Inovio Pharmaceuticals (INO) 11 May 222022 Q1 Earnings call transcript

Good afternoon, and welcome to the Inovio Pharmaceuticals First Quarter 2022 Financial Results Conference Call. [Operator Instructions]. I would now like to turn the conference over to Ben Matone, Senior Director of Investor Relations. Please go ahead.

Thank you, Operator. you Call. the thank XXXX First and Conference Earnings afternoon, for Inovio joining Quarter Good

on and call Officer; Skolnik, Dr. me Commercial of Mr. Clinical Chief Joining Clinical today's of Officer; Senior Officer; Peter HPV and Shah, Scientific for Infectious Senior Development Kies, Vice CEO; Dr. President Development David President Chief Vice Twyman, for Jeffrey Financial Mark Dr. Therapeutics. Liebowitz, Humeau, are Laurent Oncology Chief Dr. President Jackie and Diseases;

corporate update our ended DNA review financial efforts will information as quarter we call, today's our the and March well for For across platform. medicines as on XXXX, XX, provide an our

a analysts. prepared we Following reserved for question-and-answer will equity research conduct remarks, segment

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

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

I'd chapter. you, the me Thank to call the Inovio's its the by next to Shea. Inovio Dr. and to call like everyone joining afternoon, you Board everyone. to turn begin today. for call good gratitude lead expressing Jackie and today's into President now my will Ben, CEO, to over I Thank entrusting

challenges and face, and in the many significantly of medicine to have our affect I strongly positively health. potential While we to technology DNA human ability believe its

going fulfilling the its medicines for for underpin our are guide globally. co-founder. entrepreneur date work greatest thank would DNA our Inovio our been to served the continues and like foundation forward. impact to has efforts where field also committed seek We I a make it the to and we and of immunotherapies as the is on Joseph many of as vaccines. to pioneer Joseph and in health all This Dr. a contributions to potential his has Kim true platform to

today's financial Now turning to and program update.

our Let's begin COVID-XX with vaccine.

public can needs have primary to the strategy. Inovio the and the is and greatest booster different strategic As that the most against the a this, for impacts pressing where death COVID-XX we opportunity. boost evolves focusing of illness now pandemic by booster and this And on need believe on health vaccine represents vaccines a protect phase, COVID vaccine light serve towards growing used to endemic In heterologous is vaccination. severe a our

our to advancing regarding countries in as in regulatory trials a COVID-XX clinical noninferiority evaluate for currently potential efforts are goal, Towards pathways regulators select compared is to Inovio we that licensure. with discussions vaccines. INO-XXXX continuing authorized booster

review preliminary addition by in the Importantly, these which Advaccine, boost for partner, moment. efforts data in are to a heterologous trials will conducted our the we

going and in COVID-XX to instance of boost heterologous trial We DNA subsequent decision Phase the readout forward. public severe against It position necessitate to prioritize vaccine COVIDD-XX global our in for allows Inovio's strategy, strategic platform. This to data an believe for obtain this contribute the more our will by COVID-XX develop flexibility strongest [indiscernible], places in that indicates INNOVATE to caused our efficacy continuing Innovate a also severe shift discontinue omicron we a to medicines costs would lower trial. emerging disease. we cases variant health global us As reflects shift X increase initiatives size which

provide that today VGX-XXXX, HSIL. meeting we associated about also the intraepithelial recent against lesions FDA high-grade and regarding update with an will had vaccine HPV-XX cervical squamous a our We XX or HPV

from As who use you need study at those are indicated the a Skolnik least FDA product our will that most candidates. therapy completing with for of X Dr. authorization we COVID-XX detail VGX-XXXX. if know, more trials be our identify diseases call Dave? lead commentary introduce I'm Jeffrey evaluating to our David and been Liebowitz, to program. Development obtain pleased in close provide REVEALX describing additional a this has to this of SVP additional My Jeffries first, be women infectious today. for and on to we colleague, to the will likely Phase X have Clinical biomarker Inovio's marketing benefit X, not to will clinical The the COVID-XX later development in But

very and protection of T-cell global to of booster much, the of of INO-XXXX's ability one and key everyone. to effective responses. cell greetings, the responses durability We vaccine-induced for T you believe increased Thank significance advantage generate CDX+ about the strengths, Jackie, works its awareness vaccines

