INO - Earnings call transcript Q1 2024 | Inovio Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Inovio First Quarter 2024 Financial Results Conference Call. [Operator Instructions] This call is being recorded on Monday, May 13, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.

Thomas Hong

Good afternoon, and thank you for joining the Inovio First Quarter 2024 Financial Results Conference Call.

Joining me on today's call are Dr. Jacqui Shea, President and Chief Executive Officer; Dr. quarter Officer; Financial Chief our a Officer. Today's financial for Medical Peter Officer; corporate general Chief XXXX, information Chief XX, Kies, call the business Sumner, update. Mark as Commercial Twyman, and and as Michael well March provide ended will review

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

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

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

Jacqueline Shea

will forward. the greater to recent call. throughout begin to our areas XXXX. I we've discuss emphasize afternoon, but and are Mike, for driving main and to like that important go made I'd progress business it's detail Good with key our today, joining into you in the presentation for Peter To X thank this feel everyone objectives today's Mark

the developed papillomatosis. is Firstly, of first potential INO-XXXX, the of our for commercialization respiratory approval being product, for and treatment preparing which recurrent

as business strengthening particularly our a INO-XXXX, and other our advancing pipeline, promising candidates in whole. Secondly, thirdly,

on Over remain has our strategic ensuring based pathway. focus on the to the half work XXXX the areas are have our we using and on last on utmost time efficiently year [indiscernible] these DNA patients. Of in alignment believe to feedback. under second accelerated this instrumental of deliver we of a promise BLA been our resources X FDA's in to medicines to for the recent we years, importance, confirmatory that And on proposed FDA with file design trial track proof we our the toward

for we're is trial energized as Our the therapy now deliver disease devastating to FDA-approved to by team initiate moving and first possible. this opportunity the potential the soon as

from of blocks As XXXX, pipeline, next assets believe with into FDA been parallel, have advancing you a later-stage high and combination on for establishing will throat plans relationships potential. have R&D promising plans and regulators. focus across continued to XXXX for clinical our on And our teams launch cancer. and the putting reached medical unmet hear on need commercial advance other key Phase trial place. In discussing with in for successful European with the we commercial design those also the with commercial Loqtorzi focusing Mark, we candidates strategy III have we'll building alignment strong We the

the and to we second first of vaccine Ebola submit study of a readout in a the candidates an forward in the feedback from year. Following booster data I Phase evaluating the the from FDA, expect look anti-SARS-CoV-X with II/III as half this clinical also quarter INO-XXXX plans Phase dMAb to trial for this

remain to and our operational and our prefunded future XXXX particular pass financial our position to an common committed of $XX progress Mike success. I'd additional our and details raised April. million the other key believe continued strategically to recently Finally, strengthen call managing clinical achieve Of we support through excellence like business, provide We objectives. now our stock resources to on and across adding pipeline. approximately over some we've offering who key to note, personnel, to critical to CMO, to warrants strengthening which Mike? the our milestones, discipline continue financial our will be Sumner, I will in

Michael Sumner

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

they remain Jacqui comments patients. design. FDA by seeking that BLA promise XXXX. to half accelerated the for on proposed on to I'm advancing submit second that we for mentioned, I'm excited advised no medicine that pleased approval As deliver of potential are pleased to and in has our XXXX additional on all our RRP you the DNA on the INO-XXXX also focused had of us the inform share trial help to confirmatory we target

reducing disease But our while European based believe the study importantly, that placebo-controlled will perhaps randomized indicating global licensure. require reflects number are in trial at broader damage trial of trial benefit designed again improvement matters soon initiate most also approach strategically with for life. to we surgeries we cord for and clinical X The as This placebo-controlled XXX working to a a as surgeries a vocal We trial supporting into focus or of So on reducing randomized spectrum the interventions be from and time prior risk end. The evaluating treatment on That option RRP year we marketplace. surgical majority heard involving regulators feedback the permanent most, have the quality a of this a in with into for of we've placebo expansion is the targets of approach is more will they arm and received significant patients possible. patients history RRP in patients. the translates what reduced of approximately believe face.

