INO - Earnings call transcript Q1 2020 | Inovio Pharmaceuticals, Inc.

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

Operator

Good day everybody and welcome to the INOVIO First Quarter 2020 Financial Results Conference Call. All participants will be in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, today’s event is being recorded.

I would now like to turn the conference call over to Ben Matone, Senior Director of Investor Relations. sir. proceed, Please

Ben Matone

our who Dr. INOVIO’s together of President and and and of first infectious Research and operator are financial, everyone disease the joining joining related for development Clinical Officer first programs Dr. Peter our will review for J. Broderick, Bhuyan, and for Senior Vice for Dr. us Thank Operating President Q&A pre-cancers; and will Programs Vice XXXX project thank to earnings Development also corporate, INOVIO of Jacqueline Kies, our CEO; and the quarter Kim, lead and following with today Financial call. session Chief remarks. be the is progress quarter Officer; Shea, Joseph Prakash Head XXXX. prepared you Development President you Chief INOVIO'S With Kate Dr. HPV me treat

call Today's today's our ir.inovio.com, call of and webcast replay the after is a be shortly on is being available concluded. will website, call live made

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

our these will which of future platform of operations. we future particular INOVIO’s conference clinical company, call, events well certain include DNA business, performance develop making to as the on course impact in developments data INOVIO'S statements the resources During pandemic and forward-looking to regulatory this integrated the relate plans be strategic of of business as the matters, regarding medicines, the events readouts timing capital and and clinical and along with of COVID-XX

as read a as revise as well and the risks press risk should today's of XX-Q the assume differ described certain actual statements based no carefully result on future SEC. and factors results whether with We Investors the filing to release, All and in statements in assumptions, obligation could of as of today's of uncertainties, involve the beliefs included or uncertainties are These update to these management cause information, expectations or otherwise. today. materially. events risks new forward-looking and statements

with the would and attention to for turn that you Joseph. like to now over I Thank call

J. Joseph Kim

of Thank across demonstrate Thank you, Ben, developments programs had on and joining multiple continuing with us a afternoon call financial medicines differentiating INOVIO first than Please clinical release productive results of and broad applicability good first value quarter to the today. platform. the you less for the we quarter for everyone. corporate extensive press an DNA hour our see and issued ago an highlights. just list

our brief, your program, an have to that into keep to to updates delve going of the programs our remarks address for we and questions. progress. But so on each before COVID-XX impact on prepared the first we I'm of therapeutic update pandemic, provide time plenty want I

of our continue during pandemic, importance at and to challenging clinical to in them their thank safe programs environment. a personally DNA for focus enough teams cannot ensure clinical medicines the and COVID-XX patients receive times. patient and participating development gone have and global within our operations safety dedication government these the vaccines the during I be recognizing state adhering First, orders great home to to our to lengths able

track. of – XXXX pandemic, COVID-XX catalysts we various as clinical clinical outlined anticipate beginning of result our while While year, not anticipate trial, this of we remain as do on we for a the impacts the at have today, every do that on

likely pandemic April, REVEAL rate X impact have COVID-XX March during said, that will impact been months we is project will lockdown, the exact pandemic on REVEAL it programs. has XX% continuing enrollment to which difficult timeline. for the our the at of do the That clinical development XXXX, about X, Beyond anticipate still clearly to the for

both and and will remains changing be guidance to we true during ensure this will sites time, a the XXXX track anticipated timing midst to Prakash with of even accordingly on continue we but VGX-XXXX, remarks our global on company. in this not to work integrity. transformative X to at his statement are on will to year BLA this the confident speak have well-positioned REVEAL and We data INOVIO pandemic. this remain patient that safety for the for

survival quarter. which data diligent Our lead for X our in INOVIO followed OSXX deliver X remains to GBM team for data or our data financial efficacy sheet, related quarter. fourth And ASCO from and in on being objectives a continues OSXX well-capitalized, the key you'll development product to Phase by business afternoon, asset ensure to continued from data in and be uncertainty abstracts for at during properly which we fourth more milestones top-line strong essential are resourceful track data executing to at REVEAL having Overall XX-months INO-XXXX therapy is available hear presented the global Peter his XXXX, VGX-XXXX our and this but include in update, COVID-XX. balance

global physically vaccines, vaccine taking teams necessary is not play of our a share that part our we team San measures our while practicing in our teams our relentlessly and in [indiscernible] safe. crisis. XXX working to all INO-XXXX, develop mission our seamlessly together health addressing urgently of are Rest our development significant distancing including, in believe immunotherapies side-by-side, keep employees in remotely our R&D social are and plus this to and DNA the While will manufacturing facilities Diego, working driving and

one. elaborate highlighted want Kate speed medicines of in clinic platform this collaborative and vaccine the development INO-XXXX validated the that to against candidate press has entering more INO-XXXX release, and been our our a preface novel global I our the has on we effort but INOVIO with DNA DNA in truly As versatility rapidly COVID-XX. by will shortly, today's fight

up new working premier And of a developing the Since a leading The vaccine. U.S. and collaborating collaborations to Gates Department & Foundation. Melinda team funders, forging Bill scale Defense, been INOVIO we it's including we capacities. have CEPI, with with with began in private is existing vaccine world of around manufacturing COVID-XX to and expanding January, government manufacturers entities, and the the the labs test contract and

prepare access device helped plan have and massively relationships global the of expedite vaccine. effective of satisfy up urgent safe update and hundreds the We in you more demand These potentially to scale months. and to to [indiscernible] INOVIO vaccine a our for processes resources, coming doses to create detail millions INO-XXXX manufacturing untapped in development,

