MGNX - Earnings call transcript Q1 2022

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Operator

Good afternoon.

We will begin the MacroGenics’ 2022 First Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in a listen-only mode at this moment and we will conduct a question-and-answer session at the conclusion of the call. At this point, I will turn the call over to Chris James, Vice President of Investor Relations and Corporate Communications of MacroGenics.

Chris James

Thank you, operator. to financial call and welcome first discuss and XXXX quarter operational afternoon MacroGenics’ to conference our Good results.

afternoon a For the anyone Investors release tab issued macrogenics.com. website under chance had announcement, this press to review on is who these results, the has available outlining today’s not at which our we

provision I beginning website, will forward-looking statements, be including those completed. for archived of filed may to from differ section conference with like Securities this call the the factors, materially it Private Act You as various annual, would hours call via indicated the XX future important that the listeners where results reports discussion days in approximately purposes plans of alert Safe also listen and webcast X Litigation these after by a constitute our on may about and of prospects that our quarterly those include will Harbor to result for expectations, forward-looking the under Factors is Risk of statements the today’s discussed Reform company’s XXXX. SEC. Actual statements current

our subsequent not views In today as should of represent as be views date. any representing addition, relied our only of and upon any statements forward-looking as

Executive elect call applicable required in to President over like even update if extent views of now, While the we our the any Chief the may statements to And Scott point statement by so, do to to except I Koenig, future, these turn disclaim MacroGenics. at some forward-looking and obligation we specifically law. change, Dr. would Officer to

Scott Koenig

call today. afternoon, do our clinical But via key will review Financial I’d conference I the me Chris. to like I everyone updates you, to Jim Karrels, from call Chief and will Officer, let before our turn results. participating who webcast financial This first Thank our so, programs. provide welcome

Jim Karrels

position our as XXXX progress. recent well March results the This quarter as financial financial highlight afternoon, MacroGenics which ended our XX, for reported

collaborative described for $XX.X $XX.X revenue afternoon, for XXXX March XX, quarter release quarter from the quarter million MacroGenics was the agreements, XXXX of in $X.X revenue total XX, million XX, the included of Revenue sales net for our million March total ended revenue to March MARGENZA. XXXX. As ended this compared consisting of primarily ended

has costs development Our $XX.X research and expenses million development, discontinued. the expenses to in for clinical expenses. XX, quarter million discovery quarter well were consulting The compared related compensation the March clinical increased for to ended partially manufacturing, the XXXX increases increase selling XXXX and MGCXXX, clinical primarily development March offset MARGENZA These related to costs stock-based decreased to of to as related were agreement, related administrative the ended Incyte. by general Decreased manufacturing The to and XXXX. Zai flotetuzumab, Selling, million been lorigerlimab. to trial which retifanlimab costs XXXX. margetuximab the for million projects $XX.X trial XX, was compared molecules and costs as XX, decreased primarily development, and costs Lab increase March and to ended preclinical and were expenses related $XX.X was manufacturing quarter ended XX, related development manufacturing for for $XX March quarter

Phase cash cash cash XXXX securities March $XX.X our MGCXXX the of loss further full ongoing. the XX, March us anticipated XXXX This should quarter runway does in to to million to XX, of currently cash, payments $XX.X fund of net not through net a of March that enable by cancer million marketable XXXX our in $XXX.X equivalents cash, operations as to XX, And cash compared was XX, loss XXXX. expansion collaboration And anticipated addition and the prostate guidance in as for was December and XXXX. for Our runway, compared million equivalents development studies or securities terms of as of our related begin of reflect ended marketable XX, anticipate March we other balance end expenditures ended XXXX. to XXXX to X/X million year and quarter anticipated potential $XXX

existing for call will the of However, can to sources and a prioritization. study reasonably Scott. back obtain And it a that believes company portion combination variety planned MGCXXX potential through or revenue funding of now, turn external I funding the Phase X the the resources, project of financial

Scott Koenig

resistant MGCXXX cancer. program productive castration on plan Phase X/X year Phase advancing recent with feedback the key by FDA dialogue the you, end. regarding of I prostate conjugate study initiation the made directed X/X and toward for the the with progress with Thank clinical our quarter. patients our in especially of of Administration MGCXXX, the underscores during our meeting are and by U.S. Jim. delighted A Food and advancements BX-HX received first antibody metastatic outcome of we with the am elements Drug am pleased drug the I the

