Inovio Pharmaceuticals (INO) 8 Nov 182018 Q3 Earnings call transcript

Thank you. Greetings, and welcome to Inovio Third Quarter 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. pleasure Relations. your my Director Ben now Investor of is to host introduce Matone, It Mr. you, Thank Matone, you may begin.

corporate This and press thank live will the quarter be you you on for conference Thank good and indicated joining Inovio afternoon, our website, available Pharmaceuticals a being as is release. also call everyone, ir.inovio.com, and earnings webcast call. replay third our in

in uncertainties relate these would this certain statements are devices, platform, I proprietary begin, which our like our and that call and forward-looking of will we could and everyone all based develop on on to cause statements. These the delivery include to Before capital of today. to that from in which making of we be addition beliefs statements management actual as to our our to business, remind resources, combination plans with materially risks involve certain expectations immunotherapy assumptions, results our differ DNA

differ post expectations. information, future in Our forward-looking should the a as our release described new of results in revise and We result included risks as statements, or factors website is whether today's from otherwise. update risk the to obligation may which read events, Investors or actual on uncertainties no our as SEC. assume materially carefully well press our the with filings

J. President to that, CEO; CEO, and over Dr. Kim, Kim. and and Chief Joseph the Inovio now would I With Dr. are like Financial President Kies, Joining Officer. us to from Inovio's call Peter turn

afternoon, everyone. Thank you, good Ben, and

attracting progress publishing to with grants multiple we that and from efforts to pleased on advancements, build been Fueled to well-positioned to particularly our R&D from date, partnerships immune-oncology new efficacy results quarter Inovio and previous on by our the and executed. past clinical data For programs. I've clinical our extremely delivering and year, team remain successes has the

over creating provides coming with the multiple months. which Inovio value of catalyst All

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Moving Enrollment year. bladder Phase cancer both next going INO-XXXX. planned target data for glioblastoma II report studies onto as and to interim and on is

use cancer remains checkpoint options room and more given patients While of recent therapeutic still bladder inhibitors novel immune for with GBM limited certainly hope. have and The more improvement. has

really Regeneron combined are inhibitors of checkpoint three SynCon PD-X is PD-LX of active composed We cell to INO-XXXX in single product. excited from INO-XXXX into most effects T a cancer antigens the Genentech. generating our or test and of separately with combination

remain The two ESMO our specific the Our antigen Clinical INO-XXXX, in data observed goal is Phase data Phase II can prostate cell these that men the of at with International to of last the percent progression presented a we paper. studies, patients prostate free lastly, time responses INO-XXXX in the doubling We XXXX for week responses study level XX And Medical see T of in from cancer cancer. responder replicate prostate slowing INO-XXXX as II if from Cancer Research anti-tumor Conference, demonstrating showed we and XX. one presented, data month. data complete

repeat checkpoint INO us Let partnering to in coming of and results on weeks, from makes this track. me the Expect After a obvious XXXX, trial our more immunotherapies that. treatment tumors. showed a see but for XX plan their phase increase cancer in two attractive discussions. prostate license no data inhibitors half almost and combination and in treatment. patients nine DNA year with This after in out with as on a and progress we partner out continue remains to development more

program through run events. of our updates, financial platform I’d our a Before notable development to couple like

combination First, our remission in patient in HIV obvious anticipate Enrollment randomized trials from grant ability of interim or the million We $X.XX XXXX. first dosed trial infection. HIV and track NIH attaining a that PENNVAX-GP’s multiyear reported to of of the clinical a we using, to results PENNVAX-GP, evaluate PENNVAX-GP drive on the therapy remission. in will single develop August previously in with the part remains long-term goal

Seconds, INO-X,XXX and respiratory Phase Vaccine virus the ongoing our sponsored GeneOne from Korean I/IIa partner deadly or is MERS GLS-X,XXX first in Life development from The with South subject a infection our to syndrome prevent by International Institute. a Middle the we trial Korea, full Science, funding with a or study. built East

move the infectious first vaccine targets supportive and next and regarding CEPI, will human collaborations disease our our with Lassa year. Lastly, early trial other we into

to clinical who third publications additional the expect from will MERS trial discuss Kies, Peter. the also vaccine Peter our call Ebola trial that, in are our CFO, our financial. vaccine and With turn quarter I'll over We U.S.

