MGNX - Earnings call transcript Q4 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon.

We will begin the MacroGenics’ 2021 Fourth Quarter Corporate Progress and Financial Results 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 will turn the call over to Chris James, Vice President of Investor Relations and Corporate Communications of MacroGenics.

Christopher James

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

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

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

any Forward-Looking today should representing our be views Statements only and date. as of as our relied of upon any as represent not views subsequent addition, In

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

Scott Canning

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

James Karrels

which XXXX, the results Scott. recent XX, ended as well as position Thank our year reported December highlight MacroGenics This our financial afternoon, progress. for financial you,

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

costs for and support margetuximab year the costs XX, ended related clinical December development and year were research was The million Incyte to related ended to expenses and for as related launch, legal million Selling, MGCXXX, and by year as costs MARGENZA other compared $XX.X enoblituzumab primarily This increased increase to partially XXXX. well XX, and to expenses the offset expenses. rated XXXX, XXXX. well as primarily Our development the These and molecules he increases the increased XX, prior was clinical December the were and for decrease retifanlimab, manufacturing to and increase ended ended costs December were XXXX, BLA XXX.X year. and compared as XXX.X million million XX, labor related general year compared for decreased to development preclinical December clinical trial expenses related the administrative to to for related lorigerlimab. $XX

XX, million XXXX, ended for to December compared XXXX. net XX, for Our year December year $XXX.X net loss million the was ended $XXX.X a the loss

$XXX.X as equivalents $XXX.X balance to cash, marketable XX, and compared as of XXXX. was XX, December securities of Our XXXX, cash million December million,

to and through should anticipate cash, cash runway, our fund XXXX, enable potential payments, addition XXXX. of marketable operations in cash equivalents XX, we terms us in that as of Finally, anticipated securities and our December to collaboration

further Our stage potential development prostate or currently MGCXXX of cancer expansion late guidance the from ongoing. to related does not of reflect expenditures studies

Scott. to back call the turn will I Now

Scott Canning

Society promising I’m you, data programs progress showed presentation lead and Oncology in which in MGCXXX. for the by our during Since XXXX. in our our we molecule European September, ESMO for Thank Medical our the BX-HX-directed at fourth made development the Jim. of plans quarter or encouraged meeting

next a and the molecules. MGCXXX CDX We CDXXX taking positive to are that molecule included by tebotelimab of our development two product these these of prioritize all are or for advancement by the year. DART dosing cancer patients enoblituzumab on registration, are malignancies, of candidates, programs patient the BX-HX with the moving next hematologic prostate and LAG-X we later directed first the closer programs. advancement Outside generation MGCXXX the in operationalize to steps steps with study of targeting PD-X investigators MGDXXX This for planning with CDXXX this DART aspects additional working bispecific of towards metastatic

Beyond Starting immune that molecules. on these a investigational fuel frequent of molecules ongoing targeting in our BX investigational product updates portfolio of you involved a significant use of BX-HX, treatment programs, let cancer. clinic With backdrop, the we with activities to of molecules walk regulation. pipeline this member time candidates to through have potential a to family me

an target are advantage broad multiple solid across advanced consumers antigens of is patients out. through molecules drug investigational expression critical antibody come types. our tumors payload tumor of that study with Because mechanisms of designed BX-HX. from deliver to solid this developing BX-HX alkylating September complementary of We two ongoing has update that data presented conjugates duocarmycin encouraging MGCXXX cytotoxic our take in MGCXXX express action we that

MGCXXX plans. the our prostate data intend today, registration aiming will currently to to of interval effects. castration-resistant of with Based quarter we plan increasingly we modify of directed this study are metastatic for of help developing plans in the on therapeutic study discuss FDA analysis X/X are doses, slightly various potentially later achieve We MGCXXX operational meet parallel, cancer a effect phase aspects dose and between the and a to administration these which including In maximum believe to and side reduced potential dose the to reduce advancing program. we while

enrollment study steps for these cancer, addition phase the squamous dose castration-resistant continues In triple with and patients fully with while carcinoma for enrolled prostate and patients expansion lung in cancer, neck. metastatic cell non X/X small head to of negative next cancer, our is MGCXXX cell breast melanoma,