Another that hematologic exciting announce look a generation IND and mid-XXXX. initiating MGDXXX Phase in malignancies tumors. initiation X of to DART for solid I positive also X in happy FDA CDXXX am with our cleared our CDXXX We CDX MGDXXX, forward of PD-X x DART escalation study study lorigerlimab, in the combination the has molecule MGCXXX next Phase to advanced development bispecific targeting a molecule. was of dose and CTLA-X

over investigational a clinical with our molecules involved of clinical family to our BX to of programs, me use candidates starting our continued the member expect targeting let preclinical in this time immune regulation. through progress on this BX-HX, to walk other backdrop, and we molecules updates addition molecules year. and further With our these that of In course you of updates portfolio and provide to the partners

mechanisms finalized will modify of to deliver expression of MGCXXX the increased on the the enroll axis-targeted, Phase expressing or PARP abiraterone, study study X/X and had reduced Based and administration two path X/X exposure we help cytotoxic reduced inhibitor in MCRPC. which including expansion as a study analysis study, duocarmycin have a prior believe a reminder, MGCXXX receptor will solid dose we a effects. between plan take and apalutamide broad of of therapeutic molecules one effect to such to in payload to-date, to our designed target androgen interval dose The As complementary upcoming maximum recently of registration appropriate. dose types. our and DNA-alkylating MCRPC achieve at action multiple that to our ARAT a we side Phase BX-HX. enzalutamide a that registrational data is patients antibody conduct with antigen’s investigational BX-HX We least doses, agent who if taxane or potential drug tumors conjugate advantage to and MGCXXX are through across this tumor developing plans

kg During not or mgs weeks Phase will per study, of X.X his XXX mgs either previously or per X to in MGCXXX experimental X the choice receive every patients randomized control be of to received the X in kg approximately an the to ARAT X portion agent of X X group. physicians’ groups

us group. or receive end and two that we an data Following agent best analysis completion further an for either ARAT Phase of further the allow interim study, patients dose the of the one to MGCXXX Phase Phase the study. the environment, one the of levels the evaluate portion X to assess proceeding cost control select be X dose and in In of recognition will safety, current the Phase dose the to portion additional X X inform portion before to an MGCXXX at will randomize recommended futility plan capital to which inclusion of of analysis of to performed the tolerability of to

Finally, secondary study radiographic as constructive was X/X FDA key March. response endpoints. survival This Phase progression-free design for discussed study, endpoint, will during the we objective the with utilize an the as overall and meeting rate the survival in primary

to expect quarter in begin XXXX. fourth We of the enrollment

dose the about indices details with X per to X.X doses and performed a portion X X reductions MGCXXX how determine X the dosing interval provide with of me the X/X in modification, of Phase weeks dose to and starting between modified evaluated dose study. and subsequent every in with evaluate dose X compare interval, Phase study. tolerability. Let any dose and per simulation versus from Phase dosing and Phase of The every plan few study, evaluate patient mgs longer at these data delays modeling dose the expansion we including we To study a key relationship kg of the X/X and reductions arrived safety mgs planned lower exposure kg weeks, doses of a X we and pharmacokinetic more the

slightly that and to lower decrease improve stay potentially on longer. therapy events by patients adverse efficacy expect will We allowing doses

melanoma with MGCXXX, every X we administered initial melanoma dose X Phase kg dose with a XX Again, in patients compares ongoing by of our patients recruit and to observed kg any dose X/X Regarding every clinical are plan X mgs per study evaluating dose per weeks of mgs expansion. additional administered activity weeks. encouraged the during subsequent this to reductions X.X starting expansion of dose

patients carcinoma tumor from provide with cohort. possible the negative additional in cancer proceed data Phase clinical cell time. the in the with an enroll dose We second half of as squamous patients not of at for we further to triple cohorts types to cancer other and the next expansion for in patients with intend the to the steps on enrolled study, breast As neck in study head this plan data evaluating expansion expansion and continue the are advancing non-small X/X We update treating lung matures. XXXX do cell

of renal combination patients with undertaking solid The meaningful dosed this enhanced recently suggests tumors, data, cancer, study MGCXXX PD-X advanced toxicity. rationale is melanoma. and In carcinoma, without cancer, with agent an patient the pancreatic cell by bispecific scientific addition, MCRPC anti-PDX dose preclinical we by anti-tumor in CTLA-X in carcinoma, escalation including which lorigerlimab, activity MGCXXX combination our therapy for with maybe ovarian with supported hepatocellular the the our incremental first in trial by

