Inovio Pharmaceuticals (INO) 12 Nov 192019 Q3 Earnings call transcript

Good afternoon, everyone. And welcome to Inovio’s Third Quarter 2019 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, today's event is also being recorded.

like the I’d to call time, Mr. this to conference turn over At Director, Relations. Matone, Investor Ben Senior Sir, ahead. please go

Thank you, conference operator. joining the Good afternoon. And Pharmaceuticals quarter thank third XXXX earnings call. Inovio you for

Inovio's On the Kim; Chief Clinical Skolnik, Officer, Financial Oncology and Jeffrey Dr. Kies; Dr. President J. our and President Peter Vice call Joseph CEO, Development. are today of

made Today's is of today's replay ir.inovio.com, and call a call is being the will webcast available be live concluded. after on our website, shortly call

we will be update, a question-and-answer research Following will business a conduct segment, which reserved analysts. general equity for

this well capital statements in include immunotherapies we our resources. clinical and developments as our platform On clinical our call, relate which DNA as will synthetic combination be and readouts regulatory with integrated forward-looking business, along of Inovio's with of that timing making our plan proprietary data develop to devices to delivery

and a today. actual assume as the as in XX-Q risks in statements result to update and involve certain filing All of expectations press of revise no the on risks management and and these the described materially. These or We new statements well events to or beliefs information, whether included differ uncertainties otherwise. are could carefully Investors uncertainties statements forward-looking today's as SEC. release, the risk future factors should of as obligation based read assumptions, of results cause with today's

the Inovio's call I to and turn that, Dr. like Kim. over to J. With would now CEO, President Joseph

the and And Thank webcast. you on thank you, call everyone joining for Ben.

some time for accomplishments, a our of the on transformative year, period we do but XXXX close to more XXXX I As on near spend as want reflecting Inovio. also focus the

a data VGX-XXXX, trial and Middle year, top-line our By orphan vaccine X XX vulvar up Africa vaccine Xb to and Phase cervical study and product months from survival East, anal dysplasia, on VGX-XXXX INO-XXXX, and in the both funding take in dysplasia running for me studies time shown with results full for all have XX our via efficacy GBM and Lassa you, next in in will our be a us Let overall designation, data X Phase REVEAL for CEPI. Phase X November we X at RRP machine Phase XXXX. time MERS this will

China partner, Our AstraZeneca be expect X inhibitor. Phase VGX-XXXX. to X combined we checkpoint their Phase ApolloBio head MEDIXXXX report on will cancer neck China in in and results And with with efficacy with

focus off set drivers one machine time What and the of my me an value on in present. turn incredible But year. let

reported Inovio's XX our diagnosed trial we a as week, INO-XXXX, positive tumor-specific from antigens, GBM, interim Last data ongoing INO-XXXX, with which or interleukin encoding activator in immune an newly multiforme for and encoding immunotherapy Regeneron’s combines combination for well three cell-activating X of hTERT, Libtayo, WTX, T inhibitor. Phase PSMA, glioblastoma our PD-X

In of from XX% data interim measured key of that six at their clinical unmethylated promoter the from of Annual data. of XX-patient survival overall and week, standard-of-care at was That exceed Immunotherapy data the data. These dose. first historical Society XX XX-month show patients disease summary, months, time patients, Meeting year results next and MGMT progression-free for Cancer the the report will were substantially gene methylated trials presented Inovio coming last XX%

historical Inovio's have at this Before immuno-oncology standard-of-care. Jeffrey Dr. data, on to who presented provide how and other granularity more data combination Jeffrey? development, update, we compares into the week we’ll this to who it go SITC program last cancer some Skolnik, up heads

You, Thank Joseph.

garnered our the clinical share from obvious data over as investment significant with these remarks, Joseph very data in his meeting excitement As mentioned was was both SITC clinical we're week to very to this presentation poster program, positive attendees. was last for GBM community. and opening me attention and our new The excited late-breaking