We the update second expect mature. year the this the the as during an of half to provide for study data from

activity our anti-PD-X may data, I’m share ongoing is weeks. monotherapy trial with exists MGCXXX as known plan lorigerlimab that coming agent suggests anti overlapping initiate with this significantly by that enhanced for study, MGCXXX toxicities. be formerly the pleased tumor to in rationale by undertaking we an combination study to the preclinical Beyond combination a and meaningful of supported The without which scientific MGDXXX

study, exciting our one from from dose some on interesting initial study. imminent seen dose on data Relevance I of six escalation study with for the support chemotherapy, combo prior including of Abiraterone, study therapy, been we will our this further lines A patients an anecdote combination cancer have the lorigerlimab. MGCXXX, share with lorigerlimab As patient and escalation had cancer Cabazitaxel. of systemic metastatic enzalutamide to prostate prostate castration-resistant

weeks in as castration-resistant for on normal has of we to the XXXX molecules. this treatment larger like and PSA. a normal as metastatic have total why with achieved with remained a for last they a checkpoint tell cancer responsive produce lorigerlimab December recent over prostate and with received his in XXXX We resolution bispecific XX treatment not elements. protocol. a with a this after profile to particularly been confirmed disease a regarding patient six We January update with from Stories thereafter, industry investigator inhibition, of of complete lorigerlimab PSA began patients developed based then While every of a within created and CR in just one the CR dose per weeks, this individual Netscape drugs. checkpoint company video year

patient including part rationale of experience, study to combination various underscores story this solid single a patient’s cancer. our lorigerlimab for prostate of tumors a only wanting and MGCXXX the Although

to castration-resistant melanoma expect in As a metastatic cell I carcinoma, cancer of tumors, the carcinoma, prostate and with ovarian combination cancer, in study MGCXXX, coming patients cancer, mentioned lorigerlimab initiate urothelial renal a earlier, including solid pancreatic weeks. we

using neck investigational Fc-engineered BX-HX platform. antibody created our initiated in frontline enoblituzumab. In enoblituzumab over patients of for of are exploiting Another negative, head And tebotelimab free regimen tumors who of molecules either chemotherapy a carcinoma and who with or in combination PD-LX positive. in retifanlimab March squamous solid we are study PD-LX in the expression a patients cell the XXXX, Fc-optimization is with

partner next options CTLA-X. pembrolizumab is to of cancers. enrollment complete base portfolio. an including provide in our will update PD-LX cancer, in Center enable dark simultaneous from and or combination in China, other submission IND its the investigational the of IMAB enable to Medical cohort of X bispecific carcinoma, during announced further half with and the patients an to with of existing solid cell initiation designed of walk a our you during Phase PD-LX enoblituzumab year. Lorigerlimab expect Blockade lung Product across designed broad non-small positive Administration half first base independent in PD-LX China National tumors, selected PD-LX the a and of and differentiation year through China’s a molecule combination urothelial December a for to bispecific for Drug molecules touch that balanced, options Greater approved of for set and I in trial Evaluation the cohort the second We patient on provide this this

Tebotelimab study this and colorectal types, expect enoblituzumab in this with year. expansion We non-small ID being studied and nick. dose checkpoint on an Phase bispecific are X/X stable currently carcinoma XX cell investigational cancer X/X a in currently cell melanoma several dose evaluating by lorigerlimab provide evaluated squamous are cancer, and is with Tebotelimab at castration-resistant patients combination in in dose Phase LAG-X a DART. tumor head the to metastatic kg cancer, per the mg and expansion PD-LX study of is study update with prostate in lung microsatellite

in to other company China’s are We and XXXX. of enrolling It of territory second for in indications. update for provide development half indications. tebotelimab development plans future Lab recently plans expect is that its the discontinue MacroGenics partner is was of informed development future in an and formulating Zai Greater tebotelimab to evaluating the decided potential in

