generated Starting first

our be $XXX to and to slightly are $XX is equivalents Operating unchanged $XXX cash financial at million XXXX. for million. to Revenue increased. Moving now cash have at lower guidance expected updated guidance expenses and $XX to

We expect $XXX $XXX to end. million at year to between have

addition sale and current warrant call questions. With will runway of sufficient XXXX. fund of our million approximately the open the to during Operator? facility we'll into With cash our ATM an the the quarter. for pre-funded our believe $XX quarter investor to fourth that, through of the We be operations

from Genuity, your Instructions] first question [Operator Newman Our Canaccord John comes with open. is line

taking all on my Hello, Congrats good progress. for and the question. morning thanks

any SORAYA, with the meet in readout, prior you there quarter? question Just to Thanks. one to on need data for which after is, BLA agency submission the the first is the

sponsor we choice is agency meeting. Virtually all the between talking yes, the sponsors is interesting well Need so meet line an with is the to that very say What would of that, I any advised the ahead filing. do the filing. will to of and agency It's pre-BLA words. top called be the

great Okay, you. thank

Sure.

Michael Our Guggenheim. Schmidt question comes with next from

line is open. Your

Michael?

Yes, hey guys.

that. about Sorry

just regulatory And process? the on Just response, think of study that's response then spoken was me. I primary hurdle how quick from about before. rate six approval question is for question you one. independently overall in the you've the number duration And important months so just a second ones the rate assessment. the few Can assessed response The investigator endpoint about is per talk of obviously

a spoken wondering cancer [ph] on thoughts hurdle, Some of what potential updated months about four that? your your in peers are ovarian dur have just

Sure, Michael.

ovarian central blinded our So primary independent FDA to to overall cancer we protocol overall know, rate with as by both in and them you endpoint response rate have overall investigator sensitivity benefit by Consistent a datasets inform response review the have is analysis. the risk. approval will in prior available as

was the agent resistant had data AURELIA there, associated X.X therapy, months for lot with duration of population we're group certainly received recall unmet months in months after of we the meaningful is two essentially and but these the bevacizumab. platinum including can XX% going of said, frankly response with rate duration on this the higher that folks our in believe AURELIA or That not that response prior foundational to patients of chemotherapy a the with had being three response need of prior a worth would of naïve AURELIA data, that response great from with control Regarding have response median of and around understand recall, said, it's based patients may clinically because of other XX% out may has patients as describing all study there's that of and lines one duration a just greater the be response meaningful. and with arm bev certainly are X.X in a of six they anything rate a months, you That four of population, study we that disease lines therapy a months. XX I AURELIA duration associated being you immediate single X.X

Great, thank you.

Our question Andy Hsieh with from next Blair. William comes

is line open. Your

Great, for taking progress. good congratulations all on and question my morning. the Thanks

Thanks.

comment? and you mentioned on Avastin be Mark, that Can little [indiscernible] I about labelling will think that strategies the quarter. closed carboplatin colour combination after comments and you've something a more combination give next us

Sure.

of of So, a both been have the pursued those have and at and the studies pleased as combinations. number mirvetuximab we very tolerability early-stage combinations know activity looking with you various

combination that duration progression seen partner. what and response measures typically So the of we’ve exceed relevant is and rates for the response free benchmarks survival of

where example, you rates response at XX.X in rates of of carbo progressively with nicely saw XX% X.X reported mid-fifties contrasted range that months. look if mirv XX% to patients high carbo free have you we and months was progression of and and about for see doublets and So what in response alpha with you the data know been that early XX our the other survival FR survival and

So along that we include strategy label combinations. to studies working with formal comprehensive we've of expansion we will data with those mirv-bev benefit seen speak with these what through are with support respect will a that the as

agencies, with about in first work to that we come studies with them and we of quarter the are conversations on that through to talking points look our quarter initiating. those and fourth Some and the where out forward with investigators and taking requires so you the we're to

it. Got

optimizations clear. one done in And the IMGNXXX, Okay take kind next think any compelling on terms about mark. asset. then, winners HERX your of conference that's at looking the of Thank ESMO, the of generation sets. to you, read data through and is there curious guess just very I I I'm back

you're could So, thinking. Andy if you clarify what

you're talking an HERX and ADC builds build So, you of success what HERX asking Kadcyla success the that is choose with in for IMGNXXX you're analogue you're about you're how might [indiscernible] mirvetuximab, that thinking about on and how of at? that the driving upon