Joseph. Thanks,

$X of for ended million XXXX. $XX.X million revenue same reported year million, expenses for were to quarter XX, same period which Inovio third the in the For total period the $X.X operating million ago. compared Total the a compares XXXX, $XX.X September

consolidated the While and to some our XXXX outlined would to it the all in and provide press a XXXX, on surrounding I details contra-expense agreements are received from statements standard from the recorded third opposed update adoption of operations. been quarter January revenue additional XX-Q current of our as pertains contributions like contracts financials customers. grant X, accounting to as with Beginning have release, as color revenue within

ended grant For the This was XX, this grant contra in – funding comparable as million three variances. and not respectively. million decrease for for been as our primarily to months were change been $XX.X $X.X our $XX.X compared have third expenses increase been period due revenue year. the months $X.X operating DARPA research in occurred? $X.X as amount The million compared for would by a recognized million MedImmune to recorded three these million expense. Total Ebola XXXX, period to among grant offset classified ended increase in XXXX. XXXX September million other applies Had XXXX. presentation our the revenue in our in increase CEPI have XX, grant in from $X.X September XXXX have MedImmune was prior total an of to revenue in the compared recognition of increases $X.X and of same development would and agreement for the and a grant the collaboration to same quarter XXXX These of of $X.X million would The million our same

same $XX $X.XX to period quarter net a or per $X.XX basic compares XXXX basic year-ago. September for or $XX.X dilutive Our dilutive, million for per share loss share the $X.XX XX, and which ended the and million share was per

XX, September $XX.X investments as equivalents were cash As compared June XX, to million short-term million XXXX, of XXXX. and of and cash $XX.X

Thanks. on found As website Form over reports. in reminder, be third With as well release can as XXXX press Joseph. balance that, investors the our quarter sheet I'll the financial or turn in SEC, the statement and a and filed call today's with XX-Q our under to back of operations

Monoclonal kinds back is Thanks our this Peter. included If I get I your for sales the this to our emerging in can than could to products XX consider want using potential. That year see part DNA What of billion questions, mind of I account program. a monoclonal may future pharmaceutical entry. provide dMAb antibody in offers your even remarkable and with Antibody better Inovio or Well, exciting upside a disruptive our that upside more program? inpatient of dMAb keep class. by and dMAb’s each new and significantly We upon antibodies synthetic production. please design traditional improve monoclonal do build

into deliver plasmids the me to patient's Let explain products. by coded antibody provides protecting difficult and manufacturer publishing potential issues infections of mean inpatient that this platform drugs. deadly costly the the which If cancer. of I of directly DNA preclinical or genetic the the factory, successful, this We've by become against Monoclonal removed demonstrated eliminating during were manufacturers the production. to and results what several dMab enable cells own When body instructions therapeutic Antibody the

checkpoint also the patents human to We first U.S. technology to a office just study effects. clinical platform dMAb we anti-cancer and with dMAb The This initiate our in in inhibitors dMAb product covering published future. the two first last more is a plan XXXX. clip as with demonstrated come own granted in recently at our rapid patent advancing quarter our on

in of wind the the through and combination be positive you combination our collaborative Inovio finalizing a From see with generated by XXXX pivotal for cancer as guided trial in will trials, will XXXX one we XXXX you novel inhibitors health report you steps. More continued giant including discussing progress shareholders. will Institute global Regeneron checkpoint together XXXX year. Parker in our and our I of Inovio, molecules, backs vaccines, at with Speaking partnerships, the additional and next beginning our the data, a to partners, combination of on cancer advancement MedImmune, most of III the infectious other of you portfolio studies, Phase with look our forward disease to Genentech efficacy our with REVEAL and especially trials. Inovio’s important

open line the for Now analysts. the your questions. please Operator,

conducting Our go be a Please Raymond will comes We question [Operator Chris from now first Jaffray. Instructions] question-and-answer with Piper session. ahead.

