Inovio Pharmaceuticals (INO) 10 Nov 212021 Q3 Earnings call transcript

Good day and welcome to the Inovio Third Quarter 2021 Financial Results Conference Call. All participants are in 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 Operator. thank for you Thank Quarter afternoon. XXXX the Third earnings joining you, And conference call.

President call Broderick, Kies, Anza Vice Development, Dr. Senior Vice Joining CEO, Mammen, Chief Scientific Officer, Senior today's are of Senior Development. Jeffrey Kim, Humeau, Dr. of Joseph and on Skolnik, Dr. President Dr. Mr. Research Laurent Peter Clinical Shea, Clinical Chief President Jackie Officer, President Vice of Office, Financial and Kate Chief Operating Dr. and Development, Dr.

call, we for today's September will For and review financial the XXth, our information ending corporate third quarter XXXX.

also variants development efforts of will and efforts that future well our as homologous and our as current We COVID-XX concern, around discuss address boosting. vaccine both both heterologous

partner, other as and developments clinical in various X global hold INO-XXXX Phase Food has medicines U.S. review Inovio INNOVATE address partial candidate, the updates, vaccine that DNA this segment of our Company's lifted X and which recent vaccine COVID across Among Drug as U.S. progress our involves Advaccine, with with on therapeutic DNA our platform. recent the morning the announcement Phase trial the we'll associated Administration -XX Additionally, we our our programs INNOVATE well from will the our

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

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

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

like call President CEO, Dr. the over would to I Kim. Now, turn Inovio's and to Joseph

and taking Thank you everyone. us to afternoon. Ben, appreciate afternoon good I you this time join

to I'm by begin the and world. call. how deal The me some XX% of with community COVID-XX to progress the I over share but opportunity during this the discuss Global areas stating with efforts context certain made of continues additional Let And is of that rates the our impact am grateful in pleased the below pandemic last approximately few we've concern. the still for global vaccination resource X% months. evolving are and variants

Phase III proceed you in in Inovio This prepare Thailand, addition read, on also authorization plans vaccine conduct proceed continued INNOVATE segment have biopharmaceuticals without advance are the Social to on our our data, series COVID-XX, mutual can to primary excited has the Inovio partial better Phase aiming reflecting public and for provided Together our trial, technology efficacy Phase and for threat towards receiving continues Colombia, with Philippines, INO-XXXX, to-date, from now with and of U.S. efficacy the intent in enrollment of have knowledge for the in review Colombia's To Inovio. just point, in a vaccines and to Inovio use in INNOVATE people follow. COVID-XX hold trial the non-binding globally. clinical The of INNOVATE emergencies this X and for Protection, the of of the XXXX. expand global focused has non-clinical, recap, the our Ministry Colombia, efforts that Colombia. this to FDA device vaccination. Inovio Pending as continued government the supporting Phase to by segment. signed booster as safe important Company that X X is clinical, COVID-XX our health to have authorization in framework apply remain emergency other access lifted a public we're quickly regulatory many countries half participants and information our along respective trial opportunity to U.S. Brazil, countries. the to that as posed combat We're to for well vaccination countries clinical additional a a India, dosing memorandum to to understanding by to authorization recognizes Colombia. in developing of future first and probably for as with play morning candidate, following in Health Colombia's the effective as Very FDA further to can to authorization crisis total and data vaccines Mexico, So announced includes to projected which which Inovio The of and vaccines. U.S. the the X Interim additional and U.S., health for still role need the we explore capacity-building producing provided agreement collaboration under and for response regulatory sharing, creates we and underway licensing, contribute received both its enrollment potentially just

immune X vaccines all Prioritization international, INNOVATE in composed candidate selected World I recognize and colleagues their and morning's new also vaccines protection Inovio attributes the and of of efficacy positive routes one protection, is from conducted efficacy has variants -- greater we offering access X needle-free administration. global this designed leading greater that independent specifically against diseases and to greater is measures be Group uncertainty well-positioned be immune experts. October and included appreciation cellular having would believe the that shared of humoral both trial, includes profile express additional Health DNA the initially pandemic, like shown Solidarity duration Vaccines process. to on put medicines in X a They XX distribution. stated about this favorable INO-XXXX candidates vaccine the COVID-XX. Trial and uncover Solidarity which potential Trial to for an balanced to and/or shared to generate funded, offer hard concern, of using combat responses that facilitate With second-generation a with of ours, X scientists outbreaks platform Phase against INO-XXXX communities Further, like global by is the much of well-tolerated Vaccine of to to is the trial like public INO-XXXX, longer rapidly efficacy, an to of vaccines, safety the I work Vaccines, requiring trial the vaccines sponsored, still throughout my health by infectious to X this to WHO. randomized, WHO and and to evaluate thermostability certain release, promising response Organization a of our my controlled future Phase Advisory global conferring As Separate