with combination combined antibody cancer further with in investigational in drug demonstrated conjugate androgen when cell anti-tumor evaluating at in these studies. Annual prostate titled poster MGCXXX MGCXXX preclinical Lastly, patients in to Cancer activity lines and or receptor MGCXXX data MGCXXX, enhanced American BX-HX potentially support advancing PARP BX-HX study. presented a April, in cancer, prostate future on with We targeting for with and for and lines Meeting. Research proof-of-concept cancer agents in Association prostate led effects these the forward in look some we inhibitors a believe we preclinical

the is overexpression Another of exploiting antibody FC platform. FC-engineered created our in optimization our solid tumors molecules of investigational BX-HX an using enoblituzumab,

with therapy recruiting with combination x receive patients and of therapy our are Phase patients and X in antibody molecule. an patients tebotelimab, squamous head retifanlimab, PD-LX enoblituzumab with PD-LX in receive frontline the cell anti-PD-X positive which carcinoma neck negative patients study DART We combination PD-X LAG-X of in an

enrollment the year. the this during it half patient a Journal the expect for X tumors half at positive of and year advanced for combination to cohort BX-HX Annual We expressing Immunotherapy of of Society initially of data update In second of complete and of were the Cancers provide the study Meeting. the during PD-LX this cohort were on the the pembrolizumab Phase April, results from presented solid an in XXXX Immunotherapy These enoblituzumab published of in first Cancer.

show additive and the note, As chemotherapy. progressed head evaluable patients Checkpoint first the of favorably with to previously X.X carcinoma receiving of XX% platinum-based data after reached. overall interval Of with compared of rate and objective XX objective a for of previously XX confidence and in X cell squamous occurred and XX% to squamous neck patients response head did responses or of in OS reported, after line previously months progressed cell of who XX.X%, have the neck, a toxicity therapy XX.X This anti-PD-X of The inhibition median of the updated XX% median with not single carcinoma survival the X.X while and potentially patients pembrolizumab, We from given data platinum-based expect feasible anti-PD-X squamous combining months of agent agents. results PD-X demonstrated the cell historical beyond with the that monotherapy. use anti-PD-X with what combination an efficacy head believe study with would a and seen chemotherapy. of is reported in recently BX-HX and published with small neck are carcinoma enoblituzumab agents our minimal from encouraging had

molecule of and let enable you Next, to update DART CTLA-X. investigational lorigerlimab, me tetravalent bispecific blockade our PD-X on designed

of mentioned, in with tumors. study clinical patients advanced we MGCXXX initiated recently and As a solid lorigerlimab have

expansion in dose cancer, evaluating We stable with Phase lorigerlimab and patients mCRPC, are also in microsatellite melanoma X/X X a checkpoint-naive a cell of mgs non-small study lung in dose kg. per colorectal cancer

study of in XXXX. from to this ongoing expect the an We second provide half update

discuss while hematologic CDXXX/CDX by a incorporates our malignancies. generation minimize in to DART our molecule bispecific designed syndrome, our will activity I for cytokine CDX with a MGDXXX efforts April, permitting and for to the half-life. release is cytolytic CDXXX positive through Next advance up, with component IND that patients treatment next maintaining of evaluation FDA hematologic In malignancies. intermittent dosing longer anti-tumor patients was MGDXXX cleared

enrollment leukemia begin positive to in study Phase patients MGDXXX myeloid with expect of We in X CDXXX acute neoplasms, including of midyear. the

of accepted to Bio Biologics for date response an payments diabetes. clinical X for developed that of XXXX, teplizumab Next, milestone on that the our at-risk and developing I XXXX, royalties candidates diabetes delay monoclonal diabetes update August In Provention receive License future in retained teplizumab’s being partners certain X from XX, we an letter a Type Type is acquired was of for for product assigned July Application our March, economic anti-CDX complete for the the Teplizumab X XXXX. Type of individuals. right. sales. for provide the agreement The clinical will under in announced the FDA BLA purchase are a for Provention collaboration issued FDA an teplizumab PDUFA entitled treatment is FDA which In by delay asset at-risk us by Provention the antibody we net which to individuals. of in

