IOVA - Earnings call transcript Q2 2022 | Iovance Biotherapeutics, Inc.

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Operator

Welcome to the Iovance Biotherapeutics Second Quarter and First Half 2022 Financial Results and Corporate Update Conference Call. My name is Andrew, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. the and to Communications Public turn Vice Pellegrino, at now Investor President, Relations will call Sara over Senior Iovance. I and Corporate may you begin. Sara,

Sara Pellegrino

Thank for thank you, afternoon us. you operator. Good joining and

Executive our and Madan we on our the Executive Jean-Marc our on Jim corporate our Chief on question-and-answer Friedrich and President, Chief well Igor at Jagasia, the Ziegler, have includes Speaking Executive website can Dr. a for Officer. Medicine our in call, Dr. the Vogt, Chief President, afternoon, as President Raj as Officer; This Operating our recent Chief is that Dr. we issued our iovance.com, President, three ended and which Vice also Finckenstein, months Vice Vice Medical Regulatory results and Strategy six Bellemin, session. press Medical Fred Financial Bilinsky, June financial our Officer; participate on and Interim Officer; Dr. Executive call the updates. Dr. XXXX, found to XXth, release Translational today's Commercial; Affairs; be Puri,

Before call updates. and we strategies, cash plans interaction, licenses statements include like start, and clinical guidance, activities, Iovance's that remind and position, results, plans, trials regarding of business manufacturing business pre-commercial will goals, focus, future payer and applications forward-looking guidance, this our future collaboration, during activities, and I technologies, statements made everyone and regulatory interaction, would potential conference research and preclinical feedback capabilities, expense regulatory to

time-to-time risks and are and in many from which the our numerous beyond control, risks to subject described filings. including our SEC are uncertainties, statements Forward-looking uncertainties of

during to turn update materially statements. that, any publicly no We will to differ undertake call. may today's results I from over forward-looking With those call Fred. the projected Our obligation

Fred Vogt

our I'm and lead our BLA everyone. therapy potency highlight license a lifileucel one at lifileucel of we patients and to track and I'll is completed provided progress Iovance. are planned good feedback see significant The safety clinical to FDA number This of first clinical cell that eager trial, was meeting the are efficacy or priority assays favorable for begin the in Thank that submission. review clinical you, our for Cohorts the with regarding provided and behalf pre-BLA our of year-to-date the who on this BLA afternoon, parts metastatic submission melanoma. biologic from pleased matrix. Sara, successfully FDA application life to with We sufficient BLA advice a on FDA also The month. approved. feedback data valuable planned begin X the follow-up agreed of including and and BLA on the various X data IOV-XXXX and duration July,

approval. the Medicine the BLA of as The on early ongoing is or begin to BLA align received, for of they the Regenerative to pre-BLA submit allows meeting, sections process commence FDA as BLA Therapy the this month. are submission as Following This available earlier to rolling our FDA documents submission enables the designation. rolling review RMAT Advanced as an basis. a under submission they we possible BLA the will benefit rolling The

expect of quarter fourth submission We rolling complete year. during the to this BLA the

cell value to education, activities, and to including cancer launch lifileucel. activities, onboarding, planning, shareholders. this and senior we of the with medical continuing Key therapeutic meeting, multiple support commercial for we're near throughout readiness preparing patients long-term precommercial successfully In parallel for in the forward collaboration pleased FDA look outcome actively which members capacity manufacturing attended. create payer review and aim level to center FDA are treatment the of The engagement, the to and We engaged deliver submission of pre-BLA BLA-related of team our has BLA process. we management lifileucel,

about our excited TIL also of the are pipeline. cell We therapy advancement

We cohorts trials, of Six these lung trial non-small TIL our are first on focus therapy. cancer genetically cell across trials, reflecting patients our indication. modified initiated of X of inclininal X active of that recently the patients including recruited are part

on trial of initiate III to lifileucel frontline pembrolizumab year. a of the with are also end in towards We Phase the track in combination melanoma

