INO - Earnings call transcript Q4 2019 | Inovio Pharmaceuticals, Inc.

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Operator

Good day and welcome to INOVIO Fourth 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, this event is also being recorded.

I would now like to turn the conference call over to Ben Matone, Senior Director of Investor Relations. ahead. go Please

Ben Matone

Dr. Peter regarding VP of Good Kies; INOVIO the operator. conference thank for vaccine is and the Kate company's Development Research on overview current you With our Senior provide Thank targeting will fourth afternoon quarter the DNA CEO, President who INOVIO's an Pharmaceuticals' today and COVID-XX investor INOVIO'S Joseph and Officer, joining Kim; me Chief you, are and J. and Dr. year-end Financial call. Broderick, continued outbreak. efforts which XXXX

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

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

relate INOVIO'S business, to data our clinical of this our plan readouts platform include integrated and to timing with our as During will regulatory statements we call, well develop which clinical along DNA be of medicines, making and as resources. developments that capital forward-looking

these on of risks are based These could uncertainties involve certain differ and of as cause the today. and materially. statements expectations and results assumptions, management to statements All of actual beliefs

Investors new assume statements whether of XX-K with well as update factors no in or events risk risks included information, uncertainties carefully read the forward-looking today's future filing today's obligation or result a We press release, the as to SEC. otherwise. and should in revise described as the

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

J. Joseph Kim

January. everyone. our program two ago provided months good clinical Thank than you, in when announcement Ben. It seems afternoon longer much And update we

emerged coronavirus. continues all months, even of to last evolve We have that the in two the accomplish midst much with the of and has in

is vaccine over that last a couple been has January, this to attention INOVIO. COVID-XX for months development. setting in be Back on the And while investor remarked up we period our transformational year

our exciting our programs fundamental This I to and reconnect to call to us and like think our upcoming would But novel core emerging update catalysts, before the as allows the data programs investors I core on is upcoming and timely, pandemic. address coronavirus catalysts. pipeline it pipeline

our vaccine introduce our of COVID-XX Dr. to overview team Kate Senior development, COVID-XX I'd Kate? Broderick. lead an our and For of R&D VP like

Kate Broderick

Joseph everybody. according the deaths. of WHO Yesterday, afternoon with and X,XXX you, Thank than good XXth, COVID-XX XXX,XXX to cases reported been March approximately have more globally

rapidly response the swift reported of a in cases has deaths. the CDC total The XX and XXX is U.S. world. a from evolving around companies requires collective total This alarming pharma with biotech and situation

like diseases. vaccine our INOVIO progress on steps platforms points. During to two; cover time one against lastly, together respond next emerging number of And COVID-XX. one, main three; Number I'd to our Number three point why today milestones. developing INOVIO's best today, our may infectious anticipated have to the INO-XXXX,

optimally is of Well, clinical have why rapidly T to demonstrated potent all to previous consistently vaccine diseases from suited cell, first, emerging we trials. killer antibody So responses respond infectious an and INOVIO like immunotherapy our COVID-XX? CDX

working extensive Middle Syndrome. In with fact, MERS coronaviruses with Eastern has or experience specifically Respiratory INOVIO

candidate vaccine a MERS Xa trial. with clinical against company only the a is INOVIO in fact, In Phase

with in is who MERS are it funding X With applying our same Phase MERS We our experience support organization Middle from leveraging to coronavirus trial the CEPI here East. larger COVID-XX. and the

X,XXX When other to degrees degrees. for at patients. messenger safety minus these must INOVIO vectors at RNA XX profile years. be after and over have kept our formulation in viral LNP DNA you DNA that contrast vaccine a proteins, medicines temperature importantly, acceptable more the demonstrated Perhaps step, and an room over [ph] are three for more stable like recombinant approaches than addition, In year medicines XX

caused an a So On progress December China. scientists about SARS-CoV-X respiratory XXXX, in XX, of learned novel to-date. development vaccine outbreak INOVIO which COVID-XX disease on let's move coronavirus to Wuhan, INOVIO's named

Shortly we sequence vaccine thereafter, this a of genetic novel the INO-XXXX Chinese DNA coronavirus. shared information Using January on designed XX, researchers in the XXXX three hours.

do So virus this a we not We the to require vaccines how proprietary employ quickly? able vital our DNA to so just design sequence. make possession algorithm were then While of the DNA vaccine. to gene need vaccine. do the we a And

quickly. addition, us our corona related MERS in ongoing to coronavirus move deep our from causes be In with and understanding able development and allowed that the vaccine expertise virus previous to work very

saw second of the we the February, and began vaccine scale in to completed we expected I'm see half of In pleased into the responses small preclinical type immune phase testing. manufacturing and of studies. the first that January of these

been has as in can generating a dedicated team private I with in public consideration And peer-reviewed our for data and assure preclinical our currently data we global publication our journal. research that are scientific you preclinical even partners and and Robust collaborators more shared is speak.

