Earnings call transcript Q3 2022

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Operator

Good day and welcome to the Inovio Third Quarter 2022 Results Conference Call. [Operator instructions] Please note that this event is being recorded.

I would now like to turn the conference over to Thomas Hong. Please go ahead sir.

Thomas Hong

Thank you. afternoon. Good for third you results XXXX the call. conference joining thank quarter Inovio’s financial And

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

Inovio’s We here today of Q&A with part leadership Session. also be members will us other our have of who

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

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

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

of and statements events results beliefs could All differ today. expectations of based the Actual are as of or these materially. on management

with time within to We factors the you by time made to identify cause factors heading that press as refer which differ file could important release. those verbally as actual well documents from under the from afternoon’s expressed risk results statements the to the this materially we company SEC,

call concluded. on This can this made be webcast and a a will has be and our link being is live, found replay ir.inovio.com, after website, available call shortly

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

Jacque Shea

for to you, today’s Thank and everyone joining afternoon you thank Thomas. call. Good

greatest standard and/or for tendency DNA for strategy benefit generally medicines to delivering FDA-approved The recurrent often drugs prioritizing those which a lifelong RRP. cause or include a treatment condition after they have by currently medicine These respiratory papillomas candidates benign RRP grow obstruction for surgically, have papillomatosis, and or the complications. small to caused which care. Inovio the while therapeutic In development promising is implement wart-like RRP. near-term treatment airway debilitating, by of papillomas, patient the our promise the the There have our third quarter been potential characterized or DNA HPV-X the respiratory removed of of candidate commercialization. to the life-threatening of HPV-XX of are and current can INO-XXXX, continued resources vaccines our of growth back severe, is no that

Phase be are positive toward We our patients build encouraged diseases, a disease. upon improve because because DNA we to steps last new associated HPV this work of importantly that by potential only the indicating the month, from first results lives interim suffering not horrible but announced X/X have more data therapy could ongoing to the treat these those medicines they the

developing data will I’d Mike the moment, treatments diseases. to detail has greater to long While innovative Inovio been a talk committed that in HPV-associated like for highlight in about INO-XXXX just

have the a memory, may that exhibited which completed like DNA are chronic potential have uniquely area. be characteristics the medicines long-lived in factors therapeutic favorable and loss tolerability cells, important immunogenicity of have clearing of Our to of and number both antigen-specific, in of DNA been associated have play In previously we make trials, role believe and we virus. without HPV profiles, also HPV which treatment re-administered conditions the medicines the safety RRP. to induce medicines them observed T a this believe suited killer helper, to DNA

patients in forward clinical data date look need. to to have foundation options bring to shifting potentially the generated franchise our HPV build of upon paradigm treatment continuing we We to in to

XXXX, the this this steps help quarter program. development for quarter announce or first to X expect next Phase HSIL of we which in VGX-XXXX with X addition, intraepithelial our lesions or REVEAL data cervical define squamous HPV-related in will In high-grade the later

We’ve as such encouraged remain we our and potential at pipeline, we reported glioblastoma which of continued ASCO, the with for cancer INO-XXXX, demonstrated key once to we Moving beyond the franchise, steps you next fatal forward always a our results this working next almost HPV finalize candidate treatment positive our other for on year sharing some plans as brain. and decisions. as this by year look earlier in candidates product

We continuing other forward in to look our coming programs to for months. we announcements the anticipate also advance which pipeline data

running product reins drive we ago, six Since candidates on operational our I we to excellence optimize do of months to took and over our throughout market the resources, to managing capital to continuing chances been patients. helping successfully bringing and working from the our almost clinical have trials, everything other Inovio of

COVID-XX our INO-XXXX reflective strategy. development discontinue to changed to due decision internally booster of market funded of this heterologous Our vaccine is as a conditions

cost deploy those quarter we from move resources portfolio believe of our advancement we XXXX, to extend ahead. deploy across to and currently candidates. promising savings of effort first will as runway other plan the now will We cash savings cost these this into our continue how best to We evaluate the we

With over Mike? the that, update it to Medical Dr. quarter. Chief our Sumner, to Officer, Michael like clinical provide our I’d turn for to

