Earnings call transcript Q4 2022

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Operator

Good afternoon, and welcome to the Inovio Pharmaceuticals Fourth Quarter 2022 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.

Thomas Hong

Good afternoon, and thank you for joining the Inovio 2022 Fourth Quarter and Full Year Financial Results Conference Call.

call today's on me are Dr. Joining President Shea, and CEO; Dr. and Jacque Chief Michael Mr. Officer; and Sumner, Medical Kies, Peter Officer. Financial Chief

We also our have with us other members of who be Innovia's will part of Q&A today, session. leadership here

and update review platform. our DNA as financial the XX, Today's call efforts year provide to corporate December an will ended as medicines our information and for quarter on well our XXXX, develop

we remarks, prepared will question-and-answer Following conduct segment. a

of we call, develop and be making company. regarding to statements relate events capital performance platform, Inovio's which to will forward-looking the include regulatory future our future clinical of resources clinical along During timing data the medicines plans with events strategic These and and the business and readouts, developments DNA matters.

on as of and based the All beliefs of of management statements expectations today. these are

replay or cause results results with to time to Risk Factors factors materially. file shortly by expressed We identify verbally under is is heading the differ call this be materially time press we documents could website, within afternoon's as on link and made available call be statements the This actual refer our important ir.inovio.com, the to could a well Actual and differ made found you webcast release. from from can those the which after live, being this as a will SEC events concluded. company that

to President CEO, and Inovio's over Dr. call the turn Shea. now will I Jacque

Jacqueline Shea

programs for commercial probability to pipeline regulatory has you, our difficult strongest today's potential. Thank on to taken times and highest at of success everyone In focus joining and steps the to the and afternoon, you thank year, and our measured Thomas. call. clinical past Inovio Good with prioritize

Dr. of Later the we Inovio to Mike from the trial to will as today, medicines of RRP, line on our VGX-XXXX and DNA X we of a release our financial INO-XXXX Sumner, diseases. best call, are potential papillomatosis, announced work for in and programs for Guided the by Chief advance some operational detailed realize In respiratory which patients. I'd our as provide REVEAL this like press excellence the trial summary to our our take positioning about Officer, commitment highlight or key a clinical top to our of treatment discipline, but recurrent both potential X our points Medical opportunity REVEAL are well clinical HPV-related programs, as key results

made As to you participants REVEAL year, April in may recall, all decision this of We biomarker defined likely treatment from on data changed analysis last from REVEAL an the population endpoint X an we based respond that investigational identify population. primary selective those an to of our we to signature women which may with VGX-XXXX. from to more the have investigational have biomarker potential X

biomarker lesion X, in for of selective endpoint and primary REVEAL not the significance viral statistical the regression VGX-XXXX achieve clearance. In did population

However, all primary The trial population. VGX-XXXX and the viral regression achieve did statistical for original participants' endpoint population significance lesion the in clearance. of the for

that we've lesions. HPV-related combined X and package virus and trials, build the that clear now the considerable the obtained indicate multiple X HPV DNA Furthermore, upon and over data potentially X trials REVEAL medicines able the across participants regress clinical REVEAL or are data to data REVEAL

those RRP, life trial. patients' second cohorts where strengthens RRP and a has INO-XXXX terrible can believe to also in overwhelming HPV-related our first encouraging the X/X including other data truly we that the quality disease. INO-XXXX confidence is It suffering programs, burden recently the a in of our for from alleviate And we for this be lives. this from from and improve potential reported devastating Phase help disease in

coming the to months. on you forward development, our progress I sharing updates to on advancing stage the with and focused of INO-XXXX are in We next look

an announced a a in positive injection we previously Moving vaccine received Phase evaluating Last have adult as an clinical healthy on DNA FDA-approved as of primary vaccine be trial that Xb against candidate part diseases, who us medical global to boost for our results Ebola. countermeasures as infectious We single INO-XXXX booster participants existing believe important supports either infectious our this Ovivo, from could of vaccines. month, vaccines, portfolio. a data medicines disease or to position

threat diseases Infectious an ever-present Ebola, remain like globally.

in INO-XXXX. partners potential and development discussions for We also are currently steps the with next collaborators regarding our

to position. to our emphasis will addition the cash reduce we burn Peter since to the clinical strengthen financial pipeline the In discipline working financial provide has on prioritization last front, details, have progress us but allowed excellence our substantially and on been our operational year.