in address from lifileucel we strategy cervical will cancer. noted standard this As submission to updated of sorry frontline registration further. feedback care which release, BLA expecting afternoon's our Friedrich reflects -- discussions the press and C-XXX-XX highlight the are cancer, study shift This support that for in C-XXX-XX FDA cervical

are records prepare manufacturing within have questions cell our Cell oncology tremendous networks. organization therapies. to nearly therapy forward I’ll and to now Iovance and we reflects The field. commercialization. enthusiasm organization developing discuss advance ask strength employees track and expertise during growing call. addressing bring innovating, successful your first later within development and our of As the global to in launch delivering I that therapy XXX Therapy leadership we Igor mission the tumors, our TIL to we for this the solid cell onetime deep look Today,

Igor Bilinsky

Thank you, Fred.

facility with on Our and just from XXX manufacturing operational an is needs birth more in patient a We square or launch, X.X the iCTC otological Center, our treated critical with to patients to particularly is manufacturing Iovance Iovance foot date. studies. excellence is ADR. in success custom-designed ground XX% dedicated rate facility than years, XXX,XXX TIL for network in of the The Therapy internal iCTC, operational consistent Manufacturing supplying and Cell TIL to Iovance therapy more constructed commercial for any clinical therapies. manufacturing it and Philadelphia than

supply. flood submission for BLA readiness operating and manufacturing suites. conducting prepare to is clinical top suites core activities iCTC in the Today, our BLA So priority commercial for and iCTC the is

are and demand. flexibility In optimally manage our therapies fully contract inspections. expected upon the addition, preapproval approval of track contract commercial preparing iCTC iCTC most use on with the facility FDA and supply to in for manufacturers’ manufacturing we to is The capacity cell mediation to

capacity the class next paradigm-shifting for also as of TIL needs. cancer our are establish we to look we therapy, As future planning

includes core Flex constructed, treat year. and than XX projected suites X,XXX to suites iCTC per more four patients capacity As the currently with

streamlining us space double Philadelphia option XX,XXX still facilities of annual than to we more Longer our iCTC, provide allows intellectual property portfolio. in plans processes our manufacturing new under an annually. own allowed exclusivity Within more term XXXX. technology Gen patents, annually, capacity We suites available to similar terms and where US adjacent more new or I reach expected ADRs, or existing and preparations. processes, for the growing provide protect number and to include are commercial patients including and the for These patients granted than increase to the the potentially to automating include hand and have solidify that launch manufacturing TIL than now and capacity X,XXX while call structure we rights TIL like to quality our adding shelf Jim in the patent at facilities. are build an core support currently our IP into therapy, international iCTC. manufacturing to as further Ziegler proprietary highlight X know-how, our would To XX leadership to to and

Jim Ziegler

patients. other launch are key of positions for lipolysis metastatic Leadership melanoma currently and commercial and place Igor. functions the important in roles supporting you, for Thank

cross-functional regulatory launch we upon team based and efficiently has accelerate foundation preparations scale as key Our to built milestones. rapidly the

We or centers with ATC. become collaborate top continue treatment to our to authorized targets

soon to are centers leading treat as as prioritizing possible after approval. patients We cancer

of designed and we approximately the ATCs XX% are development XX% to least unique while of new train the we are leveraging market, meet the From to for top approximately ATC training and and of to workflows data, prevalent our each customer-centric CAR-T where to needs at for ATC. CAR-T approach are in are that is the therapy Through top at goal Our interactions structured in ATCs, XX centers CAR-T similar service TIL first onboard centers. a cell patient within just-in-time center. XX facilitating our treated workflows launch. the and CAR-T treated existing within efficiently the concentration days the lines XX patients analysis preparation cell of ensure with therapy We XX of claims anticipate lipolysis patients

we to oncologists expect between foresee to with ongoing treatment then ATC strong lipolysis patients one-time monitoring onboarding target the for community encourage at and In community increase ATC. care. we ATCs the ATCs, a and preferred awareness medical to and to addition We high-volume receive the and the plan referrals the because to transition community to practices collaboration back

to reimbursement our Moving strategies.

are securing on coding, We focused coverage and payment.

