INO - Earnings call 3 2023 | Inovio Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Inovio Third Quarter 2020 Financial Results Conference Call. At this time, all lines are in a listen-only mode.

Following the presentation, we will conduct a question-and-answer session. (Operator Instructions). This call is being recorded on Thursday, November 9, 2023. like the now Mr. over would I to conference turn to And Hong. Thomas Thank you. Please go ahead.

Thomas Hong

and joining Good Third you thank afternoon for Call. Quarter the Conference XXXX Inovio

Joining Financial Mark Twyman, Shea, Commercial Officer, Dr. Michael call prepared Peter Chief the call Chief me Kies, will Mr. CEO, Chief Sumner, a review our Mr. and DNA remarks, Today's Dr. Jackie Officer, Medical as XX, and on today's provide Officer. President development XXXX, question-and-answer update September will segment. medicines corporate and we platform.Following quarter financial a conduct as ended information our are progress for for well

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

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

Jacqueline Shea

thank and for today's you afternoon to joining Good call. everyone

closer regulatory of bringing than say to RRP. are important to the significant first the two After the in on delivering the medicine for treatment very advancing ever States. DNA the candidate, we've promise medicines delighted made few DNA I'm months, and developments, respiratory progress United patients recurrent papillomatosis our of Over lead that we INO-XXXX last to market or to

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Our Chief a Medical longer that III faster pathway. to ultimately Officer, Mike allow no complete but means Phase this Sumner, will shortly, potentially BLA submission need and provide development will before more for a trial we much context news

products quarter. building other and Commercial This pathways in a to therapy our we by to a breakthrough and for the prepared filing the and expedited as new nearly approval access to in very the I past the leaders the combined to of our glove for access commercial of of to corporate the confirmatory it in Merck, decades of months however, experience benefit help of readiness across am the the a to successfully pleased addition space. achieve bringing this his market extensive time, Mark therapy and strategies Officer, for a and while building on candidate.In progress critical XXXX meeting other efforts intention of accelerated to spend hard shortly, the specialty submitted a initiate stand putting pharmacy with many capabilities innovative expedite difficult strategy optimize goal up to ensure government requirements implement XXXX, preparations late-stage commercial to rare we've our achieved leadership to requesting distribution, next Dr. be achievements so at success, we've submitted biopharmaceutical submission pathway, and, it market, for pipeline.After our our worked our I'd as fully to support FDA to including our commercializing about really hear with sales this completed XX of we disease over determine rolling and we current see lead has time We every new submission.As distribution approved. to BLA meeting organization.Mark an and Officer, for and collective and provide FDA such turn if advantages MedImmune. plans utilize I've such approved, restructure to our with whom personally already been Mike developing a the the affairs. current priority candidate pathway. and team accelerated experience favorable Behring from on same make plans Sumner, plans a satisfy Led progress FDA dedicated cross-functional and creating usual brief for technologies other difference. every over They've number communication moments Mike? timing optimized comprehensive retaining value market. will reducing the offered required our commercial fourth overview have for BLA Medical make designation, submission initial of months you'll should his submission model, launch Chief BLA I'm be products deliverables regulatory and meeting such prior increase like the the products With preparing to Chief will, team's efforts align a pleased development our to and to organization they team experienced line to XXXX, BLA.As to and that, as today our commercial FDA our brings with in this bring accelerated talking all involved team of be an and trial from place companies as further BLA has payer, the quarters, our Genzyme, time proposition of worked as field the few focused regulatory Sanofi commercialization our aspect efforts and pipeline pharmacy or critical multidisciplinary critical will result line, the with management needs real CSL our this the to review that, team new to request and marketing the from described, with key company breakthrough sections To the steps expertise to from progress and establishing have for of launch the spending, a team associated Mark for opportunity a by hand Twyman, development to and is the

Michael Sumner

and Thank you very greetings Jackie, evening, everyone. much,

announcing the has received BLA thereafter, line. Phase filing development, year in has from of Phase support positive for I/II year, Commission granted this concept from the proof our by FDA Inovio working granted have After To of progress a XXXX, in the drug how our lightning with a Accelerated status. a I/II we've lead the this important the work To drug same FDA's in could review Jackie hard earlier the of we the that been fast we feedback is years European May, team. orphan three final status in a FDA's trial trial through results from trial Therapy speaks collaboration to take Breakthrough followed submission this orphan designation substantial to provide time the INO-XXXX. created in our and We candidate, BLA on and data span started candidate advancing September.Shortly little of Program. candid As the made broader speed mentioned, under perspective completed Approval on