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the VGX-XXXX to and regarding We for the trials of to We'll met associated recently VGX-XXXX for in that Thank HPV-XX our our in which two this approval support the efficacy HSIL. potential the analyzed U.S. biomarker Phase trials REVEALX, VGX-XXXX the exploratory respect X you, the efficacy. recommended would sufficient trials is or analysis REVEALX evidence population. using a And evaluate to us efficacy then The selected REVEALX population. population two potential FDA prospective, all-comers and cervical Both evidence for regulatory marketing primary clinical second Dave. likely to be that disease a To we one with that the biomarker-selected would and population of to talk intraepithelial all-comers the representatives use as biomarker-selected marketing positive HPV-associated the from approval biomarker with of enrolled population support application. population additional squamous better strategy FDA to provide the fully FDA against provide well-controlled to high-grade evaluate late-stage more now application programs. advised population about an not a lesions from biomarker-selected assess XX to population in during sufficient study or in amend that to to be conduct biomarker to Inovio's plan will biomarker-positive revise meeting, population,

forward completion will and continue the analysis path the following trial assess REVEALX results. We of VGX-XXXX our the program for to will REVEALX

HPV in of and our likelihood BLA in maintain full we the in a to longer additional submit in no trial, one We for medicines DNA VGX-XXXX. development XXXX our expect programs conviction least Given at diseases.

respiratory lesions evidence prior and respect clinical medicines our X/X immunotherapy both or treat our platform, rare obstructions. caused in recurrent DNA to HPV-XX candidate VGX-XXXX With DNA virus This by characterized and incurable life-threatening papillomas with trial XX participants lead These caused repeat XX disease the of the can recur, Phase yet tumors multicenter or our lesions. HPV-XX/XX XX completed to enrollment papillomas to open-label papillomatosis small disease, and in tract growth HPV or RRP. by a and to often orphan airway our clear Given interventions. by INO-XXXX, HPV-X requiring from we've is specifically associated RRP, respiratory of those of regress to

doses required have to frequency least adults endpoint interventions to and first cervical of relative undergo Our interventions to the of HPV-X weeks. three reduction following dose therapy. four year at papillomas past their disease. in of be study XX then INO-XXXX prior who efficacy removal two participants receive RRP frequency The the up remove to trial with Trial INO-XXXX a the will of clinical first once includes in every or will will the

trial clinical and preliminary the on this of based a efficacy, steps safety And of results, portion will immunogenicity determine next second these development. expect year. then in participants from for data half We we

summary. trial diagnosed presentation next Inovio's an the the providing excited glioblastoma ASCO or the of turn And DNA in of meeting. financial the like call immuno-oncology survival, combination text programs, first INO-XXXX Libtayo, I'd are will safety for be to inhibitor, newly full over GBM, we month's for data of PD-X very website Regeneron's on INO-XXXX Peter available overall immunogenicity The our abstract that now Peter? was our Kies, and meeting Officer, medicines, novel treatment with to our Regarding May quarter annual Financial oral at beginning and selected Chief XX. ASCO

million and December the USDXXX.X first and good We to compared afternoon, of USDXXX.X equivalents finished quarter Jeffrey, XXXX. as XX, you, Thank with in cash, million cash everyone. investments short-term

shares XXX.X the for USDXXX,XXX fully first a As of common March XXXX, million XX, and months outstanding revenue diluted three Inovio common XXX.X was Total shares on outstanding had million basis. ended for million XXXX March XX, USDXXX,XXX the first same period million to the quarter in USDXX.X for XXXX. USDXX.X in Total compared quarter for operating first XXXX. were the in XXXX, expenses versus

equipment the million net to for dilutive. million million quarter reflects this million three million in and employee first expense compares the XXXX. share loss These related USDXX.X were increases USDXX.X variances. employee and expenses, to XPSP per year-over-year recorded USDX.XX the grant mainly device This offset was in higher expenses same related and for our for in USDX.XX months same the increase compensation to automation was the a among a expenses period research quarter by XXXX. for share Selectra year-over-year related XXXX. for and trial agreements. contra-R&D million an USDXX USDXX.X in in net drug higher of insurance project, from and was compensation. USDX.X the clinical among or basic to period increase Anovio's USDXX period lower same compared expenses of services were to General for other compared increase Our related R&D or a dilutive loss The were per manufacturing other expenses variances. engineering million expense development increase basic and expenses That and USDXX to year and G&A array primarily to administrative INO-XXXX The in

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

Thank you, Peter.

