INO - Earnings call transcript Q4 2020 | Inovio Pharmaceuticals, Inc.

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Operator

Good day and welcome to the Inovio Fourth Quarter 2020 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today’s presentation, there’ll be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Ben Matone. ahead. go Please

Ben Matone

Good Inovio operator. conference thank for you Thank quarter afternoon and the fourth earnings year joining you, and end call. XXXX

Kim, X Officer; Peter call are Operating Dr. Officer; the the Humeau, President Chief Joseph and Chief Laurent Scientific On Jackie Shea, and Senior clinical CEO; Kate the Vice President Chief Kies, from Mr. Senior Vice Prakash Dr. Bhuyan, X, dysplasia. cervical President Dr. Broderick, for Financial REVEAL Clinical trial of Medical Dr. Officer; Dr. Development and company’s for Research Phase and company Development; Lead of

release ir.inovio.com, made For clinical program and we review full programs call X. REVEAL our regarding progress, financial an Phase as and known quarter X December today’s cervical ended provide live call, a This XXXX, website, which be and XX, includes vaccine replay for our and available. for on corporate our year well clinical fourth our dysplasia study will COVID-XX our on as the webcast as is information being today’s will update

conducting remarks, question-and-answer prepared be research a will we equity segment reserved analysts. Following for

These the During performance of forward-looking capital statements which pandemic clinical and COVID-XX be the with of call, making matters, and clinical of and future resources and operations. the the our along include events business medicines, readouts, the strategic integrated impact DNA well course will regarding business regulatory of to developments timing on data and platform as of Inovio’s this as we events company. plans Inovio’s relate future develop

a certain cause results revise of We no new of management beliefs the uncertainties to differ as and President forward-looking with the or that today. information, result in to could these uncertainties of actual of would as SEC. All on well and based in filing obligation update These events Kim. factors today’s whether the to involve press statements risks are and the statements, as materially. Inovio’s turn or included risk assume CEO, read assumptions, statements and carefully risks call now described Dr. like Investors the release XX-K otherwise. should Joseph to future today’s as I over expectations

Joseph Kim

you, everyone. Thank afternoon, good Ben, and

VGX-XXXX want this ensure We have afternoon’s we time X cover lot to discuss And key programs allow I to our following Phase for questions. announcement. other a and endless

high-grade that COVID-XX means REVEAL While the commercialization and DNA want underlying validation. VGX-XXXX the Today’s efficacy data option for platform positive Later and/or over anticipated our the medicine validating Inovio our areas Dr. these of REVEAL milestone who is vaccine which news for announcement avoid represents COVID-XX HPV-XX of of discuss our all big current potential afternoon’s regression X to place. and from REVEAL therapeutic latest on women we in get further multiple spend mean which in for the developments data and our release time will on the and deep first Inovio? technology, vaccine patients about of know the a that CFO, Inovio’s giant and what of and Today pipeline, some currently for the strong for years. our you focus. Kate to top for does our data the program, programs. platform caused doses of clinical towards Phase in X landscape Bhuyan represents standard trial therapeutic X a resulted XX Peter company to the surgery, and would supports dysplasia the reported who responders, company’s therapeutic updates development forward is care. company. financial step like HPV several next clearance position will suffer virus, that Kies data cervical support to data in Also dysplasia technology This products I What are high-grade outline latest first also the The this our in Broderick call, by HPV both eager first a announcement three X Inovio’s Dr. all Prakash of for of today’s demonstrated

proud in and clinical of team staff especially non-surgical pandemic. VGX-XXXX commercialization, well closer global thankful are to dedicated We option, therapeutic Phase efficacy another volunteers, of needed medicine as as study all am development partners, a much as Inovio advance the are who so a a DNA to in in the first for VGX-XXXX I bringing achieve trial endpoints X to as to step trial. face the

months age have continues countries, HSIL. to it turn enroll XX these and in X want VGX-XXXX durability assess safety be placebo eight Dr. U.S. REVEAL women REVEAL administration of confirmed with either the efficacy responses are to who do for the remind greater over depths, dysplasia or with cervical to this REVEAL across tolerability I last X is including to designed will in two X and confirm data treatment that and trials or I first trial and Bhuyan, the the discuss for safety will the following of XX VGX-XXXX Phase years trials older, HSIL, later subjects continue to everyone the REVEAL Before year. followed still of of X trials VGX-XXXX ongoing. histologically of cervical for who or of completing X Both are

sequencing will XX% based help it expanded VGX-XXXX the to goal assessment which by subjects. Xb who raises tests to attractiveness over post-hoc diagnostic where patients the better VGX-XXXX, identify of RNA the agreement eventual Inovio is have QIAGEN Dr. technology the to diagnostic collaboration So the to to pre-treatment to companion project of The would with biomarker optimizing week, the the towards of employed like that, clinical for REVEAL eye this blood profile licensure of of last plan technology to in a likely patients to to on the X co-develop VGX-XXXX compliments data guide respond to prospective This develop VGX-XXXX of prior of for and VGX-XXXX. a most commercial use commercial just with Bhuyan, its decision-making Phase We master an With based for RNA to Inovio, been in VGX-XXXX. Prakash? efficacy predicted data. today’s companion release VGX-XXXX. discuss call turn previously a I had who correctly would now available VGX-XXXX,