Looking a to like run granted submit our XXXX to fast to Approval have hard.I'd FDA's the file BLA the for under will we Program. assures why briefly need opportunity as continue team the ahead, and speak Approval to the BLA to Accelerated Accelerated that been opportunity Program to under our

for FDA treat to that instituted medical First, fill unmet an mind its allow need. drugs of Accelerated and approval that keep conditions the early in serious Approval Program

or have general, rarity to available disease familiar and/or before In tract. characterized to release program identifying coming this those last wart-like papillomas press with further condition utilize and desire disease address a HPVXX. this of treatment candidate the condition development in a year, a debilitating by rare by are is must category consideration caused severity, and issued not the who to RRP, the they upper to of small myself drug growth therapies. primarily their in of include qualify, must with recently accelerate or I prevalence or the it's options.For Inovio HPV-X Additionally, for the life-threatening serious respiratory RRP rare development a and

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incredible by medical make partners The to communications those work advancing But and of to for commercial work functions sense them.With develop of our experts fortunate sure done can with years are important of who for scientific on one affairs We team with receive our the the medicines ultimately over operations. in be area benefiting call I've important working to one slide with is juncture and between to approval medical work just is and updates is give commercial who just function on team is affairs plans such success in field Mark? that, engagement, how the Mark of Chief here of ultimate goal innovative underway through patients.Every critical. has an to who commercialization our Commercial the the price them implementing you turn now medicines a patients Twyman, bring working medical listed and important on the developing Officer, focused ensure some to that. an I'll

Mark Twyman

Mike. Thanks,

how it's am have to with prospects the speak say a excited today Before you and for about opportunity of the all pleasure the jump I our like I'd I INO-XXXX. specifics strategy, just to commercial into that to

biopharmaceutical on on who have both been Inovio, a first time of small years been have mentioned as of team.We patients I their in many plans my quality been extremely my as six years, large for for to of are benefit in need implementing the is we companies, financial options begin has the many I've with working and call improve desperate quarterly of company to life. are excited this for the and to involved about While Jackie earlier, products for commercialization

take few to launch the key what Let's minutes to in are orphan we drug. believe a achieve success areas discuss an five of

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RRP advocating mentioned, Foundation the with Mike patients over the their wonderful with regulators done alike. and a job sharing years, experiences policymakers in RRP As has for

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XX,XXX each and per only epidemiology and standard cases many path so estimated of on prevalence to of there current of snapshot taken adults The is far. a of have variable factors. care active about is a data cases widely high-level by patients, Incidents The RRP rare HPV and care chronic, most inform surgery and to option. repeated our that year. we HPV doctors, caretakers depends needs patients X.X what U.S. as really XXX,XXX with globally their forward.Here and understand of extra caused XX. X facing disease cited were in surgeries advocates RRP several We the new a is understand lifetime

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of the prefer In and sales locations in process RRP practice those approximately to that estimates them many estimate be mapping in for the heard currently validating geographically that are with we centers. these institutions. opinion one-half field-based decisions laryngologists INO-XXXX.Key to about of We treated alignment regional and patients, their at support academic size our recent practice leaders discussions all of final of academic team

As potentially providers could are ultimately, that and I've every to INO-XXXX to commercial we work strategy outlined today, care our market. patients, considering as we bring detail impact health

functions with We the continue partners seasoned on working update. line Shea, to demands will of for now Inovio the and our time the strength back of a the and call Jackie across Jackie? deliver promise on drawing of team turn CEO, pipeline medicine.I'll accelerated this DNA meet the to

Jacqueline Shea

Mark. you, Thank

across Before why from to which commercial today was from believe to its spectrum of pipeline, was trial, X ability XXXX highlight XX, I'd generate of antigen-specific a both paradigm from I the take to what of our and key T and completed the heard our and against we in In potentially disease HPV transform observed cover Mark, to Phase reiterate RRP. Mike additional some XXXX in responses you've the updates for potential moment result patients treatment severity. I/II takeaways cell some the like that able a

that by tolerated factors cell line see efficacy refrigerator over antibacterial XXXX may disease HPV persistently pain symptoms, our use which time Mark other to be Unlike adverse medicines made potential a and all DNA it's in treatment-emergent resulting the be RRP XXXX believe chronic be Celsius, an down the of in that important vile, potential saw in the cause as require platforms, is does reiterate surgery remain will an a in that unlock patients XXXX INO-XXXX distribution injection to of generating or severity.XXXX to DNA key re-administration larger that extending We at to don't earlier, process. dedicated a if general, low-grade if administration.We and in to was can across ultra-cold is in needed. X patients, further in approved.Thinking We which exploring again, our a viral achievable an X driving exemplar stable mostly of effects, to and market, packaged lead such Because and in reduction is in that XX is potentially important trial, positive the boost as X occurring and of lifetime. participants platform, this response across opportunity spectrum in we T means globe. disease potential factor to fatigue. of across well also will we pipeline readministered a storage could anticipate further And frozen over response, the for a that point degrees be medicines single-use immune site three-step the not progress XXXX