runway Given these to XXXX. into Inovio to high continue underpin of our process Financial us decision-making be area an prudence first expected efforts, of will forward. at is going take cash the importance our quarter and

that, detailed With more on and a I'd the over Mike call update to recent clinical like to provide to highlights. Mike? turn our pipeline

Michael Sumner

I'd sharing release. talking everyone. and today to VGX-XXXX press announced much, REVEAL by more like the Thank on results very detailed some you in X start about and financial our greetings, insights we Jacque, today

for efficacy, as and regression immunogenicity of REVEAL virus to cervical VGX-XXXX treat of a and the tolerability endpoint. trials with REVEAL HPV-XX/XX associated primary safety, HSIL. Both lesions trials along used program included X X-dose intraepithelial of treatment X Phase or high-grade clearance and Our VGX-XXXX III lesions cervical X, includes the regimen evaluating squamous the

XXXX, endpoint But biomarker population. evaluated investigational the the to REVEAL trial. against trial on the of X, quarter X in REVEAL all participants in selected focus In we clinical second amended was the

described, decision potential to likely the an we we this have signature those biomarker data Jacque made on may that identify with in VGX-XXXX. women which treatment to defined more to our based X, respond analysis investigational of As from had REVEAL

would X trials that be or the was had indicated no biomarker additional and trial lead selective application that pivotal population. license to longer for publicly REVEAL would required. biologics Food announced Since amendment, to a an a to we be deemed Drug Due U.S. not and that a trial Administration

population statistical significance. REVEAL achieve As the participant shows the next results intent-to-treat not the from slide all did X in

a indeed did intent-to-treat significance. reach population However, modified

Following of or primary percentage group. placebo participants statistically the out the versus was result X of group was zero the XX out the of in XX.X% biomarker REVEAL primary also population participants the of significant. in four in the meeting change treatment The endpoint X, the the in not endpoint

shows The and two the in the right side you REVEAL next two X that can results quadrant. populations just slide the studies We bottom discussed by detail. see in side biomarker more

the participants group group the patients top versus in X, the meeting treatment green statistical quadrant the XX.X% However, group. all in the The right percentage in in significance. REVEAL X.X% achieve did endpoint was in shown of placebo

than REVEAL saw X. we observed in higher effect treatment the addition, In was

slide, clearance in significance for participants treated all the group. of X.X% on the placebo shown also XX.X% we achieving viral population viral not with statistical achieved group, in versus the While clearance in the X REVEAL

programs. of for importance have clearance HPV-related our may other removing positive data the Given the in underlying viral this implications of diseases, cause HPV-related the

Next, and we performed can biomarker the at that populations. integrated both ad analysis efficacy results utilize analysis of REVEAL participant hoc we Since both This the look same results. X. from endpoint, the the significance X we statistical and in trials an all in integrated the these achieved showed

the treatment of group. For in XX.X% of meeting participants, group group versus group, the percentage XX were was XX the of the which placebo in in biomarker combined the and participants the endpoint the placebo XX.X% consisted XX in population, treatment which

population in which in treatment group. meeting participants percentage XXX For the in and group the of group was the of the X.X% of The in placebo the XXX group. all participants, the participants treatment endpoint were combined placebo XXX XX% versus

forward considered X in to set to HSIL. trial, moderate. the and in be this REVEAL cervical respect REVEAL continue consistent will Inovio serious VGX-XXXX what combined will there evaluate safety results was mild With be to observed path the in for to events, adverse the supportive no in events regulatory X. treatment-related adverse These were data results were future And were interactions. to with determine most

to the plan this for data publication submit in journal year. also later a peer-reviewed We

While treatment meet particularly diseases. announced brings as me for to These data the give recently well of confidence am X development, that INO-XXXX not stage I the also encouraged up population, results next handed HPV-related suited indicates we RRP DNA the REVEAL for disappointed additional the medicines to treat endpoint that we which for biomarker the in be by may primary further it of data as advance INO-XXXX. the us at into did

open-label of interleukin-XX a medicine a was RRP. composed XX DNA in HPV candidate As encoding XX, EX X two the immunotherapy in safety, an adjuvant trial its one encoding second plasmids, and for INO-XXXX and This evaluated EX and efficacy to tolerability, INO-XXXX, a to the immune reminder, as an X associated for and/or HPV immunogenicity is HPV patients assess and multi-center with DNA plasmid boost human response.