We of specific brain to associated of created their latest to indicated, challenging die survival within data treat almost tested want six clear We only by most two of far would one confirm that to controls. year a the about patients extremely of our antigen were you’ve demonstrated months. our progression-free so diagnosis. unmethylated to is cancer In progression-free very interim look when our MGMT patients to at overall that methylated We is data expect Joseph, glioblastoma months. that very and a years patients to we XX% disease as to And them promoter underscore of XX% T our to XX% MGMT that at their is potentially generated of and promoter antigens were tumor This historical next XX% forward compare REVEAL, be an we all cells favorable about therapy. the patients unmethylated patients we methylated also patients excited benefit. six

Thank you, Jeffrey.

feel a While we it and what cancer, for the very really of capabilities certainly new that can Inovio’s in Furthermore, provides this should not treatments witnessed is for far-reaching we all implications. additional encouraged treat two I GBM by that future new years. appreciate immuno-oncology data and this difficult effective a any data to means has want with to GBM who patient for suffering stress here

also comprehensively many and INO-XXXX, to global pancreatic, dozens renal, to are these comprising potentially can address treat opportunities and First, plan in lung, other perhaps cancers. because of WTX, and of a other we expressed methodically These with cancers. hTERT, partner. of are these We tumor-associated overly namely cancers, HCC, it use antigens PSMA gastric

represents as mountain GBM very products. just data only are tip important overall even is the commercial certainly SynCon GBM to program very a this from a our have while cancer Inovio, and validates our beginning GBM we our opportunity INO-XXXX witness the with also for utilizing tumor-associated suffering important for of great it. for platform Thus, below patients other peak opportunities developed we of Second, antigens greater additional

been working and a for to possible. have call I make began we transformative XXXX for a referencing year this today our as while Inovio,

adjustments portfolio ago. is We have Inovio we with sharp look management, workforce support. and we were When just funding where than a at I see resolved been years preparing two more it today, and strategic

versatile to alternatives on be our to RRP HPV capabilities surgery advancing diseases develop like our target HPV-related continues focus lack strategies market that that products to to core GBM. to and Our add and best therapeutic we which treatment

let fourth of remain completed REVEAL address for provide the me and XXXX. with quarter our patients most First, top-line women in for advanced beginning of VGX-XXXX, Phase efficacy target asset, X We data our XXX X, quarter to by the X second cervical REVEAL we on trial treating dysplasia. from with high-grade enrollment

our data the death had already we looking in X, of safety efficacy XX to Remember, We on which addressable leading if XXX-patient HPV the subtypes believe in why community. globally. all among seeing we will forward are REVEAL is can are as more we and graciously Thus, to women and by surgery Xb And cancer an cancer studies. still VGX-XXXX responsible be XX cancer. to patient of in effective proactive reason the demonstrated one about Phase the precancers cervical causes for still of achieve and immunotherapy cervical accepted XX% alternative

to and X within globally. opening vigilant, continue REVEAL sites be U.S. diligent on we the and cost for effective Meanwhile, both, clinical

X globally, new of end patients the having remains As Spain. course. in opened XX Argentina, enrolling recently sites actively October, on we sites recruiting for and Overall, of Lithuania have REVEAL enrollment

a one-month required two versus mind REVEAL a As to file X a of X both year trials these safety exception XX-week that keep seeing trial for are one follow-up identical safety one be a will reminder, a follow-up being trial, BLA, timing. in an includes includes XX-week trials safety REVEAL long REVEAL while with which follow-up. which long

Coupled our the commercial VGX-XXXX is of clinical most collaborator to and QIAGEN. respond are Again, upcoming profile purpose to with this data, the improving kit with and biomarker our identify VGX-XXXX. the pretreatment will co-developing we kit to diagnostics patients for likely be

occur later most programs X the X the readouts while being do year, AIN from few Phase data, next and ongoing Phase VGX-XXXX top-line X next significant months. REVEAL VIN for data over that uptake anticipate So, we our will

from high trial well vulvar for Following patients a grade as XX-patient enrollment anal the studies interim X next AIN dysplasia, of first trial conference the in Phase with we data quarter as and our dysplasia, year. the VIN enrollment plan of XX medical the completion Phase VGX-XXXX HPV HPV-related of in in a high-grade of both related patients X at to in completed report

conference garnering the disease time, feel While this the specifics we share the on to attention at appreciation and and this will safety and be we most AIN interim VIN can't for the most targets. provide that appropriate venue efficacy data,