questions. Hey, the taking thanks for

VGX-XXXX, the think interesting are attaining sites XX data, give for think the sort we to any June, think frame and look these these goal. as And that end to sort I had updates. Thanks. checkpoint by of quarter coming expect? going you Or the number I XXXX heard site I year. so then any you readouts with as the where gave you've of the rate end last you wonder on on sort inhibitor got XXXX, great? I you’re Just of of updates of looking like last specific think Can you we you to XXX really sort be guys color if readouts. I combo data, PFS in just And at towards of of could to data, response what for what are would are – us targeting

sites gave X several to patients. more trial. all It's sites weeks so fail several months, globally have Yes, dynamic keep don't XX open. closed than We for absolutely. them Yes, down, all XXXX altogether we so they chances the for these process. the thoughtful Thanks a we enroll over productively Chris. them questions. Thanks we the indefinitely If opened or REVEAL

onto more your So then the patients Yes, almost XXXX opened excited of XX-plus be our the across sites inhibitor world. meeting targets. productively I we've moving combination But PD-LX total we enrolling couldn't very sites, actively And certainly have question. study. checkpoint any XX-plus about

atezo Genentech, for with both And ORR-based in a to non-PD-LX CR the immune for would are cancer in from cancer patients. bladder combination will trial. These it remind overall So and with bladder checkpoint-refractory metastatic/recurrent PR cancer and the we study, be experience response so dosing rates – you, just safety a INO-XXXX along responses bladder patients. look muscle-invasive bladder and in

in look these It's at Secondly, progression-free from a the as as efficacy in survival. also XX besides six this and GBM overall is study months PFS, XXXX, is months having designed. and responses But tolerability survival safety slightly we'll the differently at to readout well immune forward primary study patients.

PFS give our survival a into we will overall the endpoint, effects although good of the us So anti-tumor efficacy response think INO-XXXX. numbers primary is window

excited about and studies. have head here, then MedImmune a the lastly, both we're of in neck study to the dissemination So reiterate those and metastatic of And I cancer setting. data very is and And MEDIXXXX controls so on. the

saw sequentially So we're on conjectures just we of received inhibitor, Research where based the complete a Phase published some providing one here, patients we checkpoint but who Clinical responder. expect I Cancer data the the

We expect plus be cancer who response they're CR, various as has the in where to of of really XX% and overall and this neck Phase across CR study, setting. from trials X% run durva rate some additional as that head metastatic achieved target and with well combining II data XXX MedImmune Keytruda, study PR

beat MedImmune So that's that. in, we the think and a bar hopefully to can demonstrate

you. thank Okay,

Thank you, Chris.

Our ahead. next go question Please Citi. comes from Sean Egan with

for Good calling evening. Egan Thanks question. Beatty. This taking for is my Sean Joel in

Hey Sean.

are How you?

Good. you. Thank

across generated today kind of the Board. So lot immune a really of strong you've responses

Looking have identified respond any you at factor your products will help a predict, from immune could it to tumors clinically which high you level, responses? that

INO-XXXX. Well, well strong second programs. so which We've overall, is hTERT PSA responses I also our to antigen, think we've a the responses cell seen our PSMA. PSMA anchors Coincidentally INO-XXXX INO-XXXX to cell T antigen strong as as in T our demonstrated

T every So antigens. of obviously but year, can begun cancer we bullish And cell National particularly responses list by antigen study terms in these immune we're cell, spectrum, think pretty much antigen produced tested T XXXX positive XXX generate on, has Cancer we've pretty we top across antigen the this just earlier Institute. CDX the the

number perennially by been antigen has Institute. one INO-XXXX and component third a National Cancer is a the which WTX, rated fact cancer In

we're our see through those vetting we clinical the systematic a yes, studies. beginning now translating models. across And extremely to antigens into So preclinical selected have INO-XXXX

mean of more I matters PD-LX have terms the give In the what expression is, data, don't responsiveness, it I think but you these tell my what is really I to tumors. of can we feeling levels

our delivery muscle antigens of the their the CDA properly cells. cells SynCon especially think these antigens MHC T where and of the through I T patient, the their and muscle become the class factory of to cells, the into I presented to process

I responses action cell the mechanism right T of the immune think to in patients. these maximize it's

in excited well lastly, II a isn't study as And So checkpoints. the head at as we're about our MD Anderson. MEDIXXXX GBM neck the may combination at see very say, to mentioned, studies collaborators had bladder their with and what needless and I in in we Phase just stopping as neck through MedImmune

