INO - Earnings call 4 2023 | Inovio Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Inovio Fourth Quarter and Year-End 2023 Financial Results Conference Call. [Operator Instructions]. This call is being recorded on Wednesday, March 6, 2024.

I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.

Thomas Hong

you Year the Financial thank Quarter XXXX and Full and Results afternoon, for Inovio joining Fourth Good Conference Call.

today's Officer; Chief on and Peter Kies, Chief me call Officer. Jacqui and Dr. Joining Financial Shea, Commercial Chief Officer; Executive Officer; Dr. Medical Sumner, Chief Michael Mark Twyman, are President

year review a XXXX, XX, as as provide will our information we December and call, financial the ended for business update. general Today's corporate quarter and full well

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

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

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

Jacqueline Shea

half be a call. the the patients we this to XXXX. XX year medicine everyone Good transformational first first the approved, and for have planning first option the with submit States. past the could and afternoon, nonsurgical United The for therapeutic our are to for of in second in our products months Inovio. BLA and for joining of available been If in you commercial first today's also RRP potential launch preparing INO-XXXX become Today, company thank DNA

prioritized To of leveraging other achieve committed with focus of promising potential. expenses advantages platform discipline, compared medical We've cutting we unmet medicine. need pipeline on this with to our the focused strong transformation, and to on nearly our our to in all XXXX remained the product late-stage have promise commercial deliver XXXX high assets, financial and on and operating half DNA

across progress pipeline, Coherus combination to develop with collaboration the addition and XXXX, clinical our cancer. helped made supply new the including agreement a throat LOQTORZI drive for INO-XXXX In significant strategic with with in progress refocus to BioSciences

candidates, other encouraging next-generation for research Ebola promising progress opportunities also booster stage for results the candidates to positive momentum. made continue to clinical We as vaccine, preclinical shared an INO-XXXX with advance and adding

Looking ahead, catalysts help that key our continue several will pipeline. momentum across

submitting for preparations approval XXXX and XXXX BLA trial accelerated we in second XXXX, confirmatory In to for plan to we'll addition our launch. a program, initiate of continue potential the a half under FDA's

trial the XXXX brain to XXXX deadly a glioblastoma, for candidates, as in design determine combination with For our of LOQTORZI as patients of for cancer steps finalize of immuno-oncology well we cancer. next form plan in in evaluation throat

I in and trial of partners XXXX, readout the of booster the milestones discussions key potential We the also plans XXXX. Phase vaccine and in candidates dMAb disease development collaborators Ebola expect first of the clinical around as some for data half the an evaluating first anti-SARS-CoV-X infectious candidates, INO-XXXX second including with from our the for half and

our additional past Sumner, for year who our to progress over provide will year to like on ahead. details goals and the now our the I'd call clinical Mike some pass over the CMO,

Michael Sumner

Jacqui, much, very everyone. you Thank and greetings,

our past with across progress promising As year. strong commercial Jacqui vision to strong a Thanks over candidates the made strategic outlined, potential. prioritizes have significant pipeline that we

of treatment significant highlights One the for INO-XXXX the the been of recurrent or has of progress RRP. respiratory papillomatosis

primarily For rare of XX. caused X wart-like tract of malignant. that larynx and but affect spread is can It speaking the most complete lungs and In respiratory the devastating breath episodes. choking voice those is characterized swallowing, disease cases, not with difficulty by can RRP papillomas throughout HPV familiar rare the difficulty or become a or cords. the called RRP, vocal who commonly it causes by develop to respiratory growths loss, tract, shortness papillomas and are

several of estimated doesn't depends and that both juveniles address cited way The about most the but RRP published per cases of were there epidemiology the adults on new is prevalence In of surgery, is hundreds infection, globally and widely emotional XX,XXX be speak data variable adults and year. U.S. per HPV ever over cases, This only surgery patients surgeries to X.X the the including cord Incidence again. vocal XXX,XXX active an physical for remove grow year. extreme papillomas to factors, underlying permanent XXXX, lifetime. so could and in often cases the multiple impacting normally and there papillomas patients, ability on threat puts the patient's a back, damage, to a surgeries worst burden have forcing the

or desperate In had XX% cord RRP had damage. nonsurgical even providers, than A conversations chance patients surgery and XX% have are with a surgeries, recent increases less a X a treatment who that of chance. patients study XX patients to more permanent our patients From for that healthcare found option. vocal face who

