INO - Earnings call transcript Q2 2024 | Inovio Pharmaceuticals, Inc.

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Operator

Good afternoon, ladies and gentlemen, and welcome to the Inovio Second Quarter 2021 Financial Results Conference Call. [Operator Instructions]. This call is being recorded on Thursday, August 8, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.

Thomas Hong

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

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

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

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

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

Jacqueline Shea

business To XXXX joining lead as today, thank and advancing everyone on for begin like for the goals discuss program, That far our we we've our finally, INO-XXXX a candidates in pipeline; made afternoon, you of Thank at our the to this based you, promising out includes today's Good progress strengthening set and other the development with beginning Thomas. thus year. I'd whole. to call. advancing

been has papillomatosis of focus RRP. the commercialization primary towards respiratory recurrent treatment working potential or the for Our XXXX of

made pre-BLA confidence and important track the year-end. Europe, BLA the week further progress we with progress to expect that remain right FDA and our submission. to to by positive for provided A also on continued advance be elements have preparing the both significant We completed trial. We've planning meeting us have last package, all U.K. our with and redosing made in non-device-related regulatory

have device Every a a However, issue component this and single-use testing of impact as BLA with filing, day our patients, of resolve will we're to to process matters BLA working administration submission. support earlier to identified and as manufacturing we quickly possible. our issue that today, timing disposable our announced as during the the required

Our excellence. to Chief Phase next on prioritizing submit be trial for glioblastoma, in design use time, with trial with value approved RRP the of brain combination FDA only to our and our want we've treatment Mike to for our the progress by emphasize will focused opportunity we also and that not more, program to the for remain Medicines details, INO-XXXX Medical longer-term and the making I path as our has therapy partners planning review. confident Inovio what for in in Sumner, Agency III INO-XXXX the objectives near for the cancer to Phase continued to for month, both an deliver pipeline, our in later FDA-approved II key same medicine stakeholders. for We're forward, the strengthen have Officer continued INO-XXXX operational and cancer. need and lactose other but business discussions first submitted for States. booster deliver first provide could trial this Ebola we're deathly throat the to European a in the But devastating Elsewhere advanced United disease. for DNA to the financial At discipline vaccine this What's on more

As will to Peter $XXX common and quarter no short-term past approximately through April. offering we the that and closed current operations sheet on investments, in million estimate into will XXXX. cash shortly, second third $XX fund with million quarter this We our discuss warrants prefunded be an the stock sufficient balance our raised cash debt our with of of and

to leadership franchise new vaccines and XX experience, Chief also his spent including delighted of vaccines broad Steve women's We have at as Sciences, also both Chief diseases vaccine Commercial roles, an career him new their a leading Myovant at by Marketing product the and recently He launched our years leadership later where as and was our acquired and Steve Officer, and in commercial disease, spanned Sumitomo Officer health pharma. which HPV-related has rare recently large he HPV Steve held join biotech I'm has including number Pharma. team. area a welcomed Egge for serving therapeutic cancer, senior division. Merck,

Steve XXXX. expertise Over the his potential more we work XXXX share about commercial will why advance or be candidates. I'd His he product of joined contributed overseen promising launches. course Steve? a invite for broad to career, more Inovio, the to to has to invaluable like he sees than or dozen rather commercial as and

Steve Egge

leads working living with health I a am patients, medicine care RRP that could lives transform like Jackie, and spent choice of I be for my a number the to from commercial it back. for residual unmet compelling believe United in market here cells also the RRP, product surgery people has cells and I against to DNA disease. the of reduction dosing significant career the XXXX severity targets reduction by by that note XXXX to generate XXXX in important States. RRP. demonstrated to year. continuum with providers shown and make disease treatment Phase talented the had the profile caused to start to innovative maintain you, antigen-specific the previous excited impact eliminating to everyone. It's broadest candidate needs, medical we to window and patients medicines hello, how getting the first across has that require leading over I/II advance not both believe of could in during X the HPV XXXX significant HPV surgeries trial, regimen payers. lead and I in very the ability patients bring growing thus the and potentially compared the offers Thank saying to of papillomatosis in efficacy and which T a number to our that be XX, I'd preventing where our team Inovio, preferred surgeries believe patients does in infected to XX% patients demonstrated minimal