DNA In platform. clinical extensive this advance experience medicines the and addition, expertise to clinic. able know product I XXXX to vaccine clinic and to XXth rapidly We're our the this enter using the leverage regulatory into is

future final milestones. related steps and to third is My point and

is human April. in to trials begin goal clinical Our in the U.S.

and planning We clinical our thereafter funders. trials clinical are begin soon with potentially China South with in partner human Korea also additional in and Advaccine to collaborators

our positive delivering we capacity. INO-XXXX existing data public million on of funding, on are year of capable end by based one upon and resources Contingent doses and urgency

force, his committed fight progress to in forward look public to COVID-XX, to contribute and we as global you American this White As to the during curtail up will And pandemic. updating on to global scale our House the to INOVIO the resources as meeting the additional Joseph effort help well with make near enough to future. the from collective U.S. against virus. this leading mentioned we need prepare doses coronavirus was task

probably Bill smart the million the device you we morning, Foundation Melinda the up will Lastly, from intradermal scale a of new delivery XPSP proprietary CELLECTRA announced testing INO-XXXX. as Gates $X in for to this have released grant our and seen accelerate and of

$X.X of our started from intradermal an medical for with was will Threat of support vaccine devices, the development of continued Consortium. grants in million essential U.S. these XXXX disease delivery CELLECTRA the smart our Collectively support arm which are platform. funding Defense Initial development XPSP

grant development the funds earlier received latest that This INO-XXXX $X X fully CEPI of of the in funding million, from which the in we through comes addition to testing. year U.S. clinical Phase

potential grants sharing as confidence more months. in INOVIO's and these support such urgent support Altogether, the as with these We with future partner we both endeavors platforms forward convey you well and on ones. continued in the look to and sincerely pandemics technology appreciate to address ability coming our COVID-XX, as the an

turn back to Joseph. Thank like to And you. you, I'd it with that,

J. Joseph Kim

and companies into Trump on really address doing. to as other of Thank effort the as with And force, around a COVID-XX cooperate public safely and that this threat We I all work tell my this INOVIO the interactions humans your looking vital appreciate and you development, team getting organizations and you, be the possible. are important they you working to with task leaders health part Kate. continues part as as of ongoing community. President a the this team vaccine recent can INOVIO to one a quickly the towards our coronavirus vaccine clock and are of from

program truly This core a enough updates. everyone team that, at continue on With effort. been let's has INOVIO. We thank pipeline can't our

received to product First, INO-XXXX. Phase this year, In Recurrent trial a INO-XXXX, treating for X/X IND for or our we February of evaluate DNA Respiratory RRP. acceptance candidate, our Papillomatosis new immunotherapy

and airway RRP by leading obstructions tumor non-cancerous is to a caused This threatening growths XX disease rare infections. life to X progressed and occasionally Type HPV cancer. condition causes can

which restores Currently, this and incurable treated the temporarily by airway. surgery, is disease is invasive mostly

almost must often However, recurs, be tumor the a the and always surgery year. multiple repeated times

long-term with improvement to of to how an do You clear potential especially debilitating their those designed with INO-XXXX not underlying frequent in tumors to destroy virus. imagine the as provide by often has disease X XX impacts people alternative life living infections. disease. causing is the that the disease, the can living RRP caused HPV surgeries a for and It severely and quality address and RRP

with injections RRP of to the INO-XXXX robust which X the scientific to immunotherapy two We RRP recently. two potential patients need of in first a from patients a published pilot peer-reviewed and delay vaccines degree. journal infection, surgery results for Four study allow HPV saw were

previously for over surgery year dosing to after per our surgery But this to and surgeries a three year able for years. two with had disease. and delay manage was a half, free required immunotherapy has Both almost one remained second patient the

in with INO-XXXX at trial evaluate and of X/X and/or patients HPV RRP surgical XX adult efficacy, for have years. require the Phase associated past approximately immunogenicity multi-center year The per three interventions least XX safety, the two who tolerability will X

between primary The then and of or first surgical a the three more frequency to of doses interventions The relative subjects efficacy therapy. the the be weeks. every Papilloma will undergo INO-XXXX study following surgical removal endpoint in first INO-XXXX time to receive doubling prior one four will dose of their

In exciting growing very DNA efficacy INOVIO of designation diseases. initiating INOVIO's also opportunity to clinical to trial, for multiple Office Development. orphan in This related the efficacy addition that body HPV to disease plans with this for Orphan apply of INOVIO medicines Products adds the FDA evidence drive

separate demonstrated in We efficacy indications. three already clinical clinical have