We expect plus the to cancers caused with obviously II that and HPV study. II major XXX start current a study other head in is durva other second already than Phase Phase with covered all neck, basis

next clinical see data months, expect Medimmune, from lot and studies So from a we our collaborators our of several with with Regeneron Genentech. to

couldn't any about I more excited study. tuned, So stay be these

Great. then HPV advancement confidence with advancement studies. I provide or the look as Joseph. And well as indication from other through of a AIN to indications? indication just much VIN well one success to and How the brief would forward of one studies follow-up as MedImmune him read how as the your in with and another for

but expect feelings that because feeling a �� why. my way we Well, the our here's reason is could through, good

area cells, normal eventually in caused in virus. the precancerous normal and those or area, HPV cells, one. infects cells from So to HPV that the cervical area the EX diseases. or whether turns and it's the the the In anal oncogenes vulvar particularly cancers It's especially one a same once EX

the dysplasia high does efficacy double-blind very these exactly strategy against with VGX-XXXX and the cervical meeting EX EX immunotherapy great with of VGX-XXXX Phase And developing all So study. p-value, a against oncogenes randomized II is cancers. endpoints control attack for against what as and demonstrated

action, be mechanism to same the own other should clear lesions is T-cell – be immunity, and to the in think we the which the the body. virus So patient's of organs able and

that's have will help months. and VIN, studies what these AIN in Of the Phase three course, ones II for for next that us we prove and AIN still separate two determine to few

I could just Great. real more gears ask shifting question. then quick one And

How look? have long the HIV point? be Regarding and will look that assessed been and include endpoints what study, many remission patients your interim patients dysplasia will will how that

that going looking cells well of total Yes. XX patients at infected we've the lot CDX a be T HIV It's patients. responses is HIV as responses immune it to reservoirs already in as of seen the

HIV expect we HVTN saw vaccine. we in similar where of saw HIV T the unprecedented that be We XXX patients CDX to naive cells to in level vaccine, already study a

So combination clear not used really, does benefit because study pharma we're a That know drugs we amount very in it's humans. and has that HIV of together not seen about big Gilead so been clear risk, HIV high saw of this did where and excited no when in can infection this using it's combination infection high drugs. all just companies other

drugs the KOLs viruses is combination that demonstrate could can with combination away checkpoint And we're that a hiding inhibitor out of these as immunotherapy study overall monotherapy or part flush thinking hoping in like So what later a in drugs a maybe study. vaccine with that this a are we a reservoirs. this come with and maybe very could these ambitious in

good for Thank a all Have color you day. the Joseph.

Great. Thank Sean. you,

Thank you.

question. proceed from Our Please Capital Renza RBC next question with is with Gregory Markets. your

for my guys, taking Hey question. thanks

Greg. Hey,

on there, you data generally, generally to just the valuations. views in evolved broadly just interpreting have just trenches of to Joseph, partnership just XX/XX. and certainly confidence given that's how in Any to views the I around in you? how and to and combo oncology are wanted assets the just in you're the to certainly on views your it be general environment I'm more willingness partner context start get that curious great? stage regards Hey, your in certainly would Thanks. the just assigning early

that question. have has inhibitor, is really previous PD-X, landscape that, area. an of going that's PD-LX – because description inhibitors CTLA-X there a think well. be answer is exciting really I a been but plateauing. to very certainly been that's immuno-oncology some evolving And Checkpoint Yes, to doing a been good growth phenomenally

of lower basic believe of effect level to and and I cancer a patients PD-LX expect much around in the true GBM XX% perhaps PD-X, efficacy minus melanoma perhaps all going that to are board across and is pancreas ovarian. ORR be the going – So

the has there the how inhibitor PD-LX improve about will five been PD-X, those the be effects that because products XX landscape next XX hit upon just market, in So could PD-X, in China. PD-LX we years do different

So how are improve took upon that the we step think Nektar big for overall program, partnering a goal Myers upon Bristol their of broadly going responses. I to in with with for improving ceiling? XX%

I think that was immunotherapies an ambitious deal. And other then there are inhibitors. or vaccines other checkpoint combination approaches other that with

X% I PD-X, on is I mechanism and to don't jury and every still think what company for only where our is thinks I That's status high X% out the lies, looks all PD-LX of you're or use. I agents or of sure for low is, regardless But value of what regardless the where that see considered and care going that immunotherapy high. sure, is at. One know the Merck time what is high Inovio’s thing or more other proposition PD-LX action these. PD-LX. of

whereas way considered positive kill kill high tumors. a B, need T-cell to activated T-cell. or every is so perforin killer you are most you other these. high, different expressing but – thing I The positive has on CDX for group need XX% There CDX tumor efficient CDX granzyme perspective cells, XX% is So MedImmune to know sure ways one