trials. not to electroporation health significant As to and CELLECTRA, refrigerator opportunity which temperature. U.S., disease. XXXX will a considered years over to immunity, was represents believe rest device the our such Phase we important be enhance chronic the stability DNA platform by well up we X clinical XXXX generate believe Inovio do providers and a re-dose is efficacy needed, if medicines with patients global care for as our Europe easy have the tolerated proprietary use in We XXXX Administration DNA anti-vector of by at often III was for viral typical time, for important likely also medicines attributes to world. in to potential offers and other previous X of maintain or lifelong

for see a you in preparations in key As the to pleased U.S. compelling can making is here, regulatory to linked its Europe global treatment I'm our XXXX. in and there product regions, key advancing we're report strong that unmet in profile, U.K. need and including making the progress both addition significant commercial progress

next We going are keeping months. focused more and forward be momentum sharing coming to to the in on forward the quarter look this going going over

Now, I'll some Mike? broader and update. over for to turn it pipeline XXXX insights a additional on Mike

Michael Sumner

Thanks, Steve.

on really We have board. to excited you are

comes Patients desperate are and year the said the so a in, surgery life-changing. the bring health, be patients. XXXX disease. a would that is dive is promise repeated we and working hard a reduction to important hard on is treatment. with to time to the well-being. a that mainstay of risk This it think surgery Repeated are I and medicine This of so we're to for It a again I RRP vocal reminder patients' community. on about toll Before it's emotional working why why of huge and have cords provide X time takes brief deliver DNA to devastating even

to As delivering we you've patients. heard from towards progress to continued make meaningful have XXXX Jacqui,

with meeting for of as the sections and strategy end our We clinical of the package Last would complete our our week, with I we non-device elements which device, of the expect the our to being the of overall held submission pre-BLA and components our BLA all package. the year. approach FDA, positive supportive CMC characterize related by

of on are track. have by the and are right agency's encouraged We modules and confidence for that BLA our content engagement our the approach level

XXth data cutting-edge XXXX on Annual at disorders, X the We International also clinicians Conference. a of platform International designed and look for quarter. HPV in is fourth for the focused sharing for the Society to a sharing voice, Conference, The forward important vocal conference immunology leading research, conferences international Papillomavirus which full Vaccines

routine which of support of CELLECTRA a in our safety studies. molded device. inject manufacturing from parts unfortunately issue and with array, during single-use This and disposable This The pleased broader otherwise to the XPSP have as global the was or of electroporation. issue device, our administration very our not plastic this one the medicine to is array The with a was known efficacy BLA used While testing this DNA the progress, the the of X and used identified is into filing. component, within administer III reflective array. component Phase stems we run issue

device support this has the anticipated for our working to The issue, repeat rapidly extended external additional BLA needed our work of testing to with mid-XXXX. time are the and required address Our component for completing time submission manufacturers teams testing array. the for then and line the

to course, a of we'll line, at this will, you updates quarterly work report. and time for endeavor more faster our on if possible, have We complete next

on Moving the XXXX to globe. efforts our around bring to patients to

on Advanced This review important confirms be data. that authorization Therapies. work recent marketing for to complies the a reviewed We Europe step XXXX to access an the also our time innovative Agency's therapy and an far U.K.'s that by access shown Committee accelerate line Medicines pathway designation data the achieving indicates thus progress drug our is that the was that of CMC as process a Passport part on designation evaluate following of and builds is and as medicinal U.K. used European certification innovative product application, in that development of This to called certification have recently for from licensing XXXX orphan a medicine with The standards Europe advanced our would XXXX the first regulatory track. nonclinical right designated the advance is the European could an XXXX. receipt made development offers pathway. regulatory enhanced tools regulators in in receiving on This and approval. Innovation

We The confirmatory XXXX. to only reasons require confirmatory our year-long study of our licensure recommendation in year, development required and the completed with strategy trial and system have selected believe we U.S. Mesa On placebo-controlled was pathway of enables will our audit, quality the in the X at track of to establish their occurred to prior is that U.S. likely regulators EU. for for prior global spectrum potential the the indicated a markets Inovio which ex commencement for in our mark Inovio baseline surgeries surgical that prior for include to the CELLECTRA has the recommended one continue confidence use of period or right system. and placebo-controlled an manufacturing conduct disease RRP which a will of The further such placebo-controlled site, well-established patients as previously broad for to a warning observation And preparations CE conversations our external This many European related in treatment. indicated provide a expansion global on be one U.S. EU. results study we frame the design, company's with a we regulators in a design the the design was that next for a will critical not the randomized maintain high-functioning of us ISO into also does design is unscheduled We in clinical commercialization efforts. certification this device our preparation Ridge is support representative successfully without markets. audit to quality note, highly time, steps