and In prior day and was a doses once into the Enrollment in cohorts were received during including nine. minimum cohorts, dose both for two to dosing four patients any to was year weeks baseline, zero three, required performed There trial. the treatment. counted in against prior establish day the surgeries disease X two order on INO-XXXX the of performed in this two efficacy. trial six a the surgery first following Surgery but to weeks window of

interventions, the second reported echoing in results clinical significance from data port on using needle. announced of reduction the INO-XXXX the we cohort cohort preliminary administered data statistical a XX from cohort exploratory from number achieved month, of who the of in the second were positive The XXXX. of side surgical the Last first based patients. October endpoint

of in the treatment. the Of reduction XX during year surgical patients trial patients, XX a the we of saw required intervention second or those decrease saw X XX XX% cohort, median interventions a period. the In X following no in in surgical interventions, XX-week particular, surgical

cellular interventions prior responses with XX and the had HPV both induced cellular after to HPV against between X T treatment X also CDX were these of patients median In activated cells. and X indicating INO-XXXX, treatment, persistent was cell year XX a CDX at XX, X. T Treatment inducing surgical activated responses and which weeks both XX, memory final with response. a week lytic observed

viral we key RRP. believe of could be response previously, in this such memory As as we factor treatment the a mentioned chronic diseases

reported observed fatigue have commonly DNA injection generally all we was seen most our low in cohorts adverse AEs. grade were and with INO-XXXX trial participants with events As both the the medicines, well and the in other pain first second tolerated course. being site treatment the Treatment-emergent completing with

not from data of just the both compared these important, in is can RRP. found more the of XX% INO-XXXX XX interventions the impact, but importantly, from have of of show potential a saw incredibly suffering or XX that the year. the the shows it to potential on We patients participants because previous results surgical they platform, because combined, our reduction number When cohorts

after and change this of photos This the required two trial before required on the in the airway management from show year prior that patient as of our had instance, in the slide surgeries improvement For in one trial. the which the was treatment. frequent a in patients from surgeries treatment. marked can on you perspective But this clinical patient to no there see the meant the right, following disease,

patient next the disease. of visible the slide, the can is in on And see on the day here you improvement this airway, completion residual surgery after tremendous. some of INO-XXXX impact patient any need the X is In did side disease more The much through this trial. significant a XX-week while of not with right

to and less to be procedures patients, even investigators surgery, on schedule for patients reduction that their from heard have around disease. have life-changing in control any entire often would surgical lives who their surgery We

an are for impact of could results the potentially X/X Phase the Our community. have RRP indication INO-XXXX positive

in to need. the the bring treatment to for with RRP to this regulatory the and next the of discuss expeditious in steps most We agencies discussions this potential determine are benefits patients path currently program

the We the goal to in we globally and advance with continue recruiting next discussions next clinical stage have to of with for Europe trial. to as development U.S. KOLs plan the

year. important about excited also Broncho-Esophageal data providing at conference. presenting Phase our trial at data We the look additional to in be this Association May X/X our of details at COSM We American are this to forward

candidate press on release. product to like today's is I'd mentioned our other turn cancers. for to HPV-related INO-XXXX the few candidates treatment of updates Now a in

asset recall, in us As returned the was you from may XXXX AstraZeneca. to

ORR, Updated partial combination immunogenicity a in safety in published results durvalumab, Xb/Xa clinical XX.X% of or trial, antitumor responses evaluating included of was which a the an activity meant PD-LX from rate, have tolerability inhibitor. and number complete Phase recently to and research cancer and which ORR from improved updated been and response used from both when X XX.X%, the X. to The responses checkpoint INO-XXXX increased with overall

development Therefore, INO-XXXX INO-XXXX. reevaluation We date forward. the our the steps program to currently believe move next from evaluating of results and also to we collaborators supports HPV are the potential

year trial from additional the with Turning we evaluating announced data to inhibitor, PD-X in our overall survival combination of Libtayo. INO-XXXX INO-XXXX. Last at ASCO,

We steps in next discussions the regarding are this with for Regeneron program.

