MGNX - Earnings call transcript Q3 2017

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Operator

Good afternoon.

We will begin the MacroGenics' 2017 Third Quarter Conference Call in just a moment. All participants are in a listen-only mode at the moment, and we will conduct a question-and-answer session at the conclusion of the call. At this point, I'll turn the call over to Jim Karrels, Senior Vice President and Chief Financial Officer of MacroGenics.

Jim Karrels

Thank you, operator. to and call operational welcome third discuss and financial quarter results. afternoon MacroGenics' to conference our Good

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

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

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

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

Scott Koenig

you call welcome for via Thank and today. I Jim. Thank like conference to participating you, joining us. webcast everyone

an the for we'll submitted quarter. MGDXXX which X clinical global and a encouraging XXXX most collaboration with was MGDXXX, and and new of an data MGAXXX in fourth the ESMO, expect The third close licensing for IND in enrolled agreement application Phase executed at collaboration. the recently patient progress first We of of trial Incyte, exciting one continued presented flotetuzumab X Phase we quarter

at December. and data We this on an for will more for posters an the be detail I the will of programs Society meeting of greater after all Immunotherapy sharing in week deal quarter. American programs or later has turn have ASH to on various Cancer the financial the and two Hematology MGAXXX licensing we'll I'll oral back and or results discuss presentation call PD-X the at flotetuzumab Society Jim. based our overview in Jim SITC over reviewed the provide for now our

Jim Karrels

financial expectations. generally Thanks, with after results Scott. in reported line we This

in expense to We had increase consulting quarter described due professional ended compared expenses million continued XXXX, million and compared MicroGenics $X.X expenses R&D for multiple and $XX.X increase to for support to of This This release study XXXX, $X.X MGAXXX initiation quarter primarily increased G&A the was XXXX. the Phase $XX employee ended expenses primarily had million XXXX. benefit XX, for X overall compensation the fees increased September As September trials. in our XX, of September to ended and ongoing including of for September ended quarter the clinical million growth. due the XX, enrollment to our the was XX, quarter

of previous the million revenues $XXX upfront September periods, this Revenue anticipate XX, XX, On transaction revenues ended such from from well expect we recorded collaboration. September full compared ended upon XXXX. million received quarter the the in the primarily $X.X received agreements the quarter amount payments quarter XXXX, collaborative to Incyte We recognition the XXXX quarter the deferred includes in not revenue the Revenue receiving XXXX recorded total during fourth consisting an for receiving year. as fourth MGAXXX recently recognize of $XXX from million the and does third revenue for closing side, period. as the of as of payment announced from in the $X.X agreements we during for million anticipate the payments quarter collaborative of include of to

quarter we compared had net $XX ended ended for a million XXXX of million the XX, net For of the September XXXX. loss a loss quarter XX, September $XX.X to

Our totaled as million XXXX. as which of equivalents cash, XXXX XX, cash with million, and XX, marketable December $XXX September securities of $XXX.X compares

operating fund the plan, $XXX securities combined million will Incyte after cash, hand providing rate, our once as multi-year specific equivalents Before our year. and we've closed that payment upfront our believe on anticipated defer our the Obviously, million anticipated XXXX. And later into including Incyte finalized I'll with operations revenue will our cash $XXX as we existing transaction, to and we but we the collaborations received based marketable the from budget until run from stand now well cash believe back operating this current Scott. our call under guidance

Scott Koenig

Jim. you, Thank

well in redirected for a as initiate and plan in MGAXXX enoblituzumab. the potential basis We that several therapy the our the core including announced will collaboration Through molecules pipeline Incyte MGDXXX the assets and while the of with of combination of commercialization As and the Incyte recently targets our MGAXXX, to year-end with the of one these as PD-X exclusive margetuximab internal retain immune-oncology global programs by develop We agreement programs in mentioned combination MGAXXX, three licensing agreement obtained asset and DART this believe we we molecules MGDXXX, within in and has study I one for XXXX. franchise. opening, first right flotetuzumab pipeline strategic PD-X which and is with the development directed remain namely for with our worldwide and our to MGAXXX. be rights combination MGAXXX T-cell

assuming week's worldwide solid will this SITC at Enrollment being is study MGAXXX of the Incyte currently the is subject monotherapy, of As Phase escalation exchange In will also will million upfront clinical MicroGenics to and for million complete commercialization. $XXX to approval royalties and to the dose close. portion $XXX manufacture Meeting. also results right the of have need. for potential poster safety across MGAXXX of to pay be receive four tolerability the company's evaluated supply in a and commercial tumor MGAXXX be types. and of of eligible X deal presentation rights both portion global We've XX% upon payment a tiered milestone up XX% and MicroGenics

