Inovio Pharmaceuticals (INO) 10 Aug 202020 Q2 Earnings call transcript

Good day, and welcome to the Inovio Second Quarter 2020 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 being recorded. I would now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. ahead. go Please

Good Inovio's operator. thank for you Thank quarter afternoon, XXXX the second earnings joining you, and conference call.

are Broderick, Chief Peter of Inovio's Chief Joining CEO; Financial infectious disease Project Officer, today Dr. Officer; Jackie Kim, Inovio's Joseph us Shea, Dr. President Lead Dr. for Kate and and Senior Kies. Research President Operating programs; Vice Development and J. and the company's

our XX, For quarter corporate and we today's replay review and second provide June live will be for which includes as our XXXX available. information well for the ended on a accelerated This will made program. on being clinical XXXX call vaccine progress, financial as webcast the website update our development and call, an COVID-XX is our programs ir.inovio.com,

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

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

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

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As a recap, quick over the accomplished we quarter, following. the

trial are First, data we Phase Phase presented trial the interim X/Xa syndrome respiratory our forward our from East our East. at positive DNA with ASGCT moving INO-XXXX X Middle Middle vaccine in for and

the with We coronavirus the X coronavirus COVID-XX. the of family first vaccine is causes are is the as that company which MERS for in same viruses Phase causes that

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a of in fourth mentioned during May, Third, Fourth, from we VGX-XXXX the against VGX-XXXX pivotal track dysplasia and reported of we we as remain to result cervical and X quarter. HPV-related positive pandemics for last data call efficacy X, pre-cancerous report dysplasia global for the HPV-related on for a Phase results precancerous vulvar REVEAL topline as against hit X conference interim anal Phase since our patient earnings year. X in recruitment first took REVEAL this quarter

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we As surgeries. calls a around their and plan during their patients undergo regarding mentioned lives surgeries scheduling literally RRP, year multiple typically these previous

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the half of As this to is with in next an hoping trial, second share the year. to we're you open-label have data

Broderick, to like of an Dr. R&D, program. I'd call update COVID-XX our Kate who will our SVP turn Now to on over provide Kate? the

fight earnings you against call, afternoon, everyone. Since good last and amount our in disease. huge the Joseph, accomplished you, during have a May we spoke Thank COVID-XX with I

understanding Joseph build of defeat is stated to to the the it. key to continue our approaches the and COVID-XX virus and disease to As combat have multiple on

We by our our are to Phase look immune forward planned and in beginning of we encouraged very September vaccine trials DNA FDA candidate, X/X responses the concurrence. upon INO-XXXX

we today. on So where me are begin of let as first,

reactions medical Our trial process subject adverse a safety events U.S., to no been as redness. manuscript events only for a data peer immunogenicity journal. reported the no in week adverse per is monitoring COVID safety program and as there of such comprised related review concerns the undergoing transient top serious X and mild with in eight XX initial at is Phase analysis, which Today injection-site board our have safety the few primarily

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COVID higher could tested including have related greater even a four Many T possess that of can more vaccinated cross-reactive of previous proportion even likely virus addition, cold. some durable viruses the with Several Leading cell cells cells infections XX% that before. that which of COVID-XX COVID COVID-XX were large perhaps while T more responses, are having helpful almost post in are samples limiting and disease participants T previously T despite vaccine were infectious believe common and T these cross-reactive explained disease. cells experts reported responses might well may cause magnitude CDX the These and the milder them cells established against in generate ultimately very new asymptomatic. severity from specific responses those cell than candidates. In population similar who both studies T naturally convalescent infected course Therefore, a CDX generated the cell strong coronaviruses, antibody immunologists disease, significant responses cell responses increases other strong recent generated T frequently so-called T encountered developing that help actually become recognize SARS-CoV-X these revealed that much could neutralizing better more vaccines partly Interestingly for as or responses. others were as to generated make vaccination. why COVID-XX. in noted statistically believe never efficacious cells T be and than of people be could could represent sick vaccines,

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profile anti-vector data clinical the addition, boost-able expected. immunogenicity a In with fully immunity as also suggests no

study, the Our build to vaccine's a currently virus. upon recent thing have we closest efficacy challenge our primate X that Phase animal live confronting when data testing nonhuman a human is which

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from acute As protection high such, the study and of post-vaccination antibodies present immune our not circulating memory phase. addresses from challenge responses during levels