First, in a pre-cancers in cancer MEDIXXXX. respiratory INO-XXXX. with with in cervical tumor neck VGX-XXXX. head with and now Also challenging And

cancers, think HPV be related we on all go I to the way major to there. immunotherapy are to remains goal provider our Our effectively and treat pre-cancers and

sites. program X X in line is efficacy to lead and of and South be to recruitment. our based REVEAL track sites fourth of in has Phase and REVEAL total open globally trial a asset, our VGX-XXXX, quarter new for the X Brazil now enroll X along cervical to for open top sites Phase with patients new Now, reported continues data Also, XXXX. HSIL on four Phase Including U.S. from Africa trial X XX

Phase this safety Preliminary are & on be vulvar to VGX-XXXX Meeting HSIL. also the American ASCCP anal at Diseases. for and Society X or efficacy Pathology Colposcopy planned the evaluating separate and month XXXX Anogenital HPV-Related HSIL provided later treatment in We're for Cervical Scientific two and trial of data

last to on positive X on at diagnosed November our interim for exciting GBM Phase SITC and our XXXX immuno-oncology data progress INOVIO treating Now reported evaluating glioblastoma. newly INO-XXXX trial INO-XXXX In turning treating of Meeting. Annual for year, the

activator DNA hTERT, and antigens, INO-XXXX three and T combines Interleukin for a tumor XX. encoding specific activating immunotherapy WTX immune cell is INO-XXXX are encoding PSAMA,

a that Libtayo, by with promoter We're combinations from gene in and their XX% blocking the XX also progression measure the Sanofi. Pharmaceuticals XX% free patient trial patients PD-X of interim six dose. unmethylated early data these first Key from antibody with methylated months Regeneron of MGMT at patients collaboration time evaluating MGMT were of produced showed

MGMT for approximately care XX% XX% exceeded MGMT patients. XX% Again for historical unmethylated XX% about standard methylated and MGMT just XX% versus and for substantially patients that patients of This XX% for unmethylated data control, methylated historical control was patients. reiterate of promoter to versus

hoped The that positive data XX continues approximately and is newly better historical diagnosed unmethylated controls. to patients slightly population. population MGMT median methylated INOVIO overall GBM months in our patient for for be could with MGMT respect with survival

and historically, unmethylated to one alive Just us patients, all give methylated of both gauge, patients about are a including XX% year. at

to in the fourth our in We XX followed expect in year overall months survival XXXX, from quarter. of trial months survival by report XX June this overall

not With would that, Peter? provide update. Kies ask our to CFO, a Peter I financial

Peter Kies

very research programs Thanks, and and Joseph that cash enters the a about. with continue position strong Joseph. INOVIO talked funding and balance to just XXXX sheet development

XX, $XX.X investments reported equivalents earnings. to XXXX. December and XX-K on cash cash, short-term as our in reported we filed of compares This were our today, last quarterly million $XX.X million As

this In by first selling common company proceeds from agreement. through January year quarter net ATM of addition, stock $XXX.X the of XX, under X in XXXX, in million March the brought its

development, the year-end year programs plus the our in INOVIO of cash strong today, multi-year runway. whatever raised provides on we've with Based cash as since position end

$XX December million and development million million XXXX $XX respectively. $XX.X to same in periods This XXXX. were for For the and compares quarter XX, research the year and and $XX.X expenses ended million

offset expenses and one-time by R&D our other and manufacturing trials This AstraZeneca partnership a in expenses decrease variances. to drug primarily the among personnel due incurred of XXXX. compensation employee during related an decrease with quarter to clinical decreases third increase year-over-year was charge related related in in small expense expenses The restructuring were to a

this year, the Total a operating XXXX. compares $XXX.X million million $XXX.X which year to in XXXX, in for by roughly X% reported expenses we where full decreased

periods $X.X the million and Lastly, year-end This to $XXX,XXX the quarter million respectively. million same fourth and compares revenues $X.X XXX,XXX for and $XX.X -- XXXX. were for in

of decrease and under XXXX. year-over-year one-time of arrangements in development quarter This upfront of from ApolloBio during due was $XX primarily revenue the collaborative a second payment to million research the recognition

for XX-K statements also the our Relations reminder, -- can website quarter a complete in fourth our Today's As filed of on reports. and the our today's be XX-K SEC. can all find in accessed release with you press Investor be financial XXXX financial under also

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

J. Joseph Kim

Thanks, Peter.