XXXX. believe ladder will is our efforts of PD-X MGAXXX. needs operation manufacturing expand and believe the existing We for these using the track be fulfill under suites the franchise our construction will which both strategic candidates. with directed to and on the future collaboration in in is that development GMP MGAXXX Incyte We of accelerate and we first

an address based PD-X as rely knowing which the additional provide related now to update on PD-X we me can MGAXXX upon the other our regions details that any Let for variable programs, clinic. specificity and industry in molecule agreement the to blockade collaboration enter actively checkpoint dose in session. is the proceeding Q&A We the believe licensing bispecific to escalation. the first now MGDXXX that the It is same

FC-bearing provide are DART Two T-cells molecule LAG-X. expressed to We and of immune treatment range on molecules and PD-X developing of for checkpoint co-blockade of potential malignancies. MGDXXX a the

and candidate Phase on co-blockade T-cells in also MGDXXX the well is data, poster a CPLA-X. DART we're SITC. two will PD-X provide is molecule this trials immune introducing our designed case candidate describing We progress preclinical product study SITC. at This X molecules to in expressed of as at as preclinical present checkpoint

are of has IND in our advancements XXXX. for activities also support important potential We an flotetuzumab submission made the application with conducting program. MGDXXX to MicroGenics

demonstrated syndrome AML that myelodysplastic treatment myeloid of MDS. Phase of or molecule leukemia in and in September, tolerability and patients. acceptable DART dose being ASMO a acute Our developed activity recognizes the with both or encouraging anti-leukemic which we early escalation X AML that study CDX, in is flotetuzumab initial CDXXX for showed the observed portion At

in four of achieved the objective evaluable cut patients patient with CR/CRi patients the and update Servier data in session to U.S. well a AML for MGAXXX. the XX flotetuzumab an at I'll expansion August the had Europe. our experienced We be in the treated including molecular and provide on for a now XX things at oral a MDS of threshold poster December This response will XX% flotetuzumab and dose, Updated as rationale or on of update XX% cohort featured the as who presentations response. continuing combining three a and CR. one an provides partner X study cohorts patient enroll Xst a who our As that the franchise. or XX included ASH data an including patient cohort BX-HX

continue combination cancer study monoclonal recruit to studies study. ongoing with candidate most neoadjuvant collaborators Our enoblituzumab. patients BX-HX. a and antibody We and an enoblituzumab multiple in studies that anti-PD-X These a advanced antibody prostate include our in and targets Fc-optimized

the evaluating of be completion good continue which the combination of We indications the provide end update different PD-X combination four of the to year XXXX. in believe near in to in a study, half first is by that we'll clinical in a position enrollments and the

franchise candidate types. clinical several BX-HX molecule in MGDXXX, patients that recognizes solid a DART second study across and tumor and different Phase in being is The X evaluated CDX BX-HX our a in is

schedule to continue dosing explore the We administration. MGDXXX for

BX-HX franchise candidate an MGCXXX, animal anti-tumor ant- third that antibody conjugate drug models. is vitro has potent The in our in activity BX-HX shown

an include activity to recognizes MGDXXX X conducting to XXXX. escalation recognizes in and which the refine further We've IND the CDX MGCXXX of recommended schedule and completed Two this HIV cohorts dose molecules support envelope gpAXX protein application additional and of evaluating Phase DART and molecule. MGDXXX, clinic potential submission the are are expansion CDX. of which of various for the We MGDXXX, dosing the in study

MGDXXX anticipate Our dosed and for XXXX. early be cleared first FDA our we IND the will patient submission by was in that