Michael Sumner

greetings, Thank from for patients with in X/X announced or Last you INO-XXXX respiratory RRP. recurrent and we Phase Jacque, everyone. month our very much, papillomatosis results positive interim

delivered and and seven INO-XXXX for encoding of respectively a is INO-XXXX XX a As proteins plasmid early reminder, plasmid and for composed antigen with X interleukin-XX. a encoding human HPV six

tolerability, the to statistical the participants. XX an reduction in of interventions safety, X in treatment statistically of was year – on the endpoint administration in significance a in surgical the its RRP trial candidate of compared year associated in cohort following HPV trial demonstrated of the vaccine XX The clinical prior initial number INO-XXXX, open-label assess RRP. evaluated and efficacy immunogenicity, with multi-center and to based This participants with

interventions, XX% the the year prior in of trial. surgeries XX trial, In INO-XXXX decrease three relative year the participants overall in median administration decrease of a there to was of surgical the following the a or in surgical interventions number of XX to showed the

surgical responses CDX induced CDX or and T during to baseline. no XX% cells six T HPV cells XX, all Importantly, positive the antigens and demonstrated an X required peripheral increase entire against participants Treatment INO-XXXX period. one in are trial intervention from of including those immune both XX XX-week more XX with participants,

XX We which cellular immune Cellular was XX, against the treatment such HPV of the persistent diseases believe after response. factor last treatment memory X and this memory XX weeks observed a were also indicating could in of at responses chronic RRP. as dose, key week response be

the of event, were other which were experiencing one treatment adverse of INO-XXXX we at as the Treatment assume with participants generally well with with emergent was X. medicines Finally, completing events course. XX% participants observed our trial Grade least all in grade tolerated treatment low most emergent adverse DNA

adverse were Grade are none event, injections to participants INO-XXXX. site a treatment pain commonly adverse and fatigue treatment X events related were experienced XX% Three deemed emergent reported most but XX% of emergent at shot at these XX%. The

to While two deemed serious also adverse events unrelated INO-XXXX. were these reported, were

data, potential with discuss to on to expeditious this announce meet Based of benefits determine RRP agencies we planning the next to [ph] patients the bring most for steps are regulatory the in path INO-XXXX the to program and need.

will discussions We initial expect populations. bodies our these pediatric both adult and include with regulatory

determine perspectives advocacy opinion leaders clinical consult steps. and also next as for their groups the patient key will input we development and Inovio

earlier candidates also for are promising we survival Jacque year. including we path other INO-XXXX reported for As this months which the overall considering at forward glioblastoma our data mentioned, positive optimal XX

steps near-term our that to Over plan months, bring solidify for more next and offer the strategy advance to to our candidates in pipeline DNA market. the coming opportunities medicines we our

to responses T In identify cellular competitive cell a to generate advantages. required only addition, response we’ll be but not will to ability and that our belief broad commercial clinical pipeline for on potential significant exhibit specifically working the current existing be leverage our encompassing Any targets data, candidate antigens. based compelling the in clinical that candidate’s to in drug new prioritization product qualities, the ability emerge also to would target offer

a that will market on time to possible reach can contribute lives. Inovio to in improving these focus patients as shorter the candidates successfully

turn the quarter over now our Kies summary. Peter? financial our I’ll to for third CFO, Peter call

Peter Kies

with finished June afternoon, million and short-term cash, XX, everyone. million investments We cash compared equivalents of in the as good third $XXX.X XXXX. quarter $XXX.X Mike, to Thanks, and

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

$XXX,XXX ended our resulted CELLECTRA to the period Our under increase revenue from our three XXXX, Defense The XX, revenue same in was in for contract months XP obligations XXXX. $X.X of million of compared for fulfillment September the for Department with the program. U.S. the

R&D research services and the study and same expenses million to and for in expenses $XX.X primarily was three XXXX. costs, expenses drug XXXX clinical Inovio’s for development months related September manufacturing were VGX-XXXX. to INO-XXXX related million lower ended outside a compared decrease period The in $XX.X XX, the to

were decreases – research expenses lower project. XP offset had also lower XP grants expensed million – CELLECTRA device array $X.X related other from engineering among services array to and equipment and our These variances. automation We related device other by development recorded contra to and

were the other decrease G&A non-cash for employee General three XXXX. $XX.X XX, ended compensation and same and expenses million The expenses months for versus variances. primarily decrease million in consultant in was XXXX to $XX.X in period the a related stock-based administrative among September