me let advance hematologic patients up, discuss efforts positive of to treatment with Next malignancies. CDXXX our

permitting We development At MGDXXX life. meeting demonstrating MGDXXX intermittent presented by activity maintaining two a submission the Venetoclax our which CDX generation announced treat in and the cytarabine in of with of designed replace the anti-tumor minimize specific while care development cytokine-release our program. dosing with of November of half and longer molecule, incorporates cytolytic flotetuzumab activity to CDX anti-tumor data standard combination MGDXXX through AML. the next by prioritized enhancement encouraging will have escalation dose We the and for CDXXX expect X MGDXXX a December, used to by or in preclinical syndrome refractory components refractory ASH to have study DART CDX agents we a patients DART In malignancies molecule discontinue to IND infusion which evaluating therapy, relapsed first begin threshold patients application manageable clearance with may with pending in we we FDA. recently study prioritize are profile. met to the IND AML continuous to made by in single analysis patients to was flotetuzumab, decision CDXXX the believe interim we efficacy safety. the the flotetuzumab our enroll generation who hematologic superior MGDXXX Nonetheless, the phase induction with

Next, which of being we product our economic for an retain I will provide certain collaboration by update developed candidates rights. partners

same In that type the year. targets clinical the for leading investigational phase in types delay individuals. development teplizumab Provention in in indicated letter and agreement I in us solid for disclosing Under by Provention anticipate developing for update collaborations, X in our antibody this BLA XXXX. anti-CDX Least XXXX. the is is from is on solid under that with over-expressed clinical acquired announced being ImmunoGen. XX/XX tumor advanced surface that indication. teplizumab multiple Bio Provention’s with second X a FDA diabetes. of Provention BLA, July co ImmunoGen a protein have ADC the several ADAMX, an type which complete BLA types a average monoclonal teplizumab development diabetes IMGCXXXX, meeting is type data study tumor FDA week, provide an they Teplizumab they issued Earlier Our was the this cell initial X for treatment response XXXX of margetuximab. will had The followed for they resubmitted earlier B the resubmissions from

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

therapy cancer from benefit MARGENZA believe metastatic options. in may market We as patients continue another to breast

reported net our agenda were As sales $XX.X million in from XXXX.

cancer we that realities competitive MARGENZA including the the to for Given in new sales. modest breast multiple expectations place continue have have approvals, market, HERX-positive taken

terms of that to accepted us with China to A breast announced on of Greater decision informed treatment that study. study month for in Module and landscape. to review [NPA] in decided In enrollment the Lab NDA discontinue the last cancer, in changing MAHOGANY they recently of China, Recall we (Ph) they discontinue regard certain in data based with combination MAHOGANY of the enrollment in clinical for effort about have had the Zai’s With margetuximab patients chemotherapy partner margetuximab that Zai their breast cancer. announced and Module B November XXXX, the

happy you be through advancing to innovative Finally, the our XXXX. we pipeline candidates of call sharing would with questions. our for and open We momentum look build forward now progress throughout Operator. product to continuing and to

Operator

first SVB comes Instructions] Our Chang Jonathan [Operator Leerink. from question with

open. is line Your

Unidentified Analyst

[indiscernible] Hi is on guys Jonathan. for this

to you could something wanted the has regulatory are lower dosing what factor on needs Is and to follow-up doses that done being color MGCXXX this and these their be already provide the any into mentioned strategy? there like Just evaluated or also are strategy. scheduled you

Scott Canning

follow as evaluation the at we as we nature and effect Cmax that response modifications did profile we we therapeutic Thanks side mitigate do cancer, and two interested indications. in where the well the and with the curve, an associated the under further prostate From with particular, area could the derived were minimize well profiles. ESMO effect the We to as had pharmacokinetics maximize and are to one, side syndrome, that other to a foot both of to results at of effects, of are the saw in as looking both data well the discuss question. very effects patients we much side bothersome the After as both one as effect. continue valuation profile. responses, patients for rate the various side given we while of dosing hand response effect want grade most that those the In side

that incorporated forward have the in have and going plan a FDA. document a to that briefing in We included

after doses plan increasing going we we that feedback, modification at insights further be discussing be dose, dose, implemented. will and We the how And have time initial on will forward the that meeting. between might of provide both