of immunological patients important to can this immune their key Our ahead. year also the mount systems HPV details this underlying work characteristics sharing for one the of for the XXXX. that both that it of surgery believe teaching most to XXXX forward to what peer-reviewed response include in And submission year reduces to an it we tell supports on the to important by new in for more effective conferences. plans data infection. be But and the I look publications you I need

team strong the immune patients in activation the we types with that of adaptive both responding activity seeing antiviral of are who cells these has patients of treatment. Specifically, of XXXX clinically immune immune in responses the diverse pathways include are The airway tissues to induces innate system. and engagement found and and of are treatment

and moving outcomes. an For on XXXX our in reduction on make surgery we patient how impact to focus could on think

researchers go face time oncologist Simon investigator than treating X puts that this quote real surgeries saw think injury. completed had recent captures allowing they paper risks I that iatrogenic Best, RRP the they our and had surgeries, burden cumulative disease in paper RRP co-authored patients, trial, by also Dr. every for an risk on this specializes from who on than emphasizes patients for a permanent XX% the of had X that incurred surgery. while more The patients less in who and

surgeries the XXXX As damage. patients cumulative every by disease. risk surgeries injury that surgery risk the itself, permanent high. over cumulative put, one With we many hundreds simply ultimately, could them not an caused More of cause lifetime. further underlying injury before surgery any becomes Consider with surgery that to the for prevent have aim dangerously but their increases

believe it's and the also We'll So seek could to to caused what medical address drives let's treatment? we patients recall be number of what disease, a continue useful RRP why patients. broadest how XXXX is as for

papillomas of to the as and throat a the HPV-X potential XXXX majority human difficulty person's and T the as we've and affect with has quality about adults symptom of is which in HPV-X the shown of antigen-specific infection off, in have ability airway, in papillomavirus, by HPV treatment vocal can spoken speaking RRP seek to specific HPV-XX First substantially a patients cords. extensively, is of disease breathing, main cells patients. development especially and infected papillomas drives may lytic with been to targeting caused the eradicate disease strains HPV-XX, cause that cells. both generate the on of the These life. The

affects fight without very symptom But about develop systems some have to that everyone lives. people on HPV immune unable an common are know virus ability often we that those off their what it that even to in create is Most HPV development. the RRP have at go is adequate who to a infections, nearly Next, point defense.

For immune proprietary methods. This the the papillomas. benefits react virus delivery the to adverse teaching platform the to treat their these chemical a teach those that our response patient. vectors an system example adjuvants, we in CELLECTRA optimally potential against of to can will help DNA believe and have in our excellent to be has individuals, the of delivery an short, with of we system to technology. In cells body without our XXXX medicines mount designed effective of This to is development fight back DNA and nanoparticles the device it viral or or lipid protect associated way immune the the effects that deliver without medicines results use prevent

trial as underlying of Phase which, the Finally, earlier, the from greater the surgery, can to current I/II damage RRP than vocal I completed mentioned for showed is cause standard care Data our permanent disease cords reactions. significant to XXXX tolerated a in reduction the events Treatment XXXX most site observed common number with with that with injection of adverse trial. in statistically in well resulted treatment the be surgeries was being itself.

from results I/II trial. slide this reminder, a our As the Phase shows

X experienced required Further, patients reduction in in required at overall X window, Phase in period, a of median prior to prescribed X surgeries. As number that a The laryngoscopy other was XX you trial to patients surgery the year range XX% during window. dosing X I/II decrease the following disease and wide maintain clinical see protocol surgeries the severity of year not doses surgeries minimal results. trials, with dose. the the Relative for counted a patients XX-day the improvement conducted the were versus protocol in the a seen with surgeries first can administered also during a and residual all treatment here, during did of which include our of of week be XX% and disease

