Earnings call transcript Q2 2023

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, and welcome to the Inovio Second Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded.

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

Thomas Hong

thank quarter and joining Inovio the Good call. you second conference XXXX afternoon, for

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

financial DNA review June quarter medicines as as platform. and XXXX, progress development for provide the Today's call a corporate update information will well our ended XX, for our

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

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

on as of and based the All beliefs of of management statements expectations today. these are

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

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

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

Jacque Shea

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

papillomatosis, of respiratory continued important with progress recurrent candidate RRP. make the XXXX, to In the quarter treatment we of second INO-XXXX, our for or

as this initiate our pivotal in a in as Following trial positive our trial possible. is team Phase results from to working X/X quickly year, Phase X earlier adults

us the step XXXX, dose DNA from first for promise which patients debilitating closer in to We would the first patient on the quarter disease. first are this suffering medicines of delivering of one move targeting

particularly environment we shifts as pipeline. challenging Inovio, Inovio and a what for for we've making made better light in operational We support reduce our for of key as our like funding well difficult to pre-commercial advancing the scaled focused to and chapter some on our allocation further resource excited about spending this see pipeline, with that sure headcount align With in decision biotech in strategic company next is priorities. companies and our our as to are mind,

CFO, As Michael shortly, decision describe Kies, U.S. will our CMO, in stop Sumner, VGX-XXXX we and more in market. for Peter HSIL further today detail cervical in investment to our announced the

their advance their China in non-biomarker We HSIL will continue ApolloBio promising Phase to support cervical a to as advance ongoing medicines trial efforts in for DNA our appreciate and population, in for market. partner patients they X selected that

provide a like clearer candidates. share strategy, our To I'd decisions pipeline to these picture how of our current larger overview with an product fit of

can paces top development. is priority. our see corner, and have here, the therapeutic that INO-XXXX advancing portfolio you we we In a first As of areas and diverse into have across candidate right Phase X

As previously, in to I begin XXXX. quarter first dosing mentioned we the targeting of are patients

glioblastoma. INO-XXXX, vaccine disease infectious enter of generation launch clinic. nano INO-XXXX We're oncology about to intend potential INO-XXXX, targeting HPV-related candidates next based vaccine candidate. DNA encouraged and and targeting neck particles our see product particularly in advance HSIL, the head candidates we also and as also for addition, candidates well early-stage as In our We're our diseases, cancer infectious Ebola on anal VGX-XXXX excited the to booster the

commence. the number parties preparation conducted only on DNA the our of in underway we've Not you just highlights work you trials X currently being in planned medicines. does slide, trial extent for interest I it our Inovio's a technology. the among candidates see of with our it and on mentioned, Also the that included of highlight trial and Phase the to can collaboration, this INO-XXXX breadth but key of On partnership is slide, can importance clinical this external the for see that also

particularly chance that our our a DNA facilities our physical business estimate for focused the across clinical to important delivering XXXX. for taken these we've San those right-size reducing cost business progress our promise footprint have Diego, have in focused adjusting candidates of the our the the With California. ensuring XX%, greatest of We From we medicine third will driving by to to into the on steps resources our that standpoint, of patients. workforce believe fund needs, on operations to of initiating further of quarter company and on that two mind, match catalysts. are pipeline, to we're market R&D are current and approximately by reach relocation we We savings enable closest pipeline one in

most With capital candidates, will of development require on resources, funding to we those targeting steps next our trial partnerships, the of plans INO-XXXX the with earlier, next and, we clinical the year. for actively Phase I our current execute stage or as and can of X first also we're promising quarter the We're believe are advance additional start likely mentioned other in pursuing taking opportunities.

potential our DNA size not extend of taken the would and The on moment has lightly, I our worldwide. this on our for important behalf company and to like and that treat decision committed present, organization to their deepest technology to and progress employees, all to contributions protect medicines we're to and the to past patients making gratitude was my the reduce talented efforts take of of the

updates. our turn details our Officer, it strategic With highlights that, Dr. Medical pipeline to like Mike Chief some provide over Sumner, to and I'd clinical Mike? to on important