Unidentified Analyst

with as inhibitor? in a a I the on if then And one retifanlimab squeeze or guess approach versus I can what just that checkpoint benefits approved see do strategy combo the of you combination lorigerlimab. like pursuing with an something

Scott Canning

though for refresh anti-PD-X our saw question. First of anti-PD-X of the MGCXXX additional blockade. combining ADC with this we you much alternatively cancer, of enoblituzumab, did with all, in checkpoint a two with evidence thank combination looking the with and Bristol provide very by-specific to case study benefits metastatic conducted memory prostate endpoints the or And cancer. in some combinations we blockade that while adding meet I metastatic their there molecules, objective of could analysis a of of that for Myers study, particular had and those including did of CTLA-X as should were they benefits some combination that our of that the setting your prostate at molecules Nivo patients not

is where in anecdotal, achieved as now, of we particular a with currently year follow-up that that escalation after monotherapy normal single you CR Lord recall, Given patients today more stopping the a than study, with on PSA. a in we CR our dose while doing one know you the therapy a call, still and are highlighted as we providers patient, who study, right study extensive Joe this in and men currently as patient, discussed very

may mechanistically benefits an blocks well. something So that we be as anti-PD-X blocker think axis CTLA-X to additional incorporate just beyond there that a

Unidentified Analyst

you it. Got thank so much.

Christopher James

question Operator could please. we next the have

Operator

Our with Pohlman next comes question BTIG. Kaveri from

Your line is open.

Kaveri Pohlman

maybe enoblituzumab just ILXX like any therapies? with in play CDXX loss combining cell thoughts cytokines of any expression this on or For and role efficacy, NK

Scott Canning

for much that very Kaveri. you Thank question,

clearly, characterized our finding CDXXB, So, in product. to reduced like enhance approved finding for have a CDXX was to to designed MARGENZA with we enoblituzumab

and we as incorporated cytokines, And in settings. the addition, regard NK the a in of certain are by of that of but explored. checkpoint various various in having possibility. upregulation gamma gamma And FC enoblituzumab the that use both interest We With And parties we been modification ex-vivo, have of to in regarding have other on has of there could vivo certainly associated also combining drives, in interferon, beyond consequence interferon enoblituzumab various cytokines cells with immune other be discussions addition, engaging CDXX observed genes. in over-expression cells with molecules. results various that upregulation this

thank question Kaveri. the for you much very So

Kaveri Pohlman

flotetuzumab, type, I PD-LX to just for in your DLBCL. tumor just wanted your for plans get aren’t thoughts curious of And this a inhibitors And to there of because lot know space? in role on generally, checkpoint that

Scott Canning

And that for And including early solid had possibility stage are data therapies. who patients the very this had in received quite therapy, of DLBCL, late question. developing as in encouraging of various those we tumors. well well, again with you Thanks DLBCL we as as very result a as know, exploring in of line a cell

year. provide effective indications we DLBCL updates immunologic solid today, trials able particularly noted and for the have the correct. in next half PD-LX They blockers you and have As in the - absolutely on tumor potentially With second steps the new are regard the of be this not to treatments. should to nothing

that might lymphomas. of get an beneficial various blockading additional one opportunity multiple exhaustion by on this effects a think in are is pathways cells, I involved in

tumors DLBCL, only but And looking the well combinations this why rationale such of is some of are not solid in so as at that we

Kaveri Pohlman

Appreciate it.