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compared endemic the other may protection, impending crisis approaches. medicines that health the boosters transmission, DNA this to to of Given sustained nature advantages offer need virus underlies global the for and ensure

for trial, This well quarter, Inovio's positive boosting share as as found infectious against responses that, like make a our adults program, both With Inovio in diseases. Med was a a to demonstrate which Coalition and one in Clinical A describe Separately, in CEPI Dr. broad-based detail from Inovio data the further vaccine booster of Mammen, completed was to Preparedness that our funded Development that I'd which Anza Innovations. vaccine Anza? significant across turn clinical medicines Lassa or Epidemic Anza progress in all Dr. a recently later milestones homologous tolerated continues SVP on and homologous two-dose COVID-XX produced our at of call call, the archive. These as to the the Phase for our Mammen our COVID-XX agents. by paper in collectively will preprint immune DNA now INO-XXXX series enrollment fever from trial, platform program.

Joseph. you, Thank

Inovio's Phase the Phase underway. candidate X being global As the shared trial to trial vaccine Health Joseph in a trial INNOVATE. and separately than trial is have identified is clinical Solidarity X in X Solidarity of Organization. been already the remarks, in his included sites 's Philippines. segment have INO-XXXX being for conducted the efficacy is XX sponsored Inovio the vaccines Vaccines, Recruitment from Trial currently implement Colombia, of Mali, Efficacy World by conducted X COVID-XX Phase and More opening X WHO's

As the for received authorization recently the Brazil, to Colombia, to have Asia regulatory INNOVATE clinical that Americas has across on hold INNOVATE have X Pacific. the the we and Most the X. report now countries Phase authorization especially in recently, lifted a Phase partial total X, received FDA I'm a on effective need Indian the of Philippines, is and Mexico, persistent notable and given addition received safe pleased of the regulatory to for pandemic Thailand, regulatory impact in the the and from authorizations vaccine. proceed India. population we This

according enroll Africa the to vaccines the us medical these to changing in of countries. need, countries with discussions in epidemiology ongoing the continue SARS-CoV-X, flexibility to provide the greatest availability of and We

to safety X years randomization non-pregnant in Healthy INNOVATE virologically age administered regimen enrolled INO X -XXXX Phase placebo. and a COVID-XX. As and between reminder, men is X-dose being at apart the and endpoint in XX are a with of confirmed efficacy of least women, X-milligram the a INO-XXXX using X-to-X dose primary of the ratio month evaluate designed

booster as earlier, med capable INO-XXXX cohort X and The dose As a of COVID X a well boosting Phase "SARS responses as both in recently that, a -X we and booster tolerability homologous reflecting administered cell With series months broad-based receive serious the the tolerated vaccine preprint X following of and durable INO-XXXX X of DNA mild frequency data were homologous or responses will the the setting increase the X ages. dose. all XX it Phase induces a significantly and response booster that open-label vaccine. Found immune dose with was dose XXX the INO-XXXX homologous of months was a Use full to dose third vaccines and tolerated durable age reactions produced Joseph. local a among and of second opted second Authorization, XX.X% in responses following antibody were dose available you, a title, Inovio being subsequent under reported. adverse well to of in dosing. immune in antibody XX.X Anza. participants, you that Joseph participants X-dose a Phase in adults increased booster events to The Thank following Emergency or Notably, paper no observed as treatment-related of not adverse I of ", events INO-XXXX severity Most noted did turn over on back clinical in with T shared trial. boosted archive.