White rare would year House Kim President a X for even Foundation, the reiterated surgery less life-changing patients. As McClellan, on be at RRP of diseases, week last forum the

Phase of surgeries reducing very trial. for the patients real our has impact shows in I/II RRP had slide in INO-XXXX This

XX% during XX% As you here, no treatment. can see year in after surgeries of at surgery reduction all patients, needing majority the with saw the after treatment, a

adjunct to we the treatment completely surgeries, potential therapeutic patients believe all the As to paradigm We counted the reminder, surgery. change performed has any during for including window. a surgeries as a dosing XXXX

on the XXXX, of have see and I/II time journal, later a we milestones line, base. which results we shared leading major development in positive can regulatory Phase quarter you year. customer this physician peer-reviewed in by read first trial, some updated from were published our over our just achieved future As a In

we half the drug XXXX. In a program year announced quarter, followed established earlier to under the to We FDA received designation accelerated submission in quarter. plans FDA's now fourth BLA in designation second approval the and the of this the second BLA orphan therapy path from European breakthrough in have submit an Union the by

INO-XXXX the the and accelerated approval catalysts of in our to compared possible under the of 'XX, X XX-month some horizon submission, include the lead forward, usual which to BLA submission review. Looking confirmatory key on completing review, months half would action requesting a of submission our priority within program to prior second on BLA that rolling trial for the application initiating

We will year. also publication supporting immunological the the of target half action data of of mechanism the of in our second XXXX

And we finally, receive approval. in launch FDA if XXXX, commercial

United over Our medicine year on of and product provide to on this an the Chief Twyman, next ultimately for will Mark development preparations Officer, Commercial our promise candidate delivering promising the update States. we DNA the forward our of patients the accelerating across and RRP look commercial

nasopharyngeal announced to LOQTORZI, year. our with and exciting Coherus in partnership I'd this we supply FDA to now for some treatment inhibitor PD-X approval of new DNA us and carcinoma. will recently late-stage gears agreement another INO-XXXX medicine. that combination spend clinical that BioSciences earlier time allow evaluate like about with collaboration to XXXX This Shifting received talking a

XX be will with to by to leverage this and HPV-XX carcinoma. the and studying immunity We as by In patients combination provide potential a cell cells treatment XXXX antitumor therapy oropharyngeal the generated T therapeutic combination, is this positive for squamous outcomes. advanced improved antigen-specific approach patient LOQTORZI potentially high-risk locoregionally elicited designed

a Under for will the interactions. collaboration the plans Phase receive submitted provide clinical agreement, LOQTORZI our and in and we regulatory of trial feedback second to in support FDA Coherus development expect the provide quarter. for this III have planned to With terms clinical in the place, use

soft cell squamous cancer of a referred It's and to of in neck carcinoma. commonly as and/or type occurs cancer. and most the So is tonsils head palate, throat what base the tongue, oropharyngeal that is

new Throat diagnosed cancer HPV, HPV-positive throat XX% cancer patients with cervical cancer United which of in rapidly cases instance and alcohol tobacco the of high-risk use. as the cancers related also cancer XX,XXX in closely diagnosed among XX% are increasing HPV-related in to has all for and U.S. oropharyngeal is year. subtypes each responsible nearly to high-income with surpassed common is in the States. most associated typically There are countries

With radiotherapy. very the progression-free cancer treatment patients and measured on current the as advanced multi-therapeutic curative by patients approaches surgery chemo including do locoregionally throat are and of diagnosed treatment about focused protocol, is practice X-year through with disease a of use options Most XX% well survival. this

who very progress, outcomes. have cancer However, there those their XX% of is poor patients clinical

proposed in meet who with every X,XXX or the deemed in to with an XX patients of of in disease positive, to who Our are progression. new X,XXX be There a trial recurrent U.S. HPV-XX LOQTORZI disease criteria. INO-XXXX, risk and these are will goal are high of the year, exhibit combination patients preventing estimated

XXXX the diseases. medicines previous DNA a with PD-X proven body strong of There adept HPV-related growing on and at is research inhibitor. trial combining that combating in Based data are indicating rationale a