XX-XX X several has protein tumor Under ImmunoGen development they under IMGCXXX, and that Our Phase data will ADC, the announce molecular soon online. second being for provide cancer will indicated study initial solid clinical I accepted from agreement types targets tumors will of of co-development a leading investigational pleased is to overexpressed which update is disclosing available cell ADAMX, surface with our advanced ImmunoGen. A in anticipate solid in XXXX. evaluation the was publication be the therapeutics. am describing margetuximab. manuscript multiple in preclinical on I manuscript that an copy recently a in Last, IMGCXXX collaboration,

as March treatment coordination MARGENZA of the metastatic launched regimens, was received have EVERSANA. margetuximab HER-X MARGENZA patients in anti-HER-X commercial in prior or disease. with reminder, the one with combination U.S. breast who partner, of at for in for approved a As our two XXXX adult positive in which is least more metastatic with cancer, chemotherapy was

We metastatic to may continue patients treat MARGENZA cancer. from as another option believe breast benefit to

in As the first reported, net for sales million quarter. were MARGENZA $X.X

to to in We year deliver the an competition approvals, conclusion, immunooncology new a of the market, In positive for the anticipate patients. important high excited XXXX Given for have about MARGENZA to are MacroGenics. HER-X multiple expectations therapies remain modest cancer steadfast breast will of in that leader potential and commitment we to sales. cancer becoming our level the field including we in continue be novel

open will the to for Operator? call We be questions. happy now

Operator

from Thank SVB Jonathan you. Our question Securities. Instructions] comes [Operator Chang first with

is line open. Your now

Jonathan Chang

Hi, questions. guys. my Thanks for taking

beyond study runway cancer the do cash First those study with guidance? initiation study question by Phase timelines starting for be the study, thinking to on how about fit the year prostate your MGCXXX have X/X How you should we end? timelines guided and

Scott Koenig

much the are in question. startup of that phase working Jonathan operational we still that the with will thanks sites identification for organizations help and with study. Obviously, this the of finding us very

the again, So, have to it’s how guidance. right But study of Phase quickly With once too the willing in target I early be taking that cash provide study able really the we of get XXXX we to program. cash patients that our potentially, available anticipated able starts, be X study study to the XXX enough by the Phase should to us and coming the to Jim maybe enrolled. other are support that will be further on to end through portion is Obviously, we project the cash the of believe X earlier, to the year. to us as commented with cash now, started regard situation, and in

Jonathan Chang

about we the the it. the second be X treated of And and Phase on X how patients portion should in the study thinking portion the the count a could the you. Phase X? Got just Phase towards Thank X question of study, Phase size portion of

Scott Koenig

of at there seamless we Phase this part not the of X. Phase to prefer exact was second a Yes, are in This the answer first. as patients patients number the point, designed will identify that the is I a X. participating But potential that in design.

I’d this to the We portion. little But anticipate Phase X many have obviously specificity a Phase we on give take again, modeled would like out. through this in the before X bit we more how patients

Jonathan Chang

question androgen for do targeted patient just therapy it. X Phase one last as an and radiographic for what you And access population? the benchmark end guys PFS me, receptor Got of see

Scott Koenig

and that, continuing in in us for in we of obviously are of for a looking right given new given frontline population, are not guidance population. the there initial right months the studies regard is this We market. over conducted paradigms evolve, we have with to in the but the is obviously, the the Obviously, obviously control. There specifics modeled it’s in Europe again, control study the on hard agent give being now terms several we Well, specific therapy agent the and depending and U.S. various data experimental. have on to to-date whether with treatment certainly giving the to control castration-resistant out terms responsiveness switches population the improvements are being versus now,

Jonathan Chang

Got it. you the questions. for Thank taking

Operator

Thank you.

Pohlman Our next BTIG. question with comes from Kaveri

Your line now is open.

Kaveri Pohlman

that’s dose active PK/PD going Do very think start to get have program? an you for the or data much for to for is derisk MGDXXX, Good a XXX different enough? My and have to afternoon. of over taking and Thanks the so questions. you my has Because a domain, the Fc how you flotetuzumab it’s thanks quickly profile. updates first question XXX can safe

Scott Koenig

question. Kaveri for the Thanks

study. But attribute out flotetuzumab. Obviously, of on dosing a a incorporated, have lot you is the which designer think experience here, We are of as intermittent new molecule. the obviously MGDXXX this major starting we with the we out as for a point was

We will be starting at low doses.

will that will dose the too early study, Our cohorts start small study, hope how move be escalation we know long the we say. and it in But so dose is can to take until up these through levels the again, various quickly. move won’t to

Kaveri Pohlman

That’s data approved fair. LAG-X patients BMS it the sides LAG-X do you survival tebotelimab, both to And of or is for for screen test enoblituzumab expression? expressers population? believe I superior plan for showed although in and