the begin the to for executing COVID-XX work all we recognize response to your you Before that want the Q&A countless employees on INOVIO hours thank outbreak, pipeline work in session. have our still core while and of I programs. completed

medicines disease is responsibility outbreaks play respond flexible INOVIO it to interests. up our to DNA is platform COVID-XX for to serving a suited And this. solution in rise our to capable well INOVIO is dedicated, and part public and provide health like

forward look results and we to sharing future. updates in and near progress the

a truly VGX-XXXX Phase Phase for regarding related very Please X year for catalysts for XXXX for be INOVIO. INO-XXXX will our HPV tuned important and also data stay diseases and transformational X GBM.

now. the open questions Please your taking Operator, line to forward analysts. the look for to I

Operator

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

Charles Duncan

spike Good earlier of that wondering core I'm And pipeline you Appreciate on in the afternoon and live about of My then question the Joe should kind COVID-XX. couple program all a the variability on a programs. and I in commentary had about the just team. question interesting COVID-XX your times. call. in protein.

future? you in you other protection for that day. versus expect of us beer some Do COVID-XX corona Looking potentially cross out activity COVID-XX, reactivity other [ph] come If that? also only and could against but not provide coronaviruses could the at sense

J. Joseph Kim

Yes. Thank you, Charles.

of not the So or RNA or as some as as are family coronaviruses, or viruses a flu DNA other variant HIV like such. the

platform, be to being any using programs. so both being as such address minor you those We overall determined still early. reports full-length think What tell drifts vaccines antibody much various we of to sort than our still able seen there's T killer really but I viral And are able cell is DNA with and or our also other and variants responses. generate mutation modalities medicines but approach delivery as So, should proteins But haven't date, as antigenic we're can been responses, controversial. DNA proteins, of CDX vector well better I much still our to diversity. vaccine

of So while the we will SARS-CoV-X. in or changes be potential continually serving COVID-XX the the virus

We in approach are INO-XXXX. using quite confident our

Charles Duncan

dysplasia core XXXX pipeline Okay. to program. programs helpful, That's very Joe. considering on the cervical And moving the over

any distancing But X quarantine and in forward? REVEAL For two, the do X enrollment impact REVEAL will on know X , you maybe you the going timing States I to in terms of see is in or we of fully due see you are seeing social saw states enrolled. that in any or the effects that Asia

J. Joseph Kim

this the to in just being trials trials pandemic addressed major our And believe X, development our clinical Fantastic the impact for said, REVEAL for RRP. risk it's this enough the our on question. I XX-K. the not That ongoing globe. I pandemic which -- efforts risk and many not Yes. sector think of we factors for don't in program, and potential the X but just drug pandemic I additional for has of coronavirus the whole but and INOVIO, also across across and just GBM expect disrupt

Now that's hasn't any there be timelines impact that impact. far not say future But execution. to on and won't significant there our so been

Charles Duncan

for one then last And one one then quick and one for Peter. you Okay.

X some the X REVEAL seeing know up and But X the with meetings clinical for some you're results the if coming Phase I of well. In you've Phase X. clinical at terms being Would actually results got them Eventually results results? results, hold press canceled Or least presentation as results year a you planning for canceled thing that in for and peer-reviewed are the release pre later on just you meetings that you're or would present form? delay in. a the on those Phase postpone

J. Joseph Kim

unprecedented question. Great been Yes. many a This pandemic ways. for has event

some know, believe the moves. be you I postponed, can While conferences of banking science

medical of these scientific So I not may for conferences. some think having delayed a sense and great conferences make

in So and of even can where to Abstracts opportunities and are and some some published a be reacting presentations unveiling be we're ideal a where have these not evaluating posters logically oral to going Obviously, AACR or conferences would most think we conferences like important we be going outbreak made you're the That's in to virtual situation. data. be wisely and But react situation. like maybe will to fashion. be these held I ASCO to of to virtually. this

for up So, we're [Indiscernible] quickly, conference end a to coming month very we of data. originally have this be going evaluating this in and and Phase X because our by

So publish and able about press presentation. be to the we'll release and abstract appropriate likely, poster the most also when talk a

Charles Duncan

great. sounds the the That ATM One quick on sheet. of Congrats bolstering Peter. use balance Okay. for the one

You've But institutional just I'm because you wondering from. the it's trading -- volume lot I that not always ATM clear that that. mean, is demand demand is a and sense not where investor coming what been of part had all is with enamored that of do it there feedback? that that has I'm helps. is But

Peter Kies

There definitely. definitely into Yes, is sense mixed institutional a there is a retail are that of and investors that. combination

Charles Duncan

for Okay. the added Thanks for color. questions. taking Thanks my

J. Joseph Kim

mix Yes. day a expect average [Indiscernible] shares, when With few per to I at of million and days updated to institutions. times. that I expect yes, -- it's more in filings -- the you be going plus both we have last XXX expect be retail But a

Charles Duncan

Yes. Thanks Joe and Peter.

