INO - Earnings call transcript Q2 2022 | Inovio Pharmaceuticals, Inc.

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

Operator

Good afternoon, and welcome to the Inovio Pharmaceuticals conference call. [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. Please go ahead.

Thomas Hong

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

Chief Michael Joining Development and and for will Infectious Dr. Skolnik, information Immuno-Oncology Laurent efforts Senior HPV update medicines and Kies, Jeffrey of Vice Jacqui today Humeau, DNA Dr. Senior Shea, Officer; me ended call on Dr. Clinical President CEO; today's Chief Scientific corporate President President Mr. David on platform. our Therapeutics. and as quarter Officer; review the of Chief Clinical our XXXX, Diseases; Medical as Sumner, financial Vice for call Officer; Today's our are XX, provide develop Financial Dr. and June to Dr. Liebowitz, well Peter for Development an

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

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

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

Jacqueline Shea

to thank you and call. the everyone goal medical bring and Inovio, our Good to Thomas. you, address globe. is health At around market today's conditions for afternoon, the Thank help joining unmet to people medicines of improve DNA

to from DNA by through development achieving research an leading late-stage a of candidates to medicine innovative with this dedicated are pipeline early commercialization. We clinical building biotechnology goal company

XX During reshaping to the resulted focused second operating with reduction in expected cash we cost-cutting the including goals. in runway by organizational a product on workforce our corporate initiatives contractors. structure We months and quarter, our development of in align reduce reduction quarter our approximately full-time to XX% and the an measures that into third our over an expenses are extend reorganization next These XX% XX% our announced XXXX.

R&D call Medical also to has In addition, addition bear leadership leadership with Mike as to we Sumner, the bringing Inovio, Inovio's addition Michael Officer. team organization Dr. strengthened strong cutting-edge of new our executive Chief experience, a been proven having we through multiple product and great over and pleased products I'd develop strategy candidates to the to like through delivering areas. across himself. therapeutic several Mike? his that now already clinical introduce commercialization. Mike experiences, insights and to is briefly turn Mike to I'm taken value

Michael Sumner

my update impact very on that Inovio those forward of immense delivers DNA Inovio's sharpening our to as to that across advancing Jacqui, be our joined pipeline the as potential you I Jacqui platform. our well candidates data pipeline that team with continue an the I desire our that provide X. to excitement that focus and diseases. provides the like and and and would design of The reinforces platform our trial about I to our to our working clinical everyone. announced a therapeutic earnings of responses have for across immune meaningful on potential. programs we the intention Thank areas. potential to potential have for due argument On generating amend medicines of capable call, much, clinical look HPV-associated solid our our existing compelling the part team multiple has product and commercial promise. REVEAL greetings, date generated prior organization DNA the to for highest the foundation are medicines

this Our to have data the safety the trial last FDA's that through patient Phase are population submitted follow-up analysis supporting likely high-grade visit the later treatment and intraepithelial been all-comers evaluating to September. track that of early III they you last slated share remind we amendments recommendation report the as of on lesions marketing what next I the application. also like HSIL. our said regarding by week primary what revise or most about to path the XX cervical Therefore, to population biomarker-positive see year to squamous as population quarter VGX-XXXX for HPV-associated approval from is for the a an still or efficacy we I'd year. want

additional recommended in that use X trials an positive exploratory selective the a biomarker to conduct then recall, FDA or might we the X you As X well-controlled study and REVEAL biomarker evaluate as population population.

for positively said will continue in VGX-XXXX believe diseases. the DNA our forward for VGX-XXXX path last the we program time, following impact potential X program, the Even the to we this technology disappointing of HPV-associated the with of As assess results. our REVEAL to medicines adjustment analysis we

patients Dave? program. Dr. Infectious clinical benefit I or a from this disease. alternative Clinical half that we in efficacy, the clinical suffer and the of to immunogenicity our an from preliminary lifelong often and call debilitating still quarter, for clinical that studies INO-XXXX may able expect INO-XXXX to update our this advance be share provide now over lead, that David to with from and Data papillomatosis, surgery on SVP During an turn Development respiratory our Diseases suggest will to of COVID-XX Liebowitz, data provide patients second for our to participants COVID-XX Phase of prior a I/II of safety year. in to the RRP. second with recurrent We portion continued trial study