Finally, factor the epidermal margetuximab or receptor is that HERX. human monoclonal two antibody our Fc-optimized growth targets

in post metastatic post Phase patients We of remains study trial X include the America, will for which HERX as North chemotherapy, pivotal are actively approximately compared which Europe, chemotherapy enrolling efficacy SOPHIA Asia the cancer we're at and with therapy. track. margetuximab breast following evaluating to of positive in in margetuximab patients XXX the trastuzumab sites previous on Enrollment study progression across the

of enrollment and and XXXX. year-end to or early late an XXXX announce of study complete the XXXX analysis results expect complete We by futility by interim the then

gastric we in within addition, X continue enroll study of HERX margetuximab Phase anti-PD-X positive In that for a gastric the cancer. patients assess combination cancer with patients will advanced antibody to

combination the complete of patient a The the We with patients in XX of and options these two of limited XXXX. half the provide enrollment anti-PD-X cohorts treatment present treatment free data clinical potential margetuximab chemotherapy expect during has option. XXXX to and first expansion with to

the This accelerate candidates strategy. expand you advance the position agreement with And We concludes my development diverse will to that continue and our programs product the closing entered clinical in on continue address portfolio continuing have. to questions financial strong and update our expect on to upon advance to a company important Operator? Incyte deal our We an and we glad to be forward MGAXXX. to any our we comments. of strengthen further molecules are have of and now prepared that may look we'd execute as callers that

Operator

The Christopher Instructions] question [Operator first Marai with from Nomura. comes

begin. may You

Christopher Marai

good afternoon. Hi, for Thanks the question. taking

how maybe CDXXX might on with I if Thank anti-PD-X targeted First doing with little then was rational combo colorectal And secondarily, the you. the us or to touch bit if just XXX, of your cohorts little include with those you a a help going next could of Specifically, expansion might the anti-PD-X. DART? could wondering data in forward? choose to you if candidate understand behind the upon bispecific maybe elaborate that combination some you

Scott Koenig

much, Chris. very Thanks

gpAXX this memory tract and refreshing a just is colorectal a MGDXXX to CDX cancer. targeting the on on molecule GI target regard and with expressed So,

on pointed challenged As were we effects R&D had GI were last by effects target normal late Day tract. year, but target out the on our on the of we the at drug, seeing

And support modification. over past designing we providing of so, care, course as as the of doing have additional been well year the ways dose

have We provide including regimens basis, the dosing, at One site. QX at dosing mg as a of a this looked dosing to now initially satisfied a QX drug basis. of dosing weekly with normal I GI the metastatic on per two on very as were reduction for bind these well is involved say the tract of to basis, plus using kg we to we Right of are tumor progress then now, concept Using the drug can we budesonide What monotherapy. the year. much was ASCO tolerated these steroid of a at able XXX? leading to the on delivery AACR the question, both X expanding to next you with as or conferences dosing drug combination topical Q in on weekly that a be we've on been test weekly other didn't patients. by patients hear update likely be seems MGAXXX and cohorts oncology several Could planning question, XXXX. this to made combine completed one here, I an there? should of Are to and And we're was Chris, at able starting regarding repeat your in the we've to better additional either provide we've the you as second the analysis

Operator

no it looks is connected. And like Chris longer

with from Our Lawson Peter SunTrust next question comes Humphrey. Robinson

You may begin.

Peter Lawson

Hey, Scott.

utility suggest tumor utility this the abstract that that types data, I thinking the guess anything to can So, guess in think the the then I SITC with and for the you is XXX C, eventual response - drug? the us broader could and around thinking about how then anything ovarian was there cancer, Just give tumor that around you seen around we've of, kind types anything you the of is of drug? about

Scott Koenig

Yes, thanks Peter.

that and that's in data and going escalation, of data we presented to bispecific With as dose SITC, dosing data various first molecule, obviously for an tumors PD-X posters to the that the at shown PD-X be going MGAXXX, DAR occupancy LAG-X, molecule associated we're the the DART have and So, submitted CTLA-X. the noted to Tumor with PK by two five MGAXXX will the all comers were of which be on preclinical evidence show two responses to of are and targeting essentially related or establishment one regard and types. introduction the PD-X the objective abstracts related PD to of

as time started expansion time. the this four is already course monotherapy of just have early the be to that SITC and will poster. distinct revealed of that types in at But, discuss too tumor at We data

Peter Lawson

a QX, that just didn't then spread does about of payment, get in And Incyte get it it out or the time? is I P&L in just period does you. longer once over Thank just it that, thinking -

Jim Karrels

quarter And fourth quarter. Yes, the $XXX closing all thinking as upon the it receive that to we of million, expect the deal. the current would in P&L the during is fourth hit our revenue

Operator

Thank you.

Our from Yigal next Citigroup. question comes Nochomovitz with

You may begin.