I capitalize the medicines effectively other involve to for and be and we in strategies to enhance we the plan shared quarter. future look candidates' results trial redosing potentially on nonresponders. for strengths. immunological able third opportunities we a partial to on design plan redosing redose We FDA submit data on responses previous believe we product's will As to DNA Based to from on the impressive redosing, the plan the clinical development XXXX which on historical slide build INO-XXXX, programs, and the to investigating to immune

We in for U.S. our help with confirmatory by Europe frame markets, continuing development efforts utilizing be conversations which study will for trial. we regulators to design ex-U.S. expedited are believe our placebo-controlled also clinical a

the and in granted designation granted indicates previously year, Europe device, Our the strategy the requirements. meets CELLECTRA health is for Commission drug orphan it European which safety by that certain supported CE Mark European by and last our

Turning another some INO-XXXX. now on provide lead important stage like to I'd candidate. updates to

we this may for to immune you recently the regionally antibody as year cancer cells of package boost for us FDA this supply announced ability and cells the treatment within high-risk clinical ability III We're HPV-related patient on first and XXXX giving collaboration leverage has survival. trial combination for with and our high-income our for previously monoclonal of potential to agreement rapidly cells. move the the cancer event-free Loqtorzi, by group. countries response common Loqtorzi meet recently quarter about the reengage excited combination, to is when HPV-positive a of trial and we local aim could Phase in of United surpassed XX a The to submitted therapeutic that most Coherus related throw therapy and approach forward designed States. received used elicited III increasing the approved with treatment T novel of with the can in recall, study need rise this combination first in cancer with high antigen-specific BioSciences evaluate XXXX, as this feedback the the is the investigate anti-PD-X the an HPV-XX against Phase and XXXX of confidence a Loqtorzi, to combination T in incidence nasopharyngeal unmet to carcinoma. In the diagnosed quarter potential the cancer in As throat in believe cancer cervical the it growing advanced with We

conduct to in study are our European North trial the and with and next steps a goal regulators. discuss Our design to Europe, America is multicenter

market study previously to some reported antibody FDA accurately encouraging that with our space is new generated in are us INO-XXXX, by to our used strong We candidates, from against on the also assay, XXXX as earlier-stage utilizing being to progress We drive the FANG primary including primary studied which continuing Phase allows is a Ervebo data response of more licensed Ebola boost heterologous some vaccine, vaccines to our assay. I a the the data Ervebo. other which disease benchmark often antibody recently comparable This and elicits this response, vaccination. indicates the

on and journal planning from with publishing are based this We in on collaborators. the FDA discussions feedback and KOLs peer-reviewed productive data a and

forward clinical this Phase for quarter. II/III aim and revised with protocol the We are moving XXXX submit to trial our

the candidates to from Phase medicines, We sharing are trial clinical the nonhuman look trial half allow antibody immunobridging the the to DARPA-funded finally, a of CoV-X we primate human in XXXX. evaluating dMAb on with aiming readout to data DNA protective forward nonhuman I next-generation primate work first a study tandem the to challenge second of anti-SARS from conduct in the titers. And levels our of in study

For our enabling that, on turn platform for monoclonal core the I'll We evolve encoding antibody our our a to we're to innovative the has medicines specific commercialization call be a those DNA not provide dMAb in functional traditional transformative technology antibodies familiar an Mark to therapeutics XXXX. using DNA technology, the DNA efforts monoclonal with directly monoclonal plasmid. to for within believe update by antibody produced Mark? body. With over potential this sequence

Mark Twyman

listed from the Thanks, option for and are will and focused our highlight we them. the actual friends today RRP with I'd that start treatment us game-changing taking of patients the all case disease allows for the can us this you them. slide diseases, and Mike, on it a efforts from serve impact what's those act burdens to with us to patients continue to XXXX can't to that really patient provide everyone. groups in bringing market we patients, how them. RRP are understanding like our patients to affected quotes and physical to in they to XXXX thank has to potentially come desperate they work patients. desired relief profession ensuring and their to of care real, to their patient is treatment that a to lives best to. Listening living advocacy their has to be bring to RRP, who like surgery, The emotional point by or to are the market impact of their and a and family like the would moment hello, and enable tell health life on driving the about altering we've enjoy I needs. assisting can in I meet used that develop rare providers spoken journey best is for

for part see While clinical are the Mike laid foundation XXXX, as out advantage X just we of they of our commercial what success.