XXXX demonstrated. by response PD-X. two, – that what the own CDX the excites our have of that that we case, was think on one we all not positive this patient investigators at the the one specifically really follow-on Cancer fourth I Clinical of INO-XXXX, is Opdivo the Publication can demonstrated the professional T-cell in MEDIXXXX the system, that porosity immune So backing In we're dissolve fact month dose dose the and of are of we complete the complete and complete read patient, tumors. saw by power end our and but these yourself, excitingly but in day, And the in killer a other patients at fast that programs of it could was velocity how responder response Research fourth the you

of never is fast. our at inhibitor of type that seen has the for Nivo biweekly PIs this So that anticancer checkpoint Medical and twice Center doses alone UPenn response demonstrating

we'll partial and think excited both responses this. we database and partners in out that gets and and of licenses we as to products I and build approved will patients years, us and partnerships turn MedImmune are and And several partners, this complete next others thesis number excited able So our able on. really really be demonstrate about and months very be and into our with the so to those

answer question, So you that's to really a long your winded thank that but for thoughtful question.

a that that helpful. arranged MedImmune do in those where of or XXX, partnerships, see very characterize Is to would with you that benchmark perhaps some Thank the how quick structurally? you. directions? way perhaps And respect future just follow-up, that with as you other a Absolutely, for your collaboration on something a deviating model you view

think be the payments of well. $XX.X And is this I and as in million out XXX liked pipeline. speaking the competing share value license where royalties could it's the to is there market. and received here, will a we in continue line I – think I relationship standard [TAVO] very will time. Keytruda we the of for It's is against upsides close up stronger and Well, because MedImmune And life but and We Opdivo receive as milestone this first a front, our every agreement spectacular with all, and of advances relationship. gets knit progresses I future when MedImmune sold his XXX in it

there's like like years. Regeneron in $XX and more, I PD-X, said, next the semi several potential So new and newcomers there's like entrance

world. dog-eat-dog a is this So

durva can it double cancer in neck and answer from market to neck you head how So XX% share think be cancer? I out? is XX%. Merck does Keytruda you let's with setting, MedImmune stand significantly. my say Keytruda be can head the mean, if that taken does and compete in We Well, How true that's ORR metastatic opinion

to model And, Durva, strategic MedImmune enhances that very or that Opdivo. of Keytruda see work compared So to and positioning well. we

If chose Now, describe, bladder we're these product colorectal cancer. let we not back license standard cancer is to do INO-XXXX, with treat treat that and can this cancer, cancer we in we treat these almost universal multiple was brain the me types like step can successful cancer, efficacy three MedImmune just I in lung a XXXX cancer, and because agreement demonstrating It's can that. is WTX two, XXXX just PSMA. antigens, or did against breast not mean priceless pancreas. hTERT, we

do not later to we not still say or Pfizer we a or will potentially these don't of from we That's efficacy like And But another then because see our after such a too out did valuable or I to pump get to Merck our INO-XXXX. potential want short the a an a from wants deals I with will our So in that we products bring we let also bigger can Regeneron. open far us But strategically not are GSK thereby No, INO-XXXX platform first, ahead. almost trials. license XXXX. Genentech deal partnership or do think time. anti-tumor a And similar of do in even is the to be demonstrate for deal with matter that whoever activity. platform efficacy value

building think know, from been Greg, we we've like – as I So I foundationally. you

So our platform. we built

have We the technology.

have trials, now we from and to demonstrate agents. against partnerships efficacy different to and or so going of to from We tip cancer expect the Then we or our cancer a settings setting. more we different Then continue and targets, build-out see established cancer events And platform products. to the both as of months a you're lot anti coming capabilities now seeing our responses immune infectious beginning these patterns. clinical technology you're iceberg efficacy aid next the in measurable more data disease have pre-cancer we're about the to our XX will

So we're we're very from to about going now are very, where months and excited we be XX now. where

the appreciate I Joseph. Thanks all color.