J. Joseph Kim

Thanks Charles.

Operator

Sandler. from question comes from Please Raymond ahead. go The Piper Chris next

Allison Bratzel

is the question. Good for on afternoon. for taking Allison This Bratzel Chris. Thanks

is can understand your guess the the a for fluid for path So forward situation. you us that I'm another regulatory INO-XXXX. expectations COVID-XX But coronavirus, on help I obviously, acknowledging hoping,

widespread kind regulators what what end as now with about forward see And talk discussions in for it from path maybe be use discuss takeaways maybe doses kind XXXX? talk about helpful the could if to should most hand of think of coming looking in a would by you in likely million milestones and be from your we to months? I you the just your

J. Joseph Kim

Ally. canceling are Great and other question. things uncertainty saying, still this I are NBA and seasons major Thanks unprecedented word Yes. and used Tournaments there, I moving. would this preface canceling. there sports their NCAA lot a by of canceling, suspending before

district and for kids two suspended weeks. school -- So has our

elsewhere. certainly expect and and to interruptions of dire type of and the situations and disruptions Korea I homeland So this China Italy in in occur we and saw this type South

we INO-XXXX first-in-man Every said, being is our X on well. is in we razor That into trial our Phase clinical the getting today know focus what teams focus, our executing have really thing razor U.S.

Our ducks team are target believe U.S. are hard and said, our very is to April. INO-XXXX. was to just dosing in Phase what of lined our in That X two we not the opportunities the I for and up safety in starting being order. X the looking trial in And our live objective at additional working up immunogenicity levels Phase also looking of

We're and looking at of efficacy at we're signals to in potential three looking seek early areas. geographical

China. is first The

with able We have X, as into but partnership to to. soon Again we're to Beijing a with we're that setting Phase efficacy with as INO-XXXX. territory enter an looking accelerate Advaccine

don't Seattle. Second, similar conversation opportunistic trial at me why during House task meeting. President White Korea. to He as Trump said, opening our you in go thirdly, force to upon South And the impressed

in we are Diego So -- Philadelphia could but or Los these Angeles or City. or San York New unfortunately where be

to of early immunogenicity vaccine. getting So safety nimbly our will after opportunistically act I and our be able we and believe

end from it, million Just of putting others the outbreak by can as our we of doses this up as and provide partners and as INO-XXXX and ball, X calls funding for year. on to the situations support, a crystal

the be be need doses goal This could and million make X from want delivering States. -- of an agencies our million our if two, a X I make testing they Number team our and existing of manufacturers clear. arrangements about year focus the the further emergency we using our setting. have regulatory assuming again, in government on strong which that, capacity utilize need our continuous by the be to support have to one. our very is Phase to used situation. Now, current end. Number and And outbreak or and could deliver and for of on them, from the the Phase to doses contract network that just own globally United them could capacity the doses funders expect million we in is used from But manufacturing our

Allison Bratzel

to device. maybe on And follow up that a Thanks. as that

level funding needs -- saw I got with confidence we you delivery done additional XPSP. VGX-XXXX for hold manufacturing you advance more had and to and think the I just to And device, device. Can some CELLECTRA be issue ability capacity up that a related about this just XPSP talk that? an your for that scale So to overall that XPSP the work brief was testing clarify, to trial

if be that could gating So just want to a factor? understand Thanks.

J. Joseph Kim

Ally. All right,

me clarify Reveal first. last delay phase prior And testing. very FDA asked being for is additional in without three currently things Let trials. X any and tested just XPSP the Reveal those CELLECTRA quickly trials, X starting to

Gates many XPSP And very announcement prior six in That accelerating our has trials, is And XPSP. in delivery scaling well extremely the field and Foundation the of device So we CELLECTRA our strong that CELLECTRA has nearly Melinda level delay commercial the morning sure operating the XPSP. generously INOVIO I'm to completely than called vaccine is supported. CELLECTRA months. the they -- everyone which for a past that and programs testing device. and a for supporter the start Bill scaling different the been engineered for R&D We currently of slight generally finalizing had a of this in seen have up about

to go making way a is happen. in funding that long This going

that doses start development. anticipation well accelerate coming as additional us us multimillion the delivering years. CELLECTRA is device. million year the We in are disposables or engineered XPSP up the health help lines for and require doses, funding going that the CELLECTRA for that setting we manufacturing This also XX as to which public a our completion device. to the XPSP. funding a be million for had of can delivered doses planning But $X.X arrays, automated cost just will this XXX INO-XXXX manufacturable ago some of in forecasting that About had represents device utilizing of the testing, experts doses million in million effective and the pilot massively One of current have

But So, we're challenge tackle these and should of scaling funding. for believe to we're in we're various Foundation efforts sources. happy quite this of And external be also happy direct grateful lot that funding about up. the type more Gates I putting from you with of hearing

happy grateful coalition Now to But we in to we're this very and CEPI months. and grow the Gates will coming expect and funders the continue weeks Foundation. of

Allison Bratzel

for guys. Okay. Thanks Thanks that clarification.