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that of should this the patients excitement study off disease. I tremendous same and was a has, this program about our get INO-XXXX most as to in poster mention constantly share the all benefit to I that INO-XXXX the you trial-in-progress So, at in and at of SITC, clinical share know, that it a also presented eagerness opportunity featured are to terrible our ground offers late-breaker also reminded poster addition the importantly, market conference. the

in inhibitor study INO-XXXX, the Institute established FLTX of Parker INO-XXXX being In platform cohort Research as Cancer INO-XXXX being Institute nivolumab this for and conducted study, part cohort is which clinical of INO-XXXX of with combined this PD-X being agreement. Celldex one Therapeutics is Immunotherapy collaboration combined Cancer Ligand three particular, previously Bristol-Myers' arm core and CDX-XXX. and Company’s platform formulation incorporated cohort exploratory by a is the

can head Let year. with survival me Phase PFSX immunotherapy. in fully that will Regeneron sponsored for solidify Collectively, third data data product as partner anticipated neck synthetic combination next data GBM, the and combination DNA recently by again MEDIXXXX enrolled presented. cancer trial X pipeline all cancer our leader portfolio, emphasize these Inovio’s the from efficacy AZ be cancer promise Inovio here great promising readouts that in for you building overall by inhibitor AstraZeneca point and XXXX quarter our trial INO-XXXX our Moreover, upon the to expect the completed checkpoint was combining further with

business, disease update, and the cancer HPV, being within that I excited is I’d about the which progress believe for over remiss within often our done latest it while infectious to I underappreciated development we’re is extremely financial Peter be by recognizing to mention Before a turn not this area, an continued investors.

with As established we diseases, narrowed back infectious previously focus were we affected realignment. resources in global partnerships while our not July, this stated and within our

continue and of multiple and both of devices We our to partnerships and which utilize development support investigation disease ongoing for dMAbs the delivery and the embrace development vaccines, pandemic targets. infectious

I Epidemic Preparedness Innovations. our and In an partner fact, infectious by for the you disease from vaccines Lassa update for CEPI have or MERS funded Coalition

the For we of enrollment we year. study of first ever where Lassa, May in human began vaccine this enrollment completed

begin trial and fund in This Phase INO-XXXX, our CEPI X West continue of the is early with Lassa ahead expected upon Lassa Looking based Africa, to Xb for trial will where trial performance is to next the Phase year. next infection endemic. enrollment the partner

therapeutic all to Africa advancements organizations where our our well outbreaks begin in X moving for you will we're the vaccines technology. and enabling Phase antibody HIV the the making studies. specific the waiting about become Moreover, Middle in in monoclonal customized a in ever Puerto will have partners as instruct also Rico, body Zika lead direct to certainly which by their synthetic the in them manufactures products, to body’s patient as MERS, the genetic using other into for CELLECTRA and been Additionally, more leap Inovio East provided vaccine again finish by antibody dMAb the local for and dMAbs hear first factory, major analyses own a dBiTE and our a We're and cells future, platform, technologies delivery observed. study vaccine codes

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Inovio application development has Inovio innovative Wistar already in grant million Institutes its recently, collaborator external technology. $X.X the Institute, received paradigm corporate continued of this impact that overall the results of in dMAbs, Inovio's partnerships, from shift received dMAb goal National is Inovio's monoclonal pipeline to anti-microbial this to advancement for over approach be develop create and a external which collaboration. of $XX products funding to a products. to the with cancer resistance infection, support in high and of developed Health Most million technology antibody support of funding and of can a

data example, Bill antibodies an reported to safety dMAb of trial full be tuned first Melinda & expression Phase its escalation from advanced dose dMAb this INO-AXXX XXXX. earlier and As to year, Foundation. Gates for Inovio in X the and produced assess funding Stay candidate, to the ever with tolerability

Peter provide CFO, to our ask Kies update. will I financial that, Peter? a With

good and Joseph, everyone. afternoon, Thanks,

a also touch and financial the realignment overview in I'll we begin third the then recent announced with results of on that general quarter July.