BRCAX term, candidates DNA diseases.For monoclonal eight DNA-encoded Inovio other finalizing diseases, can have targeting on COVID-XX and disease disease as cancer example advance pipeline. the patients greater to partner, of KOLs on working Obviously, excellent candidates, the medicine INO-XXXX targets this treatment the infectious cancers DNA including and that and our is breast and to treatment discussions some nanoparticles of potential This medicine our had is RRP that several key targeting the about technology, is building mutations. glioblastoma prevent report next-generation and advance. DNA-launched in longer vaccines clinical Ib the closest antibodies opportunity investigator-sponsored -- an University support partnerships patients. in we various developing the study with particular, INO-XXXX or cancer DMAbs mutations. on may stage next those The in the was currently featured vaccine to with trial. midterm, infectious targets.This versatility power Basser both DNA candidate steps medicine with are and XXXX term, potential studied patients people of DLNPs, today slide the being help newly market, patients.We also show, to HPV-related is targeting also on gene In research detail slide, progress potential of drive a of diagnosed As on on to XXXX XXXX a focused you accelerate is Regeneron.In evaluating in analysis treatment Inovio for for our working like the continue for progress We're by candidates there we're as Pennsylvania's optimizing for the one as see the near partnerships for Researchers but the Phase trial BRCAX to center. of continue highlighting we're or or for data well to recently medical innovation this value. ultimately, strategic provides In aim for patients, and to shareholder have Inovio

the checkpoint earlier INO-XXXX encouraged and PD-LX the with the reported in We head inhibitor. cancer neck by from combination this in also data of year remain final study

steps study opportunity we proven disease We're potential announced is checkpoint our year, funding this to with booster. earlier advance a potential We infectious Phase believe be combination next for this significant positive from data in PD-X side, are and continuing discussions discussions determine XXXX a to that PD-X as for a the with potential to partners for partner continuing find a I candidate. there evaluating Ebola I program INO-XXXX a vaccine explored opportunities. promising checkpoint inhibitor.On to

DNA development. next-generation early clinical in exciting some have also medicines We

our significant XXXX for development. and over call financial DMAbs over next-generation summary. platform CFO, candidates candidates also Peter? to and believe preclinical medicines quarter our DNA third the advantages other on potential in our built platforms.I'll the these instance, For now DLMPs We our with strength Peter turn Kies, of

Peter Kies

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

from the environment, period see noted period our XXXX, past third slide, in to in is September and organization bringing and XX, over this To our pipeline, to for XX we quarter been the has Jackie today's advance goals, Inovio months reprioritize XXXX. As the as discipline both scale as committed economic down we our strategy to spend.As pipeline. in financial and can reshape longer-term our our required operational ended our our spend the same nine-month you have succeeded operational compared achieve

expenses same XX% quarter to third period from the million million For compared $XX.X dropped the XXXX, in XXXX. to operational $XX.X

The million. noncash onetime for a that charge $XX.X third goodwill impairment quarter totaled included

months Excluding expenses that from third XXXX.For Breaking of of from the operational in months same same in bit declined operating have total down $XXX.X million first nearly in nine we or for the expenses more. quarter a nine onetime charge, first dropping period to XXXX. our half, $XXX.X the would operating expenses million our quarter cut the XX% XXXX,

associated other COVID-XX quarter, the to the in $X.X compared stock-based employee same of manufacturing, outside XXXX period $XX.X was in decrease and XXXX. be for same for R&D compared factors other discontinued. same third XXXX loss and noncash studies for in quarter for XXXX. Inovio's to compensation, U.S. $XXX,XXX totaled and to for have expenses per to was million million we XXXX bring $X.XX Department dilutive. R&D period INO-XXXX for $X.X charge dilutive.Excluding For the for and our would basic and were previously share, been used quarter onetime for third to period XXXX per quarter including $XX.X $X.XX basic or Revenues were the impairment, mentioned clinical primarily contract our the procurement the consulting related since combine for with reported services drug among our INO-XXXX, goodwill The These device have compensation, and million XXXX the lower expenses variances.G&A of the in of third expenses quarter for accessories to loss lower delivery share The of the compared XXXX. third Defense million result third revenue and a million $XX.X in the which million of trial to with $XX.X expenses net