Thank Yes. you.

comes with Stephen question Please go Our next ahead. Willey Stifel. from

questions. taking Thanks the afternoon. good Yes, for

Steve. Hey,

Hey, Joseph.

a know expect the to you're of of dictated be on with for prescreening or that's date to for post the a by think just as could Is disclosure to conference Just number patient may look really kind - little calendar. threshold follow-up data treatment XXXX, wondering can the samples that you at respect think data? the response the about initial maybe about, with biopsy that just XXXX that is just something talk presentations? that and there respect aiming that an a you with if medical and if specifically, calls protocol bladder I we trial And is I both bit

year. in Thank around IO our like predicate are you. the conferences, Those right? seasons Great ESMO in Yes. we ASCO, lives AACR, four a feel a those question. a

conferences publish the minor be where going I'm of and other quality size as of data. and really and where weightiness well. to can we we present sample about and, well the as dictated the So the as

give are quality be to So I really just answer, evolved of that's can cruel you data going to around simple and a we're going the but the get.

for data, actual as for PFS in conference well competing each size of objective and terms yes, we're So of depends to and we'll projecting titrate a bladder sample response to that against I the able the think as the And the indications. as GBM, XXXX, obviously as that of it in responses the quality data those well specific come as the level immune of that. not I'm better we rates safety, on competition close really but

data decisions smallish, just based within of development fact data? kicking Just principle? of then lot Got is the establish proof open IO kind there's companies kind the of making that important space on out are just trials a of about Phase II it. future to on And obviously response somewhat really given mechanism, how been that label, the biopsy that debate

made couple a of Yes, on beginning. field the in it's whole handful the PD-X I we inhibitor memory, investment have huge data based a such patients Carpi on. decisions all so mean short and

So in I a larger think there the are scale small failures inability or data setting. to some replicate

questions being that very is responses alive also seeing that and still are are but in fields we making important, no also I science scans know on create of because certainly I is think biopsies endpoint – also – versus important those now. there so Perhaps exciting. durable on great seeing a think it's And And to. one think tumors is is important shrink immunotherapies a Obviously survival not. important, just the the that's overall but there's players, most some measurement. those medical survival patient in immunotherapy out right visually, PFS but

mechanism this. at per biomarker periphery, scans single I that's T-cell the CDX action I come generate our you tumors, relevant, the that take in to said on back infiltration the which antitumor biomarker we're I’ll antigen at look look activity. obviously to T-cell at these come radio think a systematic tumor is after a fundamental at of shot earlier. the I studies. and activated against fundamental the But in to we're I rely going we that's part great all the approach scientific We different cancer. in the what of don't of we going We basis responses can to showing responses in se, biopsies, especially a look And thesis, have T-cell if at think back we

we're and going hTERT for XXX WTX VGX-XXXX, on. PSMA so now XXXX on So and and going after and and we're and HPV antigens so after

far been against forward decide generate upon able all payout responses setting several look dollar to And, us not. so science, will build multibillion and whether we'll point. antigens or time T-cell a these help next that And and months really thesis to important this patients in that to and we for aim is of to we've

that's now Phase still I or and open XX enrolling guess just about so, trials And the VIN been about XX months actively I II then sites it. the for trial, Got guess patients, accruing. think I respect there's to maybe

I a or the screen could bit indicative these guess of commentary that is triggering around curious provide to that's there if of enrollment you of kind a is that Just harder find, failures? lot wondering something patients, just trial some into trial. specific if being to So protocol piece of the

Yes.

speak enrolling. than about indication detail, is XX have in in trial enrolled. we population X,XXX that are about open VIN a we yes, for small months that We're more Just half about still to and to the U.S.

patients So the a our expect that we those disease morbidity is job and similarly horrible But the think more patients. it's the in results AIN And pudding, speaks have anal an occurring proof to their VIN team than sometimes to those much quicker in orphan a was I on the indication. are dysplasia so illness. than standpoint. And is, is It that day disfigurement I great be daily, in is will where almost XXXX. several recruiting doing reminded from horrible diseases and still times a think

a and surgeries there given a through so So status. is go these patients motivation high accrual demand for year, reflecting there's multiple I think certainly is in and higher that our that

they'll So dysplasia certainly indication yes, and attractive commercial all present as well. attractive indication very these think we we translate of medical think into as a

we responses interpatient would I the humand to that have component antibody here then to titers. imagine And basis patient patient or should both, influences it. or And you disease? an preclinical just on that systemic perhaps expect guess far transduction dMAb right, to efficiency, there's some lastly differs product, interpatient infectious Got that be guess, as I of then, first that somehow variability. injection data injection the compares on I what's that