Michael Sumner

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

start to INO-XXXX. with like I'd

our an we've key mentioned, in to some further across effort pipeline. strategic made shifts drive Jacque progress As

patients with where focus currently disease a the therapeutic treatment greatest to this need candidate has market. our clinical our There be immediate chances first our candidates RRP, face to unmet late-stage is is success, INO-XXXX, for potential the on including of for Our high that surgeries. repeated for options candidate debilitating new

to patients in surgeries more would year two have or again have which prior treatment. shared compared in even a and X/X advocates prior time our had impact. year, as who we've in Patients a profound surgical reduction surgery the reduction saw previously, a one that As and to recent XX% in included trial, Phase expressed the interventions

announced clinical We X dosing the clinical of in we a patient are in anticipation initiate hired to organization the for today assist in after we us first with multinational discussions Phase targeting conducting initiation, XXXX working trial finalizing RRP sites. trial FDA. begin opening plan research is that of In this to the this on to trial's quarter the

trial call, as May the Dr. were part our ABEA Mau, lead program during shared from quarterly by data COSM at in X. we investigator, Boston As last of Ted presented Phase completed X/X on

CDX T responses Inovio's thought indicating surgeries. cells mostly experiencing reduction cytotoxic week CDX T-cell treatment-emergent As clearance also AEs. induce T with a presentation responses were activated of of might a remember, cells. at important including correlation was cellular well and responses observed for against to between immune also virally INO-XXXX the cells, you observed memory be CDX that T-cell cellular infected tolerated with XXXX to was indicates HPV-XX, and both and highlighted response. low-grade preliminary patients HPV-X potential analysis persistent XX,

was for XXXX European a Also announced Commission during that treatment designation the as RRP. second orphan by granted potential we quarter, drug the

indication was RRP from receive it the product EU the July in a reminder, bodies. designations XXXX, designation from both orphan first XXXX As and of drug the to candidate orphan granted making FDA regulatory same U.S. for

VGX-XXXX. on to Moving

several VGX-XXXX As including conduct is to U.S. before announced that be the press decision in potential of cervical This will additional HSIL population the would factors, required Inovio for further or the cease by treatment driven trials our release, development announced as for feedback previously considered more well-controlled FDA in one a being biomarker-selective registration. in we

we It trials. based with assay based collected our is a novel. quite was QIAGEN data the developed that specifically microRNA cutting for was in on previous this addition, In biomarker developed trial edge

not expected error in as need previously occurred of significant develop in reported, perform An did However, the be work be why the additional new a REVEALX. any indicates to to trials. would this done X amount it as prospectively further before biomarker could of Phase biomarker used that analysis we

These challenges, opportunities market less our for in other and in continued the HSIL of a significant timeline, cervical make lead long our investments which attractive than to U.S. development would pipeline. require pursuit very VGX-XXXX

That which for we dysplasia data, by our the of encouraged studies, global both achieved lesion for very to different. are supportive the for will and where options cervical remain REVEAL treatment said, in be regression data clearance believe evidence markets we particularly and access on being both the other focused viral partners

utilizing the to for in of Of partner our X in of biomarker trial we instance, Inovio's was to China, that indication. where market a XXXX treatment REVEALX cervical see HSIL is ongoing to Phase ApolloBio note, ApolloBio potential not for this For developed its a conduct patients continue part be novel continues trial.

the in recall, population. And of trial. we the REVEALX, viral primary secondary regression clearance may clinical is is achieved and in ApolloBio's endpoint ITT you that the endpoint in As same endpoint this tissue

discussing believe current be result if We can we XXXX treatment approval. and partners the valuable could additional also ex-U.S. trial other development XXXX potential where markets of with are in option, for a future regulatory

disease potential to Europe. HSIL. U.S., treatment now with in as million X for XXXX estimated This XXX,XXX turn our a for anal affects Let's people over similar developing for to estimate a plans the an

for observed factors: patient potential firstly, treat now approach for a Phase to indication, cervical the with secondly, in the this paradigm the slightly to more thought two suggests has clearance XXXX Our has conducted treatment evolved primary anal believing target; in target viral this has warranted. that and increased HSIL, interest based difficult because trials on data leaders promising proactive is care both disease that X the