to feedback throw with our for XX for nasopharyngeal our Last quarter, as advanced combination from Phase received in when approved related Turning the now on a cancer, to one XXXX INO-XXXX. locoregionally III PD-X candidates, HPV and recently a potential trial the we FDA carcinoma. treatment late-stage of Loqtorzi promising monoclonal and XX other used of investigate antibody treatment high-risk

have diagnosed incidence as this most meet has cervical United surpassed in on Europe, high We study make progress and plans Phase of multicenter We novel and the within package rapidly The study the cancer to HPV-positive believe this conduct throw is unmet with America continued European the and to therapy unique has North III in to to our regulators. the in have patient cancer submitted HPV-related need rise cancer combination potential a States. high-income growing group. common countries the

heterologous which our Moving and Phase and INO-XXXX to preparing journal. review month, designs on licensed FDA with plan trial data vaccine. study for Phase to boost a to peer later review submit to animal along submit II this our a the our to IB the as collaborators are FDA Ebola We studied being bridging is to

the the last I'll highlighted to that series a that trial generated is turn Ervebo some elicits Peter from response, antibody encouraging quarter, comparable commonly new the strong I for it by assay, a vaccination. FANG update indicated utilizing As antibody data to that, and response With XXXX the utilized over recently primary for quarter. financial assay, we which

Peter Kies

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

Jacqui critical the total second our I XXXX, million and pipelines. to at the from the to late-stage on in been business reduced of XXXX spend $XX.X second our call, as position a start a XX% in strategy dropping financial report quarter am and whole we internal pleased our As quarter the that of our again operating enable to and have of almost million noted has resources to strengthening our part focus decrease. of $XX.X us

notes XXXX $XX.X As remaining activities million and net per convertible in of on as $XX.X quarter, $X.XX to short-term net an approximately net equivalents cash loss second and $X.XX We and $XX.X runway burn the loss quarter includes for runway with of paid projection compared -- noted and we Inovio of million runway cash capital investments the million $XXX.X these for per dilutive, for a million the last December quarter our balance of XXXX. of share, basic cash, or to sheet. third include of estimate million compared raise do no of XXXX. any estimate debt Inovio's of the quarter $XXX.X quarter We not operational undertake. third quarter the cash to of balance XX, projections that may cash further These cash our the have $XX extend into was This million basic XXXX. share dilutive finished or the XXXX. second

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

Jacqueline Shea

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

Operator

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

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

Anish Nikhanj

It's Anish Greg. on for

And could steps the and potential the issues issue your manufacturing resolve was How give the noted. reflected way. us issues help along some manufacturing lastly, it from the administration you us and and pre-BLA color line, disposable how during us you on more the anticipate when for to this on if along Could few XXXX RRP the challenges component the detected. a noted in Just you time discussions? emerge is understand

Jacqueline Shea

to with Nice Anish. you. Hi, talk

And part happy So, conducted couple BLA support that's first weeks a our to we've issue of uncovered the the to has all, recent week that the past testing of just BMV that's I'm submission. manufacturing light. literally being or just answer questions about been the recent to as come issue of over this

related So, plastic disposable is that's a part our medicine the the piece very can issue the electroporation. say is think part provide and the to of is inject that DNA array, that a molded what issue. used this which I it's recent single-use And to I forms

confident as manufactures we'll this possible. working our very are resolve are he solve to quickly. together external as this with component able be that us. We're of We manufacturer; And quickly issue we issue all our available resources with this bringing to

recent pre-BLA I'll I'll In let let that, BLA, a more talk -- terms Mike of bit recent about meeting. Mike? Mike our

Michael Sumner

Jacqui. you, Thank Yes.

of BLA CMC, fairly pre-BLA sort very in honest, be of with the mentioned, So, the we into to Jacqui be and arose this course the verification. appropriately agency it said, will I it I our agency. document it components, as gained wasn't normal have But to interaction mean, And those. with in business, the of fixed sort ongoing terms fix good for part thing of we recently. it not from device the align on for issue been device include, as the pre-BLA. And the for part overall and pre-BLA us picture of mean, meeting alignment issue of will we we part present have our bigger clinical would to the the of I be much recent of and the how agenda components very us strategy, to was adequately, really, that the and an internal that need