Broderick. To turn we like speak Dr. more where disease over would I Kate? to on the experience, and with now our infectious are Kate to INO-XXXX call

Kate Broderick

It's and be today. you, good Joseph afternoon Thank pleasure here a to everyone.

a team. during his so with I'm times. challenging and As during opening Joseph these remarks, honored team brilliant expressed dedicated exceptionally has be And working productive such been exceptionally our to

of our collaboration position first be companies allowed this disease to pre-existing and infectious challenge alongside initially us dedication expertise health to be Our to to called few being to one rise have public and develop on vaccine. in the emerging a a

January, nearly to exist, six we few and with date this on In I'm four to COVID-XX you expect share and development the later, back months. in in the first weeks. a here the DNA you didn't over name And months deemed we embarked very our should next on fact our virus what another vaccine, and not see for yet, five, was fact, pleased when are, pandemic COVID-XX progress to

healthy is the first study first all design from against volunteers a we speed. we two-doses vaccine clinical that In COVID-XX XX of with on Phase went dosing human in XX completed X to disease. remarkable a On days, our INO-XXXX month, last

the at the a of and in at Missouri. we University X study, For Kansas Phase enrolled Pennsylvania, sites City, clinic

preliminary of dosing frame rounds track initiate volunteers of the which of in in advancing rapidly to As is by multiple the and frontline support August safety the by complete all time medical in our U.S. Phase efficacy today, X, for to which second in data we health have May, care late trial, after expect to to major July, centers of immunogenicity are planned XX potentially the in last X week workers on June we

we Korea in also expect separate partners trials and Concurrently, clinical China South summer two respectively. initiate Advaccine Phase and IVI to INO-XXXX our of this X

providing data the Therapy great vaccine at COVID-XX Phase will Society presenting of a our MERS for positive foundation this Speaking previous the you our Cell current & Gene we X/Xa week. work, from of trial, Conference be American work

XX binding receiving receiving and three-dose in getting X, demonstrated XXX% at weeks. intradermally converted those full zero zero after assay zero protein with for and XX% Spike electro antibody participants after regime a two-dose a two-doses the and weeks, eight mg XX% after already device X.X conversion of conference its the by abstract INO-XXXX length X, As a the study published regime as measured the against while three-doses,

antibody in after both vaccine Interestingly, group. intradermal two-dose in XX% X.X response the regimen to the of displays XX% neutralization the of resulted virus XX% T antibody after cell vaccine the dose three-dose groups XX% neutralizing of the Robust binding Additionally, using mg recipients neutralize the rate vaccination recipients a responses rate. were response observed INO-XXXX in assay. of in those and single and a XX% ability

designed have our as full device. intradermal of of Spike length protein same and including using for the did we the vaccine CELLECTRA the as the COVID-XX We use strategy INO-XXXX the selection INO-XXXX, delivery target

immune a hopeful We level and clinical X for just have responses Phase of clinical and data trial are INO-XXXX would with reported safety both we that as INO-XXXX. similar generate optimistic the ongoing

INOVIO really new data of has and Furthermore, Phase of that able vaccine from construct to the say our delivery including bring latest coronavirus a proud in of non-human power that this the vaccine trials strength I'm Furthermore, test the primate. candidates, multiple intradermal way demonstrated robust while to clinical experience. able responses been up we both to all animal still to confirm record to INO-XXXX we X all typically the in immune times, the models our animals, small were design

antibody In animal nature been in robust communication, peer with in fact, for INO-XXXX responses, models accepted vaccination. responses demonstrating publication our including has several reviewed neutralization T data a and preclinical antibody

from months, leading Over data the some animal report at of will of world's attain challenge the expect being next collaboratively couple several conducted and laboratories. we to also studies

animal response randomized move a Leveraging clients having X/X efficacy and and safety with results, large studies work our pre-clinical anticipate the our along immune data we necessary Phase June, with X to Phase study. these expected challenge in our data continued to into support