monitoring from study in treatment National Results Cancer progress more community the approach the lesions that Journal the preventing HSIL published cancer medical risk called the cancer. The without June towards in sponsored study of active England Institute a to reduced the anal the New multi-year are a that ANCHOR can produced by compared anal to XXXX study moving of treatment. of showed results in proactive

very shift, however. need we in had critical X no of evidence HSIL treat not but label clear one fill HPV-XX/XX There's its HSIL of negative observe catch biopsy. in as HSIL HIV participants in options both virus ability lesions and evidence open to no given at beyond XX% to or X XXXX the There trials, anal XX of medical effective trial showed surgery. saw positive could believe or out XX% we and potentially out cervical of available XX week few XX in are on Phase in this this the We HPV-XX/XX also which our XX anal Phase XX patients, only

supporting individuals HSIL. anal Consortium, by potential VGX-XXXX of addition, with In study run HIV-positive sponsored the the an Inovio examining AIDS Malignancy is externally in

booster. vaccine steps continue taking for Ebola INO-XXXX of significant their HPV-related advance INO-XXXX each We also glioblastoma, identify opportunities as there cancer, development. We're for is is believe and for candidates focused neck funding to partnerships Inovio late-stage these to Jacque as strategic INO-XXXX to potential noted. and working head and an

have additional We in updates earnings calls. expect future on plans our to candidates for development quarterly these

Peter XXXX financial With quarter that, to over for summary. I'll Peter? now the second our Kies, turn call our CFO,

Peter Kies

Thank you, Mike.

Today, X. quarter I'd the an overview the financial for content additional XXXX announced some around condition like of Inovio's to August reorganization of we and second provide on

discussed our $XX We cash shifts made us XXXX, to important quarter burn approximately pipeline late-stage well the Mike announced million a earlier, operations an into help of one-time for today we to aligned savings the headcount million catalysts. advance of ensure in fund spend our and and will Jacque As operational third approximately the quarter expected including includes reduction. charge and $X.X development third to This to Inovio our related XXXX. strategic estimate of allow some projection is cost to candidates headcount estimate we positioned

at-the-market other cash the be include will do there our the expect capital activities. existing XXXX. These through remainder XXXX of funds or incrementally burn raised that raise We decrease projections throughout any and from not may program

from Taking from I've our the as first operating of XXXX, million, XX% our operating total XX% which in see at second the our reduction expenses In of down $XX.X a the in second can highlighted and down the were is expenses look XXXX last quarter quarter the operating year. XXXX. slide, the you expenses, on over quarter

other down $XX.X The reduction Breaking the employee among and in manufacturing that operating expenses lower to lower the research XXXX, and expenses, well million total primarily of quarter-over-quarter. compared for for a see were the related period development -- $XX.X in expenses, of and clinical compensation same result and compensation, XXXX decrease R&D second outside to drug was million actually, services consulting XX% expenses we trial as quarter other INO-XXXX, the variances. studies, costs, including other COVID stock-based as

second for drop. the G&A the a to The quarter decrease XX% related of as in of the for was the expenses of XXXX period variances. $XX.X severance million XXXX G&A were one-time expenses cost in to second litigation related settlement other and primarily the legal expenses, in among compared $XX.X significant class XXXX, in million same related a quarter to XXXX, as action incurred well

revenue $XXX,XXX for Our were XXXX compared for second to the period quarter in the of same XXXX. $XXX,XXX

combined second million $X.XX quarter share year-over-year reduction for in $X.XX These $XX.X per our net basic in or the factors XXXX. bring to quarter second net per a compared for loss. net to XXXX the represents dilutive, share basic loss million our loss of XX% $XXX.X This or and to and dilutive a of

million as $XXX.X cash million December We in and cash, investments XXXX. $XXX compared short-term XX, finished of the XXXX to of equivalents, second quarter with

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

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

Jacque Shea

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

Operator

We question-and-answer will the The now session. question Please begin with comes RBC Markets. Gregory Capital from ahead. first go Renza Instructions] [Operator

Unidentified Analyst

Greg. taking questions. for my Thanks Hi, Anish on It's guys. for

Thanks or pipeline into in consider assets, on give the potentially of And that constrains external ask, you resource sale to labor Just far conversations current BD and any for wanted are the requirements restructuring, any associated any to thus financial I much. us clinical developmental decisions the with offload strategic some given of partnership restructuring, of these would levels could development perhaps you of assets? insight so interest?

