INO - Earnings call transcript Q1 2019 | Inovio Pharmaceuticals, Inc.

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Operator

Good day and welcome to the Inovio Pharmaceuticals First Quarter 2019 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] Please note this event is being recorded. I'd now like to turn the conference over to Ben Matone, Director of Investor Relations. Please go ahead, sir.

Ben Matone

operator. you, Thank and XXXX everyone the Pharmaceuticals Inovio Good conference welcome call. quarter investor first afternoon to With are, me Dr. today Inovio's President CEO, and J. Kim, Kies Dr. Peter our Chief Joseph Officer, Scientific and our CFO, Laurent Humeau. of live Today's is website a be also available. webcast today's call on will call being ir.inovio.com our and made replay

relate Following looking immunotherapy to well risks will resources. for assumptions our platform question in materially analysts, equity our differ to answer a combination These clinical as we with statements of be which capital our segment our a statements. certain develop a business results proprietary involve and conduct delivery from these update, uncertainties we making research as devices and forward certain will that data general reminder include as to which statements will our and be and developments business readouts could reserved and certain actual timing plans cause

on today. to of statements future expectations the events new are and of information update or or a revise assume All We whether result for Dr. looking of on in Investors Joseph CEO, risk the described over uncertainty the read I SEC. is J. based as our filings posted risks these carefully as press beliefs the should statements of no our release otherwise. as management, well that as and Kim to factors website our turn which like in would included obligation today's with call to With the

Joseph Kim

financials. I statistical review and Peter Thanks, detail Kies CFO, will provide my good with then Ben. first And afternoon our you everyone. our today will

our our R&D will joins dBiTE our dMAb update efforts Humeau, with Chief Our you today. call also on Laurent Dr. Dr. and programs. focus Scientific Humeau exciting on Officer

on shareholders. commercial development given would remains area the new plans. saying potential on our development timelines our to for have these business meeting and excited with both along that clinical like start patients Inovio and track by our about technologies off I extremely Our were

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ongoing high partnership beyond turn which and Inovio's bolster excellence, development other overall helps a expertise is VGX-XXXX in recognition and to Additionally, technology programs. technical testament cross-functional this our Inovio's towards quality standards discussions latest on

means it of what by and that EMA the precancer XX XXX,XXX cervical to cases Europe to HPV commercial deaths there for potential, XX. VGX-XXXX new roughly in and annually are estimate we pertains caused alone it As

surgery. For of proportion and high is which in the by cervical XX precancers grade current standard estimated caused XX it's cervical year. HPV Europe million aged of is the where like and this it or care XX The about will just XXX about is women XX,XXX XX% that risk older at cancer of women in are years from developing at each cancer die US

XX as are that our annual and almost cases anal XX,XXX vulvar dysplasia. and caused device and addition, already the HPV approved CELLECTRA-XPSP is there such diseases in rare Europe. CE in In Mark by Remember XX already

not continue investors at and approval and X diseases related we to for scientists notice. latest can patients presented month clinical respiratory certificate the trials recurrent papillomatosis novel associated and conference, for two annual over surgery progressing has our valuation the RRP tumor therapies, needed EMA multiple patient INO-XXXX repeated leading years, step type by patients tumors dose to only Moreover, lack closer we throats. therapy, pilot commercialization. milestones surgery two Inovio's first recurrence. can last on this temporarily year. surgery HPV the growths Inovio year. In every enrolled we tested see always therapy tumor to RRP HPV and incurable cancer. Their a had against disease therapy, an adult VGX-XXXX of demonstrated months remove clear in the to These potential with a non-cancerous life in approximately an form HPV the X with disease clinical HPV threatening important for last efficacy data that surgery X. of -- globally. AACR restores airway study be surgery their study, that and Same only airway. clinical take been for HPV time while positive both treat tumor to rare this for the ongoing two or execute condition us is HPV Phase which which required We and tumor HPV one who RRP. from their usually is with free Europe Since their on have times made latest a six towards over obstructions VGX-XXXX. for HPV other X patients to the patients cause of real to Phase offers must the from our growth the One So due Currently target to helps treated The and recurs bring occasionally

RRP and medical being for a same cause genital warts of provider towards rare results, strains INO-XXXX cancers. another You immunotherapy is non-invasive as being HPV built also to we complete populations. plan predominantly Please treat breakthrough as will certainly orphan more related a major now goal early develop a that of precancers adult novel and disease for Based here these report What support, on cause see develop RRP, the more to further we treatment a these to prepared of for immunotherapy publication. pediatric effectively our the recognized steps the more HPV giant diseases. note see all both

and summarize five me that towards let goal. achievements Let

efficacy demonstrated for phase cause to for in we treating root virus. VGX-XXXX already cervical our First, with study HPV be strong and eliminating dysplasia the