XXXX $XX.X period million for in same for expenses operating Total XXXX. the compared decreased the third to quarter million $XX.X to

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

quarter XXXX. burn cash million $XX of operating fourth an expects Inovio forward, the approximately for Looking

mentioned, be XXXX. that into other should Jacque and us any our from does are and updating may projecting funds take now raised first equivalents we our guidance quarter prior This the not projection are sources. ATM cash runway As or include not cash financing or cash may our of

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

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

Jacque Shea

Thank the work we and to our as realize enabled focus during medicines globally. patients last of further has you, quarter to our of DNA sharpen the benefit Peter. summary, corporate the advance us seek for potential our In strategy

and initiatives. we financial to As excellence environmental, operational our ESG discipline, or governance to commitment and continue we’ve also social prioritize advanced

incorporating the and our producing particular ethical undertook to appropriate. work are impact quality With focused business of our products our developing assessment have a quarter, committed them an where a a practices manner. baseline high In recognize on and into we we the created team transparency, focus internal and the business in third we world, on safe in and ESG can

questions. for call the Operator? open now let’s that, With

Operator

you. Thank

now will And begin with Singh from question-and-answer Company. Oppenheimer [Operator Please go Hartaj Instructions] We & first question will the session. come the ahead.

Hartaj Singh

for getting and think Jacque, would just what is Thanks, everyone on the you. question of guess, kind a walk to just do you trial could update. the or trial see is, That’s of could can look one. glad One team potential me you thank I’m if registrational focused. for be and question. that kind I Jacque company Great, to of a us So pivotal proof-of-concept the components kind of sort specific trial? through like? next few be number potential Jeff,

Number Then two, sort HSIL, thinking looking the And than therapy be the meaning, even question for is me. Thank of as more could surgery before are numbers trial? neo-adjuvant would or of patient what you pivotal we one you off. And require quick got use, INO-XXXX at? just or right lastly, a after housekeeping of then Like, example, so you. adjuvant sort surgery contemplated. I excuse

Jacque Shea

you. reported patients. Nice Hartaj. data mean last from what hear you for are we really excited and Yes, we as Hi, INO-XXXX about can are excited can very around we hear month to the

over So around more give what I’m you thinking going we Mike the are to specifics to around Mike? trials. to hand

Michael Sumner

things you thank internally we for time Thank your moment. question. and you, are all spending the of Obviously, discussing a Jacque. at Hartaj, lot Hi,

signal as certainly from we other plasmas. that that saw we’ve that also we we believe by line there’s very And seen we presented, our obviously the with with efficacy DNA the efficacy there. the think a data you tolerability encouraged in is I meaningful data think were what

registrational that hope progressive design the will be We a will we in study strategy.

it’s a registrational to FDA the signal a we rare have, have will had study. we see I and that – we the would next stage think like as think disease because the we efficacy that

agency before. the were fortunate for having design a interactions perspective, with However, obviously, FDA. speak the in we can’t we From very

of And looking in of designed of should study – clues for. we a have be will be think how I lot the FDA that what terms is

are advantage to possible. design in competitive solid able We in haven’t the FDA move any as quickly design. But that and those good we terms a forward and disclosed hoping made will us of they’re a we of and the meets past to how study have I us things, forward they’ve that comments move as actually propose to we the think be

Hartaj Singh

Thank Great. from then just housekeeping you, And the questions Peter. Mike.

to off next see Thanks. the how you but the million quarter, burns sort of of quarter; you’ve do I OpEx? mean, Just, you us lasting said know year? just $XX the given sort fourth for tailing think of of class I

Peter Kies

the quarterly providing to fourth guidance not past you but I I any will we’re that numbers those see Well continuing quarter, currently do tell decrease.

Hartaj Singh

you Yes. all for Understood. questions. Thank the

Peter Kies

Yes.

Operator

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

Unidentified Analyst

and Hi, on within to what’s and X with focusing make And of first more Ying portfolio? your resource the Wang around internal and decisions progress prioritization end broadly around for taking strategy, us you you. assets the thanks XXXX; REVEAL maybe the data around that on the recent thinking of programs your this then latest allocation benchmark this path with forward and program? points that’s is Thank amount pipeline could development Maybe Congrats your for on and our expectations What’s you’re [ph] questions. upcoming. help Greg.