a last commercial the made As team. of time what drivers provider now, At each level, clear key critical strategic be health the and we highlighted also commercial of foundation expertise a care them. some I progress can on strategic quarter, and patient on includes landscapes of date success that building will against understanding significant have defense to a and our of for

examples, locking of intended secured temporary of field supporting down XPL CPT selected analysis, strategies. administration and engagement we for our and strategy. Based and As final that payer partner we pharmacy ACP footprint support XXXX deployment have ACP best strategy, we've partners and identified the our on channel in believe database phase a claims patient are code comprehensive potential a can specialty geographic nonfield-based and distribution its

methodical moving approach review the submit for successfully. I forward very to that the fast us the brand to in XXXX term. remain a will plan but for name also thoughtful, grounded carry believe We're proposed in We near agency

has of physical first to necessary. much rare might who for U.S., perspective. on burden of like for the care and for rare that product therapeutic their joints, and RRP Financial are noncancerous reminder surgery tissue results. underlying Nirogacestat and in with the overview With standard that a an places by way nonsurgical found is nirogacestat is damage financial scientific address nirogacestat life. Like the tumors incredible that risk significant treatment the desmoid for be FDA for XXXX eliminate in potential Approved approved of RRP, desmoid patients, approved first XXXX. our patients. papillomas gross for groundbreaking diseases the treatment could connective like industrially in surgery, the treatment to Chief be are the the tissues disease by emotional marketing a much for disease FDA-approved options call probability to treatment the medicine fatal, need Peter? But recurrence local the similar why replacing option same on adults itself burden which prevent to Kies, a the to the rarely over characteristics doesn't recently important characterized of offers turn we patients otherwise physical like our late RRP DNA to in an serves of in face Nirogacestat RRP first a reducing needed first Peter tumors, many or now quality XXXX, emotional patients. I'll in Officer, the hoped the soft XXXX very for of quarter from of

Peter Kies

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

Jacqui As promising advance to position other strengthen we earlier, and noted to our XXXX continue candidates. working financial while

and pipelines. of after and announce prefunded discounts warrants additional progress support proceeds These pleased offering April funds help We our commissions of the underwriter are and net from XXXX commercialization will and a with support stock expenses. approximately million efforts offering deducting operating completed in to XXXX common for across our $XX.X

million decrease in XXXX. same quarter INO-XXXX million the and compensation, in XXXX of down The for further, manufacturing, dropping year-over-year decrease and spend period operational result XXXX compensation, the clinical stock-based operating employee in primarily studies trial decrease. noncash stock-based primarily the first quarter and compared first $XX.X of to million XX% compensation, decrease XXXX. our related the to in lower inventory period among The our first the including other Breaking in expenses in related million expenses, same and compared G&A We other $XX.X variances. G&A a was a and XXXX, including among to XXXX. decrease employee consultant to expenses quarter expenses for were $XX.X to reduced other legal for the XXXX, in quarter to have from outside was compensation expensed or of in services the quarter $X.XX $XX.X first loss per the a expenses and net of totaled dilutive employee the $XX.X and spend, in lower dilutive expenses, $XX.X per quarter share million R&D other variances. Inovio's loss was million or drug $X.XX net COVID-XX compared for a of and first for again of basic $XX.X R&D million share total million consultant basic our $XX.X

any into $XX second These cash raising further raised balance During million million of of as quarter approximately in This investments of quarter convertible million XX, not Inovio the December $XX.X of million debt. notes XXXX capital in may runway XXXX. Inovio and cash short-term proceeds to to third its of of projection quarter $XX.X including quarter, estimates no includes that $XXX.X equivalents for runway, paid and an the the finished the XXXX activities million burn operational the the projections include net XXXX. estimate do have with further our $XX.X We XXXX. compared cash remaining we cash undertake. net April of cash, extend of