drug the year. for three $XX.X arrangements same AstraZeneca. in $X was same quarter and with collaborative for reimbursed XXXX. ended The primarily due to our was in manufacturing compared September for period to partnership XXXX months the compared million $XXX,XXX last period revenue decrease revenue for XX, were million decrease under third to the $XX.X million a operating Total related to expenses the development activities year-over-year research and Total

dilutive the compares same share $X.XX basic for quarter $X.XX million million for and period share per $X.XX per loss $XX the $XX.X net Inovio’s last per was fully or diluted, basic or year. share which to and

by aggregate convertible shares a due XX, of bonds amount to XXXX Exchange of assuming KDRs, Korean won of led cash a Depositary listing the secondary Market market group Receipts of of into placement the million of $XX.X million investments These Partners. are KOSDAQ time of approximately offering proceeds form Korean million as and otherwise the Inovio. compared operating Korea in KDRs cash institutional In are on stock of short-term billion to X% investors XXXX. completed at payable or conversion. were deducting listed if securities As September and August, Inovio of XXXX XX, $XX.X its of were Net after Inovio or from Stock not has $XX.X the the expenses common by principal Investment million KDRs, an convertible Korean a $XX $XX issued equivalents or with December approximately private closed

burn. plan the to Company in reallocation and of including clinical the candidates commercialization a fast-to-market GBM. high-value implemented reduced an approximate cessation staff product July, and HPV for cost efforts to INO-XXXX R&D a as XX% XXXX treat company’s its of INO-XXXX reduction lead asset developing reduction resources such In strategic treat and annual several resulted RRP programs, The which XX% also focuses while

and press also for our under the in read our in can XX-Q be the accessed statements SEC. also our you can details EDGAR SEC the reminder, third be a filed with release Investor found Financial This on Relations, of our today’s Reports. the financial can webpage XX-Q XXXX As the of on at quarter website, Form

With back it Joseph. that turn to you, I’ll

Peter. Thanks,

next Before reiterate we important questions, a areas. multiple take This could year, period therapeutic stands clinical I really many your next development to and across year for business it’s milestones think Inovio. we transformative time that have

working while we them data and leapfrog we're about Within the XX months, to to unveil VGX-XXXX, have INO-XXXX vigorously MEDIXXXX, game-changing INO-XXXX on potentially can if see market. the significant next to all

been very this diligently have to to We working moment. get

their long-term especially conviction. and thank employees our our our and would I dedicated shareholders and for to faith want collaborators

look your analysts. open forward the line taking to please Operator, the I Now, questions. for

question. question Charles go Please from ahead first [Operator Fitzgerald. your Cantor comes with Duncan Instructions] Our from

Stavropoulos you? Charles. Pete Hi. How for are Congratulations the is quarter. on This on

Pete. Hey, you. Thank

presented the on but sure I data on and remarks, GBM ApolloBio mentioned congratulations something. Congratulations that you in the that the quarter you last I'm prepared I missed week. if know not your

quarter they you last So Chinese and IND that mentioned FDA. filed

started FDA China So, sites to [indiscernible] have X? has and the been Chinese REVEAL from they opening clinical response explore with there in

Yes.

many we China. has in assured or for VGX-XXXX can fully from IND FDA ApolloBio the discuss ApolloBio. China open you this ApolloBio trial details (sic) for moment, that The executing be be China to NPMA at the [NMPA] will steps We're XXXX VGX-XXXX. but So, really accepted in can't by with plan taking

And about revenues? of patent biopsy-based so will sort completely you. will rights I that be REVEAL one diagnostic sharing companion own get for providing question Thank beyond understanding, other QIAGEN just the Inovio this is hands QIAGEN’s or and and VGX-XXXX, better in you samples,

Yes.

So, still. been do. it's and QIAGEN is sell collaboration commercialization they this -- kits. They their then, of and development work co-development, excellence. done. A what diagnostic the execution brings lot a They And develop early has

is biomarker most And usage guide can help patients complementary better We this of kit base VGX-XXXX. goal guide us where who VGX-XXXX that charge more, benefit will patients the the kit and huge doctors can can have patients efficacy. have pretreatment our a we have implications us. the to for available So, the overall can as that the and use has that

would effects. this So, we multiple who healthcare it targeted usage can has It dollars positive because well, most. the of XXXX value overall as in to have improve the patients

now. the So, this making Inovio’s expertise key And QIAGEN’s this utilize we and to advance making is we’re combination provide information possible. further XXXX. and in more really as I great really expertise progress We’ll right think

All much. again. you on right. Thank congrats very the And quarter

Thanks, Pete.