INO-XXXX remarks, during I INNOVATE opening continue be advancing to trial global a through as speak Kate broader R&D, infectious 's Inovio our Dr. X my work when prevent Phase X-dose As to now in COVID-XX diseases. Senior I'll ask of primary 's ability we our the efforts goal related demonstrate INO-XXXX to mentioned about President focused with in series. Vice given Kate? to Broderick, vaccination on

encompassing trial pre and the the INO-XXXX as with to Joseph, INO-XXXX, our today. on potentially another third -clinical work Inovio In previously our deep global ability full current our generate demonstrated expertise pan Week on This pre Our and is a with here. wild-type well INO-XX, CDX the title, DNA XXXX Thank Pan-SARS-CoV-X next-generation much you for as year's be and Conference. us binding " INO-XXXX our update, program, our tolerability to the and "Design real our concern, parallel dedication presented to is profile, vaccine. combating data T a to combat the also announced and - ID against builds is enrollment and CDX Inovio's in vaccines. -clinical We during as a in cell, and synthetic addition public this to consistency and COVID-XX on under results clinical diseases COVID serve to INO-XXXX of with everyone the pre call of since so individuals platform available and -XXXX. boost antibodies quarter, wide Early experience future [Indiscernible] also developing variance in our SARS-CoV-X results BioRx hello XB efforts who's supporting for joined late-stage immunized safety vaccine INO pleasure candidate It's and which advancing we and INO-XXXX, advancements with immunogenicity of -print end to infectious and VOCs. Phase of health. both, neutralizing on In

vaccine fever. DNA candidate Lassa for Our

placebo-controlled, potential the at conducted vaccine blinded for where Research the African dose-ranging randomized Noguchi study, be illnesses as making estimated to on epidemic of and Our for health is be of Institute the thousand thereby clinical in some effective is in Liberia a priority. development responsible XXX Accra people to vital is a an trial XX% WHO Sierra ever to Lassa illness impact one hospital The s continent fever Medical is vaccine vaccine parts currently fever first of XX and the conducted for is and pathogens Leone. no addressed, endemic. That % the which being which of in annually global with the admissions vital Ghana the the approved urgently for region classifies Lassa safe

candidate proud on X the all reach pandemic, in enrollment completing this for back INO trial -XXXX, important from milestone with -XXXX first continent the Joseph. DNA And call development will the a over of grant are Thank partners fever well thanks to to to INO turn restrictions. trial released this is as as our you global [Indiscernible]. clinical Lassa of African We with for the now for Lassa Fever, and The supporting this our the funding CEPI, against I many travel ever course you. months who's during comes the extremely from vaccine

And of Dr. on provide an Kate. will Vice other you, clinical important our Development, Clinical Jeffrey? update President now Thank Jeffrey Skolnik, programs. Senior our

very much, Thank Joseph. you

follow-up of of cervical relates to first virological a REVEAL X of -associated high-grade subjects we've our last squamous in following studies ephitelial treatment intra -XX, for X the HPV programs, and/or for caused completed Phase safety evaluating it VGX-XXXX durability, for X, clearance months pivotal our by -XX HPV As our lesions disease the the HPV and administration. XX

report X this to our later REVEAL from findings expect We year.

X our guide use to diagnostic the in continuing the co-develop to to decision-making we're Qiagen HCL partnership complete addition, with histologically And an of a look studies update VGX-XXXX on on our sharing track forward I'll adult tool to clinical cervical progress with of we In HSIL. approximately for is months. in year-end. XXX the reveal the women enrollment cervical before coming confirmed

and our Regarding pre MGMT DNA These the XX tissue turn XXth unmethylated subject Cancer, Dr. GBM. survival Reardon combination and continue the checkpoint the and will Society latest our months being Sanofi Annual our be glioblastoma our back -conference developed by the immuno over novel overall including to Phase is Joseph. discussing will Meeting correlative much. And David diagnosed data. of promoter forward -oncology efforts, sharing which a cohorts, of in as immunology at Inovio -conference presenting INO and inhibitor in cemiplimab, the studies' as we X-X X-year this week, PD-X or study partners to where at INO treating -XXXX with methylated the I'll data to and both Thank survival that, and evaluate medicines immunology well findings. programs overall very correlative you in for jointly SITC, and Regeneron or of -XXXX, And findings and from combination with tissue include Immunotherapy later newly call data, look workshop pre

Jeffrey. Thank you

continued to such sharing to as collaboration. and for forward SITC continue address focused I on to later -- week. to to this at we immuno-oncology We our Regeneron team further appreciation want reiterate our their thanks information our cancer extend look my GBM, As difficult-to-treat

call Next, I will third the Peter turn for CFO, quarter over our financial to Kies, our Peter? summary.

afternoon good with quarter and investments. everyone. in Thanks cash the Joseph. ended cash, equivalents, $XXX.X third And short-term We million

same $XXX,XXX period Our compares quarter for revenue to the of third for XXXX was which $XXX,XXX, in XXXX. the