Operator

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

is Your open. line

Etzer Darout

with first CTLA-X on one the PD-LX study for me the and MGCXXX. On

at to you preclinically standpoint, think argument from combination if efficacy an look that is and opportunity of wondered had weak, I given sort clear. a tolerability the Just

Just to from look you. the the meaningful second at the a on that wanted if to of tolerability kind R&D flotetuzumab discontinuation had Thank question know you see And impact unrelated XXXX? but then in of chance spend standpoint. any

Scott Canning

thanks combining the Etzer of the questions. so MGCXXX. opportunities consider certainly much with And a checkpoint for as we

our the a monotherapy We was our modest lorigerlimab have clinical in experiences, potential From terms beyond additive understanding on we effects better for signal worsening both paramount that we what of very safety addition was seen profiles to-date. observing, driving for in what of the for PD-LX are One see as view based in MGCXXX. things are side opportunities side the monotherapy with or getting CTLA-X we the well as as seen of to-date. effect efficacy

appear one might note one a However, clinical predict and trial. in that

So surely into are trial once way very more get and we we trial, in started. the this get this designing will the

we hoping weeks. and now. We unexpected few we in X will study that that for mgs But, dose of reduction in at get I and MGCXXX, lorigerlimab of right drug. regard dose have With lower expect the at fixed of the the current per are can’t will next but spend. mitigate now, the started in design escalate R&D get to the we smoothly advantage side for again, some three to we three comment that profiles plus that then effect the kg, do right of think dose starting a the that goes any specifics to flotetuzumab, we terms

that giving - information to providing We just investigators. are obviously

in the near-term, on the result we will now. some discontinuing still savings some continues natural. but And right do study as are patients a expect spend of So we

Etzer Darout

Great. today. you the Thank you and updates for thank

Operator

from with question Yigal next comes Citi. Our Nochomovitz

open. is line Your

Asha Babaric

the for discontinue for contributed? just on that have to drove on something Thanks this my Asha Hi, may comment questions. you Babaric the Or Can Was for profile Yigal. interim analysis it emerging what MGDXXX? flotetuzumab? there was that in taking decision the is

Scott Canning

thank you the much question. So, very for

setting. we molecule out following MGDXXX number malignancies. patients as during go given believe, an patients treatment hospitalization as the weeks profile they outpatient regard As has the for hematological in Certain is superior required the first infusion long-term of you to before pointed know, the with one, we two flotetuzumab to us with that you the initial stated, of comments continuous can flotetuzumab of

treatments. design generation an the be drug the if molecule, are new when the we may believe molecule, CDX with we important, can treatment were that constantly given expect as risks, to since want readout a final we a investment an require of a easily, And on the but a that additional significant more a of is started intermittently cytokine couple you think arm of of result With which we with plus there single outpatient controlled on current FC in years release now study, some this landscape as out conducting here, know, given will top certainly that, European approval, more with changing. will of On ago, this AML basis reduction require incorporated next version obviously regimens in have study. this significant technically, molecules, for as a we components landscape we established this that changing study study. proper but of the But that in top be syndrome that,

So in lines potentially, we all-in-all, of I extend decision to that pointed this that announcement beyond plus plus think this AML early can described extend the some molecule shown right was of tumors, plus we combination one on at profile as based standard that asked MGDXXX have care the of the aspects we of these of in various therapy data for recent other meeting, as use the that out superior today, given the our CDXXX to given you.

Asha Babaric

is you in color could Could Okay, here If discontinue flotetuzumab share with any you details? can thank love development any to you. to sneak additional I wise, provide that I one more?

Scott Canning

emphasize. me this that but I can’t at regard, in point let

continue they temporary. current it indications on with, continue were that just Just the

additional we is current not indications of additional are it But to that such enrolling additional They patients as any indications today. future, that It they now, will studies into them. have are decide and participate advance received and as in they the in to the be considering they enrolling patients that. studies. not says up So still may in to

Asha Babaric

Thank much. you Okay. very

Operator

with Zhu question Charles next comes Our from Guggenheim.

open. is line Your

Charles Zhu

what Hi it everybody. sounds you for and the Thanks NSCLC are you this for earlier, have cohorts go one decisions? how fully data like of no for those benchmarks we go question. I that to but about evaluating also, make and mature towards CNBC able melanoma potential And some taking those MGCXXX. these are kinds may points? should which, missed decisions How would are indications on think are enrolled you timelines the be of