MEDIXXXX they study complete achieved of two cancer the treated [ph] a Second with response followed and remission who four patients inhibitor. a cancer by checkpoint had or a neck we patients add

or HPV non-clinical were reported FDA patients application up a associated to to and diagnostic add Inovio an European reproductive caused our cervical having accelerating VGX-XXXX potentially and importantly option partner. health processes. we much together, And that provides potential an quest potential pre taken the products therapy provide our biomarker manufacturing great with Therapies for diseases. for mission we're suffering a advancements for pride add fifth efficacy treatment commercializing alternative certificate that most just a Fourth, granted a validating RRP tests option in INO-XXXX. with the sections two recent robust treatment Inovio future EMA patients women a three a non-invasive doesn't through women's with surgery above in and in with a for as diseases preserving. for with needed clinical for HPV. And of Third, treating by we take that we mentioned that These dysplasia, complicate therapeutic

REVEAL portion oncology our update to I of to early the for of our month study, marks announced a we REVEAL programs and another pivotal sites X the brief initiation combination Phase Last The initiation milestone of trials program. want our enroll X and confirmatory X. Phase pivot X I two provide X REVEAL Before X and the VGX-XXXX. to our regarding opening REVEAL product lead

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our HPV MEDIXXXX the vulvar that more goal inhibitor overall X This We multiple from with certainly third I treatment PD-X earlier milestone by leading progress announced associated expect with in complements stresses can in MEDIXXXX X our our HPV. begin associated Shifting and global targeting on ongoing early cancers delighted the AZ by of market. third partnership patient dosing the -- and a expand also cancers Phase HPV. potential inhibitor call X oncology You of combination I combination to HPV triggered hear evaluation it next the MEDIXXXX checkpoint payments combination MEDIXXXX breadth stated cancer Phase AstraZeneca. are our anal, on of appreciative in with an checkpoint a that April, with and their evaluating our caused their milestone We to types use trial of the programs. with cervical, multiple penile remain to see of and and in in earnings August. immunotherapy Phase will continues about a including

with combination study. our INO-XXXX I be GBM. glioblastoma cancer bladder to studies or to Turning continues two will begin for in own GBM evaluated and which

survival in disease decade. more significant April a Moving outcomes care, have neither forward month is an enrollment the Regeneron's of with way really overall XX than Libtayo, of three completed PD-X milestone ahead schedule. facing trial, to clinically with the goal exciting changed patients a checkpoint inhibitor of of was the started increase the months a this clinical We combination standard in that GBM patients, where our in of our

of end PFS interim of have the study survival this data from patients. report from or year, GBM to expect We before progression X we'll months, at the six then, free by our XXX% results

the have cancer. month of roughly We're also data unmet the will bladder need time. from progression survival metastatic We XX XX% patients at in that free targeting also

utilizing announced we before the across this sites with remain US study checkpoint inhibitor We our end. help study objective X trial this have process. immunotherapy Here combination in bolster events enroll Phase we effects tumor to Europe, up inhibitor. proactive and INO-XXXX continues for remain to year Genentech, recruitment We on additional demonstrate This opening concentric. track GBM are will type checkpoint with interim and TB-XX on the data to with along combined with believe and synergistic a our the

or advancing vaccine want on lethal challenge development to that of subjects from is Significantly a human one vaccine employed that update XXX% than viral that delivery responses. Ebola vaccine. data Before portfolio. safe, also secure our has non-human a to first against can edition and overall I most to provide specific boost a cell be generated cell couple responses those Most subjects demonstrated of the following as stockpile of T study update generate infectious Infectious administration our look expect as vaccinated was March vector article within persisted alone funding more In But to man call effectively or Ebola importantly be as any could highlighted CELLECTRA executing Inova turn CSO, in With anti-vector -- that further peer-reviewed August of upcoming our vaccines re data demonstrated The advance a vaccine. our be response. virus. initiation cannot stand protection brief administered. in of preclinical detailed to disease in and robust the that strong of responses. journal you a already our generating of percent antibody on positive in year immunized with strong tolerable now on It Inova's INO-XXXX vaccine INO-XXXX. over viable intradermal antigen to vaccine partner of antibody journal Inovio without developments Inovio's Call, Ebola INO-XXXX primates Lassa a resulted a fever. We vaccine the boosted Investor Diseases the T trial I data vector multiple very key because our viral boost and Ebola more the previously device and strategy XXX% times for skin