heterogeneity target that you just Thank you. would disease see the transduction? of kind wondering then post to of could around color give just and setting titers expect the So kind of you some if

question of Thanks, science. steepness and Yes, various delving awesome a really into

ml in that small it able been have the animals. translate per platform. where targets, different out the We're generate published of so XX taking results, because us to against with able and XXX this order range we that's infectious in the money over the gave systemically first funders, from to So in disease we've these delivery build expression monkeys micrograms per extensively ml some targets to micrograms

dMAb, as CTLA-X as version and we anti-tumor on treme just own on. and well then And strong a So of anti pseudomonas showed anti-cancer our where we've published we flu, YERVOY, so very HIV PSMA published responses. some

our We and of inhibitor version so and version own PD-X Keytruda Opdivo on. have

and person-to-person X.X to years first ago. through of may are, control variation can't and was subject still just have really you to we as but it's But as We terms subject to do I not them. so the a And In that that over might on. see. variability imagine. things can speak pipedream any optimize we there trials a little variable the a this those

we've it pushed our first to So product. patient the Gates really Bill we [indiscernible] could from with dMAb where dose

So in we've of mad been like we targets, the terms scientist. have the

the So females. anti-viral effects we've on published of

MedImmune this against as model an influenza than pseudomonas will compared we publish to fact MedImmune, as protein and year, dMAb published that or target and similarly is based In MERS, that good we protein last better well. a

are fold would and animal they monkeys perfectly to our I own say targets, hope its version the So than show because to least protein to mice have we dMAbs naturally at better models that venture or humans. terms of then in – in in whether of actually mAbs And potential host, Humira. we

then of to will in be we I'm themselves the saying the developing go in so and we'll capability after PCSKX, we're have the of various approach. of times version we with Against be own a or these to patients our again and have are can commercialization as We develop just could get licenses, the a or week but we that to show could clinic. the and dose the for mAbs dMAb because all not checkpoint all want target to therapeutic multiple to partnerships those, products. we select inhibitors. much best going deep proteins there many targets or disease candidate And perfect for quicker protein, rare a where a the

So with first indication, going the inhuman disease respect just is to target infectious then? to this be

platform It's a because Yes, the us develop yes. out targeted enabling our where with funding, so that's funder. to

taking for Thanks it. questions. the Got

Steve. thanks Yes,

with question Our Ram with Wainwright. comes proceed question. H.C. next from your Please Selvaraju

my taking thanks questions. so for much Hi,

a you Just and very being combination that regimens challenging insufficient comment tried response seeing perhaps patients with be in general the midterm evidence, the that ones, you’re patients sense validity plethora to checkpoint of establish combination are who various could three whether on studies now inhibitors, all both quick your to regimen inadequate in given it checkpoint these the trying have potentially or recruit might in approaches proof-of-concept of to inhibitors. in any future

favorable a result comment in sequence true potentially could opposed response more applicability to combination. likely a to as Secondly, the is you whether if a in on

the that checkpoint So wanted see the administration is patient patient to have administration And of you. to, any clinical evidence necessary regimen I likely from at of differential earlier Thank sequential asked to that be whether whether lastly, question you this that's inhibitor? know about was I do is the your than better a of you a in platform, administration for dMAb’s. simultaneous dMAb to then and clear relative a frequency evidence setting think plus development juncture this

thanks. Yes,

first first last with study. in dMAb we why first the So first. patient-to-patient focused our have think question Phase the That's I studies on dose let take me human we're to variability, I

hard monkeys now. consistency, to larger animals, my and In consistent even good we it's different. are speak pretty to well other humans pretty very that – So but have are

to data we for think what our and questions. in a it's application ask then. new look to the of I'm very that's I so translational the technically. going to But Steve Similar thanks not going this question study of to just really go our studies getting to the claiming development exciting great good platform. part a optimizing forward be human to pivotal first So But licensure first. our

the of study ASCO all other of there. first or participants combination, enough was the think I it conferences yes, there to aren't there question, IO a one last studies presented years that the terms the of fit was out that trial In

of competitive course, space. it's a very So

that's seconds the spectrum out after for XXXX metastatic And and GBM. test going tumors. more study, fast could and why of are or bladder responsive the we that because wanted a more desperate our enroll because responsiveness. investigators we immune for competitive very to and So cancer. the position reason melanoma pancreatic much of lot that's immune GBM Bladder that's very companies study, very, precisely We a for one

about yes. Patients hard is are and of it's different that's and so question all companies reality can where Answer like and groups And and But where patients sequence Yes, right question. we these combinations. it's different to to find controls it's, live great where – so and you have aren’t the something lot then that So second sequential. on. the go rodent, have investigators to have with.