David Liebowitz

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

of the to shared continue one still that several immune around last quarterly our meaningful of our well the SARS-COVID-X. its needed. increasing heterologous the As is the superiority of our against are COVID-XX strategy concern and vaccinations; on elicit the that officials tool world potential and profile points COVID-XX on in our as shrinking we INO-XXXX. boosters working to months strategic of to health of are last that two, programs emergence for immunogenicity and over variants have state the factors update, temperature-stable Public One, key current There generating broad evidence that The infection; over subsequent primary of that has future new waves three, responses. booster the several series safety ones and a and immune responses strains strategy. date support heterologous tolerated, strong fight are demonstrates in market homologous vaccines additional for and INO-XXXX continuing shown been protective

analysis responses but heterologous comparing by in affected to As originally received slowed of COVID-XX by from by to as had with partner, of generated inactivated in humoral We have that expect them end data late unblinded third this share of be vaccine. XXXX. We and summer, the expected with the quarter the laboratories now the lockdowns response the China trial recent boost data data. able resurgence immune the part being have efforts, who we from with China. our of Advaccine COVID-XX of noninferiority immune a homologous by conducted from await This trial in these BOOST participants in the vaccine an and booster a inactivated trial responses analysis the INO-XXXX data measuring INO-XXXX the final evaluates

loss and Institute, Turning dMAb. data Inovio CoV-X the are Indiana trial our $XX.X track monoclonal a the announced infectious vaccine half our the by to for involving now develop for dMAbs dMAb AstraZeneca's based our the currently and previously to pharmacokinetic Wistar being this Wistar-led escalation first dMAb Phase CEPI. guided of antibodies. trial open-label analyzed evaluating in study read for is XXXX DARPA our we second Ebola Pennsylvania, of University and for in Inovio the in the second is by IIa million which is anti-SARS AstraZeneca, of study single-center Funded I safety, XX-patient specific to and data our a out fever our Phase partner, profile of half Middle we technology. Respiratory anti-SARS Phase CoV-X on to I had a from regards The other This study Phase specific With of partner, study University INO-XXXX collaboration COVID-XX-specific candidates, on I to year. technology, our Syndrome, still announce of of dose booster disease East grant and quarter, JPE, tolerability

an to Clinical update expect turn share later Inovio's INO-XXXX the Development, of Jeffrey complete our Skolnik, Dr. for this over SVP program. and our on GBM We analysis data year. Jeffrey? now on I'll to call

Jeffrey Skolnik

Dave. you, Thank

was results to summary. tolerable quarter and INO-XXXX with And to combination Phase infiltrate newly Clinical presented or results upon and XXXX therapy may and can were patients Libtayo study, ability for when and cohort patients, Libtayo, and GBM in for B in I/II this while overall past from survival that The controls trial is in Libtayo diagnosed INO-XXXX cohort Overall, compares concluded months. During with the of over median remains a And held from of B in potentially survival Annual combination about with and to trial build INO-XXXX's improve the elicit enhanced methylated Peter? XX.X inhibitor, B, GBM with newly administered glioblastoma announced this MGMT our or antigen-specific and within Inovio survival PD-X to cohort the novel we the months. Inovio diagnosed favorably overall radiation robust June. data American a unmethylated T now XX.X our for immunogenic quarter, with XX survival with our A, second immune additional turn INO-XXXX at progress cohort Median first to goal CFO, I'll or were to patients. administered time patient encouraged when newly months GBM. temozolomide date The Kies, temozolomide tumors and survival call the abstract, INO-XXXX was for be to financial Meeting responses XX.X as Oncology Regeneron's to regimen. cells our from XX Peter historical Society radiation to INO-XXXX novel that the INO-XXXX combination seen diagnosed in correlate MGMT patients, elicit and patients.