INO-XXXX's virus favorable our we're antibodies with speeds the our as safety primate operation ensuring studies assess antibody-enhanced response it with that INO-XXXX generate non-human emphasize were GXXX, also animal ability pleased impact look research durability non-human to disease primate We emerged the reassessing to critical virus I also forward newly other of events to in to which want challenge is participating against reported pace be neutralizing that evolves. keeps the out, to of challenge. of stream the no profile. here ongoing at We our months XX supporting and warp animal And

U.S. our Joseph. our proceeding subjects Phase now, I'd enrolled trials begun. and Finally, to Phase forward in like X is in planned we these We on hand in quarter. are it Thank you. data that older updates fourth and fully look over expanded I/II China South Korea And and the have excited to as to back providing trials trial

you, Great summary. Thank Kate.

for update. our I'll our Now over turn Shea, Dr. Jackie manufacturing to COO,

and Thank you, everyone. good, Joseph, afternoon

moment our be a are highlight specific DNA how medicines addressing global as manufactured, platform, aspects and both designed pandemic. to and vaccines critical stability to which to of the the take advantages I'd First DNA unique recap in well as can of products, the quickly like a

In DNA in well are multiple more which large vaccine facilitates to are established. is quantities. manufacturing cost-effective They a terms rapid characterized much manufacturing manufacture other perspective, this via so through easily our to biologic manufacturing, a products than importantly, scalable manufacturers. of And and fully achieved medicines very process, and many very produce also production development DNA scalable are from and

a million target at established of million Joseph X place doses an and this mentioned, least in XXX INO-XXXX have year As XXXX. for we of doses mg plan X by manufacturing

are further working expanding on We manufacturing consortium. our also

INO-XXXX storage, meaning minus stability, or shipping not of minus no freezers are terms require In does frozen or XX XX required.

of INO-XXXX global no considering adjuvants Joseph unique two at XX the manufacturers to is room only Our projected year degrees global demands made in coalition tolerability pandemic. and manufacture positions vaccine consists DNA but and nanoparticles or months temperature that significant large-scale the very a during stability favorably, This Also quantities better shelf of pandemic. this further expanding optimized needs or a The a the of factor lipid for partners, formulation advance vaccination funders of as better and addressing with and refrigerated. when of is mentioned, stable and also meet when leading our strides stability plasmids, important water for differentiating life logistics C five-year has administered. not at vaccine, Inovio to of required, a to rapidly when INO-XXXX collaborators, salt,

funded end you CEPI. Richter expanded million Ology one give of awarded to Helm Germany, Preparedness quarter So of manufacture some for scale-up In highlights, with at partnership partially an $XX.X coalition quarter DoD with we for the our trials. contract work clinical the the Innovations to two the also Biologics INO-XXXX Bioservices Defense to in Epidemic through or for Department Inovio manufacturing

doses XXX the announcements of in million next consortium the We are Europe the also months. plan X candidate make next additional goals of manufacturing vaccine about million production in finalizing to expanded partnerships our and in year, over this fulfill few to U.S. the process and a

of patient with battery-powered the addition, similar and trials of footprint. intradermally clinician that that to provide the the and the rechargeable devices has device our we Inovio's small The In and overcoming CE our record of than X,XXX with uniquely are CELLECTRA feedback. handheld, and an been has version vaccines excellent XXXX other device safety administrations clinical toothbrush. size into deliver key other nucleic approaches. a user-friendly, a DNA earlier cells, positioned CELLECTRA leverages and has smart that an more or track its our acid safely of portable, very efficacy medicines. CELLECTRA XPSP limitation called certification DNA XPSP next-generation is smart received to Mark And used the electric of It's in DNA

XX in in The patients CELLECTRA and and to administer Additionally, it's devices less that for we the device to device. using Defense DoD into use. has the CELLECTRA device. seconds from tolerable complete I'm contract builds upon up multi-use the up the testing Very accelerate scale two five by Gates of the grants Bill is prior June, to skin. than smart from the able million from used & year clinical delivery U.S. CELLECTRA flu separate more for per DNA pleased our funding for of process to Melinda earlier and and X,XXX the than deliver in report XPSP directly as XXXX and $XX procurement Department to devices this device CEPI Both our manufacturing are standard XPSP of doses Foundation importantly, of of shot. INO-XXXX million CELLECTRA our and described in late received trials been to volunteers medicines

commitment potential We pandemics our INO-XXXX are disease that it such and combating COVID-XX. the smart U.S. role DoD's extremely in as entity device of a the confidence and of grateful sees an value major the for speaks government to the in infectious

reiterate gratitude continued and again, our we production. forward Finally, I'd INO-XXXX of like to as partners, manufacturing collaborators, to sharing once look updates to funders all and scale up our partners

Now I'll to hand back Joseph.