Scott Koenig

the Good study LAG-X not what for particularly expression. population, Obviously, the we incorporation designed, in initially cells drive the screening negative binding PD-LX was the cells Fc were upregulation LAG-X. combination we enoblituzumab question. that we checkpoints, and the and here, upregulation to tebo to can believe of gamma interferon did in in require And is way including multiple trying address other using of NK by

looking and so And it with the benefit correlates the a and retrospectively be to in the will guide post-treatment as in patients in look PD-LX expression those LAG-X populations by response how levels the not terms most treatment. more We but at prospectively, at study required that of baseline of understand that patients. obviously rate,

Operator

Thank you.

from comes Darout Etzer BMO question with next Our Capital Markets.

Your open. line is

Etzer Darout

in X/X, being sort or year? we sort those in and melanoma includes data could of Great. first, updates we this year. half second prostate Thanks And as in you. guess, cohorts updated see of that Phase a the modifications this the as second on cancer I far that PFS I for clinical the prostate reported in half? could guess MGCXXX Thank second the some on half of of interval the in taking sort have see particular questions. in noted I the data or couple dose of modifications

Scott Koenig

part been that of Phase not have design. objective in the to obviously regard modifications to-date this X initiated the with we cohorts So, of that expansion was of has the treated and that dose

this a side that stated mitigated looking this as much and efficacy and potentially reduced know we until today, end we intervals with with you higher profile side earlier at we modeled and profile. prospectively, up giving pharmacokinetics we doses test modified have as the we will looking But as at potential effect would the well effect out come As that two responses have we up think the and the that’s a at of understand forward take answer. the and the which that best into prostate then doses, Phase expansion the study. the the decisions know prostate specific the the any two XXX, X not not cohorts. specific on on specific And regard regard on to reason either program portion we will part ultimately of or looking updates those With made and to one perform with to have

some would results. an updates, study obviously like not prostate but we for out to dosed, provide completed of still given specifically patients that abstract We update that being see have the are final we now, will right before reporting the submitted

Etzer Darout

it. you. Got Thank

to We the second Thank in disclosures you. will the half. forward look

Operator

you. Thank

next Our with question Lawson Peter comes from Barclays.

open. Your now line is

Peter Lawson

Great, thank you so much.

BX-HX, for could intro Just we the on that? the potentially Phase X when see

Scott Koenig

we about an just year. that I study want we start the are targeting the for X/X, the said portion? at started. the Phase we Are question, the of earlier As to Q talking for we earlier end the described study Again, – get to

be just project be we to diligently are So data, things get clearly, answer. it’d at but point, to XXX patients operational, this we the to But when that it’s early see very enroll too estimate. early too will just that until working to

Peter Lawson

for And two two you. Thank then potential MGCXXX? doses the what the it. Got why

Scott Koenig

question. Well, I good a think very that’s

going dose maximum index our just to positive. our proceeding two practice we with patients. really test And discussion, certainly were – in a from data to doses? the two had a interactions providing we doses selected very to Well, rather the therapeutic As encouraged the And the They were define doses the the it’s said, they really these show FDA I us actual good forward. look on on obviously, with all development very guidance at based dose. is time. Why maximum them than hand tolerated

is most treating do this appropriate ultimately for point, dose to this the prudent get I most at thing to the patients. So these think

Operator

Thank you.

Our next question comes Stifel. with from Willey Stephen

open. now is line Your

Stephen Willey

the the to good Maybe eligibility limit criteria design, to does sensitive taking there Thanks a just of for afternoon. is in castration on setting study allow and for use follow-up the taxane are regimens X/X the that taxane number questions. Yes, allowed? Phase the

Scott Koenig

a on second There the on of limit taxane. is the number

likely will Stephen, will docetaxel. in know to on I with So have that one With be don’t use taxane and the castration sensitive, I the you to follow-up regard answer. it’s its actually question. most

Stephen Willey

in necessarily achieve later a was with discussion in maximal pushback conversations card terms And amount of FDA agents trial patients guess of that in some there awareness Okay. sequencing hormonals the clinical there just behind benefit. I clinical And to around the lines the some – discussion other there bit development any guess of of programs, guess having other of these design I been regards therapy. And notion sequencing little on know each has I physician a results? just was these novel in in of a with any I now this don’t

arm So outside here. even you a of inform have selection control if your the just of KOL clinical guess FDA conversations to of had I discussions wondering kind or any