$X.XX expenses and were was $XX.X loss per September for basic the or same share and million in period per compares $X.XX million share XX.X the $X.XX XXXX. third share XXXX. total net per million ended quarter to for XXXX compared quarter to or net dilutive, Our $XX.X income operating dilutive XXth, of the a basic $XX.X Inovio's of million which for

was affiliate net its The the bonds. on August the XXXX a income due sale change of in quarter investment of gain a our to GeneOne. million entities investment the Just conversion as embedded reminder, also XXXX XX for This primarily Company million. feature XXXX for the derivative related a of -- liability XX.X fair in value in in was related convertible to equity primarily recorded to

expenses the related compares quarter third outside period $XX.X to same million of for INO-XXXX study was expenses other drug expenses recorded services, higher primarily increase The due were agreements decrease in a among XXXX. grand also and and increase million XXXX, employee R&D development of revenue $XX.X in R&D expenses to higher the Our to variances. manufacturing, contractor which in for to from $X.X and the and related compensation. INO-XXXX, clinical contra was also This and million,

from compensation. Joseph. it G&A XXXX. the stock-based turn that, G&A $XX.X for expenses was Lastly, related $XX.X partial work corporate This variances. performed you, employee this increase expenses was increase in non-cash among million other were partially and million over same of quarter I'll primarily -- versus compensation, included the which period with marketing in XXXX And an by back expenses to to offset related in The lower to third communications, for

you Thank Peter.

commitment appreciation for their to and moving, a also questions, to unwavering recognize efforts. express to to and participants, programs. Inovio entire our want my team their our partners I and the trial want take forward. nothing I analyst collaborators, take thank Without we recognize Before clinical moment across moves

as Inovio response in COVID-XX, as measures of medicines and infectious as the Our platform critical other -associated pandemic, health DNA to resolve well worldwide HPV combating the reflects steadfast continued urgency the of diseases. supporting organization's as public well 's this potential cancers, diseases, global

we much are committed, X benefits and vigilant distinct medicines While we with for now do. work there have in the platform, global efforts. focused, that still on accept our trials VGX-XXXX, and DNA of on respectively, In progress, to is We remain X delivering focused Phase and understand we INO-XXXX our achieved underway. closing,

medicines. So Inovio tirelessly of DNA fulfill is committed to team and promise working the

expand of against open as portfolio, to solution underscores the Operator? call With as and Our global commitment. COVID-XX COVID-XX this that, part efforts our become well vaccines, available portfolio questions. the for the of let's

At this At time, [Operator will we this pause assemble our we Instructions] session. will begin the question-and-answer roster. momentarily time, to

question comes from go Meacham first Please of ahead. America. Geoff with Bank Our

Hi. for on Alex question. This our Thank taking (ph) you is Geoff. for

the U.S.? FDA outside previously the maybe the much. that study, that and lifting plays running for X And could that device firstly, mentioned data what holds Thank the were Phase then review? to Phase you into secondly, clinical about information? very do you talk study your you primarily development how partial to the plans, how You X provide So clinical, given additional you of non-clinical,

are Thank changing our Alex. that We not you strategy Yes. really much.

actual the Philippines, look We authorizations Phase exist on excited well authorization And the is adding huge Mexico, have the as countries based to unmet Colombia, there in to focused can into participants. participants need so U.S. safe is proceed those U.S. we to the Brazil, Thailand, now this -- of and Phase U.S. forward in That's on and the countries. like feasibility where we're availability the from participants in have trial clinical FDA to [Indiscernible] received INNOVATE X India, a vaccines global means those take for as the trial. we global why and these add and and that What effective cases our of go countries strategy number need X

-clinical, Second pre so reasons the part about we question. the all provided pleased that. have of of excited hold, we're and and information fully your device-related clinical Yes, that 's necessary the FDA very clinical, satisfy for

much. so you Thank right. All

Thanks.

ahead. (ph) Please comes Hartung go Our (ph) next from question and of Oppenheimer Feng Company.

the you. And of you data for questions. homologous a -- the couple Great. Thank presented boost got with data. patients I is in thanks One

-- X Phase number for Phase as with example, EUA need with countries agreements over and being companies ahead Is strategy -- file that various initial -- case in Assuming go Joseph, the test you off have questions. are you your to vaccinations? for like have a you And also, all with countries, X the agreements of two, framework a then what Colombia s would the an agreement Thanks to make your strategy for the adopting for other your additional that agreements a EUA have with Vertex then used other strategy to world. positive that countries? and other sort a broadening certain Colombia, booster