Jacque Shea

questions. They’re Thanks great very much.

on track into all timing end this year towards quarter data of that the X REVEAL we’re for data, one. for so or on first of So

hand I’ll study. the think a a outcome to talk bit what over would trial. primary from more to good to the But expecting I we’re me Mike endpoint for be around meeting that

do Mike? to back the prioritization go the Mike, of and question? you then want comment So on I’ll to that part

Michael Sumner

hit you, the Thank points. top on you mean, I obviously Jacque.

look read going are at benefit the to be next. primary in general early is see which clinical But into that out read we viral and data, the was We’re greater will to will be we population general recruited hoping until we expecting think really and that a biomarker year, over the that comment data see moment clinical in biomarker That the out we or biomarker to looking to the clearance. benefit and for actually of end the Obviously population data both the the the targeting population. at by we haven’t in on above can’t population going we’re potential this regression histological population what study. And is the the like. endpoint, the

You Jacque?

Jacque Shea

Really those so Thank encouraging really what best prioritizing for we’re pipeline, potentially rapidly seen regards HPV-associated chances going clinical on the few and Mike, we’ve data going those to our to in the is forward that with you, of both space the glioblastoma, in prioritization benefit doing success, candidates RRP. chances the best for over patients. be past think resources bringing product the our to have space resources IO for with I of the also XXXX months

really excited our of medicines think is that responses. T So able there. resources I focusing generate you’ll our cell of been which one in platform us see about consistent And the things sort we’ve DNA have very way been to the

cell CDX responses about specific those I is how think CDX and on antigen forward going we T a to cell think and part prioritization. be So T TSO responses; focus of going

Unidentified Analyst

very much. Thank you great. That’s

Operator

The Please next question America. from Jeff will with Bank come Meacham of go ahead.

Unidentified Analyst

one. about how taking is the I Thanks you question this number for think how the just terms forward? the, about Jeff. going I general think can term two, regarding like DoD, impact in about should revenue from for population? on think you. of question. number we of think HPV kind the have that how longer That’s guess Hey, Charlie And I treatable Thank vaccine

Jacque Shea

questions. great Both

regimen displays people to rate still vaccines. now unfortunately infected and cervical So while in of HPV, HPV And leads RRP such think number they can HPV the have at than vaccines I back were and diseases becoming completion as which this with sizable I since here. lower with helped other development lower think diseases of is of risk and lead HPV uptake consequence There infections reduce XXXX. and associated introduced

of be quite the vaccination globe, we’re unfortunately vary while associated still rates HPV that come. So think seeing for I going which mean us levels around is not disease with I whilst to vaccination, the think to a

for with So and XPSP. our including that I DoD, manufacturing of how ID the support investigational our had we’ve device of think mean, for in multiple terms been platforms, the that DoD we relationship support of development, extremely think our grateful I from we’ve CELLECTRA about scale-up across

We’re very grateful that. for

forward and the we those work wrapping obligations are We completing very soon. to up under look our in final agreements; to actually of stages that

Unidentified Analyst

you. Thank

Operator

with come ahead, sir. [Operator Yi next Chen Instructions] Please question Wainwright. H.C. Our will from go

Unidentified Analyst

Chen. Hey, on Yi behalf this is of Chaith. Hey this Chaith is

You’ve questions. of answered most our

So to What in INO-XXXX from is on quick relates XXXX? the we have or as clinical you. Thank and updates this key glioblastoma. only other expect we question it can asset and into moving decisions

Jacque Shea

currently together an steps That’s our next great I for on that thinking call think about we’re expect a the that to during be Yes. question providing XXXX next and Regeneron, with partner and update year. we the I mentioned

Unidentified Analyst0

Great. Thank you.

Operator

conference would like Please back Shea session. Jacque remarks. ahead, over turn closing This to go I any Dr. ma’am. question-and-answer the concludes for our to

Jacque Shea

I’d to us joining for thank good today. questions everyone. Have everybody their just Bye-Bye. a like for evening, and

Operator

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

disconnect. now may You

Inovio Pharmaceuticals (INO) 8 Nov 222022 Q3 Earnings call transcript