J. Joseph Kim

you. Thank Yes.

Operator

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

Stephen Willey

the Yes. in I frame update Good I terms up from taking what should for other questions. types. expecting genital A you Thanks guess first regarding couple just me. HPV of the afternoon. just we guess, outcomes Can in for magnitude the we'll in be some data that the a us the give of framework be patient you see a to each historical this just bit that setting? would of little seeing subgroup? maybe just of expect from data And XXXX

J. Joseph Kim

Yes.

So vulvar, anal orphan HSIL disease. are and

pre-cancer not high the and the of So the prevalence we're addressing REVEAL in incidence X X as and Phase VGX-XXXX are number cervical X as with that testing.

two the conducting HSIL. for are anal we small know, indications Phase each you and trials X As vulvar of

electronic HSIL we in this present are in patients HSIL targeted maybe At distinct these very well have least These While conference two separate the very and enrolled population. end a this month, of patients XX virtual trial. XX% as form, indications a have in anal name. vulvar of trial, at the enrolling we to plan XX diseases similar as

infection. regression on or XX impact or well What as the we're for HSIL the of or vulvar full down clearance, looking low HPV are grade viral as XX anal to

and are X the similar -- approach So our response present and are and vulvar and Phase XX positive cervical to setting. hopeful in Phase XX specific that X very and HSIL regard regressing anal see and to the We're or HSIL HPV the settings studies.

Stephen Willey

helpful. That's then one on I Okay. guess COVID. And

schedule, three requires currently and it's you is on think dose visits having I vaccine the weeks. Phase XX MERS a X four think which zero, So I guys I that and patient think

if curious guess little your Just schedule you could mass about just perspective? or maybe a if whether talk protracted three deployment kind of you you of not COVID? similar how I kind data out on guess with dose dosing a of playing a type envision preclinical expect a based I some you of kind And from of now would regimen bit know

J. Joseph Kim

great question. learned we've Steve, And a Yes. lot.

than -- stated during our MERS as our Xa our stated, as We studies study a better times are know well Ebola, an sufficient. administrations three that doses, than learned shots also we prepared we are two. three fact. two and two and injections XXX% And As I that That's are and remarks, Kate others. from Phase better in one. learned Zika many absolute lot we've But are HIV earlier in

primates dose. a protect And protection sometimes in completely single a or the to very non-human just MERS high vaccines with case, able in we were have

say three across the L.A., Philadelphia rather tell not I'd three in or to we're sure regimen public, setting. be I Maybe going visits pretty dosing So able but in that's dose but can to deploy you, well, I'm a not or for pandemic globe. a not not

as we'll for vaccine product we're COVID-XX. the target have the and what That's a successful a at be others for and WHO looking looked So testing. level profile that

So I'm be another able in going non-public trying month. providing to information. around what? quickly You're answer without guess very see that But to any to

you So to those I I This it's tell is a done not can with three regimen. you not going be should optimally think stay But pandemic response. tuned.

Stephen Willey

dose vaccine, a from maximum I to amount per of there could milligram be a is guess, perspective administered be that And a device? XPSP

J. Joseph Kim

micro It's liter volume. Yes. a about hundred

to limitation you are a vaccine. and for One I route, that's enamored intradermal with delivery -- both So route it's the deliver. while that is volume

generate models to submitted So for of models dose we to preclinical we immune a for looking are clinical and able even anyone look. those and animal to study. the some We're nature to, single communications, robust able in it's available we're with responses which in have at that at level

generate that to much. X volume don't to using test going I our believe dose we vaccine able vaccine study. delivery believe is the to the dependent So relevant are aiming be I be in Phase we immune responses so our will

Stephen Willey

Okay.

maybe I dose was Or we that to the room concentrate So can ask for is terms on more vaccine you in top way. mgs. MERS explored trial that Should provide X.X another just assume that? that was guess the in being COVID?. there highest able the of dose of that's

J. Joseph Kim

Ebola coming part was U.S. study our intra milligrams. using Yes. with at a dosage, different MERS up or a muscular delivery. Not for the six from testing were of at all. dose In was of milligram type study X hypothesis a study an Phase X in a similar setting MERS higher we to vaccine where The

we spectrum lot to from to were a able and wanted we of dosing that. So a have capability full learn

in So you to more or you the dose pandemic whether milligrams obviously, the can have in volume, there vaccine setting. let's dose

looking we'll others have we these based dose levels and escalating So, in studies appropriate conditions. in the be experience expertise studies a Ebola long and of at a we optimize But pretty MERS those HIV maybe. good Phase these do clinical that's INO-XXXX and on idea in But trials. our and doses early where vaccine X why including to

Stephen Willey

Thanks my for Okay. taking questions.