Jackie you outstanding for the work. for your team's update Thank and

Kies cash Our now a us Results $XXX of joins Peter? CFO, for I add include second Peter to financial have review quarter in reserves. million almost results.

convertible million to share to period revenue net $X.XX Total dilutive period the loss in XXXX It our related This August non-cash for increase fair in XX, compared change which the voluntarily the the compared the embedded per and compared in same and into per than second stock. net share, quarter in the share conversion consistent with liability per loss share liability months less to the the is period the important June converted was basic revalued million same XXXX. expense, to common for due operating net feature dilutive, $X.XX net XXXX. rather same is for is derivative was share or basic that XXXX. be these would million, the $X.XX to quarter bondholders was or period. quarter in be understand $XX.X reporting and by the were ended company's $XXX,XXX Subsequent of loss $X.XX per per Without XXXX this for for the for XXXX, $XX.X our million, primarily the would per $XXX,XXX at the XXXX, bonds share each in the period XX, expenses Thanks Joseph. XXXX, bonds. while than June loss INOVIO's for for to in deliberative XXXX $X.XX were quarter three same $XX.X value $XXX.X to

For operating for period R&D compared were in to XXXX. second quarter expenses million, million $XX.X for the expenses, $XX.X same

related the ATM an received compensation to XX, XX by related increase and sales performed trials expenses, The expense. $XXX.X increase related Here million -- in primarily communications position ended June the cash included manufacturing and company from of in work an at-the-market related G&A employee-stock-based to was common expenses the in $XX.X VGX-XXXX stock was an an agreements, COVID-XX higher marketing decrease equipment. expenses and net our and expense development increase R&D million offset during million The the non-cash in proceeds and shares device million in inventory three million. in XX primarily The its $X.X for of an to under corporate same expense for by quarter in QX contra-research clinical XXXX recorded agreement. legal end increase to selling increase expenses engineering in versus months grant approximately were G&A period drug XXXX. of

strong noted, we capital have resources. Joseph As

compared million As and were short-term June equivalents investments XXXX. $XX.X at XX, XX, cash, $XXX.X December cash million to of

million exercises diluted to the ATM June effect on XXX.X after outstanding XXX.X XX, vesting. restricted company basis. giving This had the activity, a common XXXX option of is quarter stock stock fully and and second outstanding common million shares As shares

is information Back quarter under Inovio's Thanks. quarterly included accessed tab. for you June Additional Form which page, Reports the to XX-Q be Inovio's can Investor in XX, Joseph. ended report on the Financial XXXX, on

next year. Inovio great one, Number In fourth will important the third, and doses. achieving It's scale-up continue trials efficacy of Peter. partners well and is transformative top quarter. REVEAL vaccine of advancing closing, forward to month, two, that on survival objectives waiting. this line certainly know financial at the out Inovio as committed with Everyone razor-focused manufacturing millions doses; is consortium strong we data, medicines with bringing U.S. funding you, and for remainder several and for European with out one INO-XXXX following the present world's very patients build conducting Thank manufacturing of in INO-XXXX, overall round are XX-month meet urgency INO-XXXX; additional in safety the to to COVID-XX manufacturing at Phase as X/X of and Phase and our executing position. hundreds because the external we for Inovio's XXXX DNA these VGX-XXXX vaccine X Furthermore, data need

questions we will Operator, analysts. and the your for to comments. the line open Now please turn

will And begin We with Renza go the now first Instructions] today Please question our Capital. ahead. Gregory question-and-answer RBC from [Operator session will come

you previous just Hey, just I'm Thank commentary. and Joseph, with for It start just going. commentary plans comment current X/X delay your Phase wanted gating trial for September the around Joseph sounds team. a curious, my I factors could slightly targeting getting from maybe XXXX. a good on that start the you the a evening, congratulations you're questions to progress. and for taking maybe for the on like perhaps if

want or be that. what maybe very secondarily, just just involved And related help the much. I would are that some to the to perhaps Thank execute understand monies to So pushes there. on that and to resources and support then pulls of you

Yes. Greg. you, Thank

been get Phase X/X we've event. working So to urgently our

discussions active the FDA with very and on we are in design feel this we process. the close are that very to We

available have we doses, to So everything in terms execute. of drug

we peer review. very undergoing everything have which Phase we – terms encouraging devices positive and data, the X of In have is

we executing support we like external to working funding So we getting concurrently on an on are are Obviously, this. this large feel trial.