the trials, small properly, sample you're do So not is of you speed the size we're of competing reality times everybody where controlling reality even but that's with usually the of else. open-label IO, which and lot

can All Phase to we checkpoint comparisons. have these well But say compare. that's of established II banking inhibitor, not our or We're using alone that so on PD-LX PD-X don't studies sequential studies uses groups that some that, we these will And of other checkpoints important. of designing I some for the think we're and well. have not that test are future as

combination collectively about going the studies more learn field to coming So the science think in these of I is years. months the and

you Thank much. very Great.

Thanks.

Our Please McCarthy next Group. question go with comes Jason Maxim ahead. from

actually is Thanks nobody on Hi. it. mentioned taking for [Noreen] This Jason. first for Actually the questions.

to nice say just way. I Joseph, by So the job on wanted [indiscernible] that

Thanks Noreen.

question with to So relates – regards to XXXX. first my

to You I paradigm presented some followed would program ADT androgen-deprivation the a patients with Erleada that if clinical history by fairly think and no in had trial given positioned had be positive do and forward non-metastatic also data with with Where the be you the have appears cancer prostate you're anti-androgens, XXXX program Xtandi Phase partner? you now therapy, moved for up of setting. treatment which the on standard the in prostate that year's this ESMO, in cancer at moving

products is, combination even established Wonderful metastatic just field stage the think of with where from question. We to later reality patients’ or castrate-resistant maybe immunotherapy. have the setting through we'll in go other

it's doesn't buck, do earlier the interventions. studies show we where bang because stage approval the – the patients really because for the through patients to that's So have harder to get field can biggest or these these earlier the

have partners stage case aesthetic in go to I late we potential this our setting, the into castrate-resistant think, So setting. will and

we where be. next So the trial to that's expect

Sure.

with if that, in sense program X% give look with you was the versus XXX trial Thanks at with CheckMate as the And great. Regeneron, to wondering view would this XXX you clarification. of the GBM of efficacy for a the could Nivo that at was given terminated regard and a so – if earlier, but this prematurely. touched Nivo I was so and Okay, sort vast program signal your you just low what positive on with ORR combination you us

confidence the rates monotherapy you in the you So would would PD-X, know GBM? response give Regeneron’s additionally, and of happen to and and what program

in comment newly The first on been I but so comment for But also can't question, even setting. setting, has especially on. recurrent PD-X last I really challenge in can certainly the a diagnosed Yes, part. inhibitors, GBM

precisely one chosen So why XXXX. go we've two of studies our as that's cancer to combination reason the for after GBM

but overall percentage to at in well survival as said are have about is survival and objective field that month XX XX is to enrolling When what progression so done, that expect it's having at year in three free patients, six, survival PFS No, we see stated next show months. data we could next we of next year, survival have benefit overall XXXX, year? Our going all both And about the both month And patients as we not progressed? the look months cohorts, we're in months. from patients XX, is our unmethylated unmethylated. what of methylated methylated rates and

and of on improvement from And But these percentages year. patients immune X overall next a scanned expect survival. be we'll these hopefully high see months XX safety, three then part. for PFS every patients have and responses refractory to ultimately So most will we're look be two for we of these our we'll we patients checkpoint focusing months. tracking. that contrast the are for the bladder, And In

for CR effects or either in So we're anti-tumor patients. PR those definitely looking

our be will ORR So there. objective

taking for the and thanks for Great. questions. clarification Thanks the

Noreen. thanks, Q&A Yes, End of

at questions comments. Kim floor to are for further time. over now to Joseph I would There no this back closing the like turn

Thank the in thank to great you with for you. through advancements Yes, call. And thank forward lot. with you. for sharing look and months of important Thanks through attention We the staying all interest a very really Q&A. you your coming this

conference today's call. concludes This

your may Thank lines you disconnect participation. You this time. for at your