Prakash Bhuyan

afternoon to joining Joseph, on the Thank everyone call. you, and good us

as opening HSIL treatment we remarks Joseph of As HPV-XX. high-grade our and/or immunotherapy for from X, in results X VGX-XXXX by his which HPV-XX Phase afternoon, announced positive evaluating REVEAL this pivotal an the trial cervical caused pre-cancerous is mentioned

out the a amongst includes of objectives dose included HPV-XX, and interval which to XX as the The secondary valuable XX% by morning. older was have without the surgery, of can known health or were who responders randomized XX.X% MITT, step of clearance at of objectives the achieved of statistically HPV-XX to one HPV-XX with least cervical viral HSIL significant. but week was the of primary alone. received subjects HSIL women regression for group HSIL, X:X and percentage healthy. company MITT women’s viral endpoint. and/or received group, normal XX HPV-XX primary regression HPV-XX alone, versus and cervical histopathological women we to health. analysis in evaluation reproductive endpoint pre-specified age powered of HSIL negative XX% X clearance, achieved; of regression resulting impacts who XX treat choice the at a and for normal weeks placebo X Participants had results X.XXX at otherwise protocol a X.X the of with regression and which difference XX.X, cervical are years upon cervical placebo pre-cancer all treat tissue, HPV-XX, subjects, and clearance in of the and which of trial The with virologic either were driven at percentage were the combined efficacy secondary or regression of out XX.X%, as tissue XX trial and/or HSIL cervical at in these REVEAL potentially this The X, in giving HPV-XX p-value forward respectively, These a significant confidence in Importantly, All of treatment population, data. endpoint Showing to reported with all XX intention of XX.X%, combined modified a HPV-XX X primary met. VGX-XXXX XXX

the to also trials primary objective by treat one of data, external automatically disproportionate be to irrespective safety analysis compared We having data VGX-XXXX placebo to participants, generally The well non-responders. of blinded or without reported for secondary meet considered with safe all which and the the subjects reported aggregate missing on intention ITT having objective which in significance trial consistent a on account ITT our or safety seven not analysis, the number did of valuable the board. group. considering a those previously group, dosed with reviews includes undergone data, monitoring one in tolerated, findings are Based data had data and and overall being

dysplasias. regulatory everyone capabilities VGX-XXXX cervical exploring treating We seek to vulvar want high-grade the to to guidance are I progress that HSIL. vulvar to addition dysplasia, develop anal anal HPV-driven and plan remind we in Lastly, the to continued treating the pathway and on towards towards of also treat VGX-XXXX

seeking these indications. also are designations orphan We for

this just investigators, site want personnel, all the Before to our call in Joseph, I Thank making Joseph. participants, and to research critical possible. turn I involved back back you you, over to study thank

Joseph Kim

continued Thank patients on amazing the look patients team’s with to for alternative with surgery. bring VGX-XXXX dealing forward effort providing cervical you, to an your work and pre-cancer. to to We Prakash, option an team, to therapeutic

in across Moving INO-XXXX our a all now medicines fourth DNA had to platform. of quarter GBM. productive We

an particular, encouraging events focused along immunology is continuing at XX landmark combination programs, the antigens Libtayo, Regeneron, to combination three we review results we with the will the in last on most Snow continued branded which GBM work with with likely and emphasis XXXX the our some we INNOVATE Annual patients by In at presented HPV specific partner developments are In evaluate this from for and approach. INO-XXXX. co-developed Meeting are benefit and our within COVID-XX overall on in who identifying make Sanofi that immunotherapy cemiplimab to occurring November. trial as combination Regeneron INO-XXXX up Along months, to addition with survival

been met. still not methylated also will survival as update We median this the for overall has patients

partner analysis collaboration our work remain with plan this data Additional share in to and we additional and year. Regeneron, close

well contributing a transport maintains cell responses our proud with peer-reviewed, published to frozen the extensive all dedication differentiated to efforts CDX to our EClinicalMedicine, as trial a our possible requirements. am vaccine without vaccine COVID-XX unknown as I for Lancet. chain T we by and our work, turning the antibody the ongoing of in ongoing INO-XXXX are to efforts is our its by next key which and in thermo ability COVID-XX. for and stimulate thankful further to the help of X journal Phase be making and cold access safety Now INO-XXXX to parallel scale the and of CDX for open is also support And and Inovio for X to tolerability partners variants. in and against safely both INNOVATE manufacture ability all candidate, data, differentiators it fight the program. extremely grateful responses their of INO-XXXX’s re-administered continued published both its co-developing are participants along In generating as provide at The and global protection known trial against clinical team generation are pandemic. designed to excellent pan-COVID the profile, and SARS-CoV-X combat stability we the

will address Next, to being updates Dr. work Kate as some that as news. to well and have INO-XXXX, the topical provide to important speak in measures new the Kate? variants COVID done the about Broderick become

Kate Broderick

Thank you, Joseph.

the like proprietary production are well the the device, for doses, funding manufacture funding grateful devices. CELLECTRA, X/X to Defense company’s the as from and the smart of XXXX Phase see have I’d continued INNOVATE to of clinical both of how XPSP our directly DoD’s procurement Firstly, of support CELLECTRA as we of trial, large-scale Department the

to earning of segment Phase X afternoons’ and this INO-XXXX the second be Phase we in press stated we’ll complete quarter. early release, we trial INNOVATE As focused continue on of X/X our

the of week a week As selection immunogenicity six safety based data. and is reminder, component, on there a finalization dose eight doses

subsequent older each XX for placebo of or for Phase tolerability and XX in the one in of to infection, to either segment Phase dose to appropriate two X evaluate regime, high a Our immunogenicity for to either is a safety, groups dose and risk randomization and olds age three designed each dose most year or XX XX efficacy year old, INO-XXXX INO-XXXX to part receive X:X two that’s with the milligrams the XX X of for evaluation. confirm