market and upon key support Our the national to approval. team continues lipolysis engage and access to to timely payers regional access appropriate

under care, inpatient one administered case diagnostic-related DRG a under This patients means will to be group end hospitalization from lipolysis treatment for generally hospitals As and on generally an basis or with patients. are reimbursed the all and payers commercial basis, a services reimbursement bundled Medicare rate payment. for falling reminder,

patients on a our identity, and Cares patient for custody care journey their launch. through chain support to of and best-in-class as chain kill Iovance assist health Finally, program proprietary track cell of is program ordering, providers

As sustained we want built our to progress. who call clinical foundation the for highlight to now core acknowledge by pass the commercialization, I and Friedrich prepare launch. have effort strong Chief the the I for cross-functional to teams our Finckenstein, Medical will Officer,

Friedrich Finckenstein

I address research pipeline at in our treatment tumor to modalities disease. stages types incorporate clinical more recent that to next-generation patients of technologies program share reflects Today, cancer and would like to of Thank the and you, evolution Jim. additional new update various

and patients XXX trial Cohorts positive X our that process. these Gen briefly summarize and in assessment and the study conference across same C-XXX-XX will in using the in detail in metastatic X same clinical press at both in from the same the eligibility results X data regimen Cohorts We release produced May. manufacturing same receive toll was in and call top I First, melanoma. criteria primary cryopreserved in previously Patients X reviewed X the line data the met lifileucel treatment

cohort as year. for represent measures OOR primary Cohorts the IRC. We was by for trial X as C-XXX-XX X X, pre-specified forward and point, improvement from to more met later over data Our our durability tariff well clinical available ORR detailed look meeting at medical pivotal of end meaningful which assessed population. the announcing trial a various this

develop continue pembrolizumab also various therapy. inhibitor the after in to upon for combination with monotherapy lifileucel anti-PD-X checkpoint to expand with types initial in naive We tumor patients TIL opportunity

as starting later is study. melanoma to year, study also X We in Phase frontline are a serve confirmatory this committed designed to the which

we Cellectis. therapy the for IOV-XXXX site incorporates recruitment leverage also licensed the of IOV-XXXX. quarter, from the model PD-X TALEN inactivated mentioned, IOV-GMX-XXX cohorts. antibody. began anti-PD-X an interruption whether The PD-X of activity IOV-XXXX therapy. Murine melanoma, alone two patient within TIL signaling non-edited study combination was superior IOV-GMX-XXX a of the second Fred with of activation is product, during technology gene the and to of antitumor in In a may patient editing and single first-in-human IOV-XXXX the TIL study or that As TIL combination includes

The similar in includes melanoma were first treated who advanced anti-PD-X with previously our patient C-XXX-XX patients population cohort the therapy to study.

lung IOV-LUN-XXX of now IOV TIL stages enrolling therapy a monotherapy genetically being which treated modality. with and study, on combination patients our trials progressed cohort look mutation. metastatic patient total therapy goal benchmarks recruiting after forward and multiple comparable I TIL TIL this receive Two in up second are patients cohorts using cancer disease non-small differentiation the chemo to out second from lines anti-PD-X our mentioned, dosing LN-XXX therapy, in after cell short-term and metastatic this for study for disease of The We appropriate tumors provide our including IOV-COM-XXX, multiple after ipilimumab/nivolumab have will IOV-XXXX. cohorts is of progression lung population clinical pembrolizumab also studies Continuing anti-PD-X will activating additional monotherapy. for in IOV-GMX-XXX we in naive our in are include just non-small lung half with IOV-XXXX. in with + various six of progressed clinical on potential cell to EGFR cancer TIL cell in basket patient cohorts in year. has modified cohort, whose cancer the pipeline, of patients anti-PD-X patients receiving first non-small anti-PD-X prior to Three study. in treatment three with patients One three who unmodified across and Data treatment

regulatory Available need we active on additional anti-PD-X therapy coming cervical into of mentioned, unmet is this of plan or checkpoint new intended to study. primary or cancer X.X Lifileucel in submissions is progress ranging are the Fred after has As Existing chemotherapy after care to for RECIST potential ORR X response XX% for has as review to chemotherapy cancer to therapy. committee an a expected weeks. is patients duration begin objective who cohort to enroll therapy. X treatment from to by using setting prespecified recruitment Cohort cervical and X pivotal the entirely with the who X.X% of support sites significant progressed Cohort be inhibitor independent and C-XXX-XX assessed ORR, in offer rate cancer TIL therapy of of months. to address median service patients responses class immune for The endpoint X.X. with anti-PD-X treatment our IRC