Joel Our from with next question Beatty ahead question. your Citi. Please comes go from

is my questions. Hi, for on guys. for taking Shawn This Egan Joel. Thanks

Hi, Shawn.

a then, well. Maybe at have first of what the you on level A on XXXX, a a maybe talk on steps -- decisions like you your any pivotal are, Hi, high or like a prior to program. until look today, high next like? plan do follow-up as what the the few glioblastoma design Joseph. path for kind just on to me full waiting I thoughts could forward And matures last data level any making could

Yes.

answer. turn we really to picture see big and out the we’re be. is to excited the we’re survival be trial as going more could pivotal a I’m over about top So, for beginning a detailed draw would Obviously, imagine really early excited. and data what data to Jeffrey But the later we

I’m any over Jeffrey additional to turn insights. going for to So, it

the quarter for has and continue third we study to obviously, what as we’d question. next help so the that current design for that our of next middle time data. already from would of Joseph with design thinking looking, next learn into us And year to we’ve into opportunity the Exactly, and trial. Joseph and year potentially what as will Thanks, look thanks then this to like and But certainly the and would be survival we’ll said, inform imagine fourth to of put the you move together Shawn our effort where overall quarter like.

to So, see. we year, extremely we’re next the to data look survival excited into forward overall which

Thanks, that your also that then, to learning Are are And a could leverage any QIAGEN. regards Jeff. diagnostic those could to follow-up platform or really there broadly in be VGX-XXXX? applicable across you tailored the from to

Yes.

but we But, further. programs think could well. There there be and into across IO certainly studied as learnings. are So, HPV be impact have details to space, certainly --

in So, really targeted therapies and this is the the for focus next generation IO biomarkers improvement field.

we to going learned make biomarker we’re in aspects, the especially everything programs our better. from to apply world all So,

enrollment that or to that XX. last AstraZeneca daratumumab Could XX MEDIXXXX on you sense? an rationale Thanks, decreased I is Joseph. for that have noticed study from down any comment And ClinicalTrials.gov just question, on I one

full present at the positive cancer and because It’s they're fully And or thinking present. what's on year. estimating give say stated to as data, next or couple we're to of sort look months by neck would next out they have and ClinicalTrials.gov, where AstraZeneca enough expecting the the midyear they they when patients head but quarter take where likely publicly we're sometime is looking Yes. on year, third want. study based and a they have but of we see really sense, And close that to what that

in XXXX. additional So, Phase arsenal terms XXXX in data X up Phase in and the I think meaningful that of X sets our expectations

you Great. color. I for the much Thank it. so appreciate

Thanks.

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

This Hi. taking on is thanks questions. Steve, and Ellen for for actually our

first year quarter just may the So, changed on have I wrong ‘XX. if ‘XX think, VGX-XXXX. first end guidance from there. I'm And me about correct to I believe

if it what this to wanting conference first data ‘XX? wondering update the quarter interim all? just dynamics to was at Thanks. or of just also wondering in And of kind that do if medical a quarter then, with related I be in that, So, from that present expect is to able first result at to points had enrollment we'd ‘XX specific just

Yes.

our dynamics have I in study. our you enrollment think X and studies and completed VIN We place AIN stated, were VIN data. meaningful XX you're patients in the and We point VGX-XXXX. Phase to referring to track. The on for to AIN study a on Yes. feel, present XX as patients

of data the in So, there's really presenting late not lot opportunities a fourth quarter.