to commitment Going benefit to and put the our pipeline, our position best forward, stakeholders. efficiently to our to is global our Inovio allocate health resources key patients, in our programs in

resources platform, heterologous a has DNA vaccine we are really on booster strategy prioritizing our where advantages vaccine a can For we believe, make that our difference. COVID-XX,

to committed HPV surgery on with are delivering diseases HPV, alternative in For REVEALX. to biomarker-positive address to the focusing we by immunotherapies population an

with pipeline in we the and Beyond INO-XXXX vaccines have for as We further in INO-XXXX providing our coming data this coming Lassa updates very forward as the we're fever, that, for our programs progress. months on let's to milestones out we've you assets and later the questions. this MERS With discussed year call, excited INO-XXXX against our on pipeline, open also Operator? about upcoming call look Ebola. booster the a including

Instructions]. [Operator

first question of from America. The comes of Bank Geoff Meacham

Meacham. Geoff for [indiscernible] is This

So plan you -- have change color point, the my about the many overall have patients any one provide just of given population? color first if is primary the CEO transition? how second CEO about given the actually versus how one for population transition. trial are you about VGX-XXXX maybe And And is biomarker-selective the then is that any change? powered additional Could already end

question about to Skolnik, think my CEO colleague, one, hand then Jeffrey Jeffrey? the I'll transition. and I for I'll take the first first the over question,

question focus the of to regarding identifying whom population VGX-XXXX development that demonstrate to on with potential move greatest biomarker. power your really forward we've the continue So shared as previously, the again, with first is biomarker, to the efficacy. And has our we the in respect of

As study, anticipate biomarker to be is the would that while say population. VGX-XXXX really see positive, haven't the can disease. specifically given what efficacy it to interrogating patients particular is in appropriately shared for the we within biomarker-positive the cervical for of that's expect the relates study that question percentage yet population powered that fully the we population we we're we that why in that Again, biomarker-positive the

study answer appropriately. is short Jackie? The So, the is yes. powered

continually. our lead his I'd the grow many first CEO years by be like And of charter. to into really entrusted regards Organizations I like say Joseph to I'm thank to contributions that all, transition, Kim, Board to Inovio evolve to to its co-founder, to honored date. also Inovio with would next and the over for So Dr. the

the globally improve ahead Here at of as lives Inovio, global on the to we focused road support seek remain we health. and patients public

continue dedicated teams Our advance to forward. our efforts talented and

comes from question Oppenheimer. next The from Hartaj Singh

couple A of questions. Great.

mean, Just my best. his I just to booster to more database, congratulations and get that I path booster potential as long work their a deepening but tried the interaction, to need is you I pathway and vaccines. got market would is would Jaqueline sometimes really think know the to One of What I to it? there? need is him a the And just Would Just market, you regards a and be want couple just the to quick quick wishing -- would broadening and best always that have how trial run team. of sort people any have say for in be And you forward? Joseph, question don't you. he follow-ups. what color run things I is out, then my it? heterologous safety a would I

to Yes. Sure, nice talk And Hartaj. it's very you. with

months. discussion about And with a heterologous booster few past path rapidly of around evolving authorities with the So that's is the this to Inovo the forward. regulatory a number the questions pathway, been is pathway over regulatory regards in

it evolving any there. would to this quickly. But if pass I'll things add is at and the say I further see landscape to Dave? moving moment Dave are color can an So, he over

more Yes, as regulatory part for of that We do the a continuing be with seeing the comment those database boosting. will And heterologous the we of We with for are are in we we're regulators, arguments safety of will countries required. more understand Jackie need we database. determining regulators our behalf said, obviously that as on that regulators, discussions discussions and licensure. but on can't target pathways size

Great.

could kind just with can the you projects undertaking, us were I your for thinking with either the entire you're California, far if you quick Fisher? they the burn, are of had what in Thermo dedicated dedicating around? some two about go secondly, parameters the you're projects give an some shifting [indiscernible]? facility that questions. then an the What's out indication, of to relation believe how And of manufacturing Just manufacturing and status of

with consortium. in question us maybe for then I'll to closely to remain first Thermo take talk with continue runway is key manufacturing handle cash scale forward. processes. partner our work the Peter, Fisher to Peter up going they're our a the about situation. manufacturing regard question. the And could we and And to plans to our them very to do you going key Yes, want

Yes. Hi, Hartaj, is this Peter.

do So, resources pipeline our Hartaj, our we're we impact we're burn. evaluating to innovate also continuing our across and of programs. anticipate definitely monthly reduction just a Right reprioritizing in now, the