And another that storage. the advantage frozen INOVIO’s to deep platform important speak coaching of here vaccines is wanted I finally, challenging DNA not do technology require our

of course stable vaccines at are for room X-degrees one-year is at temperature. normal Celsius, to our at which temperature five and for refrigeration years least X-degrees fact, In

minus most of temperature maintained to This messenger In as advantage low in as INOVIO vectors cold differentiator vaccines often key are vaccine. and is vital [freezer sensitive DNA chamber] RNA Celsius. a comparison, important and not – are stable degrees have an XX be and

now you, with And over to back Joseph. turn that, Thank you. I'll it

J. Joseph Kim

amazing and for all have Appreciate that enough and team I doing we are August be Kate. a you, in the dedication Phase Again, reiterate, that To by timeframe, workers work. you we study Really the pandemic. where the efficacy work Thank aiming update. to you thank the can't hard midst July, frontline. healthcare be on this been the of in X/X will targeting

high of rate to healthcare actual enroll at fully the our capable the about workers size this that confident We will study study the that of in estimate operations side could X,XXX largely be size one-month. teams number the are participants depend Again, on and regulatory infection we and clinical time. of around the

pursue of to task our as approval well large of planning utilize efficacy Phase [EUA data this to use We we're true potentially fourth anticipated plan our authorization quarter INO-XXXX. of as our of from immunogenicity, challenge for trial, and a planned from X/X year. to our ongoing studies emergency the achieve addition subset to to randomized animal vaccine the participants, from our Phase to designed an X/X pre-clinical well In efficacy study safety plan submission] and determine along our form also X being data emergency early with Phase

update Now, let's programs. our and mid stage late to move clinical our

virtual for at presentation be data the at available end will this month. less presentation newly been as patient at In p.m. from survival by fact, to XX followed Wednesday in Abstracts accepted the study XX than in our this INO-XXXX overall at will our for ASCO. of be public now, X diagnosed a immunotherapy GBM the hours XX available has months abstracts

progression presented at in very survival exciting last study free months We this winter. had previously six

fully I translate you data naturally OSXX promising all the really So, are excited data. see know to to this early

too You have to will data. for not wait this long

recurrent VGX- Prakash want disease, update update INO-XXXX, XXXX, on Before I an on or orphan to respiratory over I the call rare HPV targets a which provide the turn brief papillomatosis. to RRP associated for

progressive and this the treatment an life nature potentially Given so can invasive surgery. patients threatening avoid disease, of eager rare alternative they are repeated debilitating for

Phase INOVIO INO-XXXX IND the in stated in trial X/X accepted FDA a last application As we of to RRP. our for valuate treatment call, the

HPV-X tolerability, to in evaluate the associated this annually needed patients papilloma or for two safety, to approximately X/X at and surgeries who of We in to the XX have trial remove with efficacy, enroll years high-risk expect three last XX immunogenicity patients least INO-XXXX Phase and/or tumors. RRP the

to the pandemic thrown a COVID-XX anticipate curveball patients begin has we dosing While this this trial, summer. at

have much in to this forward of on our So, so we top to progress INO-XXXX. summer look

call over and update provide studies PhD, an Now, to ongoing Dr. Bhuyan, multiple I who like turn will targets MD the we for VGX-XXXX. Prakash? to on have Prakash

Prakash Bhuyan

Thank you, everyone. Joseph, and hello,

and high As is efficacy know, dysplasia be the programs, of top report upon quarter from cervical or targets pivotal our to negative that'll this fourth which COVID-XX X, VGX-XXXX, of associated lead Despite patients, our plan you our asset X Phase HPV year. the is patient impact related we line clinical REVEAL trial diseases. grade which in HPV data still

at REVEAL the since the our pandemic upon had March. around COVID-XX still and sites world, For has X an is patient underway certainly our impact recruitment recruitment

are the pre-pandemic begin as back We various getting to regions possible in rates open hopeful back soon and up. to as countries as

As target enrollment REVEAL and as patient for REVEAL of design X the safety has follow-up main in difference the is time X. subjects X same XXX for one-year REVEAL a reminder, one-month versus X REVEAL of

at to and the positive in our ASCCP, that reported March, of interim general. platform continue in Turning validate our to now broader HPV we’ve data applicability VGX-XXXX we

their a XX patients HPV of and data lesion positive XX, showed in the we've of precancerous showed XX% just subjects first-dose. of trial XX% in specifically, the the HPV dysplasia, the precancerous XX our So, clearance reduction XX and months reported X XX, Phase after available. anal that lesions, number; with positive six

in but spontaneous be anal expected are one-year do our We with this treatment, encouraging. typically in these do trial, people cervical Not cancer. without adequate to contact only only as would Phase build Xb with to to dysplasia precancerous at extremely further reported dysplasia associated exhibit data HPV five one they previously precancerous efficacy upon believe XX progressed anal the dysplasia resolution

their patients benefit. DNA Having invasive and surgical and the applicability painful medicine of after standard evaluation results VGX-XXXX’s also treatments months would had and primary XX care treatment reported encouraging at March, without initial the broad change XX provide in lesion these where with of treated Phase XX% with a that of ASCCP lesions the the area we repetitive, or trial subjects dysplasia vulvar completed demonstrated at a the meaningful that in The can shared an Demonstrating in six of burden our multiple six endpoint were X clear data true treatment. following VGX-XXXX. months women overall decrease

X% be to dysplasia spontaneous and context subjects about regression HPV Two these vulvar XX for very low, to trial is resolved their years. and completely this into to expected patients one-years takes to put typically X% two

approach. our trial for case broader treat precancerous build DNA further So and study these year. for and medicine later proof-of-concept to providing to the vulvar full data results taken anal pre-cancers both caused look We dysplasia for this the HPV together VGX-XXXXs potential forward

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

J. Joseph Kim

enough, you, is Running X thank in Great, pandemic wake working a Phase Prakash. unprecedented. study and of global large a the is challenging

these to patients. and your a showing again. alternative Thank of to truly been have providing work therapeutic dedication the life all Star You tireless improve team quality and for Rock this, surgery through your you on

provide will a financial Now, Peter update. our I Kies, ask CFO, to Peter?