Peter Kies

Thanks, Jeffrey, short-term equivalents second afternoon, of as investments $XXX.X the cash, in and XXXX. to XX, quarter million everyone. March compared finished million with good $XXX.X cash and We

of of million common outstanding XXX.X shares As outstanding stock XX, on basis. Inovio XXX.X million stock diluted common a June fully XXXX, and had shares of

of XXXX, The increase XXXX. ended in resulted Department same were same $XXX.X of June revenue $XXX,XXX period months compared total the period to U.S. Total XX, $XXX,XXX the related for the X ended to Inovio's for in was $XX.X with devices Our our compared delivery months June the Defense. proprietary the for operating in X contract smart XXXX, revenue the XX, from XXXX. million to for expenses million

Our lower that ended the quarter and million million expenses were engineering device. X Chief previously litigation The our loss equipment to of disclosed a decreases primarily as our the includes $XX onetime net million $XXX.X COVID-XX XXXX manufacturing basic was increase from and related in in expense $XX.X expenses variant the XX, $XX.X our in the costs June acquisition months as months of expensed in well COVID-XX for a research loss June security for related expenses X former a and separation and R&D to of to put To million an common drug period ended the $XX.X XXXX, XX, million for dilutive for to were dMAb related to revenue and severance related equipment $XX XXXX $X.X a million recorded XP other dilutive G&A litigation same June our stock related G&A for action partially development the installation June for offset lower agreement, XXXX. increase net in noncash period proposed the Officer to class million of The Executive our share studies among $XX.X were contra $X.XX quarter. $XX.X ended with XX, lower in issuance These $X.XX decrease outstanding million insurance DARPA were compared in by services Inovio's the basic part our anticipated expenses settlement in share and perspective, XXXX. and per carriers. in compared to versus primarily in committed XXXX, expenses XXXX, the million claims as and our in million INO-XXXX same and CELLECTRA development to grant XX, grant X ended common for we nonrecurring our expenses was $X which was or anticipate of to $XX.X settlement the per in the $XX $XX related in during due settle of manufacturing million months all proposed legal million issuing content, stock paying expense expenses, related to the increase and cash payment million XXXX. cash by other of variances. or and

class fault, While without this settlement any any and reasonably of of liability lawsuit the wrongdoing to represents the the company concession accounting has final class any estimated, proposed requires action defendant. by between accrual The action finding of parties is remains is company contingencies proposed the the settlement. as or treatment the or it when the recorded lawsuit expense what our as court probable the agreement of settlement well subject of admission, or and regarding estimate loss approval, best outcome

forward, for for XXXX Looking -- quarter quarter the into includes quarter runway projections third the cash our third cash the XXXX. $XX approximately million estimate of of in burn a

decrease burn into from quarter will the Our of there incrementally expected XXXX. third cash

financials reminder, the the and release with press find financials full full our filed in financials you the our a As SEC. XX-Q and can in

turn that, to I'll with it Now Jacqui. back

Jacqueline Shea

made we Peter. our The This sharpened we nimbler past have commercialization. programs quarter, the key towards continue will focus a on you, foundations for decisions organization Thank a with laid leaner, medicines advancing the and Operator? platform now reflect let's questions. globally. call enable us our open DNA potential our that, realizing for to make, people's contribute commitment health to to of improving to With have to the

Operator

[Operator Instructions].

Your from first Meacham Jeff question Bank comes America. with of

Alexandria Hammond

your on for Meacham. your the opportunity. Hammond has talk are specific for INO-XXXX commercial about Alex expectations And push you what boosters. Amcon for how Jeff strategy evolved is Can This COVID following

Jacqueline Shea

you Thank for the question.

then and the off general specifics. talk start strategy about hand further I'll to So for and over I'll Dave

Omicron vaccine being to undertaken some So by regards to of the companies. with the other change that is

We newly continue increasing in broader advanced protection mind to developing we factors, current to but appear against in ever homologous new to boosters boosters market both keep SARS-CoVX. monitor strains all heterologous these of and need also evidence that have delivering the of

health. based would INO-XXXX, important medicines we our technology potentially characteristics that allow vaccine, play an could like add any role Our you feel to in advantageous DNA has still several protecting on us comments? Dave, to other