this to will external Phase certainly So by please stay September in because with regard. able the tuned funding X/X be start we announce

then the And on data. just a much. quick non-human very primate you follow-up study Thank great. That's

as be I'll with the the well we Thanks, comparing length other period, perhaps studies? hop how perhaps when queue. the for that challenge into thinking follow-up should used again. back that as of study dose primate Just the about non-human

absolutely. Yes this question. Kate I'll to turn Broderick Kate? to Maybe handle

INO-XXXX underscore is. to because I me at opportunity want to Thanks vaccine clear candidate to is durability. show important in disease. so Inovio question that effective gives non-human from how anyway, is that has also the good important much and And be safe, that be do incredibly the has vaccine that that durability protection to a only this but have that to incredibly COVID-XX data for really my it primate knowledge has to we really be point to

can in for or relevance situation doesn't lot but a You a weeks have only protect whole today. of really a month the few

we when and think going as kind bioRxiv to actually much very a an by of lot opposed artificial the that on truly that helps as similar real-life recently situation a I question. really survey excited I period be in immediately vaccine challenge just of happen important are responses. to people data candidates your that answer the we is we is what would So which of you released acute to new of hope more after

Kate. Thanks Yes.

Our with go Please Stifel. next ahead. come Willey Stephen will from question

taking Thanks for Yes. the questions. Good afternoon.

Hi, Steve.

there I Hi, press And noted that any can part a in raised again. I as that just release there Phase then dose it more participants age provide study the it bracket like added the was was the timing guess Joseph. lower I around Is extended But looks there's of of I study was -- more the include was you publication? extension. guess also the to granularity think expected

So and And clear then follow-ups. response not a cohorts? that may been should we inclusion the a implies that one mg between mg of just couple I a there dose assume dose the have lower have two of

wage readouts Let -- prior person FDA response me studies having touch wanted. done were first. of cohorts. the on of the Phase question extension last do so that from the escalation the I part all that two XX No, the was that's to see One initial of groups the we immune

we to we XX-plus with first with added doses. So two XX started and cohorts one person XX then milligram And milligram have population.

that spectrum moving also urgently. X.X pandemic wanted our complete response the Those of broad dose overall down are felt coming clinical Stepping of overall very doses We escalation. plan. bit to a but as to things see we little back a we're a in done spectrum to milligram development

and feel outlined The cellular as as And detail review, doses sooner that their when what much it's waiting to process you of paper. and and other you be already in that to we're shown review vaccine and urgently going some vaccines well reports I'm are. would the published but very we you rather later. humoral guys other peer hoping immune to both tolerability, time, very responses the have is all take So approved safety will own of the than every of Back one-milligram expect peer especially compare -- strong when from immunogenic safety two-milligram the are it conventional candidates. as as and tolerability

Okay.

Phase So publication should before II/III I announced or the that guess I the have we decision's in initiation the Phase to hand expect before September? in of

two events. These are No. parallel

litigation arbitration it or be guess litigated? need Phase indeed II/III whatever this resolution lines to what does call I Okay. all guess to starting I VGX projected at then impact just you here to this want September? the the are And of does ongoing, in a on a And if guess the I likelihood time

I reaching plan I go any want even because that but doses. our process, an say don't absolutely goal on too litigation too II/III has litigation or deeply efficacy our trials development don't of million that's XXX Phase of other any the INO-XXXX or impact this XXXX we go to to So ongoing including the into discussion actual can of scale-up in want --

for have up feel our our the doses are we as race manufacturer million XXXX. -- I scaling needed focus squarely we before, feel is and on trials all to XXX device and that we in and doses So support mentioned

Okay. just being lastly like? that upon kind and maybe FDA of a a is characterized And just NIH you II/III I what it was then I something should registrational receiving little can initiation master outset, here asked I talk the the concurrence. the bit guess we looks guess program dependent that guess at FDA And anticipate but like concurrence kind protocol? as you of the about of

Yes.

So FDA steps. process concurrence you're as go to allowed IND Nothing forward. in approved of concurred just approval any actually term means it's for isn't actual an FDA approved. is process

the So just it's terminology.

yeah, have Phase go a FDA into And getting could to efficacy steps. to move previously efficacy have that quickly colloquial our upon easily as X/X we brushes that trial. -- in randomized allowing is next think Without placebo used language controlled X the us will we as get details to soon it I approach a portion of, mentioned to double-blind So broad okay X the getting be and through Phase portion a getting possible.

So overall the be from Phase those trials other other to similar groups. approach ongoing X are will --

should upon master patient NIH number based patient of terms in And the numbers, this FDA achievement a expect protocol? we like looks of concurrence to that see

profile, order sizing Yeah. In also terms we sample be dictate it similar it risk of of time. really at the would magnitude. in Who magnitude, we higher infection will of the expect the volunteers that but same actual in the -- overall rates on target depends size,

for All taking all right. questions. Thanks the

Steve. Thanks, Yeah.