Peter Kies

Thanks, everyone. afternoon Joseph good and

for the position, XX, XXX.X First, ATM investments in equivalents, in XXX we first To this of of capital an added additional million a and quarter company cash, our cash April. short-term of I as million XXXX. cash XXXX. The ended March provide will through summary resources the with

the been uncertainties INOVIO the worth the a macro associated providing pandemic we economy, strong on maintaining may that prudent in impact the with Given global proactive have with have both cash runway. of and multi-years position, financial

funding advancement mentioned both to and support company Joseph receive external As INOVIO’s continue prepared Kate their anticipates during the INO-XXXX. to remarks, of to

loss to three XX, we our X.X quarter revenue basic March the ended revenue in million for XXXX share per and and case, months the loss dilutive. INOVIO’s or reported total of was net million March Turning income, or ended $X.XX XX.X XXXX. net now for XX, net

were R&D period ended for compared the XXXX March Lastly, XX, XXXX. three to expenses months in XX.X million for same the XX.X million,

summary compensation decrease from was R&D The contra-R&D primarily due in accompanied in statements found grant financial be recorded our relations employee financial reports. complete This to headcount, press website first also clinical the related an decrease SEC. investor revenues. was accessed our can in expenses and release to expenses increase in there trial timing, in our XXXX filed for in A our can lower under a quarter expense employee a XX-K the decrease of by and Form with today's expense on of be

you, turn I'll it that, Thanks. Joseph. back to With

J. Joseph Kim

you, Thank Peter.

Q&A, all we our Before next I events turn to we like earnings the August. list to analyst of the report expect in before

Here are the lists.

on report in to be overall XX in from at INO-XXXX data presented survival expect May. to We GBM late ASCO efficacy months

and for safety our responses in immune trial preliminary INO-XXXX from Phase XX data volunteers. healthy vaccine X Second, U.S. COVID-XX

our upon Fourth, in to dosing Korea. X/X forward start Next, additional South to our Seventh, be randomized patient Phase animal poised efficacy approval. challenge to. treat to from for of and China milestones of started X/X of large for or clinical additional funding [indiscernible] regulatory studies. Sixth, trial INO-XXXX Fifth, support external in RRP; INO-XXXX to clinical Phase look COVID-XX either data trial development. start INO-XXXX lot trial

questions. Operator, the open I please line the for look Now, taking to forward your analysts.

Operator

Thank will Willey Stifel. question from you. question. [Operator with Please come your with proceed Stephen first Our today Instructions]

Stephen Willey

Thanks good the taking afternoon. question. for Yes,

ability for believe to your a here you secure today regarding a relationship they obviously CEPI your grant you to that's know, program Joseph, I think, million an in hours I you market competitive was pre-existing a organization and think funding. that times out after MERS have a vaccine. there I gave with, you the mentioned handed comments couple external XX

this you having, not say about you know, but you know, with involves active viewed sure say be application guess step anything to these need by whether agencies? I process? may is as of dialogues scale some kind some process to respect what rate I'm what can can a just know, itself, you the So, the of you extent funding here you to devices limiting potentially formal And the

J. Joseph Kim

a great and CEPI. Well, guess thanks, Steve. and Novak's Great question thing for I

As I we in now promising you and seen different Bill Novavax. all five scale both our as Gates for said and J&J case or support There's available billion to least and fundings total support and in amount extensive to candidates, and stated will and BARDA eight & CEPI to before, to Moderna, have there up each brought at both are, of vaccine for and available stated know, contracts candidates CEPI CEPI up each Melinda both in funding both probably will BARDA $XX they to BMGF billion have $XX CEPI the Foundation they six up. that have rapid funding

you and theirs. they're, congratulations already think I J&J and received Novavax So, have know, to Moderna

the I viable a think heavily think additional is think will will INOVIO funding for candidate potential XX various which I XX to these So, be great. funding invested vaccines, agencies. by there I of be total do

potential we as very good. make funding, receiving I So, think INOVIO’s you as we mentioned of remarks in external is know, prepared our progress, these the

accelerate already we Melinda vaccine track Foundation about & question Bill we're device, that. to year funding your good know, our on doing devices, this touching received Gates for commercial help and you on Lastly, the from earlier

to fundings. believe scale don't for both devices these a are receive also I external and going be rate and limiter to up us So, rates the the