HPV-positive trial T-cell head of T-cells demonstrated a neck the as I/II Phase a tumors. and XX and from into squamous cell of XXXX responses patients in single-agent infiltration treatment CDX positive carcinoma Results

from than which This trial CDX-positive an This which responses favorably our INO-XXXX to blockade in and updated tumoral accompanied resulted potential immune-checkpoint of showing evidence XXXX AstraZeneca’s this overall by survival set with median of were in X results responses months. months. partial of early of efficacy In complete data comprised 'XX, of combined the and X XX to also with median T-cells. again XX durvalumab response of peripheral I/II T-cells reports provides rate patients. once combination support increased and belief more Phase therapy of alone, evaluable in in XX overall inhibitor, approximately different This of compelling XXXX combination The LOQTORZI. PD-LX survival XX%, durvalumab, HPV-specific was checkpoint was a overall a compares published

turn on for Mark? INO-XXXX. to provide efforts to our update now an call commercialization will I the over Mark

Mark Twyman

to launch. INO-XXXX as and prepare continue share pleased Mike, that well our are for for potential I'm underway we a everyone. commercial XXXX Thanks, hello, efforts to

While there's our to reasons. strategy I'm much confident still commercial for be several launch important work in done,

year and insights needs of building made we unmet an the board step journeys First, patients advisory at of their understanding of understanding top RRP. to panel the and treatment October into on patient suffering from invaluable large. patients They diagnosis with of RRP from shared community their last adult provided experience in priority a continue market, we is the the held To our way. every have on

We other conducted have care patients. the and with of treatment specializing with health of advisory in RRP also caregivers boards juvenile provider

Next, initiated we landscape end, us physicians understand of that this deployment have our smart to comprehensive market will to To be a make very decisions. mapping will success. analysis the allow and full treat critical that that focus RRP, physician investment commercial we

an is commercial have aspect in of process team rare also products for experienced for commercialization innovative that diseases. We versed the particularly well every

the most and in expertise our compelling has that to importantly, launch successful commercial important stay INO-XXXX on and clinical that putting ensure believe that efforts. thus collective potential progress offers to serve Our a been will as systems foundation essential and forward. moving our commercial perhaps an for track advantages plans And will essential help far we in we place

FDA disease the here, generally and see accelerated submit the therapy the our was that from and I/II from the can INO-XXXX continuum the compared the data trial was in of can reduction to a FDA. approval immunogenic BLA This breakthrough you over receipt XX% Phase key the across in advised our In severity tolerated trial, of under subsequent application surgeries the well to data number a supporting use has had completed year. we of As patients and previous program. for designation

range X a HPV-X RRP. demonstrated our From surgeries of has the year which and a X key trial prior range several the both similar cause efficacy commercial standpoint, shown severity. with efficacy HPV-XX and in to across differentiators. It targets Patients of disease INO-XXXX across offers in had

electroporation for other was trial, redosing and in offers also potential use for important for CELLECTRA, our providers the stability patients proprietary attributes by its of device the well I/II INO-XXXX our years was up to Administration to with Phase medicines with tolerated X typical DNA refrigerated in easy healthcare trials. and temperatures. at platform, consistent including use

incentives which scale and and the regulatory and is EU, well-defined designations important Also for offer well of the U.S. commercialization as those as INO-XXXX in our markets. both manufacturing potential commercial mechanisms the commercial orphan-drug process in

back pipeline updates. Jacqui I'll for call now additional CEO, some Jacqui? turn the to our Shea,

Jacqueline Shea

INO-XXXX, has both advancing of highlighted Mark. INO-XXXX are those you, internal with and our we've progress candidates. made Mike focusing on and majority we important the the resources Thank

have I'd like brief stage and update candidates we we advance However, collaborations assets several of academia industry, clinical plan across other governmental next-generation agencies. to and through that to each late-stage on and a them. provide partnerships

Phase in I announced as the we next discussions of potential mentioned to we our XXXX partners from recently, trial from Ib booster development Ebola-vaccine Earlier, potential XXXX encouraging an collaborators and and pathway, in results with candidate. identified early FDA steps. and the are now a clinical received feedback More define