vaccines the the epidemic part against clinical several shared development for intradermally preparedness Lassa recall to phase and million of multiple tested produce Inovio be call successfully development large CELLECTRA rapidly leading device, nucleic partnership vaccine trials the has threats or Lassa health this $XX In innovations are Coalition like Ebola, HIV, share soon Inovio CEPI of our our clinical through countermeasures with INO-XXXX Inovio's and a a is commercial or to class You'll for has systems scale and viral field including to that enhancing emerging suited possible near we INO-XXXX as regard, our rapidly of Zika is would support fever with grant XXX% emergency pandemic. deliver for stockpile potentially vaccine synthetic CEPI XPSP. and use. that CELLECTRA available MERS merged efficacy against from be response rates goal populations advanced Inovio MERS started protecting and I vaccines this as Inovio's of to vaccines well intradermal had as global which and Overall studies. vaccines to reported immune from X

With will Humeau, our will to some that this hear more Dr. weeks. over in CSO, You our about Laurent? Laurent the turn would to who coming exciting like the call advancements. R&D of I discuss

Laurent Humeau

ph this studio $XXX than pharmaceutical you horizon funding production. sensitive of in the initiated from inflammation in and is good in Please already we (inaudible) over we infection, DNA immunotherapy, infectious Inovio developments platform you, years. markets cardiovascular and add dMAb efficient billion have virus range poised Zika study diseases, am the trial its how is human encoded broad to of $XX my a for therapy year, last share. new import when we for a may could quickly our collaborators year our foreground. his technology With is the programs on struck the and again targeting batch monoclonal ph are are thank cancer And today its a enthroned That for provided dMAb Zika paint therapeutic of design to meeting become Inovio goal result. pharmaceuticals. appear clinical infection, AACR first investor. factory Well, Inovio study and which antibody of technology. will well antibodies this on today With and infectious [indiscernible] First, new accounting and entrant remember and encoded dMAb products, DNA technology about our body, Joseph really received talking more what few d-maps instructions pharmaceuticals to to earlier million to Inovio's Considering afternoon the product non-dilutive of initial ground important to towards larger which spanning and first disease. d-BiTEs. major cancer, product, feel announced the class to first picture prevent dMAbs this in it's disease, of directly when [indiscernible] antibody data be I them our by dMAb, genetic as cardiovascular his diseases. treatment science. a into expression to this the to the present a DMA that development sell targeted inflammation manufacture design disruptive by leap amazing At dMAb deliver the the our and dMAb body's enabling buzz virus synthetic segment set disruptive what's the

in Bi-specific established [indiscernible] told product we Engagers our world tumors Cell As a preclinical studies. global in activities T conference the clear how generated

testing cancer. which sorry and the molecule published study, Inovio targeting treatment, a dBTE ovarian For of novel was a developed breast for therapeutic model the this HERX

was dBTE BiTE resulting treatment is plan dBTE potential advance more testing, Importantly a we Data HERX-expressing effectively high results, cell corresponding our few single presented only partnership. what CDXX with is CDXX. of for in just dBTE into cancers cell develop for currently displayed targeting Also rapidly dose Inovio in killed [ph] which half-life upto mice preclinical to specific as kill BiTE's approved cells clearance. HERX Inovio's dBTE dBTE near-complete a by HERX resulted as candidate The in short well a levels targeting months.exceeding tumor our can of marker of clinical promising a tumor hours. typically B B tumor four

me Let on dBTE offer some advantages give you they over background in gene therapy. the

like demand down potential The cells landscape a killing First, at suppressing side a to on immunotherapy other resulting through or engages a BiTE a for activity Lehman’s activation has system to activity and that banding the by cell molecule tumor cancer transform the more on binds killing directly immune that HERX bites double and derived antibodies against to the effect the term specifically monoclonal cells the on class T T destruction. cancer. cancer are bites of the CD immune direct whole directly system cell. statistical a in is cells. and the cells. like In One artificial T double function tumor T cell binding tumor tumor CDXX the while other This BiTe target by to specific

be our might you and Dbte. confused Now dMAb

turn deliver dMAb of When new the device, become on fact they The are ability. Joseph. to many platform. advantages programs I bites the both now with of are dMAb administered dBiTE's sequences. as vectors you In allowing developed of refrigeration progress call these RPDG the the transformative using engineer and unique by functional will of I look potential. delivery by the composed on cell both of a two will to over which dBTE nuclear updating factory deploy back mass antibody stability forward CELLECTRA dBiTE product dBiTE sequences fragments. Inovio to application -- for and -- Inovio Inovio's of known is patient present share development, formulations design with device Inovio plasmid manufacture in manufacturing Inovio strategic validated include --