Scott Koenig

very easy discussion investigators. had Steve, where we would state with extensive is the both what is say FDA. good had treatment discussions one I a right the no now. we have of solution Yes. given is with And had also there And

there answer perfect to could there And select. And As actually, was fact FDA the point. in different one things question. to commented you that no know, that are

the was raised issues deal the not have any that in investigator to the control safety the something the if for obviously X discussed is it’s we certainly up treatment obviously and is to to and as there with was examine will forward. And in Phase and that of we agreed the with a future. of time. the through the always adequate But it’s FDA unless studies, study obviously, so at we design use move portion safety matter these us the was state population of fact that that go of see again selection incorporated But the concern where definitely one this continue to they

Operator

you. Thank

with Our question comes ISI. next Jonathan from Miller Evercore

is now open. line Your

Jonathan Miller

understand so tox it’s the your dose Hey obviously, less that One on practical with account close it’s those in But I my guys. dosing Thanks to Phase the dose you taking intense, remarks question. expected are delays the after to prepared for patients XXX better the we maybe PR for X seem getting. realized profile. the and reductions getting in suggest

the how much switching guess at on that versus includes would gears you also Presumably dose? done a pipeline, how runway leader X lower mg maybe dose, to that you bit but cycles the exposure the might admirable so streamlining up or Phase I is And guidance. patients come. or where characterize secondly, in then new So, job the you QX ended at at additional little optimization that the that there far prioritization be have suggest X

get So, beyond Phase while, a and the sitting you versus accelerating a while through development backburner assets XXX, maybe lead remain focus try which for on the little program X?

Scott Koenig

We had a question there.

dose. which sort me let part, was So, first of start with the address the the

there. bounded both to the increased with I patients middle that had of X.X, right saw interval. that by of would is in say the obviously, and evaluate, a dose number made of As slightly sort we between was size modifications, X the dosing is we that given What approximated the we you that,

question to doses bit we a go the why that’s less, bit these forward. a two or one, little ideal selected is the more So, little ultimately

study for. I greatest It’s the will very the clear held we combination things the we at for prospects accelerating think this the to potentially will runway we best arm So, and X in best in a in development off is about will enough not background, of again, But safety lot study the hear later in year what and you guidance to those that of spending engage tumor select until we to success. regard point. guidance, that move other MGCXXX able obviously for portfolio lymphoma. are the the hopefully, the on have pruning capital the for we program, are that think Phase we some both committee. which looking that highest the But of the have be solid and the don’t have trial appropriate head hopes and this – programs we will the beyond be support study. will we of high determining the in have neck design forward certainly data effort monitoring With continually the to dose at the certainly to And TiVo

more we on continue greatest forward, will think prioritize you programs will So, going we the Jonathan, where to success. to we chance will how have hear our

Operator

from comes Thank with you. And next question Nochomovitz Citigroup. Yigal

Your open. line is now

Yigal Nochomovitz

Hi. Scott Jim. Thanks and

interim number is you for trigger you events. MGCXXX, Phase radiographic this will share for PFS could And have of a what what analysis about is? the interim, On that the what typical a that certain just X said if situation

Scott Koenig

We with moves forward. haven’t safety be that. to futility this But via the go specify regard committee. go/no a in decisions what component to given time, the guided are will regard position data with not things the is to we this which at analysis, There a specifics monitoring

Yigal Nochomovitz

And MGDXXX, Okay. you another just on XXX this To perspective could there [indiscernible] there that some example, cite out with same also help from competitors then the molecule of I targeting is in am put if CDXXX. one other the one curious have construct.

your you wondering help is different? molecule elaborate how Just if could on

Scott Koenig

see other I the with to for certainly late reduced our be other combining way have we this will AML, out greater profile plans, markedly certainly models, preclinical some molecule designed malignancies line are could robust I have It add TiVo we seen activity think given a we used molecule publicly a we earlier, that compared certainly in have refractory have are number dose, standalone Especially the has release. AML in version. stated it. of at in least the see discussed I actually given be that which nice of on it’s we release And class. really our much to a broader in very its to our the from in We active using once as one. value point approved do CDXXX cytokine been populations. these if we think then what molecule agents But only cytokine analysis Well, developed not hematologic established terms this that mimic constructed preclinical molecule this being beyond this has MGDXXX. this can properties superior But of a TiVo about should