immunogenicity combined months. believe profile be and the and to the coming the with we Given when investigated, provide should asset to tolerability plan in we survival continue data additional this updates

infectious our disease single from participants only evaluating to Ovivo, the results early front, a for injection On announced phase of healthy INO-XXXX as boost adult previously received the trial in had vaccine we clinical Ebola. also positive FDA-approved vaccine a who

As you to infectious an we medical earlier, global countermeasures from play have heard of against Jacque diseases. role as DNA medicines part believe important

We to regulatory steps what collaborators input move regarding seek are need product and with we'll currently and this forward. discussions in partners take to potential next we

in half the will to this We be hopefully update a further year. second of able provide

busy, ahead. for been responses, for a DNA suited are as treatment to and Attributes conditions. our profile, response viral could a chronic the and have believe important well-tolerated such medicines in cell see, the as diseases. medicines durable we've an exciting you As role play lack antivector We of we ability of DNA of therapeutics work T HPV-related lot well can readminister

about stage next pipeline We development. of the are to truly taking excited our

Kies, now Peter? summary. for the over I'll Peter financial to call turn full and XXXX quarter CFO, fourth our year our

Peter Kies

quarter you, to cash $XXX $XXX.X equivalents in XX, with fourth investments Thank December XXXX. as cash, of We and XXXX finished of million Michael. the short-term compared million

basis. XXX shares December outstanding million XXX.X XXXX, a diluted of outstanding had on XX, fully million As shares common Inovio and common

was and year our U.S. fulfillment $XXX the $XXX.X obligations under compared million and and for Department the $XXX,XXX million from revenue and Total XX, XXXX the to respectively. quarter period $XX.X same The $XXX,XXX ended in increase million the the with of XXXX, in million in quarter million ended for XX, December for and $XX.X operating compared $X.X Defense. were December same million year total to the of period revenue year-over-year and $XXX.X resulted contract Our XXXX. for expenses XXXX,

XX, XX, million per the Our basic and million or $X.XX per XXXX. net or and compared XXXX, December the was dilutive, or for loss dilutive, share $XXX.X and to and and net quarter or a December of million dilutive, basic $XXX.X loss ended per ended basic million dilutive and $X.XX share share respectively, year and $XXX.X for share and $X.XX quarter basic $X.XX per year $XX.X

expenses million $XXX.X and in development to decrease year-end clinical period outside December lower year-over-year $XX.X VGX-XXXX. for to compared million manufacturing, INO-XXXX respectively, million Research to were quarter and was XX, in expenses and $XXX.X and R&D XXXX. $XX.X same primarily the million, XXXX, services related and The expenses related and for drug the

grant recorded engineering acquisition development related agreements. were related for And well manufacturing $XX.X by automation array research equipment INO-XXXX to also expenses and the lower These nonrecurring offset from device XXXX, lower expenses selective as decreases million, installation to and as during and expenses XPSP our services contra project. of

to of well expenses million a $XX million million action and primarily in XX, periods the related securities The severance settlement and the as $XX for $XX.X and settlement million litigation, same administrative quarter December were was of costs Inovio's issuance million, litigation G&A expense XXXX. onetime the part XXXX of as and General in other to expenses common increase versus the expenses. noncash related stock including $X.X as for due class respectively, $XX year ended $XX.X year-over-year and in million

funds of at-the-market forward, burn Looking projections raised do for first XXXX of other our not a $XX estimate capital-raising program include XXXX. These through runway or cash the existing may into be quarter activities. projected our includes any that approximately first million quarter cash

our release afternoon's full can find the press you as XX-K filed this our as reminder, statements well in financial in a with Form As SEC.

that, back with Jacque. And to I'll turn it

Jacqueline Shea

answer Thanks, up any might Peter. to to you open have. like now Operator? I'd the questions call

Operator

[Operator comes Singh Oppenheimer. Instructions] Hartaj today first from Our question with

Hartaj Singh

forward had had And mentioned the that Great. And X population. at questions, X biomarker-selected just of is you're it's REVEAL got then as learned in I you you patient thanks that from imagine for other and And more trial, all lot you various learning a quick Can the a look trial at One quick going data. you ones. couple REVEAL us that looking projects? comers you're number RRP the one, going and help to patient after. with understand that a you trials how with follow-up I you other how helps That's help population? just just

Jacqueline Shea

Thanks, from Hartaj, nice hear to you.