J. Joseph Kim

Steve. Thanks, Yes.

Operator

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

Gregory Renza

commentary for taking you the on thank I for device. CELLECTRA Thanks questions. today. guys. want Hey your on just to my follow-up update the And

that the demand experience sets you. on the patient I the CELLECTRA experience with demonstration the are studies. user pros historical of data think hearing with of COVID the and just there us device, And available your and cons Thank frame up interest increasing you experience? as given that, from remind scores basically you advancing of what the are effort

J. Joseph Kim

vaccine intradermally is score around which seasonal delivery been Yes. would of vaccination. Thanks. XX zero from that patient level Thanks score to tolerability vaccine Greg. reported the expect pain what one magnitude a studies this. has we on good. in XP very within a of from and the have flu In The published conventional you flu is may CELLECTRA expect two, vast

pandemic use mass XP. So from suited these and intradermal is health we're with easy prepared happy and using efforts easy Obviously, the device care professional well for for to mode slick quite delivery a for that's the quite of preparing standpoint, CELLECTRA well-designed, XPSP vaccines. to manufacture delivery and production standpoint, large user

looking we be any quite was very excited And to grateful more component up the can't of in overall grateful we're I support. Bill the any accelerating and can and that again, vaccine our COVID-XX make be Foundation to scale arena. important progress device strategy. XPSP Gates about then more And their continuing that we're So this a for Melinda

Gregory Renza

then, the their XX I earlier you also volunteers to Thank follow just as April. up, another cases in beginning in shared. here what respect you Are other the And guided have want COVID-XX clarify efforts healthy commentary Joseph. two regions. Great. have to your with for asset that Seattle trials positive and is you on

identifying the get patient trying you're step next sense expect? and the to population that Just for we a of what can

J. Joseph Kim

plus a It's where to thousand over is already healthy for they're Phase with Yes. The not target the we be increasing where potential persons. in even or million patients people appropriately opportunity make study X infected U.S. XX even XXX volunteers Thanks. coronavirus. I But the U.S., it that in going Probably Phase about find there volunteers post number, Greg. screen little the can of its X can with we and will growing will volunteers today volunteers. healthy but an sure that's or to test efficacy slow XX signals think early with

for opportunity U.S. to the in a growing those concern test to a live is us it of It's home over who closer while vaccine time. our So

Gregory Renza

you for Thank taking questions. very the it. Got much

J. Joseph Kim

Greg. Thanks, Yes.

Operator

Partners. ROTH comes next from from go ahead. Please Capital The question Jonathan Aschoff

Jonathan Aschoff

are was have that degenerative the to you broadly you. something vaccine? useful maybe a coronavirus already fourth use perhaps there guys sequence to around use for Thank wondering, such you time I a going

J. Joseph Kim

that say again, you Can Jonathan? sorry. I'm

Jonathan Aschoff

that there sequence to you these generate perhaps the generative all going have a The a next potentially to one be one of already. useful against coronaviruses could coronavirus such vaccine you might is is tested that use hand we that there in Are outbreaks? that encounter time

J. Joseph Kim

very different Yes. coronavirus There viruses are good in That's a in question. divergence family. these the

have don't we quick a that answer is, yet. So

in can of on with the early this is universal work flu some in research And vaccines. was researching broadly But protective we stages those have and of programs certainly approaches. or developing we on COVID-XX dealing that rely where focus pandemic. we Our very have done extensive

already been we questions. the there valid the Could stages vaccine no. So a Either In lot and be that? quick very immunogenic in answer safe tested outbreak, we people. of been and early questions, produced use that's a of were to is could our MERS use

later, it understanding trying good there good immunology, researchers are vaccinology and address we what think likely tries From Could you out use are that. questions. positive in know, to most our those You found outcome. wouldn't have a and vaccine some I SARS there?