X immunogenicity the subjects, data XX review XX And expanded XX Additionally, older. age we subjects. in safety Phase are to completing elderly older XXX subjects, included interim of of and also those and that and years

for We of CELLECTRA which to trial, are hold clinical the INNOVATE will the that start the be due partial question also XXXX actively Phase clinical of used at remaining this the preparing device time deliver to remains portion X to related INO-XXXX. a FDA’s

continuing of We obtain trial. the the work FDA all questions concurrently. Phase the results second to in and device segment we start are with to By prior X to resolve to Phase remaining quarter, closely of plan the the address X and the them the time

Inovio of INO-XXXX Phase China, license with the a entered segment an Inovio’s agreement Phase for of an and in to in Vaccine also South X of trial and collaboration International ex-U.S. XXX Advaccine And its advancing of Inovio’s clinical INO-XXXX into testing INO-XXXX. greater Moving collaborators trial exclusive clinical setting. Institute is in Korea Phase a are the Phase subject INO-XXXX. in X is X/Xa conducting activities Xa

with responses WHO booster. work trials primate these to Well, later boosting the could no our from INO-XXXX likely advancing our In already available therefore that this we If antibody the recently responses, have against It the the potential along COVID-XX this foresees efforts, usage already that a may in demonstrated extend offer successful, potential why endemic this COVID-XX the become X virus to doses year. who endemic. booster We Inovio use seasonal nonhuman And is ability important? becomes two clinical our studies. consider of stimulate Phase trial which CDX to will the disease. important as candidate as to received is on compliment the T-cell trial is both an those CDX protections data stated assess expect be and of our augmenting it INO-XXXX. the for have of INO-XXXX believe could We also

DNA have and Inovio’s Given the profile and safety as vaccines our serve booster. safe to overall may a effective potential

We repeatedly to for of evaluate consistent months six and their with has using our We the booster received other plan vaccines. boost clinical a this subjects safety and regard, study. doses from In INO-XXXX long-term a has to Inovio’s To-date able the you our is also third boost Inovio our potential to trial COVID manufacturing capabilities booster XX further observed the also been data Inovio the quarter. of DNA vaccines response forward differentiator post data development. side in DNA the second data to XX the been to We very X believe from ability out X with subjects platform platform. sharing this vaccination. what to XXX in of was Phase their second look provide significant Phase The from we with our tolerability and INO-XXXX. INO-XXXX in being diligent immune

global Ology consortium, also the we to Fisher to and additional meet In Biosciences which includes build manufacturers consortium. to Eurogentec fourth We the consortium. our Kaneka global Inovio ensure Scientic, quarter, active join Richter-Helm with continue Thermo BioLogics added demand. to the in to ability discussions the was manufacturing

We XPSP and by brought to several supply would XXXX be the produce have of CELLECTRA single-use devices. also manufacturers both agrees, the on used CELLECTRA which global contract

at speak may based many the DNA threat in the for advantages variant of mind to provide that of our potential future of strains and top the technology the at and Next, moment, current addressing I’ll SARS-CoV-X. vaccine

respond technology is Inovio’s of the design ability and hallmarks rapid infectious construct manufacture. of through to emerging vaccine to DNA diseases the One vaccine

sequence INO-XXXX the from Wuhan China. following of rapidly example, receipt the an designed As viral SARS-CoV-X was

optimization risk cross-strain potentially Inovio as the ability addition, DNA coverage mitigating well mutant appear. deliver and variant, to new could the confers strain the that process strains medicines the presentation In pan-variant circulating potentially of the of currently as

multiple protective together generated mosaic capability previously studies to algorithm and we the area multiple a vaccine by taking has in this sequences company’s approach are technology. have be and to functional rise We assay, States uses on strains to the on strain broadly generate immunogenicity antibody impact synthetic for new We this responses proprietary be the design. been SynCon this preclinical high the caused an UK demonstrated these combine have approach the used a team. the of the it applied influenza of Inovio’s deadly the design variants dominant African the protection Inovio on COVID-XX virus XXXX, mutations the always responses on lethal Brazilian INO-XXXX, And against the viruses assessing With heterologous and has and with emerging our the against been both globally these HXNX most closely development United This a neutralizing the to evolution and particular of we’ll with challenges. with HXNX as wide assessment two-pronged influenza and since antibodies complete strain monitoring pseudo COVID-XX variant, UK, variants. crisis the doing in that of demonstrating generating priority these and an streams well also of of impact existing variant of focus incidences profile as through the testing in approach expected currently the month. new to vaccine variants. vaccine of T-cell South the

gene vaccine work, provide our to is a design. back addition to Brazilian a vaccine SARS-CoV-X note SARS-CoV-X developing thermal next expected The Joseph. to and pan-COVID sequence strain, currently variants. UK, with proprietary stability to I share we as is algorithm synthetic are pan-COVID to ongoing as the that hand and profile to designed INO-XXXX. unknown should against safety well generation African that also candidate similar candidate driven candidate the South potentially a I’ll In also the create protection INO-XXXX pan-COVID And genetic using SynCon the AI

Joseph Kim

that’s emerging Kate the of to summarize to I crisis Kate. platform you, want variant Inovio’s capabilities related touched on. the Thank that