So, first it we're quarter doing medical in at going year. next conference the be to a

of great. specifics X And X plans can have All REVEAL you for closer diagnostic the reading out? or about commercial right, to of that as kind outside and for then, gets talk VGX-XXXX any you tool any

ability have looking the future. with we're to interested and all potential can excited us option currently what patients last the preparations babies. that's who We're pre-cancer are we're this only couple then Yes, is for future certainly, the really, I on. we're of about with commercialization, all the into of very been for cervix talking readiness And cervical today partners for treatment suffering REVEAL data. term very excited work milestone. And do where after we lofting launch top that. And VGX-XXXX X negatively REVEAL impacting internal so years. full things have major to these data near layers mean, and who next X off for waiting their But We've about comes may multiple

and the we surgery. the the have can and solution immunotherapy HPV -- viruses XX can and treat think we that we XX cervix disease So, spare of disease, clear from an cause the

immunotherapy embrace cervical and And dysplasia, anal the indications, excited. for vulvar quite well. as and dysplasia a we we're other certainly will to think VGX-XXXX as option market So,

just the GBM XX Can months think you bar last XX and Okay, forward get next OS great. remind we’ll once readouts do see And to me baseline Thank data be move study. us OS-wise those will then, patient readouts, you. we year? what then along for additional one the just one those related to with additionally, you

Thanks for Ellen. the question,

So, numbers yes, standard general, anticipate XX XX% be or be then, and are to XX% months so and that overall at glioblastoma, -- of at in to alive OS-XX we similarly XX%, to to that upon XX% XX care standards would of use comers; patients expect around you would obviously, will be with the about XX%. based survival drop obviously alive using data current about at to again several all OS-XX if could published We look median months, fewer care. of And, there numbers. and

So we'll XX what at continue to the follow our are. data months, through standards XX a and look taking

CITC? be baseline, any it information Great. on be And limited what that or we patient will will there more to the then,

patient when So, you a say mean? tell me you what more about baseline, little bit

Yes.

So, patients full had just specifically surgical partial? or resection a

Sure.

first day of baseline are And would we more our these all obviously information zero, have the intervention. as set, importantly continue publish you'll we and to So, very as diagnosed. for know, our newly are you about data Again, our full our get study of that even yes, we therapeutic patients. from all day being data anticipate calculated data in patients the

great. Okay, you. Thank

Yes. you. Thank

ahead your from next RBC question. go Please Gregory Our with Capital from Markets. Renza comes question

guys. for Thanks my Hey, taking questions.

Hi, Greg.

just a XXXX potential. remarks prepared in Just the given follow GBM concept to of the mentioned, Joseph on global partner expansion in working study. with the you’ve and subsequently up and finding your

and just got then, as optimal matures this engagements on you point in about Thanks. of the cohort? perhaps well, what the this you us helpful. similarly, and maybe sort see if wondering as with Just Regeneron from you've the be program broadly agreements there remind partner a as could this I future think, detail just engagement arrangement any of would of And

like partner relationship regard. -- a with because licensed been Yes. a this in great we collaborator it’s Regeneron MEDIXXXX. for say full have one partnership, great has collaborator AstraZeneca blown not I the

licensed So, anyone. INO-XXXX has been to not

study. their providing Libtayo also Regeneron Now, the the of looking at get is before to everyone perhaps important -- They inhibitor the data, Libtayo benefit else. PD-X

advantage, and I partners. think, timing knowledge potential information over some For and have other that they advantage

perfect Regeneron So, big INO-XXXX GBM their have own for like other spoken with PD-LX would and for look or a But or a not partner PD-X perhaps lot other but pharmas we fields. obviously for Regeneron to inhibitors.

have are that equally with we and As shown combining almost effective immunotherapies or our inhibitors. PD-LX PD-X these

reminder, cancer is Regeneron and a nivolumab for have development AstraZeneca with our PD-X with Just PD-LX inhibitor entering with combination from their XXX, Bristol-Myers. prostate XXXX we combination just a study with