Joseph Kim

I here Inovio for for provide excited we at are our both financial value hold therapeutic Peter? everyone about future would the a can when Peter potential and the now I our Laurent. you, Kies speak and offer CFO, Inovio technologies these Thank update. to ask of express how I for patients. they field

Peter Kies

and financials. of Thank revenue I'll and our the I'll position begin end wrap quarter you, our with end the March then Joseph. total with up as of quarter cash first the for

As of equivalents the million were short which term $XXX $XX.X March compares for million XX, quarter. investments XXXX to cash, cash previous and

first the amount of million During placement a net XXXX due resulting proceeds convertible completed of quarter, aggregate in notes Inovio private senior $XX.X $XX.X of million. approximately X.X%

milestone Year-over-year Turning the revenue for for in quarter. was This same same due basic dilutive of compares the which recognized which per XXXX Total for for March to to quarter ended compares million million for arrangements were the the XXXX. $X.XX per $XX.X in the expenses was March the $X.XX XX, million to $X.X $X.X the in $XX.X share primarily revenue ended XXXX. March development Total in and quarter operating XXXX. months million XX, and XXXX collaborative from to research three to XX, loss or dilutive. million increase million for XXXX revenue now under quarter AstraZeneca payment compared period was basic the $XX.X Net ended period or first share $XX.X

the of filed Relations found be our income with today's turn release that, of Form the reminder, the Joseph. on Investor be or This it reports. under XX-Q XXXX, I'll As statement sheet, quarter also the statements operations SEC. balance website can financial for to back accessed With in our financial can first in a press

Joseph Kim

Peter. you, Thank

the second the let featuring study that several first for in months by Phase Phase We a validating data phase platform. line its our prestigious completion Before diagnosed disease, Ebola data retrial II GBM Don't in forget publication enrollment schedule after schedule. too. technology we Inovio and last the study quarter demonstrated of these the of ahead of further open productive versatile treating associated for clinical the been questions patients Company's Inovio VGX representing from patients. from just positive XXXX where with positive ahead ended by our about our have say capabilities starting for I RRP a extremely me of we vaccine benefit HPV highlighted

first platform. the for clinical Additionally, study we dmAP our initiated ever

clinical dBiTE the prevent During component which product technology, testing. unveil exciting first involving new an to we're our platform our within the quarter, rapidly working an first into

remains track open which entering our Grace, well With Lastly, on deliver quarter February along us game position a timeline on clinical development forward continue the in we're to Operator, to on I'll your meeting changing business that to clinical In line programs. following commercial financed prime second and Inovio for questions. development that analysts. our our places taking please the with plans. look closing,

Operator

Thank you.

Fitzgerald. go will question And We session. begin the Please Instructions] [Operator Charles today question-and-answer with now from our ahead. first comes Duncan Cantor

Unidentified Analyst

guys. for Hi my taking on congratulations on is multiple Thanks the This on questions progress all Charles. and for fronts. Pisaf Rubbles

Joseph Kim

Thanks.

Unidentified Analyst

and So a question data. about X a the REVEAL

[ph] an week of releasing management XX we it's through the up data when how So be primary efficacy to is end weeks. complete follow at the point wait XX? end the We'll or

Joseph Kim

week At we discussed as XX, previously.

Unidentified Analyst

have now study, met FDA And path into And a pivotal do the the a for to straight possibility forward? the with there's disease it's a of since believe you RRP going Okay. study? rare discuss you

Joseph Kim

very and trial that later course, and I that. have the to feel have we are this that meet we the data pivotal. year an excited certainly confirm We and we accelerated But the meet FDA going to would with we of potentially about with feel design plan into FDA - to

Unidentified Analyst

taking for you Thank Okay. my questions.

Joseph Kim

Pete. you, Thank

Operator

our Renza Capital. And Please ahead. from with question next Gregory go comes RBC

Gregory Renza

for thanks guys, Hey question. taking my

Joseph Kim

Hi, Greg.