Jacque Shea

Yes, thanks. question. That's an important

confidence So, of all, we our like pipeline. in I'd to great first have say,

candidates We move next different development. clearly, clinical that of late-stage at that to particularly people. And our the pipeline forward, range we're candidates great into opportunities have a the in are confidence we're looking looking advance -- of to stage our

with pipeline slides, has forward from that pipeline to out-licensing, can partnerships, a that worked sectors. clinical strategic And always of do slides Inovio as all continue have you our to fit. across collaborations seen our range including we to the academic different And going we're models, see ways in and our best business advance the

Unidentified Analyst

color. really I Thanks. appreciate Great. the

Operator

Our with ahead. next from comes go Jefferies. Song Please question Roger

Roger Song

they can And the Phase you outstanding one for design the competitor the into and outcome is around the your the for of Can one recently, question. trial, items the potential before just curious XXXX can I'm Thanks taking your they bit you. first the a Great. do discussion doing what trial us Maybe study FDA? with X a the the color key the the single-arm give pivotal. similar for RRP little RRP. program. are confirmed are potential Thank for you move discussion What for Phase FDA X?

Jacque Shea

hear to Nice Roger. Yes. from you,

XXXX. question So, around an important

to very and hand a getting color provide here. talked what trial good, really interactions positive last Mike Mike? call And on in very I'll next the quarter more to in started So, about that today's next our with one was year, -- over focus had the FDA. some we've bit

Michael Sumner

Yeah.

obviously open trial we along with in announced in not discussions you. otherwise thank mean, sites. today, be clinical we I would far design, up trial are respect as our to position the we to So,

only We I the detail that natural And to to Obviously, questions discussions but X in a haven't clinic. our that think our some this a too the asset relating Phase us very our been But are aspect of other good at happy that place the to have XXXX product. with device provided elements progress commencing respect into did addressing to very we're it's we've say study, with really, a they'd devices. related product. also and looked combination quarterly we much as conversations, is call FDA additional our we on that

Roger Song

the Okay. another Great. Thanks maybe for And one. color.

for moving your just you cervical For cervical biomarker be much particularly applied you. the the to anal, XXXX from to biomarker. as to can how from your Do to apply plan curious anal Thank learning strategy well? anal,

Michael Sumner

to studies no use there's all conducted, based we not the program. that REVEAL seen present, anal X on Phase into the have introduce biomarker and we've that. need question. the from from biomarker the think evidence in we At We good element decided to Yeah, HSIL the our

I REVEALX in taught be data. we good that biomarker anal to position and at obviously us plan a look from would that clearly, not our what other had programs, a that, the present. information is think And we learned a we our use in lot but for certainly from HSIL, at

Roger Song

That's me. great. Thank from you. That's it

Operator

Singh Hartaj The ahead. go question Oppenheimer. with comes next from Please

Hartaj Singh

evaluation and can questions updates. little the number patients? recruit how some the will bit the general your to commentary inclusion/exclusion it patients, patient the you know speaking, can period? you bit What a thanks back to you will be about, then, different XXXX, for there? Phase question. if Thank Again, That's for the just a the population of in just long to first just the just maybe If be you little will talk And constrained. the Great. relative two I X/X? roughly Phase give take you're us going X, criteria

INO-XXXX, just committee And on that, is the are with Regeneron on how there updates discussions second for questions. the the And are? going? joint Thank what your you

Jacque Shea

Okay.

question the So, I'll take maybe XXXX. Hartaj, second first,

PI that we Professor discussions We is are wrapping as study with still well about patients for Regeneron still the that right dosed. program. And are steps in that So have on on study up. next getting that David who Reardon, still program, lead as

course, next once So, we'll due we've that updates study. up our wrapped on that steps for be providing candidate in

be Phase talk of X/X we talk our and XXXX? see how in the to it moving kind about Perhaps want patient forward. data you about population helpful do would recap Mike, to just