David Liebowitz

Jacqui. Thanks,

may tolerability to may protection. I in profile of We response important. be you that add and booster. features only an an that involved the concern, also severe said to multiple lack mention cellular think excellent the be and against only readministration death, candidate the we I against think I is include on elicit properties and that a are be which what but thing are of the would expand durability its and ability all for disease think important variants to protecting These vaccine for not make observed to responses we've this are anti-vector critical that safety date

Operator

with comes next Gregory RBC. Renza Your question from

Gregory Renza

starting Jacqui a with Maybe just more question. of team. high-level and Jacqui

update And and hop the disclosures, data, I'll concept all the pipeline? With been the last you on important XXXX you surprises into bear with and few What time. RRP for how that XXXX we weave if now expectations to coming, in and and for you're how thesis CEO Steve that and what the to setting the I'm board something sneak a of months challenges monitoring then and tend queue. is just respect program for And some don't employ we're are just as You've expect seeing. mind, maybe that the or in out back are should. progress, learning? to the of just curious, maybe you question, a and then

Jacqueline Shea

Greg. you, Thank

RRP think with there, your I into strategy which I'll our question, XXXX start plays part is actually the generally. of around of last importance it and the really and

We are product those to market. very focused in that closer are advancing candidates

our HPV-related very mentioned INO-XXXX. And you candidate vaccine is INO-XXXX candidates COVID which our important. just of -- are those also So is product

resources I reaching our the to have those And past as So on And focus realign potential really trying couple believe most for those product changed. to what our would we do months, say term. market near strategy in the driving over candidates really, forward. been is those candidates would I the at hasn't Inovio, of resources say, we've the

be those focused We driving on continue to candidates HPV-related forward.

on We on mean, continue focused the with paying I obviously, environment attention to be the what's vaccine COVID going we concert. and are to market COVID.

may a impact development to we there vaccines, the effective the be as for to and that boost can particularly pay to strategies. and INO-XXXX in heterologous But heterologous We that how remain attention contribution continues make a optimistic boost continue very safe need real our that environment new to space.

Operator

[Operator Instructions].

with comes Roger from question next Your Jefferies. Song

Jiale Song

couple from A Great. us.

So waiting the decide you're review what for population? you X in for focusing for the next you forward pivotal on to looking for data the step, data move biomarker patient comment can into you're understanding kind XXXX, the to but of order enhanced of just kind

Jacqueline Shea

Roger. a Mike to to Thanks, question, address question. great That's I'm ask going Mike? that

Michael Sumner

as detection the And Obviously, our Yes. obviously biomarker, more option believe forward. still have to we with to positively that hope to of to efficacy are safety and in data the have we've we you. choice expected is obviously enable move predictive their we VGX-XXXX. important hit think a women Thank the a We women enable endpoints nonsurgical that pre-treatment predetermined it's the to respond in protocol. treatment who will that we

Jiale Song

a Maybe just it. quick follow-up. Got

into some can try forward say beat or you of surgical kind other the pivotal? before of terms maybe for the to hitting want the other historical you you move Any your like I of benchmark target to in say safety You to efficacy kind hit you're the benchmark, option sure. benchmark endpoint try and

Peter Kies

data. speculate the making I on would that be think us

So I'd until and in data, wait we context that full the can situation. clinical the then the the readout we rather present full of see of

Jiale Song

last the and just steps one, next be I data potential looks study is the Understood. I XXXX, for the can, the pretty and what if Maybe the will disclosure? ASCO the one of promising and timing think data maybe

Jacqueline Shea

were data Jeffrey over on we and was steps are. ASCO, maybe here where Thanks. Jeffrey? and hand Well, further for that I presented to the next we very color pleased with can at

Jeffrey Skolnik

able we Sure. we the Jacqui Thanks, to we Again, as few as pleased moments with And the that at Jacqui. demonstrate to survival able meeting, a said, were for patients, ASCO the with really ago we overall the certainly, question. were demonstrating and median share. were when where XXXX Roger, very thanks we just talked about for what controls, in both positivity. compared historical MGMT-methylated MGMT-unmethylated the look potential seeing we're as

and in as and II what think continue in Phase comes are partners, seeing to the when that we next, current with I we what will come Regeneron, terms shared, next we've next. we're of will trial what come encouraged by discuss our

So conversation move certainly I -- that but continues tuned. would that say to forward, continues stay

Operator

next Singh comes from Your with question Hartaj Openheimer.