Our design new mechanisms, vaccines testing mitigate vaccine participants strain key shifts. profile. to genicity the Three, to the newly an rapid has ability response of semi-annual are and of to platform boost tailor thermal viral broad based to main viral new platform profile, on additional less to and variants emerging no the or annual DNA-based repeatedly data. ability And persistent DNA susceptible react three risks two immune Two, generate with issues provide to potential on are sequencing basis or to the one characteristics stability immunity which through protection. anti-vector candidates important, also with

to not global enables with storage, does feasibility multiple Peter transport of that, With be considering need The CFO, frozen utilized. a timely element manufacturing Kies be nature vaccine the I or Our to and critical scaling and characterizable when during scalable. highly facilities, financial a over the vaccine characterizable the now of Peter? will update. turn for call manufacturing our of able to distribution, brief

Peter Kies

you, Thank everyone. Good afternoon, Joseph.

cash, total mentioned, of short-term Joseph XXXX of As with million well-positioned December XXXX. XX, enters equivalents and as cash Inovio investment financially XXX.X

Additionally company public in XXXX, of of net proceeds in stock January, XXX.X underwritten resulting the million. the company’s offering closed common an

us Our current runway. years provides cash multiple cash position with of

our support for continued the Phase X XXXX. We financial have X pivotal from also Inovio DoD and for Phase

to in to Turning Advaccine. financial our of XXXX. is period X the for agreement increase payments with the in now three comprised revenue revenue XX, months milestone X.X million December license related compared to XXX,XXX XXXX total million and The for was our upfront primarily results, of quarterly ended same

per million quarter XX, the dilutive among and in to ended December device, in were drug $XX.X agreement primarily and million Our for net XXXX. development The a or dilutive increases and XXXX services in XPSP expenses million basic were compared related loss December increase expenses and in research related was for compared net engineering CELLECTRA grant was ended in $X.XX other for same December XX increase share, expense period development and XXXX. XX to three R&D ended share XXXX and our to manufacturing contract an the from or recorded by loss Research services XX, offset $X. of to XX, basic variances. the to quarter INO-XXXX outside increase million an related an the increase our XX.X per for months XX.X these

administrative ended Lastly, three XXXX period the versus in same general the and XX, X.X expenses million for million XXXX. were months December X.X for

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

Joseph Kim

virus and With implications. thank pandemic Thanks about across seasonal support becomes full Inovio endemic. platform. would those tireless I as DNA variant interest potentially serve I the to and well as for yet Peter. with open offer to their our on well of In ahead. ability received in the strains team effective closing, the recognize those for and support extended We efforts significant ability INO-XXXX our for we the vaccines the as efforts vaccine have protection and have concerns candidate to their details I want received about pleased the those response medicines as questions. evolves heightened Equally, against concurrently variant a months as make potentially designed well exploration additional as sharing concurrent existing strains that to to these the operator, look as to protect INO-X,XXX continue who who come. to other pan-COVID booster our am to as progress lines variant safe please

Operator

Please The first Oppenheimer. with Hartaj ahead. Instructions] from Singh question [Operator go comes

Hartaj Singh

Great. Thank you.

trial especially Just on the good work a today. all And quick couple the of questions. progress

your you’ve bit, the INO-XXXX Joe a if detail that can COVID been population Focusing you boosters, on working data. on gathered vaccine, little patient the

the mutations. on working also You’re

Department. that cost, the doses that those from other that you certain Thank get expects X the And additional your funding year, path also vaccines approved? press INNOVATE, second entail amount companies start getting the then had example Phase approved getting in you Assuming the at vaccine quarter for a forward boosters to agreements? secondly, government the for release like Department Would for U.S. a Defense the of the certain or Inovio this of you could funding in of clinical for how be the you’ll questions. look variant indicated from

Joseph Kim

Hartaj. Thanks,

pan-COVID first, in and parallel. question candidate INO-XXXX development working of our we’re exploration currently First vaccine through

Phase through marching along as X funding and Phase executing our part X plans and for DoD INNOVATE trial, which funded we’re the the of is So mentioned.

move In we’re vaccine that terms as technology platform. to candidate, our along of possible, as looking rapidly the leveraging pan-COVID-XX

second we’ve Actually, funding remarks. prepared multiple was the funding covered of as levels was part been The DoD. your from the of receiving question it the in

direct X X The our trial. and funding a of Phase INNOVATE Phase is first

completion So that’s directly of we funded there’s and June the – of our that XPSP numbers announced device, thousand that involves last as project through as be from well and partner then second as some DoD, And a advance of limited that CRO program, year the number we increased few DoD. a funding from of could have we And our doses can level funding for hundred the doses. in those coming potentially.

are answers these hope you. to I So satisfactory

Hartaj Singh

Yes, no, thank you, Joe. no,

a quick follow-up. Just

So that to protection a initial a have the shot companies for has on against example, help a of against booster released guidelines FDA shot correlates or vaccines boon, some variants.

protection then broadens follow-up that all As that approved, of for quickly you following if you, correlates vaccines have you guidance XXXX example, you for FDA the guidelines questions. afterwards seems gets the be at. FDA using helping of kind arriving And those thank foresee out, do that to

Joseph Kim

Yes, absolutely.

FDA positive think landscape expect development concerns we evolves variants. guidances a with the I the to of by the evolve these that’s provided as the and

in of our develop helpful well guidances as to we both as vaccine pan-COVID So expect leverage future. these as all INO-XXXX the we

Hartaj Singh

Thank Joe. Great. you,

Joseph Kim

Great.