vaccines future at epidemics. and known is positive vaccine you're current I think preset really of was going to their that a pathogens, to up in not But scary of should thesis and future make thinking fund really That's these forefront global how the that Lassa started that's organization against they to combating MERS creating least for vaccines at And very our were pathogens. similar outbreaks what CEPI, almost it's end what that's able crazy development. fever the outcome. we

difference we with And when just having them ago. in I made XXXX huge compared COVID-XX, didn't years have believe to outbreak three a CEPI

believe like INOVIO SARS-CoV-X other line CEPI and responding like in the is I against battle, front this COVID-XX and rapidly and which enemy fighters So, others, this true virus. the Novavax causing companies even and we or are Moderna organizations

are who creating INOVIO effective on targets and and So virus. focused SARS-CoV-X while we in vaccine safe our the - in this have are best true we may We COVID-XX. least is have friendly for our enemy real who eyes competition our most at

Jonathan Aschoff

wait the has Joe, do receiving a first immunity? after to you how long dose to think someone useful have

J. Joseph Kim

challenge But have generate, help more in we're efficacy across level challenge able in immune I opportunities various answer models in sometimes the as us to arms do animal additive. it wouldn't Great as studies different we an to immune In and again, MERS vaccination Animal have weeks, responses question. until challenge responses primates definitively will have definitively. of three the could setting other patients that the early that that be collaborators weeks with models non-human pathogenic sufficient working built of and you two can more believe Zika globe. after We we or that be you models, question trial. really address

the the ability has the the one target platform medicine's or immune is vaccines see along generate to directed responses cell antigen. hallmark has advantages antigens our strong of our specific DNA response is I that with T So of been killer CDX very for INOVIO's immunotherapy to antibody responses

So, can helpful. and vaccination I the higher the be the think, arms that access should through multiple better level you

Jonathan Aschoff

to three cash looks it my you Okay. about years. a multiyear when said Is in runway, the models on lastly that And then be for ballpark?

Peter Kies

Yes. That's ballpark. in the

Jonathan Aschoff

very Thank you much.

Operator

The from next Please go question Ram from ahead. comes Selvaraju H.C. Wainwright.

Ram Selvaraju

Thanks taking my a lot for question.

J. Joseph Kim

Hi, Ram.

Ram Selvaraju

Hi. Thanks.

a So are then and on couple just a COVID-XX. COVID-XX few that non

on comment when program the XXXX you clinical see can might from data please? first Firstly, the we

Peter Kies

Our MERS vaccine X/Xa? Phase in

Ram Selvaraju

Yes.

Peter Kies

year of now of see Phase that's should I planning finishing X/Xa study is -- that XXXX. present be in this have up able driving. mean, believe able I we be should of study to this year we data this and Lot and publish some to study XXXX our and from we

Ram Selvaraju

coronavirus of has COVID-XX But any the REVEAL potential that of not the REVEAL are I full And program in this related yet question study then, other know perturbation ongoing seeing -- second any asked studies? to pertaining the reached non vaccine enrollment. Okay. you enrollment was

J. Joseph Kim

yet. Not No.

Ram Selvaraju

Okay.

J. Joseph Kim

impacted could if been not it INOVIO could always has declared even and a virus be could been be has specific. problem. clinical it's a not the other pandemic. our more it's just as or spread widely, a has studies. It possibility just the any concern. of it But It While outbreak pervasive REVEAL more and And

think sector potential I whole threat. or society be a specific the you'll

Ram Selvaraju

Yes. so the to far COVID-XX specific that's okay, program. But -- so specific

project of partner able couple be Advaccine to off Beijing a in do Just kick the you here. questions China? testing When your would clinical

J. Joseph Kim

date. as it's date really as April. after be We know and Yes. at this exact We possible to soon an provide going can't projected time, our

Ram Selvaraju

any in Korea? South plans to XXXX test there Are Okay.

J. Joseph Kim

Yes. additional We're funders. for collaborators also that with planning and

Ram Selvaraju

just that And then XXXX all respect what relating with a And Phase cover would of grants, the of the study? grant can to give activities you CEPI to of sense X cover? associated Okay. us amount expenses does funding the development, specific that indeed

J. Joseph Kim

Yes.

of working This CEPI, grant is the MERS efforts $X Phase supporting conduct including So all with said, clinical of U.S. as the in studies on $X million relationship had I up a two-year manufacturing X million, clinical the Lassa. preclinical we've also and product and to

you what U.S. Phase in from really would studies So, the X of the completion expect

Ram Selvaraju

Okay, great. Thank very much. you

J. Joseph Kim

Ram. Thanks Yes.

Operator

This There the Joseph to more for like concludes our over the answer and turn remarks. are in conference question back questions closing no queue. I'd Kim to session. any

J. Joseph Kim

us to We Have with great joining forward evening. look again a for everyone today. speaking you soon. you Thank

Operator

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

You may disconnect. now

Inovio Pharmaceuticals (INO) 12 Mar 202019 Q4 Earnings call transcript