XXXX. finalized a and of in the about glioblastoma. current is next disease X investigators first in has targets, partner, the INO-XXXX And our our half goal have We're Regeneron, to steps. plan with discussions

in prevent the or of A Pennsylvania, if with look updates is being cancer mutations. Phase study The second to Ib is of or non-cancer or by forward conducted reoccurrence X they and patients target to cancer adult available. cancer become BRCA-X we University

by XX. ApolloBio, XX partner, by VGX-XXXX AIDS by of II underway, and a Malignancy caused Phase Phase XX. is and conducting HSIL in in VGX-XXXX trial caused is anal HPV XX participants also the Our Consortium also HIV-positive therapeutic sponsored with as evaluating HPV III trial treatment HSIL cervical A a

is there Wistar our medicine work DNA including And Institute, collaborators at exciting advancing nanoparticles evaluating launched dLNP. next-generation a DNA technology, with or trial also the

of responses. provide continuing antibodies including antibody high are neutralizing while T-cell dLNPs designed generate levels to to maintained responses,

dMAbs for clinical sponsored Indiana a and to therapeutic technology, first trial I and is partners Phase enter finally, monoclonal trials, And from both dMAb the using The a a preventative trial COVID-XX. University Wistar University, vaccine in Phase and candidate funded develop INO-XXXX, preventative by antibody I or treatments NIAID. of leading our HIV to AstraZeneca, Pennsylvania dLNP DNA-encoded for and

sharing holds I'll financial what excited for in CFO, the more full year about year and to We're over the XXXX to innovative the our for and technologies Kies, ahead. these Peter? turn our future call Peter look forward now fourth summary.

Peter Kies

Today, the you, financial to full year XXXX. of I'd provide quarter and highlights Inovio's Jacqui. and fourth an Thank condition operational like of overview for

significant reprioritization. and spend progress year, Mike noted, while Jacqui, As Mark the have successfully our pipeline operational our after made past our we reduce across key advancing candidates over pipeline working have to

from our As have XXXX, XXXX slide, in from of this operating $XX.X the $XX.X fourth you of total decrease. in can million we million to quarter see the reduced again quarter spend dropping fourth a XX%

Our $XXX.X to full in from were also for operating million expenses cut year XXXX for $XXX.X half million XXXX. nearly

operating more, XXXX the of $XX.X the same for R&D fourth million down our Breaking quarter expenses $XX.X expenses XXXX. compared in million in a bit to totaled period

INO-XXXX drug was expensed other variances. for and and lower among R&D year and period lower for stock-based decrease compared full to employee expenses of the trial XXXX. manufacturing, The clinical same including compensation, in studies related $XXX.X XXXX services compensation, $XX.X million R&D were year-over-year in expenses other Our and million inventory consulting outside the to expenses, result primarily COVID-XX

and G&A the bring and for our year for the XXXX expenses XXXX INO-XXXX, for to fourth the the net XXXX compared quarter COVID for $XX.X $X.XX quarter were in that for our of devices to compared the million the fourth Note to $X.XX These of for million accessories the we the net and vaccine million factors full loss which full million to XXXX. $XX.X share year $XX the were for $XX.X the combined was per $XX of dilutive. $XXX,XXX in $XXX.X per for XXXX. to same the discontinued. $XXX,XXX period XXXX. fourth be revenues to for for period XXXX expenses Defense Department period since or $XXX,XXX period of dilutive, Revenues have same of to were with Revenues million compared basic share the XXXX. quarter were compared XXXX to loss the and G&A associated year XXXX million in with Contract U.S. XXXX, same delivery candidate, for Inovio's $XX.X basic for for full same in million or used reported Procurement our of

of its $XX in million on the We capital- matured X, and do net projections of with Inovio or projection runway compared million XXXX million of cash the XXXX XXXX. cash repayment, that through runway quarter to raised total extend operational for investments finished of Including expected This repayment at-the-market $XX XXXX. cash, cash to excludes the $XXX as approximately the that cash fourth December and $XX This notes amount second principal March first quarter the funds is be estimate senior XX, approximately remaining cash $XXX.X million quarter may the on short-term quarter of million. any XXXX. for interest equivalents of accrued be XXXX. to estimates program includes in an into convertible burn of an not first include These other burn activities. net

reminder, a release our As it financial find turn back Jacqui. that, in filed with I'll as statements full you XX-K can afternoon's as the SEC. our over this And press well Form in to with

Jacqueline Shea

Thanks, answer open now might Peter. call Operator? to to any questions like the up have. I'd you

Operator

question Instructions] of Company. Hartaj Oppenheimer [Operator line comes the Singh with first from Your