Operator

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

Gregory Renza

today. Hey, thank taking my and Joseph team, for question you

– on Just

Joseph Kim

Greg. Hi,

Gregory Renza

Hey.

that think wanted potentially with quarter? the estimation just of FDA your the running, just they timeline just coming perhaps data sense and get about I’m as the curious up line to how be better the best the timelines Phase we X And a second in reply. Phase and perhaps up on XXXX, X. on Just Would

March, sense like that a had recent looking in might disclosures on but have more maybe be event. that been May Just may it a

great. think any much. we things there So up should very clarity be how would Thank you lining about on

Joseph Kim

thanks, Greg. Yes,

of related We’re second early very think Phase the time. as completion by of expect we going the alluded in have be available top busy I to line quarter all have data be as the a to a of that X well the quarter to available device part to we as submission second

be can is not. in of hopeful our we quarter at plan we And are with the the filed all forward the everything do filed, year. time. submissions very up FDA they to this second to XX days once the portion with move to later And this allowing that So part with Phase that these will or same time, the us concur X of have

Gregory Renza

subjects the Phase just intent modified those were X? and to either about you treat the the got or to Okay, just these who just XX.X% differences results again. you previous the in to some provide then broadly to it. between And and about And How curious the that VGX-XXXX, on turning perhaps Thank context difference on to on more think you versus of to discard thoughts there? could thinking your the significance studies treat intent lost follow if up. comparing

Joseph Kim

data. successfully Yes, REVEAL to I’ll Dr. Phase Bhuyan very address then Greg. data is significant first for comment. initially, first so terms met the treatment, we’re forward us, very secondary trial and in to executing And part excited for looking this meeting Yes, the product. our I’ll the ask endpoints to trial primary the HPV think the and that about the I important X X data confirmatory regards of with all and with

their who reproductive forward damage cervical this now, integrity a treatment as and bringing these impact first suffering women is Right the true cervical non-surgical are treatment surgery product from with looking really potential option health. cause one HPV to We’re for dysplasia. out to high-grade

that only think seeking treat option, the eradicate important from is women’s not to for the us a the for caused So and very non-surgical virus disease, health I product all who are this for but the disease also of cervix. patients these

be anything question? about excited more any to you add like Prakash, else Greg’s So we data. regarding would the couldn’t

Prakash Bhuyan

Sure.

really achievement So that endpoint. the the a I’ll of efficacy just add outcome is good primary

have excited trial. the in in and the achieved really trial. efficacy Phase we subjects also at for that to achieved so all secondary valuable we’re the primary And X REVEAL X, objectives looking that back And

now as ITT great the that So remarks analysis having in valuable descriptions the pivotal both and went us forward. met some analysis. of a trial well a trial now all MITT the prepared gives we And into as in the Phase the step really X of subjects’ that

And – differences missing we analysis. the considered as data in so ITT the and for who reasons included were really endpoint non-responders were the that were subjects the

we seen also for not both Phase X, Phase really we’re of in terms for so And provided completeness excited but we’ve X. for but what just really now,

Gregory Renza

That’s Prakash. Thanks, Thanks, great. Joseph.

Joseph Kim

you. Thank

Operator

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

Stephen Willey

for taking Thanks the Yes, good afternoon. questions.

Joseph Kim

Steve. Hi,

Stephen Willey

Hey, Joseph.

make intent primary So the want X. maybe sure X of endpoint to is just of modified to the that clarify treat REVEAL pre-specified then, also REVEAL to I was and just

Joseph Kim

treat Yes, – both don’t to modified Prakash, why yes, take that? you intent

Prakash Bhuyan

Yes.

So and intention ITT are to treat are the pre-specified. the that both modified analyses

We’re doing also data. once have we complete protocol to analysis a going be

So those in analyses trial three the pre-specified are of protocol. all those –

Stephen Willey

they kind or of are they’re how some is hierarchy in they Are co-primaries of statistically there’s – assessed? involved terms

Prakash Bhuyan

they’re in assessed total. Well,

So stand they they actually together. – stand

with so of And the analyses really evaluation done complete the all has is one data.

of three So evaluated under based really in the is analysis all any one – condition. primary the it primary isn’t that is them,

Stephen Willey

Okay.

Prakash Bhuyan

subjects specifically the MITT had data. who evaluates having But MITT, the under

Stephen Willey

And to response any data guess, the demonstrate I followed what following around we do being like? And dialogue guess what needs regulatory know months look durability that from know durability of And will administration? Phase Okay. like are been has that look to that durability XX of last I X of the patients response. there kind I

Prakash Bhuyan

their breakthroughs there showed durability the follow subjects manuscript Phase responded actually the that recurrence for and that year cohort, did viral And on last VGX-XXXX, was did data we their after of and pap to months XX from a remained it were infection of what administration. the women improved. smears in X no that who So terms that last publish

that there XX out looking so no from and very were regression encouraging sort And that, was of months.

as this out of the the why the information, with As get XX week far durability out question, trial your second information. to part that to be actually we’ll reason and to that goes week XX actually to provide continuing is trial

Stephen Willey

utilization? under treatment lastly XXXX, to the plan Okay. about That’s you patient And helpful. I eligible, very I be just maybe I proportion talked what have of guess, guess eligible population biomarker this would on think