Jacqueline Shea

just about why now. Yes. the only part on to it question detected your And we've follow-up just of

submission go the low BLA. issue the part test of the the rate, devices to that's package to that of elements process up VNB of So, it part and really a into as all designed pretty occurs the of this needs at picked we

-- more in patients trials in Phase we've used involved were trials mentioned, that previously III And that device than X completed globally. previously countries. was we XX those As this

So, with we extensive and this the have component. array quite device experience

Operator

And your Roy the with line next of question Buchanan JMP. from comes Citizens

Roy Buchanan

manufacturing. confirm just trial. maybe inform to like or you issue. sounds it that the there's the no follow-ups correct? expected conduct And of to the that to of a need about Just timing couple confirmatory want a don't on I the this Is impact FDA

Jacqueline Shea

and Thanks, talk Roy, you. with to nice

So, will dosing issue you the can talk confirmatory resolve before the the trial, in Mike, do trial. need confirmatory timing to want element? to about in we start we of terms of other this

Michael Sumner

Yes.

is not moment, practice. I array mean, the clinical in So, at being utilized the

And so, will we've filing this sharing with obviously the we how we've the part of of sort issue and done we of will and be be all as resolving part aspects, BLA our as aspects sold what FDA of BLA our filing. this

Steve Egge

than data is right. immunological going All potentially at all the it -- right. Got it. Okay. later to present X more Is going year. data then venues be to presentation to the that of that the other? same All one or And you're impactful going this is the be the

Michael Sumner

that responders between mechanism action where presented That's certainly So, IPVC, our it? in spoken really sort I and of non-responders. of difference before really and at we data we've immunological to profile immunological and we've talks think focused think what really very that we a also data the is our of new are seeing in that And have it be to confirm will XXXX. I

So, we're data. very present upcoming excited to that

Steve Egge

the of regulators then one jump III, last that Great. XXXX discussed Okay. and yet? have the back. design me, European with you The for And trial I'll Phase

Jacqueline Shea

want you do to? Mike,

Michael Sumner

Yes.

strategy, patients of and guided only in the were along we what that, was treatment done of keen of fact as study us the alignment today, in that how aspects which significant study, have and that confirmatory prior our as a we heard to as of to who we one access with the nature mean, the U.S. I/II had patients we discuss placebo-controlled with future include me did study, our elements was our the to do surgeries clinical hopefully had X future. And as you enables really do original I on most to approach part really the So, clinical very to part of talk of more that the treat filing. submission, year Phase believe

Operator

of line And your next with Oppenheimer. comes Jay question Olson from the

Jay Olson

update. you this Thank providing for

We XXXX. on device And regulatory then about manufacturing U.K. on issue progress? or will the couple next have had it the a a any the also Array the operating impact of And any European few follow-up. expenses questions for Will in I quarters? have had impact

Jacqueline Shea

nice Jay, from question Great Yes. hear to you. and

of to confirmatory this So, to as a we our the quickly of support we've take until we our resolving issue it's why putting have to is possible. to some time And required testing the our be forward position focused completed issue. have then as we're on going BLA quickly we're as moving available complete as Part it We're all we start to rectify resources really the going that into reason in to submission. work; that's not And trial. possible.

the that moving in Clearly, So, the terms getting solve We're first, we bear gating and order to really bring submissions, at bear issue. that of we're of the it. progress resources our in in different U.S. to operating on the a on started moment. Yes. regulatory to terms confirmatory what's to of focused expense. trial need really bringing this the And is that's recent

update next able a think we'll I to our more on November. call in operating expenses bit be provide

Jay Olson

would that study confirmatory a regards that. you plan the study? trial? that redosing RRP be redosing to then would Okay. We'll And as to study, Or look separate with of conduct a to forward part

Jacqueline Shea

and Yes, this a not we've as study, Jay. trial. clear that great of confirmatory a We it on planning the to that's in we're as question, be separate tried pretty to conduct view our And part past.