Wainwright. come will H.C. Please question with next our ahead. Chen from And go Yi

thank taking my questions. you Hi, for

Hi.

follow-up Phase T responses My with Joseph. how you last? to healthy the long can XX trial do is first the see cell in original antibody and Hi, question the just volunteers X

designed follow-up the to in the up to one dose. as year we Yes. protocol after Currently second we have --

and will of start up XXth both trial the response. to month the the durability of be follow-up immune total of the for safety So

how tell and protocol are China And X China can Got many same into Phase the U.S. were patients us X X the trial? you rolled it. being trial? trials in as Korea Phase And South the Phase have

Yeah.

portions INO-XXXX, XX% South trial studies. of initial Korea So their trial and X both similar China very Phase to much of X are our Phase cohort

those So it's Where intent portions of is the the would of Phase similar in sizing design. differ it trials. and X the

South several we're the into in to So hundred population in larger is Korea, X looking numbers. patients, older China, estimated In Phase be trial in expand to subjects.

the our globally. to trying we're -- database immunogenicity value there to safety and So and broaden overall franchise of

in for would of entering think healthcare going With many you in the enroll you be Phase pivotal workers think year, the I a trials? candidates Phase so And in second trial to it. you competition the trials X that mentioned X of Got enrollment do this of there's previously half subjects INO-XXXX.

X question great trials think the are world, to by concerns we're the think U.S. and I country we're all targeted the don't be Phase the in heightened done to outbreak for I Yi. these a everyone about that's in be such by in Yeah, a and of going with the talking practically trials. limited available this situation Certainly volunteers that And

practical are eliminations. there Now

first vaccines I think have problem enrolling. no the or seven should certainly six

don't vaccine us. If Phase I is any to into marginal -- hitting pandemic those all around get may you're news and challenges everyone's XXth the But I It's day think the of expect in X, you enrolling, availability is life. the issues. be some because every in impacting

enthusiasm So will think, for any soon. trials subside volunteering the for these I don't in time

the REVEAL for the color on could it. give status Got lastly, us X trial? enrollment And some you

Yes.

noticed by our the was certainly So trials. REVEAL pandemic X impact

all not to get be so to else's and it's to -- you're going at sites on. clinical trials home locked you're Just able your clinical globally, down understandable when like that trial everyone

So that. deal are of with the to those trying in us industry as all of

We very sure pre-pandemic. literally rates we get and in team perhaps CRO the our back levels to also night have continue to a and are who working and day that the make dedicated can

the possible. So But here I that impacting but to give we're quantitative working or answer here as hard is don't here. enrollment surmise the ameliorate is want to what I summarize well any is rate, can pandemic as very

Got you. it. Thank

Yeah. Yi. Thank you,

from Fitzgerald. Please will Our question ahead. Duncan Charles Cantor go with next come

leave Joe and you time. for interesting questions, Thanks in taking should team. Hi, my

Charles. Hey, Yes.

the stepped call to I late. Unfortunately, on Yeah.

before out And first do apologize, Phase on details that questions you So have X/X have Phase you going X. of if from older wanted been I then to consider read separate asked. all these Or would I study when an then? that understanding of patient would data additional you adults include anticipate some some the when get in of could you cohort study? a the

absolutely. Yes,

X the middle Phase data of of peer process medical of terms at we're journals. In the top the the in one review

the of data our detailed and So all through hopefully, present subjects. immunogenicity publication first Phase the from safety get expediently and tolerability of can with the X full XX we

really quite most COVID-XX groups, think those be who age at we of from our risk disease. terms will In the are vaccine appropriate for

folks older are these more are may population. that put risk. at So co-morbidities These with them

to our have X older next of to those terms studies the in So in already two have expanded months. we're population, way up data Phase to we all one the include them XX-plus to hoping and

X/X and original -- was Phase groups all our isn't to an well. X/X. age XX include will XX which Phase as on XX-plus for including which predicated As cohort phase

any longer-term but Okay. to I'm wondering safety how And gain look you safety? and I would asking you access? for That's you these that COVID of you out you it's consider do licensure best vaccines, of guess, with to I here, I'm what broader longer-term evaluate speculate fabulous. for know that? when think will And when of comfort

Yes.