Gregory Renza

elaborate on I further as update? we for a can look to for Joseph, far as your start stay update potential with August having in respect just a that just wanted to REVEAL that, what on the little tuned of trial, you? could mention just are How

Joseph Kim

we're [ph] give and and enrollment doing Well, VO shortly REVEAL be before August initially X. certainly of way and the fall to able we by expect to X how some on well we'll you complete trajectory

work that sharing we next to commercialization our other biomarker some our We detail other in look plans including and have call. forward in lots of

Gregory Renza

back of meeting now it. and also just REVEAL with the respect you. but with a on certainly And FDA just lot Thank XXXX. Got year, the to course then going with not the of half now RRP,

So you you for are key those how are for as you and just into looking investors driving help put value Thanks. all context as events Inovio? prioritizing as potential as how could that far what far

Joseph Kim

Yeah, thank with Greg. combining inhibitor patients Well our to completed the GBM you, It XXXX with this provides rapid Regeneron is very we disease very I but know at the lip XX a a XXX in think of enrollment disease. perhaps with PDX first best difficult us treat fashion. very we study, T cells the shot generating tail difficult

it's So progression before in of we PFSX the at year and month the XXX% half patients to have XX. survival patients about the free expect in the

to population, XXXX data survival patients bar as and larger in cohort looking our targeting we're will about able forward a PD-X have rate. said is response - so into to half we're inhibitors. by the as leading this year-end But high overall PFSX very checkpoint We to continue overall PDL-X or XXX%, patient generate PFSXX beyond. either cohort population. I who refractory be generating Latter, previous the Also failed already

percentage the year rates very hopeful have overall to of the the of as a So patients we're And in and populations these first end. well. are sick terms significant response before

about and and I globally baked countries lot a execute obviously process. about just are humans getting XX completing in REVEAL us. as X VGX-XXXX for launch an talked X equipment executing That's putting the really China effort the in we it, upside well the for REVEAL and in china. X REVEAL As haven't we potential to as of

So expect see validating, our publications in their we also be targets by our our of HIV Phase on publications potential from as a with Lasa rights. disease MERS our in high X study, from we the very follow are in lot funded a study And a US more dBTE the regard. terms continue we with to efforts new next these call efforts vaccine clinical infectious that we by vaccine those and own forward HVTN to well, will study with CEPI [ph] RRP for along look in starting updating vaccine

explains, where over using technology dramatic we we synthetic T-cell bispecific promises efforts of Laurent engager think As dBiTE efforts. improvement can can DNA feel that transformative the we conventional programs - our a fulfill is a finally BiTE we our the

the as So Hopefully, that and we a selecting lives the possible schedule clinical but to having our partnerships, then a disease recurs their and about to to as already impact with as other would patients around trial. these for after a each stated candidates candidates for because excited the disease, tumor We're - to with before, the top deal process are surgeries on trial of in time. the be as small patients bring sound its FDA. of size these the meeting the we for very to available we evaluation the look pivotal remove dramatic very rapidly tough that that next all it's sample into are value. high just rapidly possible forward dBiTe think bringing to the RRP it of orphan

about excited all very we're these So of programs.

Gregory Renza

progress. Joseph congratulations you, and the again Thank on Great.

Joseph Kim

Thank you.

Operator

Piper Please Jaffray. go comes Raymond with And from ahead. our next Chris question

Chris Raymond

I sort you done think now. it's REVEAL that Thanks, a guys you're want and on Or about I split question, almost Was last have been place don't happened that the enrolled. talked done Was guess sort in quarter we that might heard last it nearly there I think I but of might was move here I last to months? when Thanks. enrollment of know be there already stating mid-year. it guys. but timing this the Joseph, nearly three enrollment last that guess anticipated X something there being three something we quarter slowdown I happened that some took months in or is done.

Joseph Kim

I No, are as well REVEAL a efforts Chris. wrapping Thanks, the X, we juggling, launching. as of up think in

So too. we feel

REVEAL we happen progressing in to very trials REVEAL X. and want will know how make we're projections full projecting in enrolment our sure you these bullish things and by of So large mid-year these - on in X are we we're that we're done perhaps enrollment and - certainly

a to we're don't think can you projection, a the but there's perhaps I been now. tell more So - detailed giving there's detailed projection closer not I slowdown,

or can So we're I our touch we're and - mid-year. the a three And It getting very that Phase both happy certainly And It execute MAA on on to sections don't sections. is that by want as the I big CMC of are FDA. doing to again. is from validates data, our quality we most to two big there Europe important high of just and section in we deal. ATMP because but the that ATMP know picture. a level for and is don't clinical approvalable on to based thing everything data all yet sections efficacy have certifying filing the do that that and track And want we and in in and XXXX course BLA three and that of remain our out are huge data is you our Obviously the Certification perform. non-clinical but accomplishment to just BLA X on that

companies products either and of that also are CMC we accomplishment our small this So or for risks non-clinical who the countless our but - huge getting the to their there a section. approved for delayed because shortcoming mid-sized is think are team shareholders in

section we’re accomplish those X team I our big – have both full in So X REVEAL that's have our devoted confidence where we one executing and efforts. still and to and REVEAL complete to in efforts we're devoting

Chris Raymond

Great. very Thanks much.