Hartaj's and the constructive second is capabilities either technology market to We relationship Yes. can you the that of Thank a do Dr. government share felt address Anza, for think XXX% Anza be and collaborative looks to would first to example going many will believe, 's question? part Colombia question question to I to our I of, sentiments. we the I'm answer really (ph) first us that you, we I advanced and the our and properly. countries address reciprocated Hartaj. us. first countries. or can a commitment Inovio on other positive to like capacity. agree other do doing your outreach manufacturing where first, forward an Mammen I had ask arrangements or Colombia with contracts Colombia

Absolutely. you for the Sure. question. Thank

followed after Just that to by second dose. INO-XXXX, homologous optional and a X-dose the between summarize, in booster regimen X the evaluate did trial, of an Phase anywhere months we was X booster, XX.X

As able with I favorable was we safety and mentioned tolerability quite to the booster immune profile broad-based were earlier, induce the dose. a response and

be. timing time, longer what we efficacy for period in once responses a might INO-XXXX over -- for And evaluating the may are month immune X however, each X we subjects INNOVATE then administered booster further subjects doses with so that a to to X-dose trial, that will in of optimal Phase receiving be INO-XXXX, time X, of the able follow a their be regimen, establish Now, understand will apart. following

So booster that setting. homologous a would be

partners as heterologous that mention Advaccine, China, concurrently potential are should I evaluating Now, our a boost. in INO-XXXX

they who in trial And inactivated a received doses boost followed and initiating with have by an weeks are will evaluate vaccine that so a subjects the of INO-XXXX. X coming

as also heterologous multiple trials, to but following further establish With primary a hope only series a homologous as booster, with we setting, other vaccines. viable setting, clinical not a the these in vaccination INO-XXXX COVID-XX

Thank Yes. Anza. you,

question. hope that your I covers

If of and I demonstrate can while -- bit, inactivated safety now, the just in INO-XXXX. 's to great really add safety boost realize studies think with for future but due a of INO-XXXX the Hartaj, the that a hope answer, strategic little -- for to are from in a to from point or for a expansion we Phase medical vaccine we on a realized great a Anza boostability view, INNOVATE utility Solidarity a need at but good also need, for and different landscape INO-XXXX boosting the my of as prepared series, and but setting, -- market could -- and be this DNA looking and vaccine pandemic are a looking the efficacy so advantage need greater as Phase or vaccines provide need we can we global stage that in the as remarks. tolerability, setting, there where boost not vaccine attributes a we X, the a forward hopefully in and the other we can changing X, the for there's and -- approved of endemic huge will even than is vaccines, of for booster maybe its against heterologous as a demonstrate vaccine also as both. It's I demonstrate touched a other INO-XXXX vaccine heterologous primary increasing

tuned stay for later. please So

the Joseph. There's Joseph the you article entity? any vaccine all The -- New that I York U.S. be Moderna. or for issue you any flaring in you just thank IP government have U.S. IP believe, the up seems And in matter. regarding overlaps too the with questions. housekeeping an Times, again, manufacturers one And I'm with Do government. government again Thank Great. sorry, to

Yes. Thank you.

XPSP thing some of so to development, received work the governments, -- be that have is we careful with including We there funding we want Inovio, the we that's U.S. overlap, any DOD we belongs IP very to device, believe on don't our but various with. government, but as

Great. Thank you.

comes Our of next Capital. Gregory from Please RBC Renza ahead. question go

afternoon and thanks and Joseph and on clinical Yes. progress for my the questions. team. Congrats taking Good lift

Thank you.

reach towards XXXX you've some a remind as of for guided think could I perhaps in needs question. what to on related And target provide has that of enrollment of for to far helpful. just across as occur. data parameters the second, clinical be environment that, then And countries? your as interim just related or least wanted lift just if you pace, certainly could confirmed half some the biologically efficacy to the as we the potential Joseph, would you at color first the about that right cases, INNOVATE, there enrollment ask you when break been within to us It sounded what like

on you the alongside just the deliver hold very evolving device about to curious XXXX, clinical I'm market of lift, international comment the those patients in order that With meet to the you much. opportunity and to for the needing device how could you if Thank in you talked think evolve needs to doses need. about you

Yes. Thanks Greg.

so the material sites opening didn't really countries partial obviously hold deeper say just a others outside You and the that need and are just question. devices good answers, folks if can Jackie have U.S. try it you and and I would I'll addressing and me in really was have had impact I out. help a in the really we important the Anza U.S.