Hartaj Singh

I know FDA bit. the a if have the for has been don't discussion One you I actually, little couple, a confirmatory mind. is, in with trial

this maybe In we're accelerated could it what how looks have it period any you're recruit guidance? then long to again, of And Can some especially, and on looking sometime for us to take FDA the I granted read valuation color out? you just would when like? not that And roughly and give going kind believe that year start year, early fact, last the process. approval the

talked therapy think And cost $XX,XXX this of about RRP. then patients. applied but to broadly that it time. to academic KOLs per up lot There's in lot a per over year, to it $XXX,XXX that we adds surgery of a is literature suggests secondly, should They of patient

Just of how comps. thinking pricing are you

any any there just there? color or so And thoughts

Jacqueline Shea

great Good Those morning questions. are Hartaj.

on a I that into think some guidance with submission BTD just covered the guidance we part different held and call, elements was design we to So as that before of in needed of our we go the the on BLA FDA got Christmas, in our getting meeting that multidisciplinary that trial. confirmatory further of number

So detail perhaps, Mark, bit Mike comparators to talk I'm the can then you over some on more there. to thoughts going provide And and hand a to about of pricing.

So Mike?

Michael Sumner

Thanks, Yes. confirmatory trial, details to in we're the with Jacqui. With think Hartaj. the respect final the I stages agency. with the discussing

soon in we So around strategy. the design position be will reveal and to I'm a future of details hoping sort our

sort of readout, on difficult the until take. about to final asked sample predict the going it's to also You totally long get recruitment we it's how size, and

X I/II option. broader included trial their original I study. go But I patient for sites about a consistently for study. to in to than clinical talked openness say treatment we going the We're need can we've And nonsurgical what that receive certainly is, confirmatory and Phase think a

So hoping that I'm recruit really quickly. we'll be subjects pretty to the able

respect next with again, color include. call, need around depend to hopefully, more going to And on be quarterly going design what some of that. final of observation that and really length provide But we're sort readout, to I'll that's able to the to

Jacqueline Shea

pricing on comparators. Mark, the Thanks, And Mike.

Mark Twyman

to talk good to you. Hartaj,

is pricing disease said we previously this RRP we've what disease, think for that rare rare asset. would I anticipate is a So and

as to say be we're would I a we're better that as to pricing position part a work as of of alternatives launch, to also number in we'll some say I that And closer positioned are we though, analog, that rare said, doing. more with are the which that. assessing there about disease that surgery of think get a

Hartaj Singh

on get quick you a have be data launching maybe that. publishing closer also pharmacoeconomic XXXX? to just I or just that Will on Can you follow-up as after

Mark Twyman

Hartaj, respond question Mike. would to to that? think, I to you direct that I'm Mike, to going like

Michael Sumner

in patients we many certainly. we will document too our process on the in mean we I include are more didn't obviously study. we I -- on patients can in study. mean, RRP or assessing and the of the life impact confirmatory how we most certainly Phase quality include Yes, of of I/II likely measures will our impact prospectively

-- we we again, to obviously, will evidence will mean, supporting I have eventually the have So that for set. we price aim

Operator

Next question Buchanan Roy line Citizens. comes of from with the

Unknown Analyst

XXXX few for Great. thinking you But a just address I say then commercial Do when XXXX? many just initial are patients the guess -- the can penetration? a for scale Or second, I manufacturing, just what do have can and maybe think sticking others. address you how population? you entire you in you you to think

Jacqueline Shea

Yes.

to So want that one? Mark, do you take

Mark Twyman

would to modeling, Sure. and a we've that we've that I'll so take team. comments, the expect, lot question way guess a our working -- respond I'd I done additional some whack closely of free been add. we've feel as there's at and with if to sort is, of you manufacturing

sort to confident so that And fully able on of we're be XXXX. based our estimates projections that for the we'll and cetera, et demand adoption, meet sort around our market of

Jacqueline Shea

just can for We other And for dose Yes. standpoint. requirements manufacturing to actual add very is scale disease I side. of commercial dose on from had this already got the us terms in is numbers the rare candidates. a requirements, a if of some manageable manufacturing product And

from a able be build the first positioned to up able well be pretty need we're over market think the easily. to and pretty of manufacturing years to standpoint launch I couple So support inventory the