Regeneron adding any space someone something these other even in. is the Regeneron inhibitors space believe applying the can our therapies molecules. additional checkpoint inhibitor interested big in pharma that efficacy we global much effective of be the in perform combined I So, be competitors think like toxicity, with would their molecules, someone increasing very the any like without But, with to compared competitive or checkpoint make reach, better goal of XXXX to this

combine could WTX, mean, and toolbox, stated at I multi-cancer remarks they targeting is take product and But create PSMA. designed antigens to GBM prepared And where dozens with I do further. is -- which that be to product, great and in and a utilizing for the even antigens specific but part, tumor different patients GBM much to these more can the utilized XXXX then, its immunotherapy hTERT we prolific the program success for an more and of we great associated And in Inovio, can address cancer short this very way own. or just in have moment similarities this opportunity Nectar's for cancers, our on we inhibitors. potent multiple that's checkpoint combine to a novel antigens like

range trial can partner we about partner versatility think, efficacy, of its our global in that are I plans. bringing limited great small broad a fully on and the utilize So, as very have other forward. own, going GBM and this broader we be because potential but think will opportunities a certainly are excited we biotech, And resources

the REVEAL me one potentially you’re Great, some the appreciate about we what as I by full comment cut cadence And REVEAL we bit time. thinking Thank XX-week the safety of for the But can if full you spoke of having Would if for on thank that a XXXX just or at and X -- the that expect following around for X a fourth data. expect point wait on and landing a finer you. around for the efficacy you putting point? well sorry can plans, there Certainly, the more curious you and line on for I'm in the quarter. about year. you. some X just later top wait just curious to timing, will, next same that past about see

Great. for the Thanks question.

level focused REVEAL full for after the be So, on is the weeks top-line group XX REVEAL weeks will results. X. full XX efficacy for X, Full and safety

pretty throughout and Now, these to study XXX-patient study. any our already are haven't is which REVEAL using demonstrate week at identical of Xb our XXX-patient study. really XX seen any X We REVEAL much XX we our safety week DSMB signals meaning. of did X and safety Phase strong And

programs we as platform across confident our quite we're pipeline. with always So, our are

safety -- a for real concern us. is overly concerned So, not

Thank perhaps for maybe much. prospect of on level to then, very XXXX. stated having BLA And to adhere Great. your a just previously comment your you filing confidence of

X, REVEAL because will on the potentially X timeline of XXXX. it Well, execution support really REVEAL depends

So, the future. in have more guidance we should

from question Piper next go with from question. Raymond Please Jaffray. Chris comes Our your

for on Gabreski Nicole is This Chris. afternoon. Good

just questions. a I So, had few

So, program. the was on RRP first the

'XX. INO-XXXX of with pivotal of in for So initiation clinical half a trial first

have So, I sounds FDA. guys you discussions with it guess, like had

out to needs So, trial? point still endpoints color you regulators, for just the worked have and on any with what be at if this wondering

that. orphan still discussing So, we're This We studies to sizing in aggressive want a of be as well. indication. as and the as timing

And would expect to have to just of next our still in I So, delay, want -- We've think shown unveil come or and overstep will endpoint RRP be with that. say out objective I study By we discussion XXXX. few we as FDA, the we're an Clinical working the to here. But confidently But can getting immunotherapy a pilot that to is what is and to RRP. of our to endpoint. we in overall the way, the to be clinical not surgery while similar on the clinical ready all is manufacture clinical publication trial the yet avoid this the half use going starting design our this using potential we’ve PIs meaningful months study. motivated of first the overall RRP in to product, our been marshaled. in don't But

prepared behind look to more getting We the And so scenes. forward more detail sharing the is in information, future. everything

And second helpful. Thanks. a then, That's maybe question.

to Just GBM we some after X whether to literature the Phase around X that update, the back debate to translates GBM seems there overall survival. be just and notice went and PFS

of OS on kind to what your this just year? first the next is wanted So, thoughts level get to and confidence readout moving your just forward

that's future not I survival. predictability overall can the But split PFS-X actually, field Well, just on point. the of say, to the is

a projecting Jeffrey OS can for add data OS. we XX, not think, to is, less waiting in But, and excited progression-free are We're than will going and have be the I we're about six XX. breath less six in we we're than But, bated we will now now to have months have successful the OS with year we this. from from months survival. at point

hypothesis were question immune combines previous activating think We So, trying are can and saying XX, our think And by inhibitor, no able the we success correlate studies of OS-XX supporting correlate we is and if confident we're granularity have we're level approach any a success. the for you that better Jeffrey, highly to optimistic numbers. not brings PFS-X means OS-X efficacy. not to PFS-X that, and with that's to But to while, and address. checkpoint of that? so the predict very we we the far, right, would the add is more

for the agree Thanks, I completely Nicole you, question. with Yes, Joseph.

overall would Joseph, enabling cell you not excited overall like. is survival And an our survival have we exactly our T to are as data the on we said, have we to see look And I think, and move prognosticate, to endpoint. what responses very an I but those therapy what that we've things that immune give us two to confidence efficacy signal. demonstrated

would I our I say chances. like

Great. That's really Thank you. helpful.