weeks. is have we concerns several That for provides of being said, the trial And additional for interim the last interim to Phase in magic us we've As clinical of X a satisfactorily. those cases. it lift underway. the and our we're U.S. it cases all and met say -- begun study -- has INNOVATE validation, the at be of authorization of country number FDA shown, efficacy dosing really other U.S., pleased around the that it's and X trial will X course, XXX lab-confirmed for in openings shows it case-driven But that and XX% already it's really Phase -- that the hold so

So faster impact regions re-enroll -- XX% all are these will when hit blinded we will that or efficacy and countries until those where rate the percent in meet cases. attack about of those we exactly XX really

why that first that's a broadly as half So we XXXX. left

what trial. design always the been And X started looking same the we we're when that's Phase So for. INNOVATE it's from

to our is well any that. achieve in INNOVATE as our open So And approvals Separately, Phase there, our with added in one that that the with XX candidates but COVID-XX two all hard of panel our or the independently, of And country's independent team wave be here safety, really the and sites, have trials. as the still there's Solidarity qualms We're operating COVID-XX but we I and has the selected, we're subjects. working we open to wave we're the demonstrate that get think We these get is vaccines. WHO has trial I no our have our highly conducting as selected really leader trial really opportunity the more team X the grateful of working vaccines, opportunities and we hard have we for vaccine, excited their INO-XXXX partner that efficacy so second and X couldn't in sites, safety. Obviously, to shots in or out so future, out Solidarity goal data. WHO's to second on have happier. selection. to X of vaccines efficacy are we initial grateful and our think being of about is we're

That's again. Thank Joseph. helpful you

Yes. Thank Greg. you

Our Excuse Please of Duncan next ahead. me. go from comes Cantor Charles question Fitzgerald.

on Hi Charles. for Stavropoulos Pete Joseph, this is

Hey Pete.

made Congratulations on all the progress this quarter.

you. Thank

one could ago, granted is what believe tell several ZyCoV-D. when to a us My an -- XXXX Authorization compared for question months advantages differentiating India -based vaccine. Can DNA Emergency you INO-XXXX what you COVID-XX Use factors And for are provide?

Yes.

and DNA -- a and having approval, regulatory being the pioneering having think for the I Zydus's India emergency measure, know-how the experience, to vaccine. its regulatory approval test, agency grant

's huge have need difference reasons. to INNOVATE there many DNA the this of to around in has demonstrated Inovio INO-XXXX a and They The lot have that We've that. trial Zydus's use additional population it's delivery of other India. studies are thousands tremendous delivery. effective plasmids. administrations. feel conducting with in We as and a DNA electroporation think of vivo us a tested I tens And and we for safe preclinical clinical been between for in system Anza optimize of done is advantage Selectra a vaccine. We've mentioned,

many to in of our But DNA. other are have Zydus So more a INO-XXXX vaccines we to there would familiarity us -- their factor huge India have working a intradermal India. it's of through regulatory delivery advantageous 's think DNA with the differentiating for potential be second advantages India. perhaps sites give and also think process I They

as of DNA we well India previous having So I India, Brazil, come as their vaccine. fortunate the world, -- highlighted as to Colombia, with have experience really as by of to and Anza -- we're the authorization in in forward why data other think we and reason very, participants parts U.S., other very places. Mexico, India and look well out is the we But India,

Thank for on Can RRP? an -XXXX question. INO provide you update you. One more

Yes.

Skolnik I'm Jeffrey give update. to have We broad here. a going

we immune potentially first is in responses Our continuing to X/X early data, XXXX. benefit the half clinical undergoing Enrollment trial. and Phase RRP of immunotherapy have is currently and hope both

Thank you.

Yes.

Congratulations again.

Thank Pete. Yes. you

Please comes And question our next Aydin Huseynov go from ahead. Benchmark. of

team. Hi, Joseph and the

Hi Aydin.

the congratulations taking announcement Thank the have my clearance. the Hi of especially this and questions. quarter, couple I progress on this questions. you for a with morning Joseph,

I about trial. to ask the WHO First, want Solidarity you

in contracts And also, is different from estimates share the AX in we much be - could the out INO the could give overlap of results or before you AX INO is of think with Solidarity after from Will about If if you it you how trial? ideas and us the the - trial of how is do will the when see the us out? INNOVATE terms design of enrolled some being is trial.