On side, FA plan for we know-how the our matrix CMC from leverage melanoma. potency the to Lifileucel

a We towards vesting pipeline also the research robust and have clinic.

question-and-answer targets provide available as Following success the TIL in our studies for preclinical using increase CDXX/XX Using selected, of negative double IND-enabling details gene and session. technologies, X during programs. target using I to editing preclinical interleukin- the IOV-XXXX, research am of technology knock to potency knockout include including licensed modification TIL gene novel the additional as several approaches and our genetic talent additional well studies in analog. are double genetic from space

I now, financial first over to second quarter call the XXXX Jean-Marc, will half discuss our For to hand results. and

Jean-Marc Bellemin

Friedrich. you, of results My will the high-level comments our Thank reflect quarter first XXXX. financial half and second

this I begin will Additional as with be the well position. details afternoon's found can release our of SEC as press cash our in filings. strength in

compared $XXX.X XX, As held and December investments in XX, cash cash on equivalents, June Iovance million $XXX.X cash, XXXX, million restricted XXXX. of to

retention-related during significant from payments. Our operations onetime cash the included quarter second usage

and As position operating advance a internal in our we company commercialization, to late manufacturing commercial into to launch these page guidance our approaching that overall We and expansion. cash prior activities XXXX. potential sufficient make pipeline plan continue investments maintained is prudent oncology preparation,

Moving income to statement. the

XXXX, $X.XX for readiness for increase XXXX, for the costs second per partially months These ended well our lower second share quarter $XXX.X of $XX.X in as $XX.X ended compared of XX, and and of research teams expenses well and quarter million XXXX, ongoing share. Our support share were build-out development pipeline $X.XX half growth were ended the June associated general and well completion growth. months increase June for and for quarter first driven by to as increased periods activities general second ended XXXX. million per of net $XX.X $XXX $XX.X net million $XX.X XX, ended costs. expenses XXXX, XXXX. of our new first the program and for a June June headquarter of ended compared for or to was XX, Research three for facility-related per The XXXX, activity This of million enrollment XXXX the increase quarter the the $XX.X million six XXXX, as million internal $XX.X six $XXX.X per million prior loss corporate administrative months share launch compensation loss General loss an the XX, higher million an and second the compared was the XX, increase XX, months or expenses ended second costs XX, offset planned six to expense internal and development an of million by June commercial the as second and or over compared research June six expenses XXXX. pre-commercial XXXX. to of to increase the manufacturing million half $XX.X administrative first attributable in periods was the June a administrative clinical of and prior costs for and in quarter including were June ended expenses was $XX.X ended in net pivotal compared XX, XXXX. research $X.XX to the and three million or $X.XX to to $XXX.X the General and for to to $X primarily Research the internal compares million an with as six compared loss million as were the the of increase and the the million for $XX.X and of $XX.X million Net half development of expenses development of million stock-based for and quarter were trials. clinical first XX, overall half administrative growth month June including expense, stock-based The team, attributable the the primarily compensation XXXX.

June approximately XX, there million As XXXX, of outstanding. shares XXX.X common were

Q&A of the strength kick continuing the spending operator our off and by plan and priorities, hand align balance will are corporate session. back with sheet we the well execute our launch positioned With our to call operating to commercial our beyond. I to the to into now

Operator

Instructions] question [Operator our Lawson you. Thank And comes Peter line Barclays. the first from with of

Peter Lawson

taking required? questions. there you. any Thank the be for the great? the was around that's potency confirmation Thanks the any the Thanks around then commentary meeting, Great. discussion guess pre-BLA assay I -- around during alignment for update. And would trial