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

the I'll call Now over back to with Jacqui. turn that,

Jacqueline Shea

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

Operator

Hartaj [Operator Oppenheimer. Instructions] of is from question Your Singh first line the from

Hartaj Singh

I of got just questions, P&L. one couple kind a the and of broad to one specific

down saying of ask while, Jacqui, published had us that RRP XXXX on vaccines. there. question, a I some perspective guess, kind what been going Just around I investors for a the Australia, have rates HPV Mark. effect broad of know the been they've But we've they

XX So just secondly, idea moving Phase the how just just us with if you of on Peter, start can you IIIs the there the you your can thoughts to next in give give you advancing quarters? burn. HPV up us would vaccines an -- for expect RRP? And then for over context on few view INO-XXXX, the OpEx that burn

Jacqueline Shea

to nice hear from Hartaj, you.

important So yes, vaccine, question very very -- HPV important here.

HPV were vaccines and XXXX XXXX. launched So in

into of RRP what achieved of all, in that certainly boys First HPV rates. pediatric countries And are very impact starting we've have seen have targeting moving girls to on that well. the is an levels vaccine then and high vaccination as

seen vaccination stalled that RRP. thing So HPV mentioned countries a where they like you an have impact and is high-income reduction have significant in in I Australia, important levels for think many countries. to instance, But note really

So and sort for vaccination slightly lower in rates HPV in the U.S., low and women, boys in of and high girls XX% are man XX%. the instance, for for that the than

there's very So the RRP. And that significant a unvaccinated unprotected is and peaks. the another that against bear in main has to RRP X mind fact proportion age point of therefore, critical remains population

disproportionately or are not RRP boys the in are likely RRP adulthood further people been So adult And those peak X. XXs. at there's people vaccination. to that received in a the tends population or around age recent age vaccinated part least groups, in in the a those rollout were these peak and And have and not for mens. then then HPV vaccination affects XXs of sort is given lastly, yet disease then relatively a And early eligible were vaccinated not pediatric the of of that of for vaccines. And the have many the peak HPV peak to

we adult HPV the providing we're whilst in together, not terms infection protect encouraging in seeing progress population. vaccines, I protection come that X seeing and some really population, of against the do juvenile which all HPV into still XX, yet taken are So think with through

like to to that? be is come. Mike, to RRP unfortunately, anything add you'd So us with to for decades going

Michael Sumner

No, point. hit major you every

Jacqueline Shea

moving then around burn. to And on question your OpEx Okay.

will as to to Mike XXXX step going it's North little and some hand we're to And the he through this interactions. But conduct those to bit the both -- financials. time color be take because to with over on us the of next Europe. European for Peter? mentioned can and go are call, provide America looking a discussions I'll during conduct regulators our in Peter, We further trial

Peter Kies

you, Thank Jacqui. Hartaj. Yes,

we do So increase quarter million. be consistent. that our did to estimated And by into burn of $X XXXX. given I that third cash we expect this have quarter we've fairly guidance

So a get lot of that's related to could see that we activities we potential increase commercial right now our is launched, dive related into and to after XXXX our but commercial -- increases once that. accelerating that fundraising some our after more

Operator

next the Buchanan line of JMP. from from Roy Your question is

Roy Buchanan

one a terms you do just on to XXXX, What are do aspects the of the device what need just naive of itself? that get to is the I few device in pretty submitted but BLA?

Jacqueline Shea

question, Great Roy. Yes.

So as is product. people may be aware, INO-XXXX regulated in the a U.S. combination as

I'll well as And we component our as means drug to the both submit device to this regulatory about over to the on around component. Mike? FDA. with that the So hand talk interactions combination need Mike

Michael Sumner

you, Thank Jacqui.