XXX believed and XXX? were are all I two So linker of is optimization versus for kind HERX clinical the from that about that and also, guess the basically benefits right? curious derived sides basically just the and of I theoretically components and so different lead the Yes, optimized, two payload optimization, through

so sure, that innovating, so antibody the built innovations we've always into we're biparatopic. XXX a and includes is Yes the

leads two very nice in cell more buying target and events broader for activity which separate IMGNXXX so in FR Alpha killing. you're with able levels low into And So and we've FR to vivo. medium and that in tumours expression being alpha we more to internalization folate Alpha, expression translates and epitopes vitro activity, receptor of of shown that see

more triple lung really Alpha cancer the as of cancer, of a also almost a then more payload and is more of has well a as the is innovated has FR tumours that’s broad stable more ovarian so into hydrophobic, circulation and including and terms a you're designed all stable linker even bit negative on right, moving linker IMGNXXX itself potent And having bit range payload to mirvetuximab, endometrial cancer. more bit killing. bystander than payload And essentially breasts, address in a been positive in

the be end year. on file IND year before get the So we're of the the early and excited to clinic for really to XXX that next into track

that's very helpful, Okay thank you.

Markets. Our next question from Capital RBC Kennan comes Mackay from

open. line is Your

your confidence just the for here, forward the just there confidence for folate response the housekeeping of rate wanted would SORAYA filed with the of to or overall rates, again, overall diagnostic accelerated with important to if response whether bar alongside just looking the May is itself I standard more secondarily, questions then, And QX to as intervals to taking that question. thanks perspective non-overlapping get data. data be sort associated to as ready in on two current here, really SORAYA you. response moving the there? alpha care? approval be be wanted overall the it wanted intervals Thank with relates rate mirv with SORAYA ahead as I'm successfully Hi, receptor, well see

Kennen. Sure,

got need that that guidance is the we from exclude to FDA So XX%. we

XX% needs positive certainly, lower narrower to means to is So confidence XX% the be confidence the the is above study size, statistically considered the down what interval. larger and that sample a the be interval the

a And so, a reminder, to response a lower rate had and XX.X%. It demonstrated right? actually was interval XX that SORAYA bit of overall bound XXX confidence designed we the confirmed patients. of patients bigger, XXX as is be where XX.X%. we was study about The And

again, So will for appropriate interval the that study. be confidence size

So that's significance. terms in again, of statistical

patients of what's of be you agent care single response with of is what terms which to get doubling In clinically rate would a physicians standard and meaningful again XX%. chemotherapy, expected from

CDx program the regarding be companion We've already of already the the we we've question of so components we're PMA diagnostic, with the contemporaneously -- the drugs. that available second Ventana filed some the with mirvetuximab your of since working been track will anticipate to Ventana on there. inception the and has Turning

Our Kelly with next Jefferies. question comes Shi from

open. Your is line

Congrats and on progress taking all thank questions. the my for you

So inhibitor. follow-up the of to percentage question Tremendous given background these more inhibitor both treatment patients I is, PARP FORWARD treatments the of actually far, trial, estimated in compared of treatment? Avastin like PARP agents also difference allows Thank prior if the are SORAYA And the they think what wonder you are Erbitux what a [ph] you. protocol had do and impact efficacy? I, the of

the and With maintenance all and FORWARD PARP study, just treatment combination PARP ovarian have time have to patients efficacy of time to who our regardless XX% recent what inhibitor. prior which a the had done of ongoing, the publicly have about over a XX% cohort. performed had adopted studies, And has continued incorporated for I a inhibitors, over of the prior most damage, reported and patients each was cohort that of ability action PARP increased being the DNA is, to trials since about past that PARP had then, were seen or inhibitor. our and XX% they tumor that inhibitor interfere with we've recall with mirvetuximab you cells So consistent we approvals is And of percent may setting PARP a mechanism of initial several the the treatment subsequent not. of repair tubulin-directed use the and enrolled drug prior the In were the with the cancer. at into years been

there's no reason actually cross So anticipate resistance these between to mechanisms.