Scott Canning

Sure. Thanks the very for much question.

and recall, previous you patients calls. cohorts These XX beyond completely enrolled said on have And as we prostate, we the enrolled between As cohorts. I these to for XX are that continuing in much They, are have smaller. ones the patients. follow those to

pointed for of patients the for still for the will have obviously X size assessment line registrational studies. we test. both before, prioritize of expect additional, stated to plans cohorts, specific decision forward. And any with do But look cohorts, further in also too as ones directed early dose cancer, with want for is out the I the As say to what we slightly we is it modified an and have What going we want of at to these to care the additional experience standard I which make responsiveness. Phase to given late or is these the addition, come in additional patients prostate

in some want so to And of decisions on all which will little these mature then regard like then we see second this make we a cohorts the that allow the we year and to data one more provide given guidance able be to together, feedback to some we the us half that to of with FDA. the after from also will get And prioritize. this

moment. the at sort So that plan is this of

Charles Zhu

one If DSMXXX sense in and positioning? it squeeze gauge Thanks. it on in your weighs how reactions or I comes to that want out it, ASCO all is MGCXXX. kind when perhaps Got to for more to on GU I to and especially MGCXXX, at makes color. data thanks coming for of thinking of need also your that diabetes

Scott Canning

cancer. know, are a clear in ADC right see that move to this and again. Daiichi with indication. stage we organization is like interested feel to expertise Charles also and forward there Again, you in we you thank is the that nice prostate Well MGCXXX have as late that pursuing with profile It

in As our data the well the incorporated following I’m very you toxins say DNA XXXX sense have is we I in in working target would are molecule the that different as encouraged mechanisms. by their by with were quite ASCO reductions the that know, data that meeting. recent reported as by that PSA reported The the have reported what XX seem ESMO, of criteria as to-date. data than to terms be this what comparable the GU they reported, that they better to at we

checkpoint I And validation provides the so that plan overall, type start this are are prostate of a encouraging are study in say of place. we we is knowledge our cancer, I data Daiichi going in similar with now very also BX-HX would for this our treatment with in combination a molecules position say we that with seeing company’s both potentially better mechanism. which target to has further would

as we all-in-all, to will think, think I it I So patients. the of benefit quickly advance try as possible to

Charles Zhu

the Sounds great. questions. Thanks for taking

Operator

Miller Jon Evercore. with question next from comes Our

is line Your open.

Jonathan Miller

guys, sort year types, you to that level data other expect internal maybe question. to is the to thing, Asian know stage my your candidates? release maybe in would conviction like relative program numbers, in and tumor for color ADAMX from of that terms led of early just being I of of by your the taking this give we But ImmunoGenis. start with on ought thanks I what Hey us maybe which could some

Scott Canning

to for tumor continues and trials. not types in they still as finding, are good that of regard They With from Jon, other to Thanks into have dose doing are expansion you correct some hear ADAMX, those additional clinical you. that running yet. ImmunoGenis selected expansion adults

We should expect the near-term. occur in that

dose with that be they provided this have year they the into detailed do publicly. consistent expansion guidance for have later the plans have announce to not So tumor specific expect and that to types us, types, been able specific

will then. to So them and wait it till leave I

data preclinical in portfolio, this overall. fits are to into It we very the expansion. just comment further regard the early with by selected to specific until on is dose that our So of is that too prospects we again, where see the and encouraged terms

on we for our our As at time. the know, lot portfolio forward data except this more and have of have you other many about more a for MGDXXX obviously encouraged things going other much programs prospects

Jonathan Miller

maybe guess when is we X on that to cohort to the kg. should that BX-HX the have does that folks going then to come And down that out? just data some questions dose I expansion Already come know per of asked, the from how mg we follow-up interpret given expect

Scott Canning

So right as I is and emphasize of profile. reductions dose will But regard of now from patients, in I in slight to dose occurred to these taking evaluated regard, a way or responsiveness tweaking interval. this the actually time real dose remember, that with understanding that planned achieve we as the a patients the modifications what effect was side said, the data more

dose in prospect these this in So, have patients do the of But want received we overall is now, of that total this do think study. confidence fact, use as right make can this we this But the obviously as would forward to we move additional drug. to surely, I decision. by good

Jonathan Miller

very Got much guys. it. Thanks

Scott Canning

Thanks Jon.