So obviously, living, I element. devices mean, breathing are

aligned updating, that used I the is file been remind latest to PSP sure Phase in before. would device the we our basically, studies so are And that regulations device. But X all the making III relate you X really has with

experience it. significant have with We

very a in of good have So we setting. the how clinical it performs idea

standards current So the all up updating just meet for it's BLA. bring device the really, to the it to

Roy Buchanan

I the actually XXXX. be then you on give on But looking take should know just of until at? enrolling us any hard Okay. the to to to we confirmatory might And in it this for immunology you you presentation point can say you it. And is sense the us start any trial? long half, I particularly how enroll Great. then can one then conferences And mentioned have second kind

Jacqueline Shea

talk you Yes. enrollment and terms the Mike, about in trial want thinking of do what line? confirmatory we're time about to

Michael Sumner

Certainly.

X today sites study the the we're I/II mean, period. targeting I clinical had able Phase to the in were we we within So said XX time approximately that call a patients approximately XXX across patients on year recruit

going are expanding the beyond We clinical be X significantly. sites to

as want what know. will at recruitment roughly available, be to soon targeting patients immunology, to With be regards moment we hoping going as wanting target the period we because, indicated so we're that that all that there'll a same we're So possible. publications we're around obviously, do so conferences the will commercial recognize product as we we the haven't to soon access to but as

Jacqueline Shea

of With I can regards need to just -- point. If We that we add just before additional the the have our confirmatory advisers. Yes. can sort BLA. study, one to study FDAs submit we just start

we'll as quickly need start looking before study as that possible, to just that whilst So to complete be can BLA. we it submit we we --

Roy Buchanan

Right.

or Okay. requirements have any at not enrollment, in on like they Do XX or patients all? anything

Michael Sumner

that confirmatory we definitely and any us it our of are I the No, study, obligation not given they can have as we to FDA. that will mean targets performing you sure that demonstrate expect, be we to believe is able meeting make to

Roy Buchanan

Got it.

on the you Or out have regulators XXXX, and have you sense reached just And but may to meeting? the timing Okay. that? EU schedule for answered this any

Michael Sumner

reached yet. We have not out

the and pathway FDA as possible. got we forward, a now We get with as meeting had to be aim -- alignment have and that have will in our we fast that submission

So I would it will X. quarter sometime imagine be during

Operator

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

Anish Nikhanj

side, been on Anish certain on another ahead, XXXX I about administration? for better and suited KOLs It's patients just step device the Greg. you the do clinical physicians thinking use with if layer you considering more to as landscape in utilizing and practitioners or of a use competitive and on And it even relative wanted the the hearing are or for how patients. subcu drug Precigen opportunity just CELLECTRA even feel of to could the what be administration, for XXXX from and on route ask this positions clinics,

Jacqueline Shea

great a question. Yes, that's

physicians not and from on tolerable device And used patients device trials, with patients used and other care very health is in now. the earlier believe device administration Phase hear very clinical it's the in as are this call, device and and that X who our of countries studies. people is back mentioned a I Mike XX We've what familiar for medicines for So use more III quick for devices, the by we've is is previously than to that the we DNA easy providers. uniformly in

as part our DNA targeted So that the important device we really it's and and our of enabling localized medicines. uptake see of delivery an

of And barrier administration. Mark, see compared so it as a you it want seeing talk about as component to core we it? do really not to we're a subcu that.

Mark Twyman

Yes.

more bit physicians, specific primary Just research easy to and device obstacle. Jacqui exactly not what little with we've be use. done a comments on, said. they've your market an It's that The said to were is spot

fact, are sort right? device you They the In much what's use conference conferences, devices every physicians, of of go day, one on it's if floor. laryngologists their pretty to

results device again, be their in use input the in the practice market their the they from use won't OR. obstacle research either in it -- and should suggests that the So of or the an decide to for the practice

that. So confident we're pretty about

Operator

Your the from Roger next is Jefferies. of from line question Song

Jiale Song

have and the that you how want by there, fewer as you trial this need show? clinically about assumption much the study assumption be size, couple just of alluded probably the reduction understand confirmatory global powering effect XXXX power related One confirmatory those are is the sample study? for But arm to side? in surgery on control the I heterogeneous related and is to for trim also on questions XXX clinical at can for the the assumption terms and less patients. studies. confirm I'm what's how for powering just And you here, to particularly patients the I effect be size the end. particularly curious size, you to talking expand curious of a what into we're site May in the option