Operator

from And Loganathan the your comes of line with Sudan next Stephens. _ question

Sudan Loganathan

team. Inovio few questions. a Hi, have I

of manufacturing part. the XXXX, the array on First

third the currently? sense component. that with -- feel one another the are the to for case manufactures be ramp-up Just yours for as only one to in be this get probably or resolved this third-party a with If party what manufacturer you trying array complexity using to the issues cannot this of agency for you're the standards backup would a started time component, get using of

Jacqueline Shea

recent From Sudan. this great a my perspective, a question, issue. is That's

we go a it's detail here. I too I this this up my at think think to ready and from have don't issue. another to path be to want manufacture resolve don't But that to we necessary part. much manufacturer straightforward to get going perspective, this pretty So, into stage,

working case issue more existing I a it's the this think through of manufacturer. with

Sudan Loganathan

opportunity have Got us the XXXX Can name early on of first potential this just kind from examples my one, year the or for just also BLA may other of update launch and the drugs markets it. based of you late that And read-through on XXXX? OUS. could innovation significance for the the XXXX early on in probably this some the U.S. XXXX last received the U.S. of some could delay as and staying markets. be potential launch path next designation filing, in there notable And granted this as U.K. OUS have

Jacqueline Shea

Again, talk you to about you I'll Brexit, is honest. that's after a great to ILA hand come Mike hand pathway. I'll But the relatively over be questions. This Mike. to over to really out mechanism new

Michael Sumner

Absolutely.

that the mean, were body have sort increased pathway sort is breakthrough clinical to we therapy had have that provide at regulatory not It's similar discussion a patient pathway. need this regulators yet. do about excited. clarity to possibly, where might is them They to I breakthrough your we we'll to excited to us. see get regulatory be be fact I earnings that the population. It's the designation So, acknowledge I -- access accelerated you another we this we're But uniqueness a next to and greater on of think, able but to face-to-face call. nice And our of actually data great there for how therapy our approval upcoming. with hint discuss special very That designation. hopefully, honor,

wait you earnings confirm what we'll a But other pathway. approved give So, more the have date our to same under think drugs that actually know. has received guidance little been to certainly I this next let But think at we'll that. any on we designation drug into don't look just But you I and and need call.

Operator

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

Yi Chen

towards the that Just confirm trial initiate you redosing to currently, to mid-XXXX, confirmatory and both trial plan correct? the

Michael Sumner

always the very So, efficacy a study, that we -- in basis And of to study. we going is, study the significant is have that from the I/II our approval be that confirmatory said seen as study. had you've Phase redosing post

And so, sample to have the to results, have good larger actually already on very we're show enhancement a going to size.

that would following we it on be the series. study always there we could recruited so, of achieve that are our easier that the market, to that a have actually approved once study product felt be primary number And receiving and, and subjects greater into

Yi Chen

it. Got

So in or just for required redosing trial the confirmatory the BLA submission. Is before trial submission Europe regulatory U.K?

Michael Sumner

just No. reduction a the This is matters surgery further want to line foundation patients, for patients. with what every in and our in RRP desire to enhance efficacy our those their surgeries, significant

have XX% of So, seeing with if we reduction. XX% can XX% seeing patients respond. patients than already of We're greater enhance our efficacy further dosing we're beyond,

that see now why only can we approval. larger achieve we that you So, post need population can

Jacqueline Shea

this when presentations think conferences publish later are we those I and data at year. the making upcoming on our immunology

the we're of we driving immune see putting benefit. good responses believe you'll from out think I the data are clinical that what are we understanding that have that a there immunology that

really make disease, relatively Mike lifelong the potentially small for a long to And response. protection is what of as that that as number we're are says, is to looking So, is as for importantly, get this here sure viral we and maintain not chronic, what people do time necessary. reduction responders can who also, at into

XXXX. management part important it's life of cycle of an the think I So,

Yi Chen

in currently post-FDA U.S? regulatory approval time do And Europe the an and going you it. Got be submission have before estimated frame in for or lastly, U.K.? to Is it

Michael Sumner

time. haven't in this to really We guided that moment at

Operator

at questions no Dr. Shea turn to Jacqui to this And it are like for further closing back remarks. I there time. would

Jacqueline Shea

RRP. Thank submit like the reiterating to to we've you. we on a remain the end today I'm team's by met unexpected for year. our this opportunity that by and potentially goal to of rapidly challenge issue, close resolve BLA in confident life-changing in although XXXX focused deliver our the for to therapy I'd our an ability

transformational highlighted long-term on we to that drivers the to And continues them DNA place, evening, a to the believe could previously, value I've and all will both everyone. for Inovio good deliver the as potential making Have stakeholders. of success and always, drive medicine near- continue forward. to inspiration leverage and us As the we key in to patients from objectives provide has benefit progress that it key

Operator

this gentlemen, and ladies participating. And today's you. conference all you Thank call. Thank for concludes

now may You disconnect.

Inovio Pharmaceuticals (INO) 8 Aug 242024 Q2 Earnings call transcript