So, will and provide a later bit be when this information to we that have updates little we more summer. should disclose

Roger from next [Operator from Jefferies. Instructions]. Song The comes question

It follow-up have this a the kind of the activated Maybe after as just booster. Great. program. a good for cellular you pretty as response COVID heterologous seems vaccine

you that endpoint also heavy any do humoral -- to response different curious, discussion vaccines think have -- heterologous possible other so be And the response primary and will data cellular for response far, need approved the I data? I study? data understand with there? your Or the be Just they on like is based regulators, this humoral

regards antibody data I'll we'll with T strategy, available and pass the DNA generating comment that cell incredibly platform which to of from to advantage later studies, really data. generally we With over the Dave think going the to to program think useful. the it ask responses, publishing to real summer on be to endpoint and over comment can I on booster the regards We be the we're hope here make Dave that medicines piece. space. our unique end heterologous to in So DNA heterologous point, our the the I'm on Advaccine

Yes.

decision-making. is critical prevention community consideration you for of in And non-inferiority with discussion forward in boost this humoral of discussions believe scientific it's a be cells So regulators, play increasingly be will Right response. COVID. appears know around as And the said, I of heterologous a key We we pathway include time, severe correct. that now, T that do regulatory But question. the over we're to role becoming the good a will that the are in the very end aware immune points. which

then one this step we clinical What XXXX, see product program. will program additional Got from some next it. when and for be the for quick can And just program? will a very that the GBM

very question that we having going excited hand over would just be at colleague, Jeffrey. that to I'm are ASCO. to to So I my say presentation

talk So, Jeffrey? I be will next But the that that about opportunity data. think to

going just Jackie think which the essentially opportunity GBM pleased just I extremely continue following at our this what present certainly, the newly about echo the shared, landscape. would really step oral are a that to has And to within data. ASCO to the have presentation is be an we're next GBM at GBM of XXXX look and year to the should regarding that and presentation, take we space totality what diagnosed

I say stay So, just would tuned.

comes The next from from question Yi H.C. Wainwright. Chen

us First Or you the mean, insights, Was the on provided the FDA was is, which basis trial? give a please regarding it could question the REVEALX recent reason, there based REVEALX data? the else? I the more opinion basis -- something

Thank you, question. Yi. a That's great

came that the we interaction and So this with interaction really FDA from an requested.

can provide further some Jeffrey, you So, context?

had meaning in wanted a speak pathway hold really find VGX-XXXX those women was just as specifically, the whom as to before, to VGX-XXXX opportunity to suggested, greatest the potential with FDA, essentially respect forward with for efficacy. again, cervical for a we dysplasia Certainly, Jackie for FDA with to with that about talked we this

consistent a would shared And we what was so of certainly for essentially they speak population. in forward, path pathway regulatory us agencies, in while with biomarker-selected forward terms with the the again, not

whom our do and to efficacious in what centered. population likely So, is to with aiming women that's ultimately, is for identify most where XXXX conversations have that really we're FDA be to really

could And pursue countries to tell the you strategy? heterologous what the you it. COVID in are booster Got which us going are

early hope currently about heterologous a be countries So to number But in I approaches that countries. what in on coming little making comment announcements pursuing to we'll the our boost be I months. can a which we're And say regulators think it's here that of with we in is yet. discussions

question last Got it. into candidates is, pipeline? And Inovio consider adding additional the will my

That's question. a great

in strong do have in So a can medicines we HPV. confident -- things. of We really are We a can pipeline DNA we our technology. different lot

We have our candidates we have our IV candidates. vaccine IO and

in products also We and some bispecifics. have [indiscernible] early-stage

However, those really our I is focusing programs forward. us on efforts important our think moving and and to what's moving really resources programs key forward

a really up the them. best We medicines key path the think the best who coming over at And into bring of have to focusing be points and early number DNA forward coming to looking year. data and we the our way and next on to data what need year patients going is the we're

on of would and looking opportunities say at for really focusing for and the I it's data So, question our a best the patients stakeholders.

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

Thank and and you much, thank all those questions joined who to you very the for us today.

I innovative focused As pipeline remains medicines and and improve on lives save technology to our global Inovio stated, health. DNA

important data catalysts have next We good year updating Ebola. early to later program and this Have and speaking REVEALX, Goodbye. evening, the on RRP, MERS, a development Lassa in company's on look and you you August. earnings with everyone. forward for again our with call several next readouts I year

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

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