Joseph Kim

Thanks, Chris.

Operator

question next comes Please ahead. Joel Beatty Citi. go from with our And

Unidentified Analyst

Thank on Hi, John for This my Joel. question. Hagen is you for guys. taking

sense most learn hope talk study serum and also expect and the you could quickly work can us what platfor, based of and you your levels initial in show first the antibody to concentrations - get the of can frame of are like maybe about the to after we on antibody how you important type give one administration of going preclinical a of of in speed kind dMAb to things onset or blood? kind The we

Joseph Kim

you. Okay. Well, thank

escalating first for perspective, want of platform levels activity Zika to patients trial to we're our the the So of dose with targets in mabs those proteins. what kind circulating we are But the the the check our getting Laurent trial. as sure dMAb of make expression to binding expression for first explained, we Zika obviously

nanograms to will in able from we per to development ML have scale several to process. we report our primates, So on In those. ML hundred non-human able up be several per micrograms been

study is going these life So whole terms C we of blood great information well the us as level on that of is for the the pharmacokinetics the platform. and human a half just to so and the give in the expression of this first learn what antibodies, Max monoclonal as

would it reasons wasn't excited Now here touch we're [ph] this. add dBiTEs that let be of though think, I just asked, the me about I well or one as on that didn't is effective hegemony even Is are is why our as to dBiTEs it serum specifically so dBiTEs, that mention - BiTEs that the even earlier patients Picogram had in prepare XXX human and and dMAb, at but Laurent levels. mentioned in so

effects functionality in type and are - in XX,XXX those of So in at concentration. tumor to bites XXXX its less effective are fold blood in the in just the terms layman's

as rate to run dBiTE in can we optimize for expression the trial with of we think achieve now clinical So expression our studies we dBiTE. the dMAbs, the continue first

pushes next really into oncology that to target major dBiTE our to thrust So of program. our as one a urgency

Unidentified Analyst

Could HPV thank big initial you've you. indications work. well, an there INO-XXXX, frame follow-up a based population congratulations the need on and kind are with the how of unmet positive other any [indiscernible] And data then you could is you now RRP on program, X X on but Great, works as and mentioned that your HP therapy? the

Joseph Kim

about There new are four. multiply that can cases by XX,XXX you. every you about the country. there's patients Yes. XXXX year, Yes, this in several throughout RRP Thank world, so

a efficacy ultra we're is clinical caused about third a What indication. HPV efficacy seen very may rare to this sort of have excited targeted indication, you that is rare even say levels we so products example diseases So of our this is benefits. clinical dramatic

MEDIXXXX dysplasia completed and INO So and cancer XXXX. with with patient responses double-blind in and with the some XXX now study neck early head

tested the type to Now thorough. to HPV RRP pilot causes we RRP which X next comprehensively HPV indications just cover study of HPV are hopefully study planning to we and going X and expand include into the effects, are will XX XX major our prior HPV

and cannot address, half X in awards about indications general thing for XX. There other of be terms should In the new the are US. cases really million are we big a

obviously of different are this against potential about much we think But and the like to we to indications bigger targets, we extremely potential awards program are develop disease have over general these compared RRP. life-threatening clinical orphan manifestation diseases. and treat which our a these could So excited potential other program nevertheless, a to rare have targeted time

Unidentified Analyst

And checkpoint the a kind final update oncology That's quick discontinuation you of just from you. helpful. rates provide very of radar question, then the Thank things sensory and going could on? blinded any kind really

Joseph Kim

mean the We that don't - XXX and have study? you

Unidentified Analyst

Yes.

Joseph Kim

like see our we discontinuation or dramatic done we've don't to rates in platform. that any our studies compared other that Yeah,

the studies. nothing to So out all there or study compared either in other other is discontinuation of our XXX about vaccine immunotherapy or drop

Unidentified Analyst

for you thank Joseph. much Great, my question answering so

Joseph Kim

John. Thanks, Great.