Stephen Willey

use this not about the the talked under just Okay, the that pursue believe the to before I you path, reference color. here think process talk an that's, I how even auspice about FDA. the of bit is submission helpful Can logistically maybe a maybe end emergency of year. that's and HHS, authorization you desire know, you And, EUA little works?

an actually So, or that's agency you're Is something filing an needs outside different FDA? guess to made? I of was to NDA to submitting I be what that submission that of kind how guess, analogous when

J. Joseph Kim

areas. of and provided case, Secretary – reports HHS the seen the authorization, been EUA Yeah, has of in I therapeutics dozens as mean, certainly FDA of numerously authority but diagnostics there's for EUAs course, provide the HHS those so two we to through the have

For any, hasn't vaccines, there been ever.

and team in team So, our the been those what working or what's or publicly. us on communicated something may through, clinical we regulatory to when and but clarity how is team are others occur here's that

level One responses, of you responses is, the tie they're immune immune data, to and challenge especially safety, vaccine has any if to can if model relevant. those some and demonstrate

in and be we studies, think with multiple to with I Phase our a ferrets in a [EUA]. that June, to position great months, next FDA to couple submission at INOVIO evaluate those would readouts collect challenge primary animal be in primates, position to will data So, non-human including be prepare X reported the and data, the proper in of mice we an be

position know, the you be in that. to great months, think exact mechanism should in for I process and clarified a we will apply So, next but the the be couple

Stephen Willey

back I'll queue. the Thanks. Okay, hop in

J. Joseph Kim

Right.

Operator

question Chris with Our Piper from Sandler. proceed Raymond next question. Please come your from will

Chris Raymond

Hi, we wanted I the presented? the you Nicole ahead just what question, versus is congrats the released progress one, Gabreski should being provide thanks during for on abstracts what INO-XXXX Could to Chris. quarter. little we this the week, data, ASCO on abstract This Maybe a to for guess, in expect just that? will more the clarify color of the be see all on and taking

J. Joseph Kim

the abstract XX cohorts Yeah, the surviving will percentage of our months. provide actual at

providing number. So, an OS-XX thus

is of XX with Just Temozolomide. radiation, comprised with chemo in and plus our to also chemo Libtayo Regeneron’s care, All have received surgery PD-X standard checkpoint inhibitor. together their of patients jog everybody's total dosed memory, the XXXX study. which patients INO-XXXX we

what able care and of population we're of total we chemo those typically – been methylated. looking comers, forward standard of overall radiation, reported at be what patient our to months, XX unmethylated of care alive what survival OS-XX The all would XX and is in the to populations publications has about these we're standard we information XX% populations for both looking will we So, extensive XX presenting surgery compare to expect of and months. being at and in from from that

it's visible So, abstract, present in evening, on our XX% will but hopeful Wednesday devastating higher we very much this which we're that a cancer, can than be week.

Nicole Gabreski

maybe as INO-XXXX, you Great, the a far population trial for second just X/X just just talked out on on to the as point? today, question this design you the about that's that trial and then received have patient know, size, FDA feedback And that Phase laid you helpful. and target the these details and at

J. Joseph Kim

we Well, FDA have the finalize a them. with but interacted to design in more little a communications we regarding sense, as general the we expect have detail trial

are what and really I prepared rough today, to I’ve provided design. So, disclose

course Of the with come. working interactions preparation seriously with refine FDA in and to finalize team to our is our

Nicole Gabreski

Thank much. great. so Okay, you

J. Joseph Kim

thanks. Great,

Operator

Renza next your Our with proceed Capital RBC from question come Markets. Gregory will with Please question.

Gregory Renza

thanks Hi, the for again to Joseph here. Thanks pandemic and question team progress. on your on and here taking the contribution congratulations for this all

J. Joseph Kim

Greg. thanks Yeah,

Gregory Renza

Joseph – yeah you. thank

suitability find in of of approach multi-asset start wanted workers Thank this Just discuss light sort if this you bit we the the I'm the be multi-pronged really would its fact talk suitability populations XXXX the and very as targets the as XXXX convenience that trial, of it distribution, profile, with as about the a and to with a well edge, perhaps particular that a just to especially or after bit, or geographies healthcare a of curious much. solution others, should course, going little a next different from you could either be what or thinking you perhaps particular in asset, about with vaccine? a patient can makes little mentioning, get of

J. Joseph Kim

Greg. thanks, Yeah,

the of earlier, out couple makes that INO-XXXX You is know, compared the of more Kate attributes is stability platforms other One product. to just advantageous INOVIO’s as summarized quickly, there there. the