Thanks.

McCarthy with from Maxim go comes Jason from question And our Please final today Group. question. your

congrats radiation those are GBM Naureen up it you? follow back indicated. of cohort on the -- was drill if I'd Good additional CITC, then I that could if the ClinicalTrials.gov, on of to So, Hi. This with some up was six suggests a entire received the study, actually, GBM the we But, How TMZ and the In Jason. cohort questions. may is Hi. to the And TMZ a design when the poster afternoon. data. cycles. at number regards like actually on just says clinically for wondering, it down trial additional I look there. receive methylated patients it bit to little

I data chemo if could B will subgroup provide or if entire was breakdown the there within received it future? a was it's So, not a the clarity cohort this, well if be the the if on on cohort? as wondering you of in And that cohort, the was additional bit there a entire

the for Naureen, Thanks, question.

So, on you've exactly on went or Temozolomide suggested, and cycles. they MGMT patients unmethylated, patients as of And promoter MGMT cohort indicated, all MGMT were adjuvant six you the radiation to concurrently. as three of up weeks received three on all then, methylated whether B, to study, patients methylated Temozolomide receive exactly promoter methylated the weeks

then were those cycles. and Temozolomide all that to again, up for six Temozolomide additional So, weeks; and radiation received receive three methylated patients

standard a for is this of care So, populations. these

directions us conduct to the the and and the follow of trial. the trial we FDA the KOLs yes, execute who helped us from So, our helped design

said have these actually And the you or and decrease study, of people there results. past. checkpoints, in in just I suggested your with sense. because at or up brought steroids not Thank I least checkpoint them a wondering, in failed efficacy all But was have And this study. makes normally compelling the past, for have that past a the in need of you. That the is it’s actually steroids

population wondering was on was counteract that, checkpoint on as have to I steroid what of just use and I So, able are a its inhibitory were platform there the steroid thoughts you -- wondering actually promote to population, was percentage to the any steroid what thoughts whether that. of effect used the in is activity. patient on and if your actually all

question. Jeffrey? Great

that’s Naureen, a Yes. great question.

one-two as in that as field. a mentioned, been mentioned, data those we we from disappointed the the were at agent themselves very with opinion checkpoint plus therapy certainly worked enabling immune checkpoint come has studies. response. protocol steroids But before, suppressive part and Joseph they an the We designed in generating the in increasing T for efficacy. So, combining give, can have tumor, of course our of studies INO-XXXX when of cell agent Many feel the point, INO-XXXX, closely single to Joseph you that very key with single opportunity said really punch to the leaders we like your as be our whom

bring an to And for so, data used does And presentation study pay all data those when information. upcoming that forthcoming amount was scientific we and we in the did that should collect of our steroid attention and control be together. those

setting. may considered in also just a similar work has it’s and in been the study, checkpoints far potential you one more with ahead, I some suggestion but hear. actually on to GBM better know great speaking the INOXXXX such follow-up, again, have neoadjuvant That’s setting? there study that

The closely been papers of the one And KOLs to aware literature. looking with. That’s as have of you or the those that we are in is, short answer of at are recently neoadjuvant thankfully, checkpoint we outstanding an question. to more publications have course, GBM. very interface the several authors opportunity paying attention And there

data the all this and keep opportunities based trial. So, literature we open to upon are science. excited emerging the and see from we the

time, to conference question-and-answer gentlemen at the any that to for and Joseph closing Kim And with session. ladies this back over remarks. call today's like And I'd we will turn conclude

Thank to much. awesome. be going very tuned. Thank you Stay you. XXXX is

Ladies for do conference attending today's and will gentlemen, call. presentation. that today's We conclude thank you

now may your You disconnect lines.