Fred Vogt

Yeah. currently street provide and topic as some the come up, Thanks, in we're a -- on have as Peter. situation, see topic assay favorable potency any favorable Yes, really meeting at is on being planning. frontline But really the your meeting, as commentary come and there yet towards the the know, FDA discussions wasn't pre-BLA any some proposing what trials we don't planning don't just that this question our melanoma did we you confirmatory did out. that of commentary so that changes a and trial. we're second prior get the on updates in major And that. matrix later part we're study on what read we We did that of to year,

Peter Lawson

lung and question the how from cervical just help the a and then, inform could And pre-BLA. final also filings guess, around be I around for cancer? read-through cancer final it meeting question Got that you. And would my

Fred Vogt

question. Interesting

that to FDA to with what take I get now lot think, approved. cell about meeting it's at therapies going right well, we learned a

going that think now I that over nothing all this, insight. that that share now. these know meeting meeting But there gave how to is we've specific as it think having a approved. think because in cervical to would not didn’t bit a So general, that valuable. is But the helpful you be -- publicly, helpful. We're some we right we know got going do that to we drugs there think that of some I it's competitively us impact There's I already quite I or lung to pre-BLA out we get learned information gone general think is general

So we'll certainly take advantage of that.

Peter Lawson

Thank you much. Great. so

Operator

And Michael line comes our Jefferies. question of Yee you. from next with the Thank

Dennis Ding

Dennis for It's durability I seeing much X question gating please. my One, data? meeting? the questions Thanks have actually on been Two their the what to guess, is second you was BLA? our to, after rolling the around This at so you is through Hi. talk FDA specific taking from in scenario a factors what BLA asked most submit that may Mike. comments And the there on were think. Was do issues going us, about then unexpected? a for the please questions. were can And anything work for discussed which pre-BLA apparently, now guys I what Cohort investors,

the decision you. do to about that talk So as well. Thank

Fred Vogt

Sure.

effectively So the from think saw later conference perspective, about a the based the about mentioned product on meeting. They And data. the FDA includes they're clinical the we was that we'll durability. of press the what at saw this at all They favorably there on they data, release. very a and clinical commented favorable We point, the first our -- there medical on be talking commentary data year. commented was supporters have that

there another. of in not out would specific think And was one were or felt things I at meeting anything came we of there that say that the anything don't nor was terms planning So for way I unexpected there. that

few comfortable of question, into BLA good part while modules our submitted. your work start first allows we a is announcing get question, the through the and something some rolling and secondary that going gives looking at your It rolling advantages. Now part of the potentially those something start BLA FDA that up The is some get are us to we to obviously second of and on finish tasks filing here.

the really behind rolling BLA submission. the that's So story

Dennis Ding

Thank Got you. it.

Operator

our Van of from Cowen you. next Thank with And line the question comes Tyler Buren

Tyler Van Buren

X for into you second Good a Cohort clarification just the and meeting, by question will guys. of questions. CXXX-XX the additional X data it for Hey, just afternoon. Any at they regarding of feedback there on be being helpful. had you the pre-BLA medical follow-up And Thank data the I is a taking meeting give do year-end. include what course, specifically to analysis bold the point for a presented label? Cohort the Will color very potential much X? the get of

Fred Vogt

Yes.

me a Let number take reverse in a order.

we of team part, before, other about second the the you that's Cohort talking said full members the On be that. tell medical and most I X. We relevant X more of think and up analysis community yes, definitely follow we'll about the can to have as

the that patient same At -- that X We thing haven't of need supportive same as the out announced same that's unmet the reiterated means X. did X fact, our the supportive, Cohort is but because to FDA They being mention conference focus Cohort the Cohort on well. and really that in is that investigators the X yet, be could support to is data population that with our intention medical the there. has

more anything They have know that's what set negative that X times the didn't say many fact that they've they're the to think don't meeting. we and anything at So about Cohort beyond we thinking. now,

Tyler Van Buren

Great. Thanks.