Eka Gigauri

in is to a Hartaj with couple for you update. and today. us. again the all also from Eka Gigauri dialing Thank for This Good

this, largest maybe key next maybe to INO-XXXX. various from fever us update for what maybe these but steps the could walk you for Ebola the explain then get through market status smallest the sizing secondly, and What heterologous I requirements And are curious the of CELLECTRA and programs. regulatory for missed on for device an we're Firstly, the MERS, And utilization trials? markets? Lassa the lastly, approved? are get might we for your booster could Where main

Jacqueline Shea

you. Thank Great.

would think like Dave. INO-XXXX you and regulatory kick there? with I the part comment going with to Dave, we're the off to

David Liebowitz

for and the you thank Yes, question.

can't the our this disclose And select for to the regulators At are in continuing -- authorization discussions of exploring we since those had countries countries, proceed regulators. countries licensure. Innovate. pathways we on with the behalf countries regulatory we're that these we're point, those with we currently, So and discussions of the continuing, names in received can't comment

Jacqueline Shea

CELLECTRA utilization. Dave. Thanks, address the To

on well were CELLECTRA is or has which IO our The -- a new infectious been handheld applications. been XPSP, our device and portfolio portfolio. which intradermal we've HPV-related as that as our And across then using which has device, IM for side, disease primarily our devices the been is that used clinical as our mainly device in X Inovio our our we've using well we have historical across ID which So is XPSP device clinical programs, used trials. as

questions market, And perhaps on then have intramuscular. devices, clinical So so for clearly, a But diseases of with established within may address market for we talk these we providing With year. implications some we be for those be later ongoing and updates potentially could with regards the programs some to some an in to these XPSP X likely of to the stockpiles while diseases in have of the we the vaccination device ID the of have regards global endemic important there. as around are role which Lassa MERS, data other XPSP the campaigns CELLECTRA sets Ebola setting. are administration. some diseases are And we'll then and

data provide we'll about talk the on the year. as later color we on more some that in So

Operator

HC question with from Chen Yi Next comes Wainwright.

Yi Chen

from is Yi Wainwright. This

So clinical for end respiratory of results Is track regarding this still year? the in XXXX report top on recurrent this the to before papillomatosis. line trial

Jacqueline Shea

great like comment? Yes, would Jeffrey, that's you a question, to

Jeffrey Skolnik

Sure.

this our before, that said, give safety Phase our the sharing I, as will half previously Phase we us we from it in Mike year of efficacy. anticipate the second referenced will results assessment potential tolerability for include, as trial. also and the of And importantly, So and do II first

those assuming Healthcare Research stay this Wainwright & Senior for again, by Analyst MD Division certainly, ideally tuned end the & of - And LLC, positive Equity what Selvaraju, the of Raghuram So next would data step? results, be H.C. year. Co, Research

Jeffrey Skolnik

that? answer Jacqui, let you Sure. to would me

Jacqueline Shea

Jeffrey. do, Please

Jeffrey Skolnik

Absolutely.

be. what with we'll be almost day-to-day. the do and will totality and we what with be is to then the look data to to regulatory information data of engagements, steps the of have. at able normally part we regulatory from authorities, really that learned those continue going we We're on So with our which clearer And next we're of what going to the engage essentially

Yi Chen

that REVEAL late Okay. XXXX, just early to mentioned confirm, Got report in will it. or data Got it. trial you And either XXXX X the correct?

Jeffrey Skolnik

That's correct.

Operator

That question-and-answer the to session. does Jacqueline turn to I like over conclude any closing remarks. now Shea would our for conference

Jacqueline Shea

Thank and you of I program our call you, in everyone to updating look a November. you to the and evening, for developments on operator, everyone. and today's with again our next you. who's on speaking questions. earnings thank all forward Thank joined good you call Have

Operator

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

may You now disconnect.

Inovio Pharmaceuticals (INO) 10 Aug 222022 Q2 Earnings call transcript