Operator

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

Stephen Willey

afternoon, good Yes, questions. thanks for taking the

n disclosure if wondering principle the to respect GBM. immuno some if around generate that as in view need immune that guess commentary and this additional disease? you outcome XXX with meeting response kind to And supportive study maybe the in stimulant had you OS today onboard Just you I any not fact of of the

Joseph Kim

or question statement actually, surprising XXX what with just Your you checkpoint fail. your question It's answer concur - not your said. I that

generating inhibitor or their inhibitor. checkpoint have own. on other In inhibitors anti-tumor None benefit on [indiscernible] INOXXX either targeted the more the or a GBM on benefit with PDX with in combination our issue. fact, case own T-cell in we've PDLX their importantly just significant why this survival it's responses with not shown Regeneron's PDX clinical That's reason of

PDX cells going antigen analysis presence tumor without your think is I to T I yeah, concur not So around specific the is successful. or alone of be

alone So what just these hopeful benefits overall certainly does that to and to standard GBM study, that our even see checkpoint mean care. or of XXX optimistic survival therapy compared for we're

in our few in next will PFSX, the the will the year-end out able we very optimistic our pan that cautiously then but are OSXX, and information to XXXX. early we show before progressively data two So be OSXX, very first year-end, OS - quarters. But PFSXX, the before

Stephen Willey

it I data respect And you immunological guess intramuscular, forward like the delivery -- administration versus Okay, intend Zika that was with cell something intradermal of we that look to look to XXXX that's vaccine about kind showing think method pursue shown given, kind that should of intradermal to intradermal the helpful. respect how leveraging T to you as had go you're is of think you I that maybe and data the some choice. improved responses of at with with just

Joseph Kim

is other say As had targets, our our X of bring not intradermal a we enthusiasm intramuscular and CDX have I of have but had literally more into to at Steve or specifically today our first very so these entry all and for just are are that programs. facing or XX on, we I these benefit and not including doses data we and we your then of XP into on therapy CELLECTRA NRP Delivery oncology to with are call levels, - received X that, activated the our if patients love and situation in here delivery T-cell. I factor generating vaccines we last share clinical delivery intradermal as or immunotherapy discussed all potential intramuscular of is delivery, working high is That's

are XPSP commercial lot in you'll design I and X for system we've lot target coming In enthusiasm a vaccines Intradermal analogous accelerating our PSP of the ability and more fact, tolerable, about efforts delivery level us weeks. I the immunological hear bring gives of our targets delivery and very system compartments might that of a therapy. all have commercial and glass about improvements better development But a these or potentially more over met your intradermal our share efforts we through very skin quickly, to commercial CELLECTRA to our initiated that versatility but

you're So our differences validates set, we delivery intradermal and additional only ahead. add going validation Every additional data our moving that also are but therapy. of intramuscular quarter, our delivery see to of not

Stephen Willey

And one right. me. last just then for one All

it specifically, How that for clinic dBiTE? envision envision some at So sounds escalation NABL such clinic and of with dBiTE respect kind therapies, individual do it's could And the possibly something point. the just I that the while playing out with going take prolonged in you this do have redirecting a clear to given in T-cell to around How of dose? onset see you like to a dose each guess is we getting you the program. requirements FDA effect

Joseph Kim

the very to with that work Again is We question. FDA. plan closely great

particular how new We about As just bispecific did that extremely it FDA go BiTE. the you with interested in and antibody efforts? we do trials the know, we new And our Zola programs is with overall do the dMAb. like and

rapidly very potential vantages ph so the You this low on. and in up certainly test be so and dose to will perhaps doses, start to we compared de-BiTE of at expression, future the you you risk, is to the partners as move position our and vantages advance We next safely -- escalate potential possible. technology a overwhelming think as

have with few the done vaccines, and then dMAbs quarters, either and candidate love So our a the give to we clinical you dBiTE first the targeted now as as can targeted plans hand either going before you HER said, bring certainly this and hear I at with be we'd evaluation. next more X two our said to within will couple lot to haven't in CDXX AACR dBiTE, our a our immunotherapy, the is you of presented I we about not as or future. which of anything

Stephen Willey

taking Thanks right. questions. my All for

Operator

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

Unidentified Analyst

Congrats Jason this actually for afternoon. on is the progress. this Norine Hi,

dBiTE program. So regards I've a with your question to

HER-X-directed recently, breast directed cancer metastatic with great data again preclinical they ICHI agent fantastic and You X with with antibody-drug more preclinically reported towards you data HER amazing data conjugate probably AstraZeneca saw and had patients. their [ph]

conceptually that us overseeing advantages see of would the dBiTE So understand how I to wondering ADC? you program -- with help was just a in