Operator

Stephen from Our with next comes question Willey Stifel.

open. is line Your

Stephen Willey

questions. taking Thanks the for

patients still less just this just frequent maybe at clarify you treatment? dosing you into MGCXXX of guess, existing that, or patients prospectively So lower on that remain regimen revised, later this treating are have to dose I

Scott Canning

Thanks Steve.

dosing would his then modified proposed coming will in incorporate FDA to is And quarter. started what part incorporate dose, design cancer. if from be discussions then as prostate additional plan any said pursue all indications regimen FDA of this with the cohorts, want of expansions I that in follows the We And we everything additional up earlier, to this the expansion have that through beyond that registration our be with operation our discussion. for study, directed also, else not our

Stephen Willey

into I So absence don’t any going at you do any, work, experience need right be guess dose? clinical of feel registrational and you to the a bridging in the design this comfortable would

Scott Canning

for the rather various as other what on to then the Well, indications. do feedback. of will will And let’s FDA in as well regards back to and that, have comments aspects next prostate we wait the the we we until you guidance come than

before the study. So like of definitive prostate regulatory that have to insight we would we design about specific more that

Stephen Willey

for excluded stage uncertainty I that XXX Okay. they trial question, study. And runway with I but little function or a types that respect and/or of kind of be a of still prostate going a clarity to Is pursuit in that guidance. not just from later and some Jim, the the refer is tumor guess that, terms a then whether is that will how you can just maybe needing the or on regulatory of cash know I bit? to put there just

Scott Canning

want you take to did that? Jim,

Jim Karrels

to No, mean, I the for quarter. FDA to question. plan do with the Obviously, Thanks your dialogue intention waiting is. we have are ahead. move We this

We We might that what trial nut the a we have is to this look have what out not we of like. to would that before define completely priced need to like sense better happen. the know make

we to want a We study. launch do be where just study. we entire we can have fund adequate cash fully the However, a in position to

So, the at, that we today, And one $XXX is where trading advance north BD whole parties we dialogue million our we stock option market have we of continue very if to a don’t XXXX. in IPO various at obviously, would company, active the off, as history like to an in with bringing had to BD We to. since had various BD obviously, it but is forward. look intend that

Stephen Willey

very is questions. Understood, helpful. for taking it the Thanks

Jim Karrels

Sure.

Operator

Securities. comes Our from Tuerkcan JMP Silvan next question with

open. is Your line

Silvan Tuerkcan

of congrats my might thanks regimen is, MGCXXX this and missed question the is you progress. of And the for or to have all and are is dosing that Thank patient it the goal questions afternoon. side good I dose on modification reduce to as to ones ameliorate the the over possible? Hello specifically keep which My the in trying taking effects? so, of course treatment you. if highest

Scott Canning

would Silvan, both effects. for to that question. the side are thanks we mitigate I some think that I trying say probably and accomplish And will

decrease were result. pointed were interval dosing that neutropenia, is hopefully time feel was effects, second side by value GCSF. treat problematic patients that again, and the greater in those And offer some period that of that. that supplementary feedback between can you We easily a the from the a reduction As we was that by obviously should on hand switch increasing growth provide you hemologic pointed benefit comment, factors like incidence also like we out Ultimately, the to as the and severity to also longer the I observing based side there. the reducing think patients for as handled times today, like most of holding as the and such the patients effects we dose syndrome. And out feel things one

So the forward. that going is objective

Silvan Tuerkcan

Okay, thank you.

update, what the are upcoming an the administering? per was at than I dose rather guess, get patient the average that label we you so dose the, idea And of

Scott Canning

to be discussion in the at future wait for after will think, a administered fully the best we guidance able dose would the the but which most we patients be we have to getting we discussion effects, will of some regulators. with till again, think terms provide I valuable

Silvan Tuerkcan

so for you much thank Great. taking questions. my

Operator

comes Barclays. Lawson Our Peter next with question from

Your line is open.