Yigal Nochomovitz

them and spend target know Jim. see how you of I say CTLA-X for the the versus this taking for but a they are PD-X you in the in and how still, you respect profiles positioned market minutes Scott similar through Hi, differently Thanks. but discussing some early anything about you anchor, it's Could the product sort Thanks the few at XXX can point? questions. obviously is for see days there XXX? LAG-X

Scott Koenig

Thanks very much, Yigal for the question.

gone as So, MGGXXX in with both in know, you in now is a of through studies. escalation regard first have PD-X to LAG-X they patients. preclinical different both dose by molecules thorough toxicology all, a

benefit in this normal of very substantial systems, from is refractory model in shown to patients view think as and model of any And it given is one checkpoint sensitivity will in in fact, we that we expression greater. very the that PD-X at X% a patients and such who the first patients. some or We to activity TIM-X and effects attractive. now particularly toxicology of the real absence are molecule, in seems [ph], As very because, PD-X which the previous be database their refractory increase expression engagement ASMO as LAG-X And have in to this a the been number has has in recent very various disclosed blockade have providing T-cell blockade on LAG-X pattern be tumor to significant that this even to seeing data PDR-X populations LAG-X given study PD-X. Bristol-Myers rate typical a LAG-X molecules in going think molecule melanoma enhance may sufficient is expression of And significant that restore responses. of regard now profile, the this of or with restoring anti-tumor is and of other the the become they clinical that exciting uptick in at

good for various that I assume Bristol solid individual in going two with PD-X and to refractory standard that and and will seen molecules. blockade up approval is in PDR-X that a the open regulatory has and obviously what PDR-X great very consistent safety the success express First template obviously - think or are opportunities tumors with PD-X

Of we therapy. naïve patients also have not at to of PDR-X opportunity will course, PD-X the And an treat then this in who Fc advance as we as ability to combination look in been molecules the bispecific and combining DART this molecule, either finally as as DART is redirected now other molecule. molecule possible our T-cell well with molecules portfolio this specifically further enhance

were we CTLA-X. by binding to and and safety for PD-X toxicology this designed And to regard effects binding CTLA-X, dose have bispecific to profile that in we to conducted Bristol-Myers able molecule, encouraged with two for we've previously PD-X the better of been when studies with significantly. and to been biological with extension sites are is published sites what PD-X, they in MGDOXX, And two Now seeing molecule study by a specifically primate which have be quite very by primate. T-cells Yervoy been than did that seems with attach

So, as now about this well. development, obviously for molecule pans how move are this as forward we clinical will the we see potential but outs excited right prospect we that into

Yigal Nochomovitz

to the market you of thinking On are have how three do updated are the the late into advancing one positioning that's and advance any all on thoughts one stage you for that's best Okay, portfolio? about find hope strategy here BX-HX, goal thanks. is the one you with Are or going studies? this you the potential or

Scott Koenig

and which cancer. early And one the four that's head Thanks anit-PD-X to whole about data lung, about we studies with next in that in furthest franchise. we neck, prospects along the and bladder to very questions completing able be melanoma currently BX-HX, optimistic updates are for expect tumor enoblituzumab, different is Obviously provide is combination BX-HX that our types of year. of

trial finishing single greater. In in enoblituzumab with off addition, newly sponsor high patients grade as investigator seven with of a agent scores in recent are cancer or we - scores of diagnosed prostate using an prostate cancer

monotherapy. as in our closing right that update DART expect on are of that we're regards provide molecule, that to the on which finishing We able use enrollment MGDXXX, With and to is in next indication BX-HX year in of study CDX dosing be the to out now completing well.

were molecule. some patients we of have that we in antibody we types the different of MGCXXX, studies the of we XX as six be conjugate. bifurcate in in And patients cytokines monotherapy the with associated toxin dosing to as out And learned from this then approximately to As in of and And linker dosing variation taking then lessons we effects, will and with with release. a finally in our combination of toxicology a is expect And leading year last XXXX. which anti-PD-X was pointed some completed but anti-tumor the completed recently that to earlier the MGAXXX tumor beginning regimen. modify sometime wanted see result, we've the the dosing development story each, including flotetuzumab then schedule an

that's in theory. they're at in and of in be the combination that differs enoblituzumab. recognized of fact, And Now and non-competitive that epitope MGDXXX least can from differs MGCXXX by from used

to agnostic or two we the fairly your question As as depending find we tumor of original the as this and the treatments disease. in right type of back right in as separate past the So see want conditions see pointed one molecule? of we the three out being the or stage quite on extensively we do three we're of developed do to the this winner

determined in during this the expect favorable all complete studies, tumors, we imagine be can if molecules, we to particular future I advance in So, by were could will XXXX. which quite that these but fact responses