Joseph Kim

a and I question. great that's think Norine

guess our So I talk great AZ HER-X program. partner a ADC the well. is targeted to think us as I

I think invested this. $X.X they in billion

play, come certainly these So different drug highly strikes you're really that anticancer to their value successful conjugates valuable. into conjugated, There when mechanisms are role. antibody-drug it have certainly - these products the are of

target think cancers be program also immune will thus into system tapping using We T-cells are the or dBiTE also important killer development. bodies zone to very the the

HER first shown that have if compare levels achieve look we compared our to us certainly our our dBiTE having be cross the its candidates and only same to candidates. now will his limited that but So Laurent our pumping developing mean, of can of even candidates. and two ADC, one the without in certainly or of help R&D we successful clinic several technology and I shareholders and focus at we the are potential are forward execute we level of our The resources by also to partners just the we've well-validated certainly additional we are time, to team more the in dBiTE out data X then is clinical in hard and level first pleased. bringing of science very is, we similar same T multiple

partners with in one multiple by first The ourselves, future. but others the

Unidentified Analyst

continuing helpful same really along lines the that's and the with Great, dBiTE program.

of it with bispecific appears Sometimes that your effects. potent do can elicit you product time generation dBiTE, syndrome and see

of yours well. something with as concern would you how So – [indiscernible]

Joseph Kim

ever able the that's again mean, also the engaging to I be especially gang manage harness the want only class certainly killer potently T-cells, T-cell, we where when but T-cells, to in it. be Yeah, to you're able it

of of traditional antibodies. other during occurred matter of the lot they careful answered I to at storm our of dosing toxic we're BiTEs cytokine and you Cmax and and looking methodical see effects as the dBiTE Number in Steve going expression early Number in Willey's concentrated peaking the ours. first very And X. know, of you trial, injections the to the as escalation compared our and X, be bolus dissipate where right question, So pharmacokinetic the

dBiTEs I'm go course, potential But be in pre-clinical wide potentially can limiting beneficial just photo only So, have here waving the I of hands because we with open. cytokine my think we the expression but to in obviously profile eyes going of storm. our data,

any be So our sites effects so for clinical on. manage RPI's, side ready our our all, team, clinicians, to and

can't how manage what CAR-T to I we point and patients. cytokine do is Now storm

the some of effects with CAR-T every convey type know side clinic. they As or you level manage toxicity and patients of it this in cytokine storm

clinical the of outweigh, overwhelmingly CAR-Ts. side that benefit management So they're the able effects to utilize clinical certainly

we approach We but think are I be beneficial in of maybe similar see, will fashion, profile in the said as at this worst-case earlier, to this the well. a look scenario, may I dBiTE regard this going that expression as

Unidentified Analyst

biomarker one any just and partners question, that Have program. mentioned you XXXX last diagnostics front? on potential for VGX with you Great actually had discussions

Joseph Kim

Yes.

Unidentified Analyst

you. thank Okay,

Joseph Kim

we'll our weeks. us wheelhouse, honing the and So we lot to a developing us biomarkers done bring what discovered that have we discover, currently, again additional in not our innovative the field make in coming and to leaders of that are so more is for commercial that have certainly in kits you'll partner with sense in about hear

Unidentified Analyst

taking thank my for Great, you questions.

Joseph Kim

you. Thank

Operator

our open. And to Please your remarks. conclude Chen, session. Wainwright. line is like Kim with from to conference [Operator your the Chen, Yi comes line This I would question-and-answer back Chen turn for over the ahead. any be Yi muted. next will Instructions] closing Mr. may go Joseph question H.C.

Joseph Kim

us. staying for Yeah, thank you with

as from well information from the and dBiTE can X same weeks look as At more our come. time, our our highly next well of RFP the valuable. our you to you as XXXX, few in excited excited exciting bringing clinical immuno-oncology forward about a is PSP about our analyst making VGX initiation as very very, questions well. We and of half We're our around the of questions, think we're months executions those revolve stage our execution As I we're the to programs. as vaccine progress tell think technology and CELLECTRA our important later in voices, extremely can tell great programs. very And

So thank time. much you your very for

Operator

conference you attending presentation. is Thank concluded. for The today's now

disconnect.+ now may You

Inovio Pharmaceuticals (INO) 10 May 192019 Q1 Earnings call transcript