Jacqueline Shea

the line around but is your there capture a So clear think we the thinking how clinical was sample not asking what your be size could heard trial. and they global and terribly the I you the Does that for are that for sites, also question? heterogeneous the implications and trial we're what potential rollout. confirmatory powering of What of around

Jiale Song

correct. That's

I are questions those Yes, was here. connection the about the asking. Sorry

Jacqueline Shea

Great.

to forward to actually about actually thinking the us. sites already using for think like why and having in very we've been the talk helpful you would So is date, sites sites Mike, we're X we going of used

Michael Sumner

analysis Yes. variability have primarily. to we that obviously mean, X from that. there to I sites an we study did not site, we precisely Phase the of looked I/II if point And see And and conducted was see site any view academic fact, across from

imagine As the trial are able United that based nature. clinical can in sites academic of in to do on sort States RRP or you

from original we characteristics. really we United the not stage. the aiming perform study So beyond as And at site any to expect see sites, are States this we X impact to expand the do this within

you surgically, access disease mentioned, equipment. time treated spent don't As have surgical The they with the necessarily while is we some European have KOLs. to same

randomization X:X be limit the haven't mind heterogeneity that we've planned we level that as but to what we a obviously treatment. respect kept do not that is will using of rollout. With effect we've So to in receive number say we active study designed of detailed patients our both because the and will that I size, want the

of both X-year also -- both of that the patients for we data Phase cohorts study, individually study. into coming significant. study, were part I/II remember, And you from cohorts the those If we collected we statistically as released as

the gone nice we really powered -- estimate very safety to effect. terms And got a the that believe, margin, use we've so try of data we've in And we and what how study. placebo we've

have we on will I/II So effect seen what size we have example. in we're appropriate statistical study that and our data -- very confident based Phase what we've we and an

Jacqueline Shea

add here, gone reasons of a couple are real reason if of key I one just there placebo-controlled why a this we've path componentry of underpinning of this. the down sort Mike, trial, conducting can Yes.

RRP First are of the is year. X than patients having approximately year. And surgeries median of is are for there all number a patients who per surgeries a of lot therefore, X less

vocal patients us they forward as to clear cords. And so population able discussions requiring to the a their it trial. in also it's regulators, And RRP be important that path well, address experiencing the our that placebo-controlled start before to with they then potentially European very see also made significant for they've as of in damage ideally Europe

want helpful we add to think we conducting to you to move think the aspects? very as U.S. else Europe. Mike, about placebo-controlled we in will start anything into a those be So how XXXX trial

Michael Sumner

I the No, think points. we've relevant covered all

Operator

Yi Wainright. is from H.C. Chen question line of Your from next the

Yi Chen

patient existing confirmatory alter from future? potentially do to patients efficacy of With the And the respect in the what to be target readout those in the the expect do the completed alter to trial? trial, population different percentage you -- the expect -- you that

Michael Sumner

No.

that population changing the the representative pleased points. significant criteria from we very things I/II of inclusion about saw Phase are set data any was of was the were and one our not highly we on think RRP exclusion I

have out than So again that the of RRP and of we there. the population we would year will that's representative X the previous hope population surgeries a in true greater

Jacqueline Shea

And year. reminder, as both positive and who I/II and we just people as People enrolled from in have people disease. XX had had X the between X as study prior the a well X disease with Phase mixed surgeries

that, the that treat. patient So population we of want we believe population really do is representative to

Yi Chen

RRP see of you disease, confirmatory what the does broader a when trial? exactly for that spectrum So mean