Operator

you. Thank

from Our Dai next comes with David SMBC. question

open. now Your line is

David Dai

Thank for Hi. my taking you questions.

at on comment will the receptor be perform, occupancy MGCXXX on helpful. able just based might whether receptors you are design. be little amount at Especially bit color So, doses? you X/X to the a of Phase similar I lower this modeling, be tough share the molecules lower will one PK/PD know to Could doses? the But any question occupy program you internalized. on could because

Scott Koenig

I David, answer can’t I question. – don’t really that

molecule What problem need don’t you I occupancy alluded this get to case, the will you the ADC that epitope this which here to think then cleavage that of a you through an and need go because that get to the actually biological an is the alkylation activity. travels antibody receptor have full is incorporate is to on toxin the of molecule. the the In promotes an we pathway receptor DNA. will lysosomal and directed nucleus

the this, don’t so saturation levels. need sub-saturating really, And full you of

intending broad have are have And the Phase to of furthermore, dose we escalation do in doses, side we by to think activity Phase study, we wanted in seen. sufficient reduction. what given the not even we seeing our this drug circulation move to hopefully lower we and doses mitigate again, some X described already at I the dose X/X do. than that different activity forward in And Given the have effects in that what the have

David Dai

That’s really helpful, Scott.

colitis lower question So, and any we where the on levels from diarrhea safety is see saw another pretty we and Grade study, profile your just some clean, X rash. XXX, facelift of didn’t

mg just kind show level? at the mitigate of lower the you reduce to adverse are us levels to can if you what event X to dose X.X and mg, trying So,

Scott Koenig

grade modeled very profiles that we side had patients two, that an big one the the the causes with we saw major and with question, grade three where saw more on the which hand-foot was this side higher in effect low pain we syndrome, we but patients. profile. the was Excellent investigators themselves, of levels not as is But fact effect issue a

incidents, are of our most them hopefully that obviously, hand-foot hand-foot. to for the And most grade, this more side notably, side And but some is also effects side both so other type driving the effects hopefully, prominent, decrease. here the instance, syndrome hematologic to grade goal In for neutropenia problem infectious any treat major the any effects or And we are one we the seeing which result. clinical not meaning a febrile to-date, include neutropenia, In are can notable that seeing increased a by case, with we not a neutropenia. neutropenia, GCSF. giving is, fact as rates infection

to agents. also good thrombocytopenia stimulating both So, ways and oncologists giving neutropenia doses have by the treat and holding

is dose intent modifications. these that of the So,

Operator

Thank you.

with from comes question Zhu Our next Guggenheim Securities. Charles

is open. line Your

Charles Zhu

everyone. my Good afternoon, for thanks And question. taking

quick one enoblituzumab. on one Just

that this cancer and you like sounds PD-LX neck update combination it later positive So, in have year. will head

look a So, cash as agent around benchmarks given of idea like. your the PD-X coming I single good and of up, some we what in as a just data well it But in pad? are terms sort runway, programs language of really guidance given pretty have for looking And registrational more pursuing out potentially you this won’t you development of some go/no-go of confidence in guess decisions? these Thanks. give what

Scott Koenig

the historical line, is, Yes. later doubling cohort were population, overall Excellent question from we as reported And prolonged much historical Charles. we out the XX%. we The rates the data. survival data seeing on as even response certainly a small, though pointed and about overall more fact was today, very in today, the

this to going with head So, a to both are achieving contract it’s in to a study. chemo in I regimen, and response combining free XX% frontline in further neck free we a range other that chemo think possibilities in XX%. a regimen or are ability the we again regimen chemo develop pursue If free rates, of we have as this potential forward. chemo

to of data look to having maturation this So, the be well, later update. we year some to able forward

Charles Zhu

question. Great. Thanks for Thanks. my taking

Operator

with comes Securities. question next Our from Instructions] Silvan [Operator Tuerkcan JMP

open. Your line is

Silvan Tuerkcan

apart and for dosing. first shot the question that have going you. PK/PD from of the guess My evidence a to will efficacy you dose patients out ongoing space reductions the there dose the from doses a AUC. to maybe giving by guess Good arms you my Thank expansion weeks in then afternoon, that And What questions. on have them on investigators out. the the or out I taking spaced been freedom have little have And three from due four to pacing quarter. have thanks congrats you. And more profile bit have weeks we further the seen received of any follow-up. XXX, to I before, Thank a is I maintaining the