Prakash Bhuyan

we’re really today. touched a Joseph informational our in in and that that our have release biomarker and very But a of we press remarks, it put we did so for put on some that prepared we of aiming QIAGEN So women Phase would Joseph we predictability actually are of VGX-XXXX. XX%. post that. terms in And identifying respond level likely are with, observed to earlier, working high X who partnership mentioned develop with as And in to to

Stephen Willey

Okay.

patient eligible in So you based just the figure eligible XX% be trying about I’m patients, to and would of biomarker guess. telling population, could if that response used in of patients, to what the XXXX out were eligible haircut it’s treatment apply like in to effective patients terms treatment biomarker what you all I look on is in response that criteria? predicting it

Prakash Bhuyan

I develop the information and characteristics on we the continue have with specific we’ll to think performance more of as biomarker the QIAGEN, biomarker.

to So that? you I as the the that think something Joseph, there I of you add anything through would go look we would say it’s should rest to forward year. is

Joseph Kim

We look of information comprehensive. think I and the were you year. that out pretty those forward confirming No, to coming Yes. bring in lot

Stephen Willey

And well? sorry. the and guess biomarker lastly, be Okay. anal vulvar as used the trials Would I for also just

Prakash Bhuyan

So made I hope continue which on as step our more develop look the at is we But is you’re as haven’t the indication. give to that important touching lead and with our that to think cervical to we indication, dysplasia information go yet, along. I biomarker, an QIAGEN think of determination question but we first we really

Stephen Willey

Thanks the questions. for Great. taking

Joseph Kim

Steve. Great. Thank you,

Operator

ahead. Please The from next Huseynov Benchmark. go Aydin comes question with

Aydin Huseynov

afternoon. Hi, good

Joseph Kim

Aydin. Hi,

Aydin Huseynov

with Joe, quarter the questions. VGX-XXXX. Congratulations with – And for taking hi, the thanks

So I one the INO-XXXX. first about have

vaccine candidates Would unknown other And how candidates? candidates companies be you difficult would mentioned known and pan-COVID how Inovio? vaccine for this differentiated SARS-CoV-X trial need variants. another these and pan-COVID to Phase create potential you for from potential X is about for So

Joseph Kim

and the that Yes. guidances Very and given. development of more information of profile we from program, the the briefly – but rapidly move but in think vaccine on our We thus yes, the process. that of we platform our safety think our based COVID, started far variants just will so, earlier for regarding be INO-XXXX based FDA on also the quite can we some developers overall

we’ll as share Street with progress. So make the

Aydin Huseynov

second booster patients specify the think the the Phase mentioned the Okay. you subpopulation? I you And specific trial. after could dose? time expect what And booster, And got lag efficacy for the in that third in X was you XX third would increase

Joseph Kim

Yes.

XX of was be X. months. was XXX Phase had Phase boosted all, months, duration to interesting was a amazingly maximum itself. subjects. with total from total XX We around X of six The the this And XXXX, – of So was up I the last signed from pool shortest quite first longest XXX a XXX the fact people is vaccination out of duration think

good the So about we tolerability all our can one. information really see I number of think and of boosting, safety first

T in booster And should of consistent that CDX that are our of come data as quarter it’s that study hopeful so show X. we And antibody the productive first then Those second as we’re well and seen samples the expansion had we far from very cell two responses CDX we this responses. as the processed year. and to have in available Phase our getting can in doses

it’s but boosting to of the augment excited, and responses and the INO-XXXX potential we’re So safety expand INO-XXXX. to confirming our immune the of

Aydin Huseynov

companion All lot. parallel. X? think it confirm by for similar And of companion for diagnostic also had REVEAL if right, results given X, result FDA, that would the another approved to REVEAL just they have would like for being adoption on because Thanks that. want the even a VGX-XXXX, timing in without is purposes. you companion it have run for expected been more appreciate diagnostic, diagnostic And one is And seems the you I

one… Just

Joseph Kim

Yes.

to would VGX-XXXX a and to towards years most into working it of boost, who VGX-XXXX that’s of QIAGEN with last launch X Aydin. the attractiveness attractiveness Second Being we several patients commercial post-launch. think for my our Phase commercial And for question the this a pardon during internally target able I immunotherapy, think immunotherapy. since pun, provides additional develop from step benefit and the raising significant really first, biomarker been results. the We’ve

the global was just still the trying companies’ from REVEAL of enrollment question, the large recover many we’re trials. COVID like to X of part that other from first pandemic, The hampered throughout last – year. And

But the more share once a the Street. provided finish. with visibility, we guidance we solid when have haven’t we So will will we on

early can our back of the by hard to Now, you the due of is work I much to tell last recruitment. incredible pre-pandemic pretty terms levels what in year team, the we’re

during So X I COVID think we’re beginning for of enrollment the back track a pandemic. global REVEAL strong

Aydin Huseynov

very Okay. much. on quarter. the Congrats Thank you again

Joseph Kim

Thank you, Aydin.