Michael Sumner

This go as in the with wanted a that study, we to made we we The population. that fact X mentioned the X very patients more representative the down us isn't allowed are relates if to could recruit RRP to that And surgeries. call, FDA do Jacqui to it earlier or single-arm of only to clear surgeries. fully

placebo-controlled design. the driving a picking So us that behind was forces of one

Yi Chen

Okay.

could surgeries change world, -- you readout? X lot for potentially that if in patient a trial, there So are comfort population the of the the

Michael Sumner

and this they expand was that as say. going treat any that clinical saw we the have expect but data don't I up we note the their I/II had exactly fully very say year we But different recruit study. X, of a maybe which in think what that trial at the population, RRP be will a have we to foundation surgeries more we similar any difficult population. we Phase surgeries. they previous on median X range I in saw patient It's what that full study, in the we X a sure they will to would starting than believe based sites, population reason to I'm

Operator

line from question Stephens. next Sudan Your of is Loganathan from the

Sudan Loganathan

be regular in to the there is the the just accelerated track Just approval for that BLA can for submission ask in INO-XXXX, there on sure that just by XXXX? under terms to track of the there being the you is accelerated chance processes regulators any quickly, pathway, -- to not would FDA you're still a the under that really if approval ability make Or approval wanted get for with on for XXXX? assurances the pathway? Is market from get

Michael Sumner

the said obviously we these which of So mean, part review, designation significant of based quality the of request is breakthrough of advantages the I our as us has recognition patients' will everything one about their the priority with pre-BLA of impact FDA meeting agency, life. to on on

We granted will are contract very review, hopeful which the we would review period. get that priority substantially

I So can't our this but half the of of in second the track to talk on obviously, FDA year. on behalf we submit are BLA

has period X-month would mean So file once that with priority hope a been review the review, we would accepted.

Sudan Loganathan

Great. secondly, real And then quick.

the of process review? line any any like to that the with with necessary two? to timing the part is the up trial approval forward -- outcomes with is a of of FDA for approval between the the just for that year trial, going or the trial, may of that prior how of full provide Or kind of or initiation going kind In needed terms of going be feedback the confirmatory

Michael Sumner

Yes.

none clinical So moving get process, the trial. are The as with FDA be on possible. trial fast that our study with the work only under CROs, confirmatory the with accelerated approval do filing us data based previous And to process respect to have will the to as that engaging thing required. asked of already commence is we BLA sites

So not hold up that, we will that anticipate filing. our do

Jacqueline Shea

we full then need approval. the confirmatory data from full will for And the trial

Sudan Loganathan

Got is on for trial how to expect trial like data? full how when to Or you. is could also get any long look there like at and final may back have long confirmatory so how extrapolate And data be we -- taken you data get that to far could to it guidance it's -- the trial? it the to confirmatory

Jacqueline Shea

Yes.

the making be will trial. we when said, Mike further details trial about started as we've So available the

get try looking possible. started participants we're as sites patients. try and are We're number XXX of expand recruit soon the We this to quickly Mike look trial going as looking going and recruit across. to to that around possible. clinical said, to we'll as we're as as the And And

we we recruited fully enrolled -- thought this trial trial, than was faster recruitment the I/II Phase actually initially and year. was the in For

Operator

Shea, call now like Jacqui this There hand ahead. closing to would are further no for President questions time. go the at I CEO, to Please and back remarks.

Jacqueline Shea

Thank you.

Have objectives. medicine momentum we're a to thank for Good in of your on with mind, deliver opening going. With strategic promise And of set have with continuing commitment a our the keep catalysts As and we this for strengthened the again agenda ahead key an at DNA attention. committed night. important other the ambitious I BLA on patients balance the outlined you on but our are year we for to the submission deliver a good focus call, and sheet that, evening, to everyone.

Operator

your conference very and call. you gentlemen, today's Thank much participation. Ladies this for concludes

You may now disconnect.

Inovio Pharmaceuticals (INO) 13 May 242024 Q1 Earnings call transcript