Michael Sumner

absolutely. Yeah,

to saw think, I did the population, And the two consistent patient the preceding study, surgeries of population year. entire which the efficacy a with So, range, eight previous we in as you'll relatively up recruited surgeries. X/X that to needed of surgeries was in the breadth across recall minimum Phase have our we

that So, our we really aspect population. re-examine patient got no reason of to

we were an -- that we very saw reduction we in X/X Phase with in surgeries. recall, you saw pleased XX% with As study efficacy signal the

number to of have this recruit, fact But detail be respect haven't With provided trial. we a to that yet. and we I to to going the talked say, global what the level long how would of is that patients just

have These the as United we've -- we're seen our And side surgery. do evaluations, patients seeing not need so, that States. options in treatment clinical looked beyond we've done the same good

in that data with hoping share that we're the and that, we X/X can a a them for the that, hook say is results certainly -- study because a this need. I clinical our always hesitate so, relatively significant would And timely recruiting but that based the will this Phase state we I'm manner. those we can recruit where patients, fact encouraging pent-up always on from hope there we to is disease

Jacque Shea

X/X can good we And add if in study, tolerability that, Phase a just I profile. the saw Mike, to very

anti-vector been very number date. candidates, various Some are to and of of a DNA of pleased and we've to data patients large generated tolerability in therapeutic platform the been different medicines And attributes re-dose our with we've have the key safety across areas ability immunity. now without and any that the

of stead countries. to a So here. I is going number think good that think experience in we've large And working also I in service a worked globally of

Hartaj Singh

two Yeah. designations something, And different a also No, I two that helps the the mean orphan think lot. areas. drug

of Like, feedback from consistent? then, Jacque, in which all any to not is Just of the if terms in the you there's consistency, is for pretty to right, care a be Thank go country? going any you questions. different there? countries follow-up, country standard quick Just surgery

Jacque Shea

Mike I'll really comment This question. on clinical a Yeah. is ask that. to

Michael Sumner

patients to the during one last site. they and with to elements obviously, other standardized a criteria did from at we and study our mentioned countries. sure the standardizing question. be come as into surgical was as the actually they'll we Yeah, interventions was were take we that We, into the have FDA. fairly account, And those study come the that of questions now earnings of site discussing to surgery we one we've make actually this quarterly way the looked as And call, also excellent it in that think of good

Hartaj Singh

That Great. lot. much. Thank you so a helps

Operator

Patel The next ahead. question with comes Dipesh from Wainwright. H.C. Please go

Dipesh Patel

Yi This guys. Dipesh in for is standing Chen. Hi,

for me Just one today. question

back the on When As April, in trial presented aware, you're INO-XXXX. data can updates Phase Xb had we of this from further expect you program?

Jacque Shea

great a That's question, Dipesh.

we XX the were remind received basically data and which so is responses able that ERVEBO we to of XXX% people, previously people INO-XXXX candidate, Ebola vaccine. have shows So, vaccine our booster XX or just reported Merck in to that boost out

discussing course. be on of with and currently those So, through stage next for plans due collaborators. that providing -- of we're studies we'll with providing going our in process our the And updates program with we'll the -- regulators

So stay tuned for that.

Dipesh Patel

very Great. for the Thank you much update.

Operator

question-and-answer the like over and conference any our remarks. CEO, session. closing Shea, Jacque concludes to turn This President I for would to

Jacque Shea

you your joining and us for questions Thank today. for

past to Over the overhaul, critical for the market continue we've DNA the I on our team development. sharing and Inovio candidates engaged strategic advancing patients been other needed focus to the our have ultimately appropriately. to to promise updates the closest and shareholders success to look candidates phases make greatest INO-XXXX efforts our to of on on medicine likelihood as innovate focusing that and clinical in of medicine has to efforts year, the on DNA important scaling These business essential with forward progress our of ensuring an resources those continues alike. for and pipeline next deliver

evening, for attention, that, everyone. good and With you again thank have a your

Operator

has concluded. The for now you attending today's presentation. conference Thank

now disconnect. may You

Inovio Pharmaceuticals (INO) 9 Aug 232023 Q2 Earnings call transcript