Unknown Analyst

you of that I Phase guess, switching you terms what what guess candidates 'XX, develop could bit you for expect And does XQ what for you the tell runway Perfect. into of assume then candidates. to that I you a pipeline level that that the development additional out us clinical-stage given -- III? runway the X in itself. the us XXXX? can those do understand it just you Sorry. of Can can a help pipeline the be I beyond by anything And deck for design deeper guess XXXX, you bit. last can slide had about registrational pipeline submitted Do

Jacqueline Shea

Yes, that's great.

the thinking the and or there Phase about why can we're talk III pipeline candidate. take XXXX Mike, I not, you rest the then what So design of don't

Michael Sumner

you. Yes. Thank

call So history. as on of we're today, you size, node tumor going There locoregionally high clearly in high-risk with smoking after. infiltration, population patients local really comes local are articulated sort and we that advanced disease based heard and down the involvement the patient risk also

certainly we global registration KOLs DNA that we lot PD-X do want be I we think feel to to this that that of on work agency. And I obviously, the of safety will of components. the medicines, developing inhibitors look a based we a we can by mean, the traditional basis understand well-documented think safety I with a on did So also decided followed of and define study. I population. we very is the candidate, ultimately agency design, going well-known of profile Obviously, to mean as contribution as profile ways. of our to mean, sort

is that element agency. of clearly we've an So the submitted design to the

to forward determine we're pathway like. looks quarter X to in with actual that waiting our so what discussion And them really have really

Jacqueline Shea

rest pipeline. Thanks, of the Mike. And to just talk the about

to license be the As on assets then call, of have and to cetera. launch its clearly, in forward. forward. then the I partnerships XXXX and moving et funding hopefully other And mentioned our move help mechanisms, of those be grants, candidates number in leveraging pipeline, a and focusing partnerships we're internal able XXXX to resources those place non-dilutive the We for going do advancing next the year. for majority our on year we're

we move the also And the preclinical can forward ourselves. work, earlier-stage of some particularly work,

forward those ways funding moving meaningful partnerships, to mechanisms non-dilutive we leveraging think well. progress we So those generate as have some of candidates

Operator

Your Renza next Capital question of RBC with line Gregory from comes Markets. the

Anish Nikhanj

Anish for It's on Greg.

Just a couple for me.

gotten -- just care some thinking on shaping, ahead your market about date education feedback and has the standard therapy how what patients engaging that XXXX KOLs when built like a pushback And and versus of getting on you've awareness on Firstly, directives. surgery? into been to RRP, to on thinking to XXXX of

question a And XXXX. on secondly,

potential and just If a us how among as combination the candidates leverage collaboration came the you LOQTORZI candidate the how Coherus selection you could other forward? can to partnership with of be going walk through best

Jacqueline Shea

Yes. Thanks, Anish. really They candidates. are great

some there. comment to to Mike, how aspects on about on thinking comment clinical XXXX. And maybe going So I'm ask to Mark you'd the like we're of

Mark Twyman

I We've advisory thing listening a looking address as more from to I boards are as X I've years. who aligned been important RRP multiple Jacqui. X doing first well an Thanks, that to launching with question. both new guess one about product. suggests patients. or the Yes. commercial And excited We've the for surgery, treating They're -- the to with the a HCPs specific physicians would speaks heard RRP never to to last that closely is foundation right? think the I been what I'm your perspective, like say of it conducted don't probably we've things is And for alternative surgery. going

procedure, and that's actually in of surgical procedure As surgical to, this that's address Mike has So right? surgery morbidity. the alluded I mean, doesn't surgery driving after the underlying the -- infection. cycle

for option, standard of right? is know holding because current you're for surgical it, I other are is the welcoming this this replacing disincentive So a There's inadequate. and alternative an use unlike -- physicians sort XXXX that them to they're And where of looking right? care launches no

from of mentioned, reduction sort as similarly, and X patient of Mike year a it's a And perspective, even for devastating could the surgery disease them. be a life-changing

So I'm launch to successful this confident that that a XXXX. everything marketplace going really we've have with learned about we're that pretends really, really

Jacqueline Shea

Mark. Mike, to are highlighting? of the Thanks, patients those aspects that the clinical the want some do and physicians about need and talk you