Yigal Nochomovitz

with better that engagement happy do data at was can on And correct target my is still get flotetuzumab, with Alright, understanding that Or you you what achieved the dose? great. you've ASMO? then in the that escalation other given think higher you're dose the presented

Scott Koenig

that for flotetuzumab. question thanks yes, So, about

cytogenetic chemotherapy So profiles patients obviously, regimens with the prospects patients of responses particularly about that actually were the of refractory some had responding these and we very that were objective to were now both previous poor with excited in that very CRs. taking

three of designed a in for We and and show weeks then course, first expand the a then completion geared show at to XX if then per over month. patients dataset have cycle felt currently evidence time kg they three which of of profile as switch to Of regimen for day effects the treatment. anti-tumor data. now, right consistency four the nanograms the course days up that first XXX the and of efficacy day XXX next the to on, few four the in days initially the of nanograms And off the safety first of nanogram the on we get

we think an study I should additional patients if on Now the presentation. with discussed what regimen Currently the we will can benefits. same have in the we which And patients XX update cohorts. the out the in additional you NDA achieve in better XX shows at Meeting oral point the be addition getting ASH relapse also on opportunity dosing with we'll interim, see as added data that new we're current the the refractory to even regimen. therapeutic some patients in with enrolling additional the point then to expansion us fine tune AML out, and that then

poster this anti the And ASH. be quite two PD-X think relevant that of have or which on the we I'll molecule, our current glean at with of We point I from MGAXXX you sessions combining data based will out rational study.

great drugs. on opportunities in additional responses combination at to add least using are theory there So,

Operator

you. Thank

Leone Our from comes Dane next BTIG. with question

You may begin.

Dane Leone

longer treatment drug of want dosing see we that or kind on couple dataset guess, of algorithm of thanks of the clinicians [ph] patients how intervals what Hi, update us of to can and longer thanks stay rats time? I that think nuance development Thanks. for How update. do with still different you thinking regulatory little want actual a flotetuzumab, could you a just as it's guys, sticking And periods the and you flotetuzumab ASH, plan. for remind maturing, the something see about to at that? on, the I see. the the ask of when I to maybe like kind bit. provide Do if as are of And

Scott Koenig

Dane. thanks Hey,

both for So, particularly relapsed are data regard disease again, regulatory we're with agencies use now that options this there additional looks given would from we an refractory we AML feedback that And with what of then few patients data. and relapsed/refractory of be the can number population have reviewed refractory and expanding have can the a that to enrolling the whether stage beyond want expect that for of CDXXX we're argument in investigators you XX% the the that pivotal physicians that encouraged a a drug control regulatory arm with that be the very number study if a XX tell this look a study. rate expand what data persistent using to of what are discussion With have is I reasonably enrolling that that or the positive we patients design the is on us. very patients at and study dataset But earlier on a We're that clinicians with the saw study, future. Agios dependent drug from which provide to promising KOLs therapeutic opportunity expanding fit will us one agencies. who obviously feedback arm additional the these and shows are actually for the designing the single the diseases of an near patients; by hearing over number to a as course, expressed. it for And from IDHX that been designed was other some and make in currently a we've to one sites and the is maybe populations can unfit where see, AML CRh of benefits, option sites, based the on sites they this all

with on and in discussions to forward that pathways we'll we're update So, we future. expect you in able the be near sometime

Dane Leone

I I more provide on going you could is maybe your ask and could Thank are some just on of view? XXXX? going of you into just enrollment are guess, escalations heading about? the cloud thinking you. And one data if kind ask that How just that timeline kind I in timeline dose for one MGDXXX, how

Scott Koenig

a as the before cohorts those And each. dose the on the probably partner XX wanted I expectation always little of then slower I faster. the - my conferencing would was patients able and you're you with likely to achieve study it that I in the than I the finding always dose Yes. of I six hoping MGAXXX, is half expansion both it CEO, first want that say to as into expansion that we going dose studies defined we at quickly by 'XX defined one escalation had that have would've provide to then the of update we that then I defining would think time, alluded scientific And will combination is described 'XX. the early to should that the be start we in it an first in of in half this expand things those cohorts I before 'XX.