some X-year the of for their So ongoing, period if X you evaluation look Moderna's that's already have trials Phase case X. at they Phase

to followed so is could the grades the quite X focus efficacy X, primary that of Phase long-term are can But trials also response, impact in or safety are really clinical acute reactogenicity I immune preventing secondary From or which Xa severity you the a -- endpoints. early disease having the is what on. mostly vaccine studies X long-term what valuable. and years infection and disease is on what Phase impacting X, the terms think of the be on one generated preventing two safety safety the be tolerability

on AEs all and touch severity. which really X mentioned can grade in X only I is were is what they INO-XXXX related as here So exciting had Kate

of they conventional some market. the other Phase extremely X on Phase COVID-XX. well against side-by-side candidates So to clearly, compares as vaccines this in X levels are But with the and already

balanced and stress two, either in what X very Inovio's having and be about against antibodies is immune participants immune important very three, number medicines it learning second we important as limitations vaccine with COVID-XX INO-XXXX we for Phase years. lack on every and responses we any particularly think anti-vector Inovio's to all toxicity this, what it's number lose alluded which from addressable profile, a can which number I can due seasonal is SARS-CoV-X think DNA to itself our became our we are folks vaccine T-cell vaccine And very can responses; and number saw these to exciting more sight if as responses both really tolerability of unique And and humoral day So, well we If but none; lot to platform. positioned DNA If extremely that T-cell as came Kate to, by one, disease. number that. more platform other inference neutralizing COVID-XX is a disease, INO-XXXX and and/or stable. four, generate five, about of unique which we two; safety we we boost is responses generate we're is well many think both and of T-cell

the to maintained cold Our long-term of a normal very stark advantage compared We a chain at refrigeration temperature at room is years. in is arduous fashion. keep a five over product to other where for some be our which storage and up vaccine difficult to the can needs vaccines year

these these vaccine. hopefully more seniors shown may tolerability unique important for have early have even that in we some we And five not think efficacious attributes and we trials. like very reasons, safe their acute of issues and withstand other a to these able who reactogenicity be some think become in will candidates of vaccine groups So, the

the you upper with you're the and is capacity on still may but addressed questions And XX,XXX, X/X. and Phase answer may a could about two probably you fund capacity more your other those and I'll to if I just And that you had study logistics is its it. have you problem other some that color only had. and folks I'm that. XX,XXX-patient throw to just talking them the how address manufacturing provide wondering about end a that related not and capacity I that can and to wondered many into some and one capacity that really of Joe for then not so or conduct I wondering solve on think manufacturing regard have capacity I'm

Jackie touch on the Shea. I'll Let me refer the and response first to manufacturing Dr.

terms concurrence Phase to we funding to of time move is up of our external the funding - presented around our to trials. trial. working to be and devices trials support Phase require the the that information vaccine same and on we X/X FDA already for Phase we expect In clinical we're doses the What the have all lining X/X the that -- material get

quarter Dr. progress manufacturing detail. addressing the really a as me consortium So, manufacturing, -- setting Shea huge far made to past let the up and in we've this But for as turn in globally.

Joseph. Thank you,

So, a to break up couple into your of question parts.

early doses So, build X/X. we of manufactured that of the our need of able have that on. we first clinical of including millions to being need, And upcoming the all, already we we recognize to supply hundreds very the for and terms Phase longer-term would doses the phase that -- studies ongoing in

As and vaccines, very reached very And early different that manufacturing a with also other consortium way INO-XXXX. as approach same January, companies in novel the out approach we've the would same we manufacturing established taken and recognized we their have way. have to that for

and so beyond talked So, U.S. we're couple months about next in exploring we've And some announcing the Europe. Ology. over and manufacturing are partnerships we'll those now of the Europe and partnership partnerships Helm Richter these based also U.S. of partnerships and further be manufacturing the and

good. for Good Very the luck my Thanks for questions. taking future.

you. Thank

Aydin go Please And The next question our will come Huseynov Benchmark with from Company. ahead.

with you. the this Congratulations everyone. quarter. Thank afternoon, progress Good

million close year potential already So is to assumptions by how the XXX something given and was that I first competition. be announced this pricing about X million anticipated that next would have question, the year

is large-scale the going mass but pricing to also I'm turn to a important to this that is very very Well commercial important Inovio. at important question this and – something question is world scale also

well. over going I'm Jackie to in to as turn regard this So

Thank you, Joseph.

the many these vaccines produce similar a of other think afraid say be stage say. I in to ballpark that, confident vaccines. I scale is I'm need will this we're the that pricing this leading can can to and what at at about that's we're affordable I at trying and that But we all be to accessible stage that

Great. I that. appreciate

Could you in that and T-cell you give vaccine? had XX% show for responses are responses are is this of in XXX% have mentioned responses percentage us CDX+. demonstrated overall patients I CDX+ press immune a release your important question how including Another the of those breakdown XX% responses converted. opinion who

Yeah. A great question.