Yeah.

countries Colombia the and trial can In difference speaking turn those and there tell the we the communications. trial, two overlap. and within do in Philippines. actual what to terms the Solidarity, I of that defer But is are that overlaps, I'll But design. sites again Anza. and the you to But to But -- around is have WHO INNOVATE not their the overlaps

but any I touch there of to would the think don't we in expect on trial? some overall to in you be that Anza, synergies conflict. design differences there's like the

point, Yes. a both dose, Sure, terms rate the And Joseph. will in really of infection, with X enroll. question. dictated largely trials X-dose not. results, regimen of project in I will second I very X that that X of virologically trial hoping that's probably cases the Thank think administered surveillance interim but which dose very be and think which able the we're timing be efficiently. the will apart, think by efficacy begin enroll would you. both each Thank similar after as really days as at of be period these going these I each force collecting the Phase In Trials. confirmed. INO-XXXX the data really All-in-all, and this are the dose. milligram a interim you way, the to similar XX don't in trials be can for would -- the say to will are of provide be It's designs we these getting first, will month I will trials administered between well that

that relatively We have, impressive. are and and low, the remains still in vaccination unmet quite I force medical their selected we're infection rates think remains of the both need, countries,

remains cases, cases. both to But the think well-positioned I are so to the trials again, I rate are think accrue with And be seen. which accrue to able the we

this timing within rather I to to or year. that that the with really I'd be analysis defer able interim it's on point, target comment our half able the -- Solidarity that projection our you questions first to those our that -- I'm to think do WHO. WHO post of be next at not the we'll regards trial.

Anza. you, Thank Yeah.

Okay.

-- the and and providing as the possible as driving soon also And INNOVATE rapidly they focused as available. having is that the they're data forward sets is look very efficiency I to become sure but their I'm and with trial on good Solidarity productivity would We WHO. of both that enrolling team as our say it's support to for WHO

Thank you. This Okay. helpful. is

on Another Right question need to to protection. duration that with the X I have every vaccines dose. the on XX market, have boosters second of is we it months now, seems all after the

wanted duration whether enrollment. you to INO-XXXX think I this mentioned this of be immunity protection much on you. cellular longer protection presumed is think longer and based expected for the do you how Thank to ask is I so

course, to Yes, of cell we responses antibody protection. pick of benefits in that I'll responses setting. trial that. a demonstrate the with provide INO-XXXX, having T potential clinical believe But the we have should along with longer

the and protection the clinical gather we're the immune response of to in -- very and antibodies the X forward from the we'll look follow durability trials, with were potential we think Med of the in of pre the persist responses data, of to of [Indiscernible]. period, Phase gathering future X -print speaking homologous So data durability and our immune also readouts. INO-XXXX have the we months boostable excited but Archive, in about course, through of data Strictly then boostability the for those determine we our seen

for All right, Joseph. Very helpful, quarter. thank this the in progress you. Congratulations

Thank you.

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

Thank Joseph. you my Hi, for taking questions.

Hi.

about your the talk X reported week? XXth expectations XX-months versus for the the for readout data for you previously REVEAL trial Could data

ask address Yes. that Dr. Jeffrey I to like to question. Skolnik Well, broad

for And thank Sure. Thanks question. you the Joseph.

X received first And versus We received Phase well. we As of our had you reveal studies, VGX-XXXX who the know, X as show year shared we study. the earlier viral At endpoint were met women that. study. a that's difference as to you week, who able between histological We statistically know, of placebo that HSIL the points. from pivotal respect significant this cervical with had to again, both with and those clearance primary clearance XX time that

confidence our virus. met again, shown give response durability secondary note week meant shared previously durability I had the and potentially of study. will also or the still we immune that previously we of demonstrate I demonstrated in We Xb this. was many whether Phase us XX the objectives. have not data to the to there's and Really, that around

So related have response, again, anticipate durability already the in up demonstrating be that of you that any point. we to We a on those an what surprises. to also XX essentially time may study. don't of the shown immunogenicity. really And absence in we aware We see expect be data randomized XX both clearance. at would durability importantly, in and to again, published regression cervix And and the months previously virus that

XXXX Thank the for it. GBM, coming XX of X, Got newly trial regarding phase soon. is diagnosed And the you. data out X months

what about steps next talk potential are after you that? can So the

like Joseph, would to? you me

Yeah.

pleased, at some to particularly data Reardon you the week the Happy as being at with some presenting again, this immunology We're present our where answer tissue-based say which symposium to that. updated very Dave data meeting, it, and pre later excited. the able SITC OSXX be we're data, -conference will

but we'll encouraged the clinicians make scientific those meeting. we key telling demonstrated previously leaders to Pending to controls, have the to would've present That's I with decisions We're and a yet. encouraged certainly in data, very again, that patients. scientists where that's reached think median -- what general, median historical bring and have along we to again, what survival MGMT-unmethylated we expected higher than that as yet we this we respect a our survival been and us data, before we're in median we've we that have utilizing - at thing can in by space. what met those opinion by peer-reviewed population this forward the good opportunity are methylated really still MGMT known very with overall our in fact opportunity haven't the overall

to so And forward for XXXX GBM specifically next opportunities the I look space. in

Thank you

Thank you.