Dane Leone

you the thank Great, update. very for much

Operator

Thank you.

Michael comes Schmidt with Leerink Our from Partners. next question

may You begin.

Michael Schmidt

Hey questions. guys, thanks my for taking

Just couple, is a one that number on triggering study? many events interim margetuximab the analysis analysis in me how the remind

Scott Koenig

are So, right not that, planning Michael disclosed to not we discuss now and we have that.

able the by obviously analysis them We we that but a January. we reach believe achieving have to indicated either or would those obviously into occur this number was to what of preset on not are get empowering and feedback And earlier yet. will be have the December. decided broad as have still that depending close December plan late events, we upon data we safety timing monitoring We

the So plan right that's now.

Michael Schmidt

the good on will - right, came enough studies you first gauge bar half thank, treatment gastric and I for paradigm, this signal how guess, wondering gastric study ramp additional year in through a to of next said the here is the what combination forward of help in And what's the in in gastric? us am I great. into move All the profile terms up in fits I to the then just cancer just the current efficacy

Scott Koenig

Great question.

label - is memory second and HERX about in we this the U.S. IHC, so are or an likely these to XX at open seen the January. you is an - the full are have the granularity are update cancer ASCO this little either the patients just at of we that at give and are enrollment in release we more Asia. came X+. study to And patients patients refresh or provide gene So, Meeting we herceptin Where out. remember to open to end label finish +X amplified is looking providing we study, expect your positive the And patients on and have complete of GI just XX enrollment of is the gastric

a the was agent, and if population. X alone approval Phase responses margetuximab So just received that objective number in response a historical the on was this XX% if population. third this type their look with rate mid-teens approximately as perspective, KEYTRUDA patients. seeing in about you data look you this our to data Merck give at that as cancer And treated single patients at in of the for line small were We with you gastric back of monotherapy

make or something you in ahead if objective like to you a having my rational move told of XX would see responses at all is there. assumption So, are something to think higher you decision that that range to least benefit additional

Michael Schmidt

and then gastric, the context second cares of how (inaudible)? the line set is to current for just or Great. HERX patients in chemotherapy And

Scott Koenig

time? your I can question you didn't say that more hear one

Michael Schmidt

those the current care is in What of center types patients? of

Scott Koenig

line chemotherapy Yes, it's plus right ramucirumab now. at second

Michael Schmidt

what's combination efficacy that level the for that? And

Scott Koenig

this the think there. state But numbers persistence in But to have so numbers from would be not a rather misquote the regimen response. also it obviously to the specific don't of the I want I And don't the depend driving numbers trial, with actual will I'm it. on competitive. chemo-free I regard certainly, that very this at

the to those numbers have advance long. As not I recall their the length of very I But was don't patients time specific disease yet.

Michael Schmidt

or cohorts cut that of be clarify on the just then of data? both it ASCO a at be on all will be And will of to the will or data extension patients the the GI

Scott Koenig

fully said I to not till likely as dosing is December. assumption we're the patients you My finished

will amount the that there So, be I look. I an be able would some conclusions draw to But of there. it be an patients majority data be would should the and integral say to look, sufficient interim think of it

Michael Schmidt

Okay, perfect. information. added Thanks for the

Operator

Thank you.

question next Stephen with Our comes from Stifel. Wiley

You may begin.

Philomena Kamya

this is taking for thanks Wiley, our in Kamya Stephen for Hi, questions. Philomena

If with for molecules combination remind have mind wouldn't DART MGAXXX in which questions. PD-X I again, trials you And you molecule? follow-up a us the have mind

Scott Koenig

Yes, Philomena. thanks,

combine MGAXXX with would I shown take MGDXXX. are a there. providing of studies patients ASH the by flotetuzumab. And think We good for and the with look in data Roche at that CDX the said colorectal in to a rationale that combination as that's which response then the given the prolonged combining regard CA-by-CDX with with advanced a anti-PD-X has their rationale data their BX-HX plus planning is We to MGDXXX cancer.