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part that surprising. So wasn't

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trial. consistent have So seen vaccine it's our to we previous in what very

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it's is let me I – years, the – do think least first it this Yeah, require but so. think to put At several going in I this way.

when the of be the in their to infection durability immune are then durability vaccine is KOLs All which natural depending would who it durable. we are early It sell The most comes on that, globally. I it's T vaccine approved, long. going vaccines think protective responses antibodies. manufacturers, we not only multiyear many the cases of And cell the more everything that several be could response, months response to saying likely that mirror most get likely will manufacture collectively

our vaccine to So – Inovio's have on and could almost mentioned can cancer think response studies, In or therapies our where immunologic advantage. and platforms this But that's touched after vaccine issues Kate that I are earlier. tolerability boost doses without We infinitely. some can with also vaccine patients up without or anti-vector safety any receive our a other say or that dozen going any COVID-XX. isn't more this something that you

XXX In terms our immediate we're production, XXXX of million overall goal it's – – doses. is for

As on. soon as manufacturing we million achieve so and that consortium doses then to up XXX capacity we'll go

supply attributes because current and sell we described of I could can our projection manufacture. doses had we much is as many pretty our So think earlier, INO-XXXX we as that of

progress Jackie's and our great both be goal the able manufacturing we manufacturing to get excited do in dose that is and Street our are to millions for we're on and really device teams XXXX of to the focus tell we ray where hundreds plasma should fulfill levels I'm those how beyond. truly and of making focused So and

be approved merge that start you. authorization? do is, Thank expect to to you. the would question earliest terms use the you you of Thank the in in And you're think assume that trial if going probably approval? last we of so What's when INO-XXXX September, via

think in XXXX. The likely Phase We X Yes. looks. build interim portion, in will sometime we

some safety it the if all Phase come X infections will depends quite at bit of on of of recruitment. is of transpose where into what's this we going going time think BLA sustain really we earlier. country, years be Actual to and emergency the across of so over things due on infection having are – also sort generated, things is that can if projection responses, today, the these along there early on – But of correlates EUA our an a for So think look to rates The time, with the but those touched immune play. the we a authorization beyond efficacy in think use follow-up or immunological approval. hopefully XXXX that we sometime through logical that some correlates we could take all

Okay. Thank for taking my you much questions. very

Aydin. Great. Thanks,

will go Group. Maxim [Operator Naureen question Instructions] Please our ahead. next from Quibria with And come

reduced Joseph. And INO-XXXX. around clarification Hi, this. of publication was to convalescent – been your a antibody of neutralizing on with asked on or regard thoughts press wanted that my your have releases And you responses T-cell that's progress. actually Congrats questions on I data one low kind guess In and there the antibodies former just of you've most indicates titer. touched I of a citation and but

if you're So T weight your versus I are on the what responses other. was just thoughts more it? putting cell on wondering Or

reports the natural cells convalescent continuing us from a these studying body. it's field, naive T factor the subjects The from tells the major Naureen. of you, T infection playing their pre-existing person cells specialty having Thank not that, the are in in severity limiting should cells Yes. the persons in and T –

positive Roosevelt, a supporting at was out and but paper and showing hundreds continually of Europe there PCR. them. China USS by important look similar that of data you Group where were very with of and So sailors came from a not there many from cell were And was when publication the by infected, sets them antibodies others, Rockefeller

don't And the stated these there's that T can lot fight in from can infection? the they how person a cells off? as So suggestion says, cells, off Kate studies How fight T cross-reactive of asymptomatic the are dispute antibodies, of importance long are neutralizing the to And time. for prepared of but the hard a thoughts we remarks likely last it's our the -- -- part causes. they

So having generated and field thesis. as the the well and best as well far And infection balanced in one-two punch antibodies with convalescent the disease. maintained thus neutralizing studies both coming potential as think our deal COVID-XX data we've as CDX to from vaccine us that cell I from responses T a responses gives CDX always supports immune the data this

then one it. Got just And one. quick

guidance will for available? You're the non-human that any participating also when speed. warm in become Has operation primate there data study to been

of That's this the or hospices whether we'll the in of presented studies will our OWS be primary but schedules few the know we months. -- not. all should together under the non-human be next something the be with discussing that When OWS, it

you've And then any you But that? has VGX-XXXX. other and have got are center of of Okay. obviously you stage deprioritizing sort INO-XXXX -- programs because taken