Great, thank you.

comes Our [Operator Instructions] next question from Jessica Fye JPMorgan. with

open. is line Your

morning, taking Daniel Thank for This for is Good Fye. everyone. question. you my Jessica

you for about For just event the can it the talk suggested scenario in for opportunities SORAYA doubling the clinically out using independent chemo blinded chemo be and with review, commercial you've XX% the the Maybe analysis and below rate for comes Merck/Texoma? would you but in that rule meaningful. what overall central that mean would response of approval

that clinically investigator on So assessments AURELIA. benchmark would again, from of considered XX% rate doubling and set meaningful we believe a response be that based is

review FDA the so about really datasets, both and benefit risks, benefit. the one know, overall you datasets. we is will both will So, have it's

to of responses So, and response And the turning what therapy. what's is duration available rate to those the risk. also compared

may recall with dose You nice fewer related and due has study discontinuations. FORWARD the mirvetuximab a tolerability events I to adverse from reductions profile drug very fewer

But risk. perspective, response from about overall endpoint. both overall the So out for datasets it's a XX% ruling a the again, assess benefit have will primary to FDA study rate

patients, duration versus it clinically relates care what studies done and double And, world evidence response look Anna have, XX% here real as said, think be rate, standard somewhat is response meaningful of the the response as than reported. opportunity, at to actually been about the optimistic have Then has longer of I would when commercial to rate we think we these that an additional you in see here. something

second under we of who platinum-resistant think chemotherapy, those the we roughly about line, patients here this and there as U.S., agent in here, displace treatment, agent market are XX,XXX with XX% single available fourth each will year look think chemotherapy. just profile, when patients mirvetuximab So, for at that are single and opportunity you the get disease through

our So express who the cut with levels, that will which of the high for alpha patient population. indication, at course, of be target receptor is about patients folate XX%

think SORAYA we're per we year. that at looking about between So MIRASOL, patients and XXXX

it maybe bigger quick in And [ph] will be is it, you. thank on be the be Okay, based response but of assessment? on the be then a will that the it based I it follow-up. will early, might know little shown investigator bit label, assessment or in a terms overall rate

for study. is So endpoint investigator our assessment primary the

drugs cancer, labels other investigator have some ovarian you have assessments, assessment, at of them and of for independent labels If have are in both. that look approved some them some

forward the So we during negotiations. label to look discussing with FDA

very you much. thank Great,

with Our Chang Jonathan SVB next Leerink. comes from question

Your line is open.

and thanks questions. taking for Good morning, my

regarding settings, thoughts treatment can First mirvetuximab question, you discuss views ovarian are on setting? maintenance your line the specifically, into what your earlier

in Yes, paradigm so become really it's PARP as cancer and are of little is bevacizumab where both really recurrent bit treatment And the [ph] well patients. now the for a part as has inhibitors changed quite plus HRD frontline then ovarian PAOLA with platinum-sensitive study recently the helpful combination patients setting it's a adopted, the bevacizumab particularly the and longer, patients, for of maintenance certainly as most with being Olaparib the setting.

Knowing some a even So profile as patients safety about mirvetuximab plus a mirvetuximab mirvetuximab had years two we're for Bevacizumab. we on also year, the for of well really monotherapy for over the combination maintenance excited and the option. have potential three,

many, data response and may nice free now having duration in very XXX patients with are cycles. really data patients over of for on You many survival progression recall nice

incorporated from know, expansion you've Mark, paradigm. combinations our maintenance to forward absolutely believe So next be sharing And treatment we as strategies for that into to heard the look has mirvetuximab quarter. we potential you label

I just maybe point one there to two Yes, to there's add this. mean, is, elements

continuation is first therapy. The of

survival when and reported you received so induction response we mirvetuximab for on they Avastin enrolled six continued that. to to imagine we to and with in the out eight think cycles simply carbo of something we a but therapy first carboplatin, about then generate protocol, progression as patients else then So numbers, could said a example, combining having Separately, therapy we free and about normal mirvetuximab an XX as months. adding maintenance mirvetuximab their small got

we're So we of we quarter. have that will speak discussion points those next working through and part the be as

Understood, provide question, on dose And second we data early the thank escalation you. the can expect IMGCXXX color Should of you year? any has how next in progressed? part

next Yes, our payload our expressed ADC, across is ADAM-X targeting is so DMXX. ADAM-X variety it tumors. has generation of IMGCXXX and solid maytansinoid widely a

a dose three that including those plus and doing pancreatic tumors we're know breast we cancer, ADAM-X, triple gastroesophageal. so, And negative colorectal in escalation three lung cancer, express study

X Phase would escalation as update I And the I that forward moment, that but it can I So get dose more sharing in we we'll data going give at to timing is anticipated. say certainly closer. we XXXX. as think look don't

the Thanks taking it. for questions. Got

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

Your line is open.

Thank you. Good morning, folks.