Peter Lawson

for taking the questions. thanks Scott, Hey,

meeting the in on DSP QX. Just

Just that dosing CTLA-X, help the and just start will you on the will PDL-X the basis will us start timing combination then the FDA in communicate that sooner with kind outcome discussion would that of around us to your of and through that with XQ? communication or the the

Scott Canning

Yes.

as March. with regard quarter So our in at of ends the approaching March, meeting, the the end to

combination that the communication has come right in next so that what we outcome of have sometime that regard are of So even start to is the study, and will likely meeting, before weeks. actually that the patient four will meeting FDA start. have meeting will The obviously, we to that dose screening comments With and have effect patients the the will no on now that written it back. see will about potentially first we within

So likelihood communicate second in is I this able quarter. to think, less, more sometime will or be the the we

Peter Lawson

Great, data thank dissemination. And then set you.

idea the is patients? going with is The the existing That versus second to half new be dosing.

Scott Canning

the the regimen. Peter, think, QX are that wanted with kg was, I on to to continue And we data point the X No, obviously mature occurred. that mg on modifications per the patients this

plan we then can the that year to would for them, wouldn’t new continue. whatever of start a until second so. apply we and update, We of irrespective particular indications the half So that, dosing, provide

Peter Lawson

Thank you. thank Great. so you much.

Operator

from comes [Operator Instructions] David Our question with SMBC. Dai next

Your line is open.

David Dai

my taking question. for Thanks

of couple So on questions just MGCXXX.

some regarding clinical could and So identify on you and half biomarker data also on your the and in set second expansion cancer And we prostate data the be also expectation MGCXXX benchmark share would this prostate then in dose thoughts expecting. should what year. prostate strategies further just Could responders cancer the of with you be cancer? to

Scott Canning

David. Thanks

line therapy. regard to patients. castration-resistant know line, prostate third expansion, and the these for were cohorts, expansion you late with dose line The So of as a patient therapy are very fourth

had As these had historically, I lay at. months usually on patients several you to progression, which they study has know previously been on depending progress, mean, based looked obviously

looking provide with a could XX clearly are what patients with we going advancing the for we feel data to significant a our So field of has, patients the experts have limited have that reviewed and forward. those that these historical markers we beyond at even and data benefits profile in

here the out earlier, Of enhance dosing effect modifications. to looking we course, are as even I further by pointed and

that the of to one different we that various have will continue per gene be will bone organs, of diseases, at and Today And to visceral versus eliminated disease. we who have a nodes that patients those predict favorable versus at se, more not to will at on another continue patients. while any certainly So but of MGCXXX, look analysis. analysis. look most patient And would that markers, populations various we disease specifically those based have clearly also continue types look identified part of outcome with

is dose this of we number treated limited approximately at while So this patients. point still again, XX patients it with

And eye keeping by see is those to levels general score we very activity. will we thing on predictions had other occasional did evidence scores of patients patients doesn’t expression. seem to-date, But H respond we low saw not, of BX-HX or had portend The an also H the BX-HX. for that that are in high patients with

does to at going not this marker the point, forward. be cancer least So seem at prostate for that predictable

David Dai

Got helpful. Thank very it. you.

Operator

There are questions. no further

Canning, for over call Dr. Scott Let back to clinical remarks. the me turn

Scott Canning

thank lot of to in want sharing future call exciting today. everybody I Thank coming you of at we you. data be during for have course and the year up participating with a conference. forward look the a will to the that Obviously

Operator

concludes program, This the disconnect. you may now

MacroGenics (MGNX) 25 Feb 222021 Q4 Earnings call transcript