a the XXXX.Following the the from with our finished pathway For investments $XXX cash or quarter Accelerated feedback compared or of INO-XXXX, second basic at-the-market the Approval of dilutive. XXXX support short-term XXXX we $XX.X December to CAS, that on XX, any capital of fourth We XXXX. operations our and raised equivalents estimate do share for now estimate program million funds other $XX $X.XX that approximately not into raise third per of and the million This for $XXX.X These may million be XXXX. includes through projections loss third quarter, as burn quarter million quarter activities. net funds FDA our cash of include of existing in projection should

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

Jacqueline Shea

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

Operator

you. and the we moment, Thank One gentlemen, Ladies will session. your first question. begin Instructions). question-and-answer please, for now (Operator

line comes from question the Jefferies. Roger from of Song first Your

Jiale Song

Great. Congrats progress. RRP the for program. all the on just focusing Maybe

timing the to and Phase guidance current the is design. items question design? in the the filing III around confirmatory BLA let first filing outstanding related approval? The the just what for And potential is the filing Can any you in us of the confirmatory study study know BLA the

Jacqueline Shea

Thanks, voice. nice to Roger. It's hear

as accelerated new. just mentioned pathway the during approval is We heard September. on in news So, the relatively we call,

that hoping is on as some few there. submission We by that past to alignment meeting. get quite meeting that the the under of achieve provide in package time really we're over into a some as be further weeks, well to But hand discussion a And upcoming confirmatory few the some to over to FDA Mike the really details what the together we've to the been considered needs to lines. as Mike? more I'll of the design accelerate FDA detailed go with our So, to to working package put study. content

Michael Sumner

Jackie. you, Thank Yes.

obviously, our of heard and we mean, tremendous September, made highlights. what in I to get you we've news single do hit some progress since think I really think I every BLA. team. to mapped the need a function out we the as We've to

we've agree need for to used terms the But through strategy. that need s-electric mean, to we're we already from I want we FDA, several again, points to our agency we We that had. strategy data mean, do our PPQ in had input program. I to we've believe going In pulling with get what propose, we significant the FDA be our the agency. what We to obviously, a of strategy. on we the the we've XXXX. gone to have to study is had from device. Phase III on that acceptable of We've confirmatory need what the input for a know, interactions device and significant We've

And our on on so, start around interactions based our the all that move with we've I the overall, so very -- need in we agency rapidly to platform forward. alignment specifically on we're place. filing we're we aligning can going it's study just BLA.But that And really through of process protocol had do as we RRP, the think to a now need good prior and strategy

Jiale Song

around Great. quick question commercial just the Maybe infrastructure. a

runway how overall for we into With think the should the the the about XXXX, assuming commercialization approval quarter for post cost approval second current RRP?

Jacqueline Shea

Roger. Yes. really That's great a question,

lines. there, with Mark will the the be I on this ask think to discussion I agency us help Before really jump really more time in upcoming definitive

can detail. think I I size on. encouraging the company points reasonable that number for bit small one a disease. is is core relatively in that this rare of things company a think Mark a for of We talk a a are our about to of more a biotech take there this us bit believe But as

We think have the in-house needs. manufacture CMO manufacturing meet we for And with our our well-established we that manufacturing relationships can device have drug drug. to manufacturing our device

we're going thinking talk XXXX. can about how about for you more bit maybe Mark, market a to So,

Mark Twyman

Jackie. question. Great Thanks,

need mean for was about if majority now field surgeries thinking nail the that laryngology hit and the space perfect this a really we're the performing XXX U.S. sales the for of that component, have patients sales exactly laryngologists and roughly to It's of when the sort sales think talking there think Inovio. that start. experience specialty organization, I that the the payers doing of organization, force I distribution about everything sort and to just the have speaks physicians. an of But we're we your you're commercializing that I products, on it about think and sort small you with XXX pharmacy. head the And the from perspective we and specialty PBMs, are conversations think needs in behind strategy, the it's about of both really between not and other officially RRP that a fit getting early we being are for she address in the the early RRP in but can organization

that's we to streams. good partners the accelerated identify being is to approval. started. leverage on the right I all have identified that's now we've work And I think this work And really that we that where We've emerging So key board. need begun about key and to been is what feel are able