Philomena Kamya

Okay.

combination this in expect cancers you would there better XXX, and where prostate BX-HX in is to flotetuzumab the expression the work to differential with XXX respect like of cancers? enhanced with So,

Scott Koenig

I'm sorry more you one the question flotetuzumab can and XXX? you repeat time, sorry. So, said

Philomena Kamya

No worry.

work So, in the target there DART would that of in can… BX-HX, to differential with is where cancers in target that anti-PD-X combination molecules molecules the contain better these DART the expression expect better you

Scott Koenig

see, I what you say.

on We recognition is at expression the there we of performance the of expression BX-HX pattern have tumors don't molecule. the that regards think with DART know that to low in BX-HX that, Kildare. I on even very data So, on

combining to synergistic. very shown that T-cells as in have that as if was combination with that recruit you mediate long anti-PD-X recall to able effect, we preclinical data regard with the we're there Now an to

that that of we BX-HX likely that is density on irrespective anti-PD-X the combination with an to the the we'll tumor of responses. see. have expect improved to So, show But

Philomena Kamya

thanks much. Okay, so

Operator

Thank you.

Lebowitz Our David from next Morgan comes question Stanley. with

begin. may You

David Lebowitz

starting a Thank for MGDXXX cancers going question. my especially on Are BX-HX with to of narrowing just the in question far given you very for think forward you for MGCXXX? array molecule, trials the I wide in thus a of and of taking some experience much had cancers. specific on enoblituzumab

Scott Koenig

so Yes, thanks, David.

head neck, know cancer. were and studies range to tumors down for that four we pursuing wide had you lung, in studies of that we of as dose narrow combination a in and enoblituzumab the and then to decided noted the escalation melanoma So, types before very tumor I the bladder did we and extension we where as

of We the the here the differential, than an intend certain that quite the tumors instance better a for in than uptake are employing which toxin respond may and with types tumor complex individual to that expect technology into has receptor to we're depending others. and of the cell you that on that mechanisms better certain tumors others. that linker molecule a have have And course,

see So, narrowing we for those of targeted stratification which each may would tumor one types BX-HX a specific molecules. include would and we ultimately of pursue

David Lebowitz

looking Thank looks more then start going year, early what you you like you could you through for are just and are next to one find MGDXXX, run out? on question us trail trail that a And that. to what

Scott Koenig

we've Yes, obviously molecule who the a any in pool measure thank the of A study. for which therapy got can pretty of latent very we proceed from in that residual to retroviral the been is virus we FDA cells. is This for patients on are of the much about, you which introduction clearance study with HIV, that. quiet

and monitoring we persistence molecule. start all at of be obviously dose The we study, those escalation viral study looking is of this assays subjects, And once be and tested, conducted we're viral the obviously the being North will the eliminating in the be of so, pool that at of but University tolerability load will also obviously can Carolina. This safety DART in molecules and acutely future. once first so parameters that plan it will that study other there follow-up followed. the combine induce molecule other that might completed, immune that virus latent is cells, infected Ultimately, with is of more - make a a this effective to is

David Lebowitz

taking for questions. my Thanks

Operator

you. Thank

Our with Raymond from Reni next comes James. Benjamin question

may You begin.

Reni Benjamin

them congratulations a of kind patients they platform. - couple are transplant, a Maybe thanks you you're Scott, patients patients, in follow-up these they was? for flotetuzumab, deal, as of bridging nice of just responding bridged can response more provide maybe these and thinking have have the down any bit the nice what eligible? in duration little you or a looking duration guys, to far terms maybe for? to to those taking the transplant, too on of that transplant of What validation that of Hey, of transplant about regarding the response a just questions are And color other potentially are questions before asked not

Scott Koenig

on question. much responses ASH. the of some the providing for be durability We'll very thanks at update Ben,

short opportunity So, it a the were therapy. that now, will on still very comment of many not lot are patients on and and I the ASMO at now. or being Obviously, still these time are patients windows of of of treated followed even

have basis of of are be don't how will So, the at ASH. provided we a time analysis responses a the persistent full in real-time

far, most - and to So most patients these - given that as be this as for alternative patients them. are get that able are no have particularly transplant, patients we certainly, them an candidates eligible bridged But into of been are is transplant, had for provide drug, circumstances. that one transplant their for been been the at had with would use fairly to not sick of opportunity of not

treatments like of long we'd of for to course, durability see the periods without these responses Of time.