Michael Sumner

absolutely. Yes,

while understand really mean damage today, of mind that me They is the vocal data all be you Hopkins recognize was that to. the caused. going surgery is as the they damage for later published I we've there beneficial that permanent sooner latest Best, cause from in of or mean talk spoken the I about sort surgeons is to RRP So hugely patients, by around John Simon heard cord the to ability

with a perspective, just life. back a sort keep as McClellan. Kim for from looking so patients. And think, nonsurgical surgery really discussions And patient's a would I of treatment excited for as Mark these -- patients, to impacts they for said, every the having really is surgical I they're going It just as

have And graph earlier, on the in we so the RRP showed you tremendous I saw reducing surgical impact on burden population. the had

want once so and XXXX accomplished that patients nonsurgical date, you again, clinical really any that on why they the safety we've from heard efficacy see I of -- isn't there we to data option. really And reason have the feel wouldn't it you accumulated with associate a

So very this forward. to program excited we're move

Mark Twyman

was other when can diseases, at and case, fact of I right? lot therapy. Mike, RRP, sort us that for originate a Genzyme, mean of real component And alternative I the identifying on dimension is looking quick. X patients XXXX. a of are who the in the originate case treatment morbidity this add voice lot them point puts right, important I reason for these quality, effort won't originate position really I be who One primary physicians adequate really surgery with of patient other causes for spent the the and because an for getting burden impact for mean, the good So and that that treatment. is rare you RRP. unlike market, the patients with again, that and a in this are combination to other of was of is patients,

Jacqueline Shea

Yes.

I are points, think excellent Mark. those

So XXXX. to moving on

take just we if here. back maybe think I step So a

the both combination forward were CDX with getting to to goes durvalumab For disappointed AstraZeneca data, not some know and we that back strengths what lesions And We XXXX, T generate durvalumab. know decided as in in in head study. ability to saw very clearing by we were and and we monotherapy programs of And tumor, we the in HPV of really excited that are neck whilst saw of encouraging and platform, space. to one it move really capable we our our other these antigen-specific are clearance. that of of precancerous the HPV dysplasia cytotoxic capable a viral to the cells leading

of some jump looking saw and that's talk XXXX maybe right the lot promise point we wanted -- So to using quite so a when for LOQTORZI. in conducted really the you we're an for where why combination. we And reasons analysis XXXX. of the about Mike, might want And about forward, PD-X move excited we to extensive

Michael Sumner

that's gives will hopefully all, clinical mean are, is seeing prescribe the insight lot a that fact partnership. LOQTORZI into mean, KOLs the value unique finding XXXX them of of with same Absolutely. that works any a see about a and as I program of LOQTORZI. we the I conducting eventually the and XXXX first excited just partner you with what

they're having LOQTORZI -- through see want carcinoma, so to with with approval work great the recent use also as of is partner, the share nasopharyngeal a I expand. they a enthusiasm And the program, very think for to they

every the had far, interaction to so bring positive. well. head knowledge as They we've has of with the very and Coherus been And space neck table

partnership perform so just continue clinical that the very trial. to And with encouraged and we're really

Operator

next the Your Jefferies. with question comes from Song of Roger line

Unknown Analyst

Roger. Williamson is ] for This [

-- study at from standard-care I regarding results? So And different the study to that powering guess -- the see how point, the about Do about thinking you're among that you we us, could are how the this for assumption of your thinking practice complementary comment impact study? XXXX, confirmatory what's on you sites?

Jacqueline Shea

you can take that Mike, Yes. one?

Michael Sumner

Williamson Thanks, ]. [ (sic) Yes, absolutely. Roger

study, about can't actually Phase site we results sample So clinical talk I in was the more elements. believe we we XX will variation, study, the only analysis. we in site-to-site mean Phase look sites an size can as so trial our had certainly confirmatory had There sites I/II address we X while recruiting the and obviously consistent we very no -- we study. our subjects be the I/II results to the in utilize yet certainly did elements

not to device, sites with previous Phase our we've XXXX. III us. So look from had of using that is obviously, for lot XPSP a as we program concern And a experience certainly

us. isn't any again, to concern that of So

Jacqueline Shea

Mike, add can in maybe I here.

sites, we to and working also X addition X In enroll HPV we both disease XX. the also with patients with enroll HPV patients And across spectrum.

a So I study, I/II understanding of built within good population. variability our in that we patient Phase that think up