DNA extremely stable. are So, plasmids

dating We with refrigerated Celsius degree around product five have to X degree years X conditions. long-term

in leave the temperature ambient the any year potency lose for and can vaccine. it over You a not of

or proteins, cold the have storage of viral which mRNA throughout it's advantage So, or to most over frozen the conditions. true maintain vectors distribution a chain and

to DNA responses Second, generate vaccines other cell major CDX advantage of our to our T Cell, against generate major antigen, T both neutralizing our antibodies. importance, the is ability compared levels that ability the high to have killer along with platforms

what to in So, is this changes publication our nature both is in important viral we've susceptible and responses, which demonstrated T I sequences. balanced immune and communication Cell is think antigen this CDX less responses really

against think as I being well or antibodies, know, or other XXX% a both not platform response, in neutralizing our provide macaques, important much. CDX MERS primates what where saw able to antibody that non-human something vaccine cell both vaccines MERS to as We saw rhesus very you have So, Certainly, will T studies challenge as to we in is important the response have that we very but it protection antibodies strong was T the pathogenic challenge. virus saw also neutralizing binding responses. cell have

that published public, our T older, as of responses responses will us segments, immune level we've well and to other know, well I both very cells perhaps immune compromised as senior to lend generate the more populations, And of terms the patient are generating. and more responses, maybe the to think ability you little perhaps I think, general to turn So, the antibody and Kate, populations, the for have publications. about antibodies that think convalescent in I primates in details. seeing already can non-human been data What we we're others T compared recent a cell that very I excited in

the like to patient you published compared our more would bit data? responses convalescent immune to a discuss about little Kate,

Kate Broderick

the both was we see I all and Joseph T one rather very animal particularly rapidity, really then heartening was of was as and really what so to generated but antibody and cell those of antibody the tested, thing absolutely. see responses, quite excited the And responses. Yeah, including rapidity that we was robust, to rightly models neutralizing that mentioned,

nature early and really our in we really very communication, not So, paper. and started responses measurable on seeing detailed

so side-by-side also So, it's mentioned, quite an when Joseph access we've but that's we at to that [comparable] the as as And very do really it's animals to seeing to levels in it's convalescent that especially important, comparisons. about obviously, the see in really convalescent – you're and patient the had to thinking levels able moment, as seeing infectious we're [indiscernible] the are disease emerging really we're patients. very very, the – encouraging we're

So, the it's looking promising moment. at very

Gregory Renza

looking Thank already That's very strategy know one, if, the if by doses maybe provided into there, devices, quick million you may? just helpful. you. be? about year expected for, to like you the one I the and dose curious and of y device capacity operation you more you've know progress. I'm ratio that translates very end how talk some what be and as specifically, can device color Thank what should on for much, to more to we X be just the have I progress

J. Joseph Kim

roughly race Well, thanks, we're we’re X say both the plasmids – stating Yeah, we million device discussing the we're in and to them. Greg. a preparing just doses, when deliver

the So, without you one other. can't really have

the We're starting we're of scale to right of next So, do and that. increasing millions do hundreds but preparing that, year. doses provide track to to beyond we're on preparing be our able to

in a of manufacturers our up current scale. additional know, contract preparations which adding do relying scale, be the can of these and in massive that help position so So, by doing scale INO-XXXX, that great you us on we're manufacturers to, already take plasmids are to we to assuming that will success on

need. the In X both arrays enough million devices to meet the device have produced we've side, and already

well in within So, we and as those additional our that on. both Diego, GMP array have brought as contract, our ongoing, processes San manufacturers facility device are

extensive very these So, are efforts.

this COVID-XX our millions had might of if for we've if prepare planning know, in doses, we that to globally. were hundreds of doses. of never required were most be to not of hundreds millions doses thousands most doses billions You of of to year, of at that doses combat for Prior

a this a has is making So, think team on. I I And challenge regard. think our this progress taken we're in great

Gregory Renza

Joseph. Thanks,

J. Joseph Kim

Thanks, Greg.

Operator

Our next from Please question. Maxim Group. with Quibria question will your come of Naureen proceed

Naureen Quibria

you'll questions. just and data on presenting for my a on Hi, ASCO, congrats on and study, all the the be GBM first days. you few taking we'll progress is that one I in the get my at guess thanks know

see XX% at one for What you are one-year you of share patients for would year, encouraging? OS? historical what hope You know, historically be survival delta able to kind are you think to data the months to mentioned you for XX with from these rates would us XX% that

J. Joseph Kim

would excited number you Naureen? what Well, get

Naureen Quibria

Obviously, well than higher that.

J. Joseph Kim

XX% follow That's a XX%, longer. be is very least the think know, finished not or encouraging, yeah, you increase great totally line, we at will over six substantive months another but I this for question, patients, will these

will mean, we building up. we we're this I that dataset be, is a feel like So,

in data. months, the curve progression between, number So, difference was then OSXX, was and today and the exciting, at PFSX, survival compared you and XX% XX XX% that care in to even early this you these overall feat]. we to very to at adds that as which another are tail us, continue validity I in confidence encouraging think at And [greater level have that very of we know, mean, know, at of would where patients to standard longer free to be I even from survival a

a assume be the to would cares what you center know, great XX? you If number XX for So, you?

Naureen Quibria

I Well, be that's… but I like it – you you it perfect, know, know to would like

J. Joseph Kim

why… of That's sort

Naureen Quibria

Alright.