Scott Koenig

our either at yes, in those percentage large dose. for for were of they dose But patients exactly Silvan, out before the were X started did mostly resuming. we – on of patients what or held doses retrospective patients QX reductions weekly. a that’s mg having effects were that All the analysis the either side

or of held actually So, patients there four up these in for were a weeks even to six some weeks were number longer of that patients.

compare able their and to And of were the so these patients we that to response intervals the on. that effects able intervals come that’s have model And with longer ultimately and and those we to responsiveness and rates. were simulate dosing how the doses and decided side we

but So, yes, treated not that basis, did weekly on frequently. in have patients were QX less fact, we a

Silvan Tuerkcan

lorigerlimab Zai discontinued question I just And think development. here, sorry, partner China, Lab actually in tebotelimab, here Great, thank on a you. quick – your

but their on may plans – have the I What your call, have half? you the future update future align those? how get you you plans. disclosed with that may in XQ that second said the and following Do plans any will update future they are think they that and in we

Scott Koenig

Yes.

are of they opportunities. towards that, think in think I looking next again, terms I us

indication have to an as formalized tumor been has before, I potential have participate a potentially potentially lymphoma of alluded a in setting opportunity we’re explore studies, we to tebotelimab. on in use of the those what And to but at will solid looking than depending As they decide, the nothing yet.

Operator

Stephen Stifel. with Thank with you. Willey I have a follow-up

open. is line now Your

Stephen Willey

Yes, the follow-up. thanks for

just on being schedule. attempt going combining Thanks. believe start harmonize I is QXW schedule? MGCXXX be lorigerlimab there a And is wondering you dosing to when evaluated So on if with any this QXW a currently to

Scott Koenig

fact, Steve, QX of lorigerlimab in amendment yes, provide will MGCXXX. with regimen coincide dosing to a on there be to weekly the an

Stephen Willey

question. Okay. Thanks for taking the

Operator

have follow-up Nochomovitz Thank Citigroup. Yigal you. And with with I a

Your line is open.

Yigal Nochomovitz

add and Scott, Yes, encouraging of elaborate X/X noted you are expansion, in I quantification melanoma more activity trends? patients think anymore seeking non-small-cell terms not signal. time this at of can to you if sure on an XXX in interesting I to point also to those that am Thanks. generating one Phase be just in appears and given that you

Scott Koenig

of on year. I think, again expansion cohorts to these plan our is later provide some this guidance some

histologies among types, to will obviously to before, the the do more additional X work need to and a to a the we we rates further in given regard like which With as this noted pattern population and expression want But lung efficacy. terms well in patients X.X melanoma, as those specific of terms on explore. population the see population lung, similar So, in stay terms tumor tuned both we respond first, BX-HX for heterogeneity that. of the on again, little different I as in of have lung how would both safety melanoma in XX to response of

bit the more in homework expansion forward little are lung that doing we a So population. on move decide for before we the

Operator

Tuerkcan Securities. our from JMP Silvan and comes And you. Thank next follow-up

open. Your line is

Silvan Tuerkcan

Thank you.

one Just last here. follow-up

a that patients in X.X that you are Phase and in patients any that or into cancer and trial into Phase that enrolling there potentially enrolling lung expression those expansion dose the at scenario pivotal expansion just cell cohorts, melanoma trial pivotal and Phase could milligrams your already X skip or X following you Now more convert is other the in patients? go Phase of non-small you. that X/X X/X Thank by that way also dose having a

Scott Koenig

clear, X.X melanoma in obviously me we not So at in the started quite be nor have population. the lung dosing let

prostate. study as the to enough will too able it having just data number the the more or early to profile importantly, sizable of adding response to the We get and be control The prostate, Phase as will actually, controlled are it’s a rate to to population well likely guide prostate as delayed patients understand sufficient it in will the safety compared to the independent of an be patients. additional ease but approximately as start use before we because given time too data, the be same that the that and X/X not

other those types guide for in data the tumor the use not will to study. us prostate we no, So

Operator

like I hand for to And the to Dr. currently you. queue am the time. no conference further questions back Koenig closing this comments. Thank at I’d any showing in

Scott Koenig

We We call programs to have later our operator earnings providing participating thank and year. Thank forward so you and you, evening. on all of afternoon look updates great today. this many for hope our in a you further

Operator

gentlemen, and conference. Ladies your today’s thank participation in you for

You Everyone day. have may a wonderful now disconnect.

MacroGenics (MGNX) 4 May 222022 Q1 Earnings call transcript