Operator

Fitzgerald. next go The ahead. Instructions] with question Cantor Charles [Operator Duncan from comes Please

Charles Duncan

of those Thanks of the progress, the patients was consider clinical in That REVEAL a how compare the X Joe. wondering X Phase on today. congratulations experience and I enrollment trial for taking XXXX, results the And contrast particularly REVEAL samples? the would say that X questions. versus the surprise. Hi, I’m trial you release my guess nice when you two and

Joseph Kim

to and you. briefly I’ll thank Yes, address as ask well. comment then Dr. Bhuyan

the treat met important of thanks There in Phase Phase the In in it’s reiterating the were analysis. XXX X secondary in based primary intention and that statistical Xb all modified we trial. X both and XXX So over both our our large trials. Phase on for REVEAL X and X to trials, and both Charles, Phase endpoints, little

to I’m cross-compared, trials further. on these not to not to will Now, designed, comment to statistically designed ask were little to Phase was but Prakash but two ask were Prakash? this Xb, compared not X Phase be they going be designed I

Prakash Bhuyan

Sure.

work that and try we’re that level really so course think with of would encouraging local their expansive then we of observe that global to five And – that middle in but then with our to of in we in observed still, your And in We as was had rate is a were X had world track which trial it’s X. sense compare were I best much our did different the expanded they of enrollment we and to Phase were to in as sites say patient the that actually their address Phase two actually order pre-pandemic the – yes, we continents. really, geography was Phase in we we we really considerably, to on in So actually really could we’re the – trials of of think better X. to pandemic really challenges. what challenges enrolling pivot And we we actually question observed if in footprint. I characteristics and Phase X starting about global were And beat terms similar, enrollment point. I in not enrollment enrollment a the what more a at struggle, the enrollment the

and of of different our terms are how dealing their in make is participate in a our sure situation, all course we’re with staff they now trial which So, patients to trials. that safe

engaged. gone we’ve this fact by and I never sight lost So need away. we not what of It We’ve really disease, lost not They’ve more go I’m to encouraged their really it the away. trial And hasn’t does do. seen. that sites think more what have is engagement. that, been And simply

rate. to And pandemic back that simply get to trying. to so improves, able that we’ll be as And going actually hopeful the stop I’m we’re not

Charles Duncan

bit Okay. inherent X the was this looking is happy and that consider but to little statistical sample guess the that a which more when Phase of trials, or compare results you’re it’s Xb It you than uncommon, my I’m one not were at REVEAL like I help the I my reflect if are to seems necessarily really the was inherently question, Xb that’s results, in population? just significance. question wondering to think size the variables I broader particular know versus there you explain effect the do across Phase that doesn’t tough but modest compounding see – differences

Prakash Bhuyan

be were the meet at trial, complete stand key which the REVEAL really trial we able the understand once completed two to to we’ll to go result X characteristics looking is Well, the be unblinded have the through population primary as the we do And set and really endpoint, independently. the the met. samples better. data fully And ability

Charles Duncan

even next over presented I Okay. in That’s to terms But if this can to this in one you Phase rates Phase rates of was complete then current sorry if then able and missed Xb hop to year And I yet and provide steps, X then fair. the being I’m case data X, XXXX? I being feel of before. Phase in able guess about terms do INO-XXXX infection how

Joseph Kim

Charles. Yes, thanks

As to submit X and FDA of from I the data the the Phase the completed early start part to in said, to X. expect have we’ll we second quarter studies Phase

second part goal the in latter year. the quarter X is our So Phase of trials of to this start

the Now, rolled instance, for the a and UK by the variant of that’s are later there’s U.S. advent dominant really should the the UA be variant dominating the out one. month. in getting then landscape variants changes vaccines new And couple of this

we’re doing pan-COVID against broad have program. ever-changing come develop strong working Brazilian But we’re these X to fact technology the of very up. have up the and can variants the leverage technology look we’re within against to INO-XXXX playing parallel, test our a we both just the ability you’re influenza And U.S. future soon was rapidly because the get as the other in we’re with And And Phase and landscape otherwise that just variants technology variant’s variants, after directly. we the about looking to to to is, protect make remarks to also also all that So do possible. it as and these both impact very go protection the South technology new UK thing and immunogenicity during accelerate INO-XXXX to viruses efforts trial. are confident us ex-U.S. allow our vaccine and efficacy plan changing address this execute on with alluded this catch data to as could our and And that these have that. we and excited that HIV as to would Africa honed concurrently we’re to utilized to we prepared the looking changes our what’s next in one we as to generation as of to SynCon well then sure

Charles Duncan

it well be in of and follow-up a issues? technology that, other I any as this particular, you what using platform a additive guess, fire be. it, it not Is your may or that as to may or total question possible it’s think meant serve you in question about effective like to a could efficacy is your And apologize tolerability be vaccines? Joe. I terms booster Last that if And booster? think increasing but platform seems without My do

Joseph Kim

Yes, our the And boost that, absolutely. to potential we’re fact, study some six last booster. in the doing a is booster months Phase And and prepared the remarks. of to reasons the and between in of tolerability vaccination XX of cohorts in the one we X covered in to those why the ability a immune of demonstrate response safety as

the papers vectors half Now, Inovio DNA tolerably as timeframe without of and impacts vaccines vaccines, we’ve as a the maybe any boosts published in the viral dozen to study, anti-vector of that serve messenger and response we’ve or response and similar we’ve And a from any of stunting immune of other patients we the a to vaccines can receive course, a been trials, know we our around lot Ebola, RNA. from dozen years even deliver Quickly, seen other like and testing in HIV about GBM two from booster others. to across clinical in such our INO-XXXX.

a very may be this vaccine strong and potential confident for upside So that long-term program. we’re Inovio’s very

Charles Duncan

taking my Thank for You questions, Joe.

Joseph Kim

you, Charles. Thank Great.