Jacqueline Shea

to answer Mark. your Roger Thanks, about cost. question And

we planning operate and model. lean efficient are So, a to

we'll as us force to to where in-house. be there, things So, sales makes do the in-house, potentially it Where leverage sense sense that. defer for capabilities our we'll and do it contract makes expense them people's doing such

provide phasing I we'll that able terms we've bit in had once XXXX the So, think runway a FDA. cash of be discussion over more guidance to of our our with

Operator

Instructions). (Operator you. Thank

line Chen comes of question from H.C. Wainwright. the Yi next from Your

Yi Chen

those has will the that a setting, be should commercially the whether been XXXX just flexibility us laryngologists any be do the or to to, how INO-XXXX. in real-world patient every payers -- dosed think And let's say, tell by re-dosed patient you have particular often do clinical could Could you of year. choosing speaking, in limited trial with with once

Jacqueline Shea

Phase clinical address the Mark, trial. Mike together talking question next over maybe about then Mike the hand on maybe I'll for you And question. can to initial the I/II So, and completed

Michael Sumner

one mean, I no the real is response, DNA benefits of and starting the redosing of capable. there's off, anti-vector believe we medicines So, platform obviously, is

But unfortunately, seen the keep me. there maybe, saw the sort a I/II such from a some we we those [didn't] have then as In we in But any to capable we've clinical I come were examine excellent a be we want redosing surgeries. programs. very who from until our But At complete with it oncology future, strategy. of say, number certainly re-dosed the all have can significant that's their three great we Phase response. of patients XX% many to buckets We obviously with study. in response know our those build on to, all efficacy separate date. fact, few how with label, not clinical any a to good partial in of is patients think present, I response we patients patients patients, of about obviously, saw on continue from reduction would off-label. And a would the --

want the they patients. with be do so, what And will it down decide to to to clinicians their

Mark Twyman

question I payers that, Yes, the I we'll what would add Mike, think decide. is let to

that strong XXXX. -- we value very that is a think I I know what have INR for proposition

of sort of lifetime. these mean and I significant that's the of have. the this that of name respiratory I perspective, might sort the large how physicians just me look and And -- the fact can case the And forward they payers and KOLs this are resolving are burden of we really and patient that with and at to date of physicians patients treating RRP value their the are both hence, of treating cost from kind that experienced with key that perspective a we with option. of to number on having papillomatosis.And of some and already know think unmet a from really satisfied. an physicians a surgeons sure lives. alignment that these just job, looking are about have I having surgeries medical from living discussions need, there's know -- the issue clinical to number hundreds started, used a the payers some it's all they but what job RRP. And how doing new their of that with kind over looking not to aren't recurrent other a a surgeries unsettles to for real it's for patient we've know that go it But the daily point results comes is still potential INO-XXXX sort address make that to option that and our a

we'll feeling I'm to about good really So, the get we have where finish to but line. are,

Yi Chen

the III trial? part be redosing Phase of Will

Michael Sumner

about. really haven't but I that -- certainly regarding discussions details that in it's agency and out as we are the the put certainly still it's something with there, We're thinking said,

Operator

There continue. no please further Instructions). at are (Operator time, this questions

Jacqueline Shea

we I for I'm and closer confident significant is strategy means remain corporate past suffering trial the here The Inovio over in that key drivers from year, progress this. enabled Inovio to advocates, months, I incredibly experienced are dedicated of our advancing patient treatment have we commercialization RRP. a to at next you. long-term moving to place providing been past the us Thank that now the has am potential has and to the nonsurgical development option team the broader patients patients, over INO-XXXX team life-changing that grateful thanks made few potentially that in confident success. steps for also implementing we've achieve our for critical And the to prepared INO-XXXX. investigators

scientific diversified We have strong and achievable pipeline candidates clinical focused to and pathways commercial with on market a promise, potential.

power have world. experienced work but the With entire could speak excellence done, when someday attention. to we have from team I a great benefit what accelerate the progress again We month. incredibly of along evening, and are DNA your for the could around that, with and technology, much to the innovation. on partnerships team of strong Inovio our of energized I DNA you focused say be platform patients by proprietary an who future and motivated Have by is And thank financial medicines for medicine that hold history we and every for a medicine.There operational the the discipline, DNA patients benefit

Operator

does Thank all you. that and for today. gentlemen, you Ladies our Thank conference for conclude participating.

disconnect. all may You

Inovio Pharmaceuticals (INO) 9 Nov 232023 Q3 Earnings call transcript