to top-level So to sort more comment comments going I'm I'll and in hand off of to kick detail. provide over some and Mike then

now and So that earlier that seen indication and those for be across And with across think X I and trial anal we've II X clearance we're REVEAL able really REVEAL different factor to we've common regression. of the for seen our really think the VGX-XXXX RRP, the and seeing from and from Phase all VGX-XXXX indications. ability encouraging also to a that lesion viral is that's see I thing

we think tissue significance did really I to well particularly I whilst did important HPV-related in reach strengthens all-comers belief selected viral regression our significance is medicines we reach diseases. And conviction the against think And in population, against data. And addressing it and X. really in and statistical the that suited this tissue DNA are our biomarker not statistical REVEAL clearance population really

I'll some And Mike over with specific Mike? more to to hand that, it make comments.

Michael Sumner

nice and you speak to Thank you, Jacque, to again.

points. think, Jacque obviously, hit all I on the main

at -- our got ago. I the and the do a rightly biomarker we as in week data We more population. the understand only start, to have really said obviously think you about work hands

that. for start to examining us early very it's So

of to regimen as in I is Jacque promising. the think mean, RRP with think IL-XX really foundation of particularly we an is include I And said, fact patients mean, as also a personally, think virus, which the our about clear when able for we disease XX% you I HPV-related disorders treatment I product, their the the me, of X are adjuvant. also

So we're hoping.

do able greater We're than to get less XX% of the year. previous have saw, you And surgeries as efficacy. we have actually subjects

across just all So you seen HPV-related diseases. that I I confident, just treat can we've programs. mean think we're the think, of the data entirety put our now I we

Hartaj Singh

is got what of which looking are just HSIL, -- these going Inovio, preclinical kind that as you into on you of as want with targets go of that into are kind with medicines? the your you're technology -- better certainty kind effect then clinic guess, getting that, GBM you bringing program targets you so -- follow-up Regeneron, to platform are I you've able visibility lead now a other the at? coming preclinical better RRP, sort after, And have to of you learnings at is have DNA in greater

Jacqueline Shea

potential. interesting medicines a question. And remain medicine say as strongest path mean regulatory I to commercial by DNA that's globally possible. would the on clear candidates bring market to we really life-saving as and that's advancing quickly for patients have of scientific our And benefit that really the promise, innovative desire our underpinned greatest focused I DNA

able disease, have infectious we With many disease, HPV-related candidates I across we're things. our mean do platform, to different immuno-oncology.

We DNA-delivered earlier also preclinical then have some clinical programs and antibodies of further in in terms development early work. monoclonal

with to what medicines I seeing really we're HPV-related potentially diseases. But our is our think treat ability DNA now

we excited some immuno-oncology other also do how it's also to in to very to think more see to cancers, cancers both that other in chronic I but the viral may very think can broadly. space, HPV-related diseases. what translate we're I And going in see interesting be

So really few had what us opportunities the analyzing and best where medicines data a I on to down to we're really for see of years, DNA patients lot digging get focus it really that readouts, and to are narrow down more do life-saving And we think products of data. past encouraging lot a data potentially and to think tells we've the quickly.

that... So I hope

Operator

question is from The Markets. Capital RBC Renza with next Gregory

Unidentified Analyst

It's Anish on for Greg.

How Just relative pipeline about a investment the the each? me prioritization should and of quick here. in think for programs one your we

Jacqueline Shea

the mentioned DNA well. pathway commercial strongest our the on scientific all, I potential advancing a we of forward going promise, my candidates really we're in as greatest we where previous as first regulatory So and think clear medicine response, focused have

we're really that's and So evaluate different as what looking we these assess opportunities. at

really and that We've the was of further to in what months. in lot process had the a data really updates we'll through as move months. our quite over be said, moment, We're candidates, some at order. and that sitting going prioritizing the how going data over And coming on down, providing I we're the boards recent

Unidentified Analyst

my difference up, And to you've given into a your capital programs, there Great. Is just investment just prudent and taking of just of each resource sort follow the question of the to part the second relative been in of time approach there. allocation?