As XX, months six in know to XX, would it, the subjects. depending these hope of time studies. like data have And to intervals achieve month and looked at you six longer data, we XX on on people certainly, achieve

Reni Benjamin

the Got of be the And cohorts next or will we MDS any seeing or then something is at that that of ASH just year? ASH we it. could to AML clarify, expect

Scott Koenig

of expansion August. we're the so - so currently XX new those The we - started that patients several treating the in

small but And to ASH, the then once short be be would plan the next added completed at given at of in will So, provide those timeframe. the conference. part update patients significant numbers several then a of the time first year only scientific of

Reni Benjamin

from been just question is maybe perspective, you which approved anti-PD-X, And regarding for look at be will checkpoints it. not to then a for approved? Got targeting already maybe which there anti-PD-Xs push a I are indications strategic or have high-level indications a

Scott Koenig

end now you week as pursuing you that we disclosure the the fall now to is actual of as monotherapy right approval a as occur. the from know principle. of let deal make that that So, we're would till have the monotherapy, to will the wait that Incyte regard to way With strategy types a tumor decision. be as for four proof to structured, I

feedback. So, stay tuned for their

Reni Benjamin

molecules. the regarding Okay. And then, DART I guess, just one final question

equal really DARTs or profile, a similar all that with the molecule. be about side As different any region we sort and their of profiles each effect DARTs to target created a it new or have side that's DART very variable call really thinking CDX all brings the profiles think we and effect should targeting

Scott Koenig

distribution It's part but expression effect an a Obviously now tissue its will tumor of tissue, with on profile. dictate part also both the excellent question, and of antigen a side particular normal large respect in complex tumor the the one. pattern, to on

like BX-HX would effect get that in of you for if release of tissues. normal cytokine monotherapy. profile think that's We target a relegated most So, why can side tumor a to be pattern tumors and we reasons the versus its as one fact fairly on restricted

tissues, so Of instance there binding magnitude has a course, CAR certain biggest We release if level you far, which doses. therapy. the that see at the be for been can with can seen has is have to expect T well. doesn't do of that other we cytokine release, but the shown see a We toxicities, been managed issue normal approach very cytokine

of you each different those specificities Now may with induce can are which then CDX regard and degree the release. cytokine mediate obstinacies different activity. And also cytolytic components, CDX, of affinities to different of a give or there obviously and epitopes

be can difference select CDX component for And your and that so, the you particular there among bispecific some molecules molecule.

Reni Benjamin

Got for it, thanks the taking question.

Operator

Instruction]. [Operator

with Wedbush question comes David Nierengarten Securities. from next Our

begin. may You

David Nierengarten

there on just a bit you the the of Thanks cohorts have expression if enoblituzumab taking the through just some mentioned I could are details for many I effects some to gone first anything you follow-up off And on want there how CRS specially - curious was tell of up? many dosing if other a for you vasculature questions. dose bit was thanks course any how you us of side on Hey, for XX, else just that XXX? popping saw given of any and

Scott Koenig

related off question XX, your most to think XXX. starts of but question enoblituzumab both David the with I So, is and

are just basis. weekly enoblituzumab kg reiterate on the Let enoblituzumab dosing me we mg XX at a currently per

we tremendous of we the the fact, have at. of and occupancy enoblituzumab in in some have we've looked serum increasing In concentration patients

that And some may the future with dosing alternative are at so, less be enoblituzumab regimens frequent. studies of looking

several dosing didn't hold So, let stage been too is it's With the if started different which have be is has then me to that a at, of theme three, of set dose. a on dose one regards would or been leading fourth don't look a me this there a think MGDXXX variations is there regimens. a to fixed that lot but that. or for the that terms a higher I And in previous dose to dose

but mg XX were regimen. variation in once is other there general So, here. I dosing would on the regimens leave additional of clinical to particular haven't reviewed I With say pursued three is but a updates you besides information. have kg we that our anything further a to else cytokine theme not have respect of if different they group dosing I concern hit to But informed safety the release, been toxicities, recently data, the per I

David Nierengarten

Okay, thanks.

Operator

I session. to the will for now Koenig, remarks. the concludes This back question-and-answer Dr. closing turn call you. Thank

Scott Koenig

joining as on thank great know discussed rest of like just again a progress. we and to continue today, look let that you to you programs make that forward would everyone each us we day. I to the the Have update for of we

Operator

Thanks conference. a wonderful and day. gentlemen today's for and this Ladies participation your concludes have

MacroGenics (MGNX) 8 Nov 172017 Q3 Earnings call transcript