So as me let mirvetuximab my question on add well.

terms any color give us can this MIRASOL where In at to it is enrollment point? you of as

year. track QX enrolling to we're have MIRASOL So is next and on data

would or putting should then efficacy data the sort safety and expectations XXX, we combination out? in Okay, terms have endpoints sort be of you for of what like, on that of what

ADC RK. activity we that and for we're triplets. in We're asking forward will where azacytidine is anti-leukemia and our are to share excited for Thank combination presentation we about venetoclax IMGNXXX the quite and with CDXXX-targeted safety looking initial you our ASH.

tuned. So stay

November will I be X, abstracts think the out

in that we again, of of expected, to you a -- know should to we're as planning CADENZA, combination slides only drug what this monotherapy, to is you to see also Yes, how when at have try that. data not about are but not I'm that and is a the top so going think as it but build data aware as your on ASH? up we I on then working, How how can therapy? that understand And

is BPDCN relapsed refractory therapy cohort, being in in is positive exploring BPDCN, designation enrolling after the received is in monotherapy That their We're setting. in relapsed also any from cohort BPDCN prior studied an cohort. positive therapy. an IMGNXXX patient we've AML both MRD and pivotal So MRD XXX to after who breakthrough refractory open frontline as FDA

or be So be line. it later could it could induction after frontline

prior past. And for past about sharing BPDCN at those additional frontline so data frontline handful had we we've three are would IMGNXXX, frontline. the official commencing in us of for talked and a those We forward a who forward patients patients of the have look that in say around each sharing are We've to There patients. setting shared pivotal to the details look patients I received ASH three to who the them cohort in CRC.

Thank much, to you, talk guys Anna. and very folks, soon. I'll Thank you you

Thanks.

Our comes next Joe Sandler. from Piper question with Catanzaro

line open. Your is

taking my quick one Hey, guys thanks question. one so for up on Maybe much following just MIRASOL. from me

you Just how rate we where head think of SORAYA the dur Thanks. in just about would MIRASOL and on should and SORAYA based directionally maybe wondering it translates response the data? MIRASOL how to sort think

So prior have The has whereas patient may had quite populations is in difference may had SORAYA every bevacizumab, bevacizumab. similar patient MIRASOL MIRASOL SORAYA in and prior are that not patients or Joe.

of X the free the FORWARD of half prior rate in survival. MIRASOL therapy And study patients overall therapy. looking X we And of you MIRASOL as in the prior lines be response it's the patients of lines bevacizumab. in of had having similar of study well. a percentage same We X anticipate prior progression endpoint to recall will number But bevacizumab. in primary is MIRASOL, course, about However, may remember, at the

I think play we and may how able will consideration you I well FORWARD think the So quarter, patient of I you share think SORAYA MIRASOL data will that taking this out prior to sense dataset. the the that into as gives about a be populations as both

my thanks. Okay, That's taking helpful. for question. Thanks

with from comes question Peaker Our Boris next Cowen.

open. Your line is

Great.

successful for if the the this, and ASH, you data in later considering but consider I what AML at you AML joined data competitive few dynamics a late update may have space? addressed the minutes Sorry,

AML. a combination, further so think, XX% rates, development. rates really something be the Yes, AML for in clinically relapsed/refractory rate we in and meaningful CRI in quite PR or are to important support And would XX% CR would of

it. Got

so development? do timeline like If for the is question have we study future take? long do threshold, last so, And And my would to a data the achieves XXX. that for is that and if how something what randomized

trials Given them But triplet and unmet many study. a single relapsed/refractory ultimately I are there's be and are single the of is start the think of potential high also to at for early need the AML, really the none in data outstanding. combinations initial us randomized and pivotal There getting really really agents the it's timing or little sharing a for to accelerated arm used, combinations. looking into We for ASH. registration however, are frontline a approval, the combination study trial forward, support potential what a to for would for

taking Great, questions. my thanks for

questions over no like the time. at for I'd the remarks. any There back further team turn are to call this to closing

we ahead much. a quarter Great, appreciate obviously, very very thanks have and you big much this morning us yet joining of I us.

await we the the expect XXX, to SORAYA and deliver of XXX with quarter. at great separately you, that we track ASH, data file then this to on And anticipation that end finally data then before data and IND program important for like So year. the the we're with

Thanks. sharing you the course to data So digital with quarter. stay tuned over the will forward we look of and

conference. This the does conclude

great disconnect. have a may Everyone You day. now