Jacqueline Shea

Yes.

what we're next lines, dependent our our looking the pipeline, cetera. really considering programs, what are, the that. when allocating costs, across So the regulatory obviously, are, on we're paths different time likely resources we're across And steps et

that the I as discussions there. think mentioned, steps coming about be for to down and sitting be Mike announcements in program as to RRP. out So the path the next forward And going with then we're banking may regulators months. over the we'll figuring We're currently

as as forward. and can proceed need into data. recent mentioned, VGX-XXXX really out this we we figure well is this dig very what to to For might We the going want from how learn down he

that need consideration. we indications for product take as well We candidate into have to this also other

Operator

is from question Meacham of next Geoff The America. Bank with

Charlie Young

for Young on Charlie is Geoff. This

kind part So guess I two have of I questions.

appetite small. whether you reason wondering is to the one I'm terms REVEAL here that patients number relatively can the in not X. tested is, the for enrolled have biomarkers is, provide of why a And were why maybe the details statistic we're fact been First seeing trial of in this due

biomarkers like patients? the follow-up why to So trial a this. a statistic after the to the And the I have going is And the on power? that's see reason we're in

Jacqueline Shea

I interesting are questions. those think

the how going might selected may biomarker be forward. I'm to Mike? our population to biomarker-selected now hand Mike So going recollect it the as implications as call, selected over using to to we details what some biomarker. you was and provide potential from investigational that the further

Michael Sumner

Yes.

a X, And analysis biomarker disclosed context other have the saw we'll present, at can in our population full detailed REVEAL sort we as X what we without what saw what that, well as in I treatment was. that So both do as REVEAL of affect of impacts the sort full on and of efficacy. of signal think, we not

for that the I to about moment. at think talk premature would little it us just be a

your I the in with comment rate obviously, the I it a mean to what saw biomarker from around power, saw powering really, on to did a of a mean, we expect number we X. issue have genuinely selective efficacy biomarker REVEAL But the wasn't based subjects higher we study. I population. mean lower

really So do the people makes to tell to what back that's that at that will and just so can biomarker went that data want on into what dig moment, happened, we and at be come what we us stage not doing the that work. and we're understand the but really population in

Jacqueline Shea

to enrolled retrospectively. the Yes. remember applied were that mean, should biomarker. And that if I the was not of were The can just on these that, basis we add trials Mike. biomarker I

developed the had of the biomarker to selective X would biomarker for And clear why or REVEAL FDA, And think seen X. became in population. part with what was we be this we signature that discussions reason I REVEAL have it exploratory defined need in the based that on

Charlie Young

development provide mentioned in you just some details into rate of -- And question. press a Can so that program? impact a RRP the you. of assumptions run GBM guess, the your you in and for I XXXX. different in Thank maybe runway? terms cash of you just the first Can the next the release steps -- follow-up And will on would quarter terms cash maybe how that on the

Peter Kies

I'll take that.

Jacqueline Shea

Peter. Thanks,

Peter Kies

costs shifting over you're increase you're ready. the We expenses then the the our in our program, going there'll developments the into to money but programs. from into seeing to So down and programs. -- still down have increase wind XPSP and few GBM a an wind commercial is get XPSP slight and annual those the be what seeing COVID RRP programs. in

anticipate and quarter, that forward lead the year, the trial the get of Phase that will RP beginning X X is the the we end FDA fourth Right toward to we able regulatory upon probably to those And move Phase now, costs. cover third of of the does approval quarter. one programs from of majority started be the

Operator

is Roger Please The Song go next Jefferies. with ahead. question from

Roger Song

taking the Thank the detail. question. a ones for Maybe Great. you few for

the expected. patient First, REVEAL biomarker I than be think seem you to of the trial, be for patients lower seems to lower, number the mentioned the

what after will have just a biomarker-driven thoughts look set of I the from population also So the market strategy? improve is population Thank any the data in given now to trials, expected a around have percentage curious general the you. how like you that. upon both and follow-up

Jacqueline Shea

Okay. Thanks, Mike. Roger. I'm questions going to hand Mike? those over to

Michael Sumner

Yes.

as the of it patients. actually we was look you -- at level from accounted biomarker presented those patients population, for And when X XX% the trial, efficacy So presentation, the at in in during frequency XX.X%. an REVEAL the terms of XXX within the

on when to population, investigate there. that a come there to difference we REVEAL was you obviously, need the X So

you -- what And what's my into data REVEAL appropriate the see an data I look the in was so to investigational dig think in double I and of I mean, need They on. that think going the But to yes, there biomarker about had answer. when Jacque mentioned, to -- set. X amount have We was to it on so improve, the population as terms signature. a for the so data of second back the team mean, to REVEAL only how now goes previous X work

delve to more into lot biomarker there's we've and signature can see really a more leads us do the a team think I once data. got where that So our on hands