So…

J. Joseph Kim

know. very you That dies population, difficult number in cancer right. Everyone five is years,

population for So, XX one months. around survival and methylated months XX, XX survival, around overall and the XX, about median population unmethylated year, is is

who these are really So, from deadly are suffering a patients very cancer.

huge we therapy know, GBM temozolomide. since can been advancement in because you hasn't So, a anything do, there

I Regeneron’s thrilled important we XXXX Libtayo So, an make the if our data. really this impact be with on – would cancer, you plus can know,

for got stay our stay, see just days think to So, you tuned a you more know, be to I couple data.

Naureen Quibria

for, [indiscernible] proportion studies, actually us, are remind of fully those enrolled? posted And the you patients March, on know, you interim also in a back data on studies you positive Right. can as

J. Joseph Kim

and They the year. were What fully yes. timeline. the we at ASCCP presented disclose last enrolled crossed the patients publicly the endpoint, actual six months, the Yes, where who

So, you I we set next studies. from have all of months, patients Phase data know, couple the will both think over the full X in

later So, year. we will have those this data available

Naureen Quibria

you that? XX curious, is and the the regarding able MEDIXXXX read one actually, of on one number the their and be that, clinical study, XX this anything from with any week And great. trials Durva just from on anticipated do they to have changed Okay, there XX, patients we XX know, patients you me, neck website to from just is actual updated might thoughts you anticipated I'm AstraZeneca last know, to for study head the last

J. Joseph Kim

belief survival patients patients we continually publicly No, that for disclosed they that had following XX enrolled had year they're well. a last these fully and benefits as

So, be. you the may but before, really can't that as this we stated year, when know, [some we – I AstraZeneca still expect say report to data]

the in in data, to present, have we expect full be control. control has when where they that AZ and XXXX. to full over but and sometime So,

Naureen Quibria

Great, it. for Thank me. you. okay, got all That's

J. Joseph Kim

you. Thank Right.

Operator

Yi will question. Please Wainwright. proceed question Chen from next with with your come H.C. Our

Yi Chen

question. Thank taking you my for

J. Joseph Kim

Hi.

Yi Chen

in Joseph. Hi, the months? coming expect sets are studies challenge How data animal shall from we many

J. Joseph Kim

Yes.

to well, are We challenge, would mouse Kate, These like you studies. this? your address have

So…

Kate Broderick

Yes, Thank Joseph. you. certainly,

we confident spectrum look And really well [the and a that primate think performing. most includes our picture Fed wide really challenge, we at us give challenge challenge consciously to that. have vaccine a chosen very We're that's the about spectrum challenge]. at going So, models how to broad of the is of

most And are partnered so. – soon getting so the with comes the their who we've it data be month going of as particular so labs the all being a challenge, leaders and fields in globe as really those clearly out to to delivered or we're across next and in data with

Yi Chen

it. Got you. Thank

X evaluating COVID-XX Next question, constantly [investment And trial there viruses. workers healthcare will do so, Phase that frontline well, COVID-XX won't if course, also regarding being in they trial]? exposed think I as to vaccines to well, after X/X time, healthcare enrolled other will you be design recruit of probably probably the Phase be workers their summer, guess this these be at trials

follow these And plan they of So, be protective to how personal likely workers the equipment. you after will injection wearing vaccine? long also, do

at end the from the getting infected, they're guess personal of protection protective vaccine know you actually but you getting who the from I protection So, how of do probably get not are those affected, getting the many they're or the measure how trial, will people equipment?

J. Joseph Kim

Yeah, great question.

So the determination duration FDA. of follow with up, obviously, will report the after get we

So, about could be months. long as a as it as could you six know, be it year,

us. if we're to these know, follow duration with successful. X sense in we continue the that for volunteers Phase You Either study we makes will up look way, a for

of double randomized be the terms vaccine study. a In yeah, will efficacy, this blinded

will participants placebo. So, we get expect the vaccine, half our half our

a will randomized design, true study. true it be determinating efficacy So,

you we we you infection So, that the to are, with is while population workers that protect targeting, virus, with their the know, are first. a healthcare day-in day-out, heroes PPE, want why potential our exposed want frontline these would know, this they're we're and feel the population to so do we even constantly and this is frontline to

we that vaccine So, not efficacy valuable data for as INO-XXXX. getting a a candidate overall the field be in of true just feel have compelling in setting but a very advancement development, highly our but will also this we whole,

tested so and vaccine So, in challenging to bring can public we very as possible. these heroes like environment, to get as this that the we it as the as general fast can we rapidly

In important receive all of second-dose XX for of are immune study, How the the a XX as is healthy bravely terms far. or profile their we'll vaccine – of June. the very get end by will been And from the I all way, thus think vaccine, I well their the overall that volunteer volunteers. before who responses in by performance doing folks mentioned the May. this of They great end idea data has safety know, you all Kate by of good earlier

study publicly run And be course, that So, we is has I accepted Challenge we're soon paper challenge the mentioned, the very our data, have excited how about in of mentioned that's being And viewable Nature a as should will ongoing. Communications. through peer animal data been review studies, as Kate in response what Mouse well that China.

have Australia, and studies ongoing studies we challenge in in [indiscernible] We the U.S. in England and primate non-human have ongoing

think very vaccine compelling to Phase we the immunogenicity we a our have know, ability efficacy just vaccine, potentially and X/X we of demonstrate protective hope you this the and not into So, leading study.