Unknown Analyst

another Maybe Absolutely. may. question, if I

precision the you after studies XXXX surgeries [ window. So included the different regarding that I -- I/II know data, Phase through from key the treatment including right ] the X

remind you see you So what if do only window? after -- include maybe us you treatment the do could surgeries not

Jacqueline Shea

patients. that not published. we've every want from time heard disclosed you Yes. if about because the I this what the Mike, mean matters. we sure we've every -- do if after the designed to trial matters a yet That's surgery I'm question. to That's patients, it's time great talk surgery because data

Michael Sumner

No, I details from were surgeries a going surgical do that. after want weeks to to we obviously window. we And excluding the of haven't we if provided full any also, think like-to-like comparison, include any a XX

looking collecting that be I mean, data. will So at we

available in that's going to So short -- not the be term. but

Operator

comes Your line Wainwright. Chen H.C. [Operator with next Instructions] of the question Yi from

Yi Chen

reimbursement do the Could would population patient you secure of time potential on Medicare. FDA take of how age to And What in RRP think Medicare percentage on range much XXXX? comment patients? following the approval are actually the typical you it

Jacqueline Shea

question. great Yes,

you do question. you want the range? to Mike, take And talk can then, the about Mark, age maybe Medicare So

Michael Sumner

Absolutely.

actually So of involves to instance. RRP X the there's groups. all sort peaks age And

the mark. onset. actual peak, pediatric is also an of XX. first follows of now sort is usually is there the is usually around which age So Then onset is peak, developed of [ that's activity around the which ] a age X-year-old XX. And And is which X- obviously adult the peak, what usually one later to around the earlier

the as all vast groups. majority. So the still not majority majority -- rapidly. -- is around encompasses The it you group age XX-age vast But really growing population the the with elderly is still

Mark Twyman

question. for It's Mark. It's question. good the really Thanks

will a sort for needs all really as whether adjudicated that, is from in kind Medicaid. pertains approach key I the mix also Medicaid. think of or our with we'll that help are sector identify landscape, to or us from to that that kind able success. additional of is of Medicare focus these earlier And the of we're the perspective Medicare the only our to be And Not efforts being the Medicaid, be patients, and there my versus going sort the patient private information or to are sort on earlier. starts in where both assessing get going of be comments to level, the we it's particularly what going us our and been commercial payers be consistent in but and for of adjudicated, I but from of that what Medicare understand lot focus what I precision this help said physician to it claims to analysis work are private mentioned is important,

There and launch, are really kind of X for market pillars as deployment. piece distribution that access on the well then we're as super field commercial focusing

a possible. I for -- patients only we when early the making to line with as So you give fast that have we to of that started private time Medicare can. as Medicaid we're objective moving and access as as both specific say quickly can't sure INO-XXXX in

Yi Chen

pathway Could on in you Union? regulatory going the European comment the forward

Jacqueline Shea

Mike?

Michael Sumner

Yes.

So Union. we European with engaged have the obviously

strategy we have I to pathway with I more to not our and there's is have be upcoming we'll what certainly forward a going in be We the based give think yet believe received, disclosed calls. able Europe. on details information

Jacqueline Shea

the I Yes. from may can There as there's medical slightly answer Mike's need a standard unmet Europe, strong of HPV is just though care like If though, the well add to RRP, U.S. everywhere. differ unfortunately, is in

progress. our consideration as to trying the provide European discussions take some with So into we'll that that's be also important certainly account, more but details regulators to on an

Operator

now over for back further this and Please there to Ladies the go closing I will Jacqui time. remarks. President CEO, are call questions gentlemen, at and no ahead. turn Shea,

Jacqueline Shea

I over year. last by transformation opened you. the this call highlighting Thank the undergone Inovio has

strengths platform renewed strategic stage company. our our to aim focus the possible by made transformation of and a our Our become DNA medicine commercial on

just We than progress. have more made

that have benefit a to on. potentially medicine success And long-term foundation for we from will its could world the promise. patients built that DNA build we We continue have for advanced around

for with your year evening, have great and a that, forward thank look With everyone. ahead. updates more to the I attention, sharing on in progress you you again

Operator

your participating and call thank this lines. We that disconnect you ask gentlemen, conference for please concludes for and you today. Ladies your

Inovio Pharmaceuticals (INO) 6 Mar 242023 Q4 Earnings call transcript