Roger Song

for later stage patient criteria given the as for that you size to And a us endpoints can investigation RRP, trial criteria development? global you. sense. the Yes, one and want do the the is key the consistent it. so just then Thank of do how you Got makes and that what for across surgery remind to

Jacqueline Shea

investigators Yes. question, and really study you across and talking we've U.S. we Roger. might study, working using with recollect Europe. how expand Phase to other been That's good we X/X and to as the sites actually were closely a multiple the if And for our KOLs

surgery ask I'm variable on to comment criteria the disease Mike and the for But going to how be. can

Michael Sumner

Yes.

So surgical of look a how trial, receive the was the in when specify didn't patient at and really and we decision when the the clinician. you surgery. ultimately between current intervention sort It patients treating the could

can the of things imagine, because efficacy. a one surgery indicator of key you is As

we a need But we're a of And how aspect to that trial. to bodies. try important standardize discussions But move position design we thinking can criteria is that will in at disclose have with we what that an and going be the that is the next of the present, as trial. we We about. regulatory registration not it one we're toward

Jacqueline Shea

And here. just we're the they lives, a is hearing needle add really are in investigators from what for the -- the thing an for I patients. reduction major and that's improvement That's we're in What really patients, surgeries. if of number patients' hearing will and move that can looking impact from on

So more we on more do, are surgery. work but be to focused discussions really to had,

Operator

H.C. from ahead. is Wainwright. question Please Chen go Next Yi with

Yi Chen

taking for Thank my you questions.

available? are REVEAL biomarker the other utilizing question the that is X, some REVEAL Or and candidate First there in biomarkers? is you're X only biomarker

Jacqueline Shea

question. important really a That's Yi. Yes,

about So to to I'm hand going bit strategy. talk to Mike a our over biomarker

Michael Sumner

I'm that of at we at data bad I level always not haven't disclosed to have signature actually select because So that only in looked biomarker afraid. the was biomarker again, the as about more we much we detail give the this. so the information But we biomarker -- can't population The too used moment, feel database. will I the that primary

Jacqueline Shea

data these to over think though I some need very going come and dig further very can our working down we It's to with partner, develop to we're for us back is this it you biomarkers. coming new. to QIAGEN, and with into recent we're what is the months. And hopefully, say updates

Yi Chen

Got it. FDA that have say Did the use trials biomarker? a to future

Michael Sumner

switching did a for more I they to don't in BLA became population. data exploratory we have it investigator X trials to stipulated decision had our in from we the do or have or our the could proposal population, before That we to that biomarker what believe we study, more a file of them. in that they mean, one say after would and I terms do was two by biomarker REVEAL investigational to saw the that. will

Yi Chen

both it. mean fact but combined that biomarker mean the the significance. does data results? population And Got statistical set sell biomarker selected doesn't population that Does really the much add for to Okay. the the did the amortization I final the and the

Michael Sumner

I XX%. mean, clearly, guess I the in it depends I group add was, the doesn't But what in by efficacy biomarker-selected you population mean the believe, rate much. combined it

significantly efficacy that population. So seen I there mean was a in increased

of nature clearly So there of an I biomarker. mean, indication a predictive that was

Operator

Shea our I This to conference back turn any closing like session. over concludes to for the Jacque question-and-answer would remarks.

Jacqueline Shea

financial our programs, our to underpinned by of the discipline with for steps DNA today, Thank you prioritize patients. key on and to measured with to the and such clinical today. questions to success and excellence and potential our of in potential. your -- our coming of our programs to the as medicines and commitment development and INO-XXXX the taken plans the lives These everyone We're about operational us joining excited updates stage on providing probability the our in To quarters. improve as on of you progress regulatory steps strongest clinical our next heard call pipeline belief advance forward to the look focus year, you've in and the summarize, are to past we've highest commercial efforts

With that, thank your have attention, and everyone. again a you great for evening,

Inovio Pharmaceuticals (INO) 1 Mar 232022 Q4 Earnings call transcript