least is And No. But and part XXXX No. -- data on and company the focus line about will data OSXX are very naturally was I'm VGX-XXXX ASCO. other our in questions the we pandemic, investor and how INO-XXXX, focus discussions And around pivotal excited coming. at any about resources first Phase as in year talking of data It's of the the extreme be top absence our been call, on a that. corner we this of touched has expanding sentiments COVID-XX at as amazing understandable. efficacy that. and X terms around the I my the

to at November in cancer conference a XX exciting in So mid-XX% And it's standard-of-care. patients. for again, months XX% presented with is survival around to at corner a the compared pretty be study XX OSXX, well-sized and very

a very horrible dysplasia, from that at survive regard. -- successful who dysplasia GBM very multiple therapies as So provide therapy, for horrible And are a designated in high I'll talking is to horrible be Again, arena procedures this not high this scheduling to then the about something novel around patients value and excited both year. diseases I it lives undergo to is non-surgical first designing value anal to we're who the leading kids diseases for to disease immunotherapies immunotherapy where novel this a have non-surgical commercial to INOVIO Really patients potentially non-surgical their surgeries if excited toughest that. cancer is look vulvar own, INO-XXXX. treatment for are we cervical getting these and adults arguably first are and just the I'm in on shareholders that about a and these our -- remiss which orphan in RRP. we mean, their think the -- our way the like

I this actually focused INOVIO patients categorically bring need and uncategorically dose these rather I our to think we doing And we heavily invested which on, down, have slowed is have them. products is vaccine. COVID-XX said haven't any always who we focused say, we and what have have I -- always into urgency to what

what there in that's surge And and INOVIO of these We're RRP, of practical So we're we're we're that, what century. GBM bringing weren't the able therapies, aspects of for very excited where VGX-XXXX on the in and new pandemic amazingly truly to indications. of doing, top is tackle to true all about. then solutions

new dealing like of to that trying that. us to year, just So But faster would the are of year, although, maintain a for. was we're probably day I to be not provide things. the diseases would how By would is guys to achieve year. all but these in at advancing and we we double that important claim working like I have think at pipeline this you transformative going night still look the that Inovio's pandemic, are, beginning just and than and I back of our down with role we other end medicines to with I be that I team said this literally XXXX

Got helpful. on Yeah. Congrats again progress. very was the That's it.

Naureen. you, Thank

And Sandler. our next with Piper question Please will come ahead. go from Chris Raymond

ask Hey. a Thanks letting me for question.

So – just I

Hi, Chris.

of Joseph. you guys XX cohort responses. in XX. I Back that Hi, I on was you now to I So it's of think Phase guess sure XX I of demonstrated the X immunological I understand XXth you? noted XX had heard math. it How June And just overall want participants say, the make are

what's patients? the So were you as I patients were make of understand think Did they sure more to dropped question, going because enroll I couple a with remember numbers. on wanted I just COVID Because I positive. out that patient there guess I the

from to dataset the Thanks. on XXth now bridge the understand us help Just the please.

any we the Yeah. rerun luxury the And we samples additional point. Thanks the clarification. where subjects those and to more time requires No, some finding to unavailable certainly, question. for but have haven't having of next samples, are this that dataset, added time

in both week a and response at make week looking six to So more able judgments those holistically little eight, we're wisely.

one the or person the – sites. to of find the totally did She can't to XX unrelated vaccination he/she drop can Now just transportation the trial. the out

antibody So SARS-CoV-X. was were responses that's to to consistently the XX other did one one people a exposed that evaluate And protein viral their other and person. proteins at to indicating responses. confirm baseline nuclear person previously have he/she we able immune All to

more confirmatory XX be to all a are evaluating who more positioned data immune available response on in So for cohort preliminary where XX we subjects lot two we in this have study. have June first

– So sorry. I'm

So were COVID those positive patients included?

that high One so include No. person confirmed was evaluation, because we not they at did entry. baseline very responses into person the and immune had

dropped person person So unrelated for positive. reason, one one COVID was

that's So XX.

on I'm release your XXth sorry Oh, talk. the press

I think three prior you being due COVID. to talked patients to excluded

analysis ended on not so were those again things. that's So suspected two confirmed, why say being up persons we preliminary

Thank Okay. you.

No problem. questions. Yeah. other Any

Not from me. Thanks.

Great. Thank you, Chris.

will the any And question-and-answer remarks. like Kim to session. conclude this for closing our turn to I'd conference back over Joseph

as sharing other studies, data. all in and important GBM REVEAL COVID-XX the as including very more updates Great. Thank and well of We touch look obviously to our forward OSXX you on staying milestones much.

Have So stay night a please safe. Thank stay and much. tuned. you great very

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

may at disconnect this now your time. You lines