Please from ahead. comes from go Chikere Kelechi question Jefferies. Next

have there clinical these in But Congratulations that's could me that variants balanced strategy well as this in. cases, shown fitting really now. U.S. color the Any that get for helpful. of have on you the how enroll patients the you Phase ability hold partial want has least be you Obviously, the with countries that would the but vaccine. Thank some fact Xs reduced at your some in provide that for color to enrollment efficacy Yes. the to removal various you -- analysis. be morning, interim countries? your that, to any around on in the as Related additional of to

Yep. variants world, the the one predominant most Kelechi. Hi, around Absolutely. are but is Delta. There multiple the

and our cell things these course, we but and some T Delta internal pre -print and another -- does antibodies have our those in month and we can s published Of few immune in -- testing, own that weeks, both INO-XXXX or the of generate in change demonstrated variant. against

that to we that is DNA regimen, their DNA India. variant vaccine. the three-dose helps think delivery efficacy able really With during their were us able 's with achieve and the using the system spike they is. the not Selecta, that's same The Inovio efficacy Zydus analysis of demonstrate in They other -- were Delta to

that optimistic INO-XXXX the very globe, the around we would in we're countries especially well selected. So have fare that

of likelihood sites of where, within selected endpoint those In have and probability to we're as soon getting we possible. countries these the of recruiting to maximize countries terms our these our as increasing

try have much to intelligence to allocation lot very to make these real a of pretty It resource our those allows decisions use behind regions. in information We time. various a hub. us We sophisticated

you do vaccine anticipate you That's assuming Got as another being And device. the as helpful. the well? with? as XXXX, The the even how well success Solidarity do launch with trial how able or much in question, anticipate in producing XXXX vaccine vaccine And INNOVATE it. to much trial

Yes.

various scaled We to have efforts and PSP up. is device our collaborators working up These getting our are Fisher have intensive commercial that. that parallel. in done do plasmid we be with the in been in work working device course our capacities, getting ready like are And to and consortium. of to X side, scale These Thermo -manufacturing global prepped others

data to with upgrading in -- the countries we plan that that first. in look safety is of first to to have that to pursue interim would -- And trials safety the in where current probably our various the course, Phase approvals point efficacy along we we we're countries are X Our assuming available. data half 'XX, the utilize plan to of emergency-use to mechanisms the

we We full as full XXXX, follow-up in licensures also And license data, these the WHO. potentially in emergency-use potentially as for to the as PLA and the U.S. as well pursue the with EMEA the full Europe. in plan to through safety well efficacy the data through data, utilize plan countries,

We have plan. first approvals XXXX. a 'XX emergency looking We're and then full pretty ambitious global in in licensures

Okay. Thank you.

Thanks. Yes.

At this This time, I closing it will back question-and-answer Joseph our turn remarks. session. now concludes to any for Mr. Kim

from questions have made listening before, collaborators our mentioned Thank for you you our we top tremendous great have couple of a our and you. and lot team Thank last still to for analysts. several thank progress. months, Last And -- as I do.

the have trials and for Solidarity both is very interim the isn't half, We off, INO-XXXX potentially INNOVATE exciting. that far efficacy and which in data first which

VGX-XXXX. and REVEAL our completing X trials have for X We REVEAL

aspects. many all thank further to Jeffrey Company to mentioned of I excitement. much I fully call expect few R&D-based tremendous to cusp Thank These We before time a want I Thank several in you in exciting in the Inovio. sharing us details like our it and Company transformative you and of -- we're from for quarters. by commercial very next to next in Inovio REVEAL in was is the months, these This exciting for pre a the at where is much. for very a -commercial you to And sharing hope transforming forward as year-end, feel times and the and look enroll are much. Skolnik. very along very I these X

Thank concluded. today's is presentation. conference joining you now for The

disconnect. now may You