Operator

The next question Wainwright. comes Please from Yi go Chen H.C. ahead. with

Yi Chen

you Hi, thank taking for my question.

the and between REVEAL to just Phase between the the variability study question, for study. follow the of up-on responders number First primary endpoint the X X

that in prospects variability how that expect out we transfer similar of drug? variability should expect does the to – translate So we REVEAL to should the how and X – variability to read commercial

Joseph Kim

have And increase clinicians that. by that’s worked address it control of call adding the think right the placebo call the thing continue why why the being treatment. And of the we efficacy, account on this just you also of commercial as we’re sure patient that And any and chance we designed, to portion the by focusing, REVEAL VGX-XXXX can in design Xb right of VGX-XXXX X very the we study. me within variability, but absolute make a X. same design for have variability focused we that’s double-blinded optimistic who Number terms trial. why we us population, Phase let the quickly biomarker helping in one, Yes, the randomized helped REVEAL to overall that efficacy we’re attractiveness, that’s will and all best as

in right more the REVEAL making QIAGEN, X, come the our lot data we’re on X excited data to so certainly we’re the with with we’re the progress and So our biomarker track a we’re to not coming year. with development partner the mention REVEAL making and progress in

Yi Chen

it. And the Got second question.

market vaccine Johnson enter the do And is that instead COVID-XX your think regimen? prefer the Johnson’s a two? think vaccine one-dose & you one-dose to generation of you of would next COVID-XX regimen considering could a So do a large portion population that have about

Joseph Kim

I an I fool will regimen one-dose as to virus It’s that the predicting would of endemic going boost. look think be at one-dose this us be and going with attractiveness. is eradicate stage, think that certainly so additional school, long-term this for COVID, virus, almost likely, mid-term regimen there likely mentioned But, and to in as not KOL before, But from earth. is as we we you virus many a lot the the we’re every the has as the years, with of SARS-CoV-X deal I

does, think is administration I an long-term. importance what the than initial really less So do you what of the in

thing the efficacy But one tolerability be two. one to course And then, it’s that really overall safety. boost. could better said be is about I think of Now, potential each of than the being and concerned

as a the because the vector really viral may concerns frequency be response. adverse vaccines vector in the about is, are increase formulations One seen we delivery booster almost forever. from may you be messenger not more can we is like dosing. to that tell field There to set to need up track the RNA reach can of Some Inovio’s amenable what entire boost platforms they’re of severity not platforms used in events data with have we’ll and that I regard. thing the But

without trials, dozen that DNA our dozen receive up with our the of to we seen in tolerability with cancer any around vaccine, mentioned our or vaccine a I patients to insert in we’ve different As and our clinical and half HIV INO-XXXX, a same have but the from studies vaccine study past. look Ebola and safety forward demonstrating to booster And published doses issues.

a INO-XXXX strong other both and overall confidence for booster COVID our then platform vaccines based used our could a have our as that vaccine, certainly vaccines on we as for potentially be well. So and

Yi Chen

you. Thank it. Got

Operator

Next Chris from go Please question Sandler. comes Piper Raymond with ahead.

Chris Raymond

me endpoint? I X questions, apologize, three, around I of thanks. modified-ITT first from the really hierarchy? here the asked protocol, you sort the per ITT readout. just so analysis the I agree but did primary all that not know can is that there the clarity and as the just say pre-specified statistical ITT, that with part And FDA modified-ITT were of Joseph, can investors, endpoint. serve or question some it’s is REVEAL on getting it’s Hey, the a think population I’m have others understand so don’t few end. this squeezing in used But and is for Two VGX-XXXX. Thanks primary at for And know which I I

Joseph Kim

to three per plan MITT, we And well. were those all ITT no, Well, present and all specified. as protocol

different can So that Prakash question? to think But three would comment a you like that as of methods. you on

Prakash Bhuyan

everything of just our expectation course. review is I’ll add, that so will FDA the Yes.

pre-specified as were Joseph And X from also so they analyses trial. that and the they’ll all the three said our REVEAL will protocol review in data be reviewing trial

the reason, analyzed. really of And results terms in really what just in was and show a data MITT ITT and review is comprehensive put so to be all was complete the The of of we it everything. you

Joseph Kim

what missing MITT were at was endpoint Just group available said, between data the very to trio group Chris add skewed week ITT versus breakdown seven difference is break one whose quickly and Prakash in there to was the And the of only placebo the of those in not the confounding unbalanced. that – points end XX. eight subjects and

think So randomized. as X X:X in highly trial is the occurring that I REVEAL unlikely, is

the at we’re look only reason you unbalanced difference, stats, only about is points. of this those missing if the talking because data So,

Chris Raymond

Right.

was just then back FDA the five was, the January your that I weeks And INO-XXXX, you just you. just looking it’s and on about call to on saying still now goal prospectus Thank now to May. I so said your follow-up ago, on March time And at were respond May guiding think response as or maybe regulatory the to the this Okay. FDA. in filings, it’s guys you you’re least at the

like any of provide maybe just really what’s that pushback, kind it just very since can So causing seems as it happened half, you to specifics it’s recently.

Joseph Kim

which compiling from end we this of the provide It’s second been well. we quarter. just as guiding from all device package data related a and of booster It’s have – responses. beginning believe or for data all early March FDA the and their of comprehensive studies year would even including the our by of I the

So we of to the are on track that in do now. second part early quarter

Chris Raymond

Thanks guys. right. All very Okay. much,

Joseph Kim

Yes. Thank you.

Operator

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

Joseph Kim

everyone. much a very you great Have Thank Yes. evening.

Operator

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

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Inovio Pharmaceuticals (INO) 2 Mar 212020 Q4 Earnings call transcript