Yi Chen

agreed your Got CDER Do challenge study this you back in is think appeared the to What's a for the cholera comment? for it? human XXs vaccine. FDA COVID-XX? has that necessary and a It

J. Joseph Kim

very concerned human challenge. still about I'm

human You know, there's challenge successfully for other vaccines been done. studies

others. For influenza, and for and, RSV,

still not know, well, norovirus you but virus SARS-CoV-X as think so unknown much is COVID-XX about disease. I and

the really for I outweighs volunteers. think potential benefit the risk those

personally us a I ethical challenge some support study human new is have that in unresolved for a to So, disease. still such questions

larger well of true think at both we of prescribed said, to all in efficacy know, being in large our that's vaccine is and In safe that our INOXXXX to And faster trial X That to safety feel a efficacy we a and the the what way with moving our as the in trial studies. INOVIO. something Phase demonstrated have X/X And I vaccine. to -designed to that our study Phase really forward across we spirit clinical strongly well look you we upcoming want previous why demonstrating is that demonstrate population. get we

Yi Chen

it. question on Got My operating expenses. last is

place lockdown R&D the expenses to forward? going country, you low as still do relatively long is expect the as across economy remain the in So,

J. Joseph Kim

go yeah, Peter. ahead, expenses, R&D

Peter Kies

to fairly them remain expect Yeah, we consistent.

be we that we will external the so of fairly have expenses a hadn't consistent, a remain little and adds to by but As we so see said we expenses to that funded expect did budgeted, more. XXXX before, we bit payout we expect forces, most the bonus

XX at looking So, XX, XX about annually. we're burn million net annually.

Yi Chen

thank Okay, you. go it,

J. Joseph Kim

So projection, runway that know, quiet a with cash our you healthy. is

So pandemic, we strong position. feel we that the know, you a financial have with uncertainty of

have months. but REVEAL other both lots data COVID-XX Even the a challenge We and up. in coming next vaccine in add Phase X and development in data of important milestones in develop results rapid all couple without GBM you in COVID-XX or then X, vaccine,

months. very the really have several know, You full data XXXX we in next

Yi Chen

you. it. Got Thank

J. Joseph Kim

you. Yes, thank

Operator

Please Jonathan from proceed next with Aschoff question Capital. with come question. your will Our ROTH

Jonathan Aschoff

rate COVID-XX. before making enrollment your you say I earlier that Thank that COVID-XX is what X wondering XX% was in REVEAL XX% did you. the was or it enrolled was comments, of

J. Joseph Kim

and is March for It April. latter

So, and pandemic level we at of globally. of in home the prior the all decrease lockdown because a such saw from enrollment orders stay to rate

Jonathan Aschoff

is think will approval? seek Okay. in point if to external much be And the successful you spent you you on the how to up do know, XXXX funding total XXXX enough clinically plus that

J. Joseph Kim

traditional or mean, it EUA BLA. on I depends Well,

the the manufacturing finish be lot scale of is we Phase element the doses. and before required counting if X/X the spending you even a application, the X/X up on the the Phase a money be trial but really not could it EUA of will to EUA know, and So, in efficacy as the spent we're provide

phase Phase X/X. trial already you CEPI funding obviously, clinical and others expenses and, know, funded including been know, you So, for studies next receive and development to additional one through we stages, expect clinical have and

in know, can INO-XXXX. think of many, funded that to going many steps society. next deliver well you The from So, I in required we events is support sure we're doses make very the be to that are

die more across to as continually the soon a States, know, in for the increasing vaccine as safe more as demand you increase know, and there's an to effective United globe, especially possible. people get the public You and

taking a we're stepwise So, approach.

large of together clinical You granted in numbers well-designed trial both BLA specific development large where it be through path responders population through first the for know, taking emergency safety like could support getting plan the a workers, approval our targeted our efficacy in then the and true – the getting and the EUA approval. and efficacy vaccine randomized healthcare of

Jonathan Aschoff

cost much BLA, a how that it doses? think process including would a million for was it you if Joe,

J. Joseph Kim

a a assume be total [$XXX I from in potentially X/X. our next be mean and registrational of trial million trial, million] If that we million Phase start. XXX we will assume could a So doses, value that

Jonathan Aschoff

Okay.

J. Joseph Kim

for you’re what looking that or…? Is

Jonathan Aschoff

yes. Yes, Totally, you. thank

Operator

Joseph the I concludes This like question-and-answer our turn closing would for now back conference remarks. to to you. Thank over Kim, session. any

J. Joseph Kim

forward I another like important We attention. look to quarter thank everyone productive for up. your and to coming

few to much. milestones you you in next all Thank with the of look we So, these forward very sharing important months.

Operator

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

disconnect. may now You

Inovio Pharmaceuticals (INO) 11 May 202020 Q1 Earnings call transcript