Operator

Securities. And of JMP our from line Benjamin you. Thank Reni next with question comes the

Reni Benjamin

were any be taking issues, might them, those Is many do -- -- an the there guys. your again or you discussions the others be included. for there afternoon, review Maybe C-XXX-XX panel? think potential it a of study, patients good when questions. can you Thanks for or pull together starting total off worth in and just with ODAC how from data pre-BLA just safety the Hi, the meeting, with package, will

Fred Vogt

happen that full the the we to something that size safety of at We hear expansion. Let think me don't ODAC part meeting I the panel didn’t second to know the Reni, answer think of the take anything ask that's of first don't and we going part number an previously, actually first Friedrich changes we said -- we're the but to meeting to topic prepare, that in safety? that us there be gave here, have Friedrich, was always the question we're be you want of the size ODAC But does case so happen. do on is any panel, indication there the well an in that you prepared to answer preparing to exact going then what nothing would the I'll because total case. it's Reni’s about that

Friedrich Finckenstein

don't we patients Yes. the think XX shared share What patients in exact patients XX the X. I we going are that that of patients from this number safety full with Cohort the from is that X the and Cohort have XXX set. from analysis

those review are that will they efficacy. do of part that the as the the and the additional considered could some are be So drive safety data patients patients of There certainly will that.

Reni Benjamin

planning study a X. many I'm the Cohort on data on you are update X? patients those on enrolling have be how Cohort went, cervical for Got And let's you regarding people expanded discussions the some chance your say, many enrolling? study, the study to remain as the you're on discussions provide just then color or follow-up, on to a can going just reopening maybe about just how new reexpanding how And FDA versus based wondering that remained a actually just for, patients you it. because plan who if new for as there's the patients

Fred Vogt

Yes.

say fully not, have patients think that. remain here, to being and always careful pivotal patient so but is point, what we with We're what potential total a So figure that here. number out that we sufficient what we as the We'll data to we broadly sample is for with that's be we're disclosed about slightly this did -- But size taking looked that we here amount on on out doing consistent we're melanoma. higher. would can of have -- study, study we account, And put you have to haven't at we a should the feedback I be sample go we BLA. some that at the size, think data of it’s as similar on finalized to any

Reni Benjamin

Right. Thanks for the taking questions.

Operator

you. Thank

line from of Your question Breidenbach comes the Mark next Oppenheimer. with

Mark Breidenbach

Hey, our pre-BLA relatively good Thanks for afternoon the and guys. questions, to hear went glad meeting taking smoothly.

more cohort does the to planning to FDA know for is satisfy, why cancer how this safety cervical me enroll. can't Fred, rolling for enrollment, database many any wondering Thanks tell what's or for the in more you're if can you of taking the fourth patients one reopening confidence And BLA I to the it that want was you granularity around completed like steps process of the But the an Is that's the patients? submission question more regard of coming will giving you request the and I Just indicate patients requirement, they previous from? addendum then on kind be offer quarter? where of more kind for with the kind questions.

Fred Vogt

of just it’s statistically what's reverse not other take accepted therapies, safety a need but -- it's Sure. for you On sure a much really I'll our order. is cell similar thinking, cervical, we part so been in of what it's them size own. size to they're When including patient. meaningful I'm the

to patients in. that's XX-plus it with So population do not in study, we're that any patient interested going

the we've we're to So bit just safety programs. well, little size be granularity, we they’re done supportive well think going rolling primarily complicated. BLA. can the data period, us possible rolling confidence got that long early as in They capacity we not that as we of completion asking Onto information the information and quickly, as are which for get and and perform the got XXX demonstration, increase super the things of such during a and mostly These set we've manufacturing efficacy will why things north submitting can BLA first for the is course, more cohort patients although of are that foremost like quarter, across to as things that. on -- the fairly safety and

Mark Breidenbach

right. taking for congrats. the Thanks question and All helpful. That's

Operator

line question comes Goldstein And from with our you. the Thank Mara of next Mizuho.

Mara Goldstein

have And X,XXX how But for just I if a requirements? much think question. at initial I basis a should the you where will from about of curious launch will we at a capacity And months for on Great. have get on when fulfill margin capacity the be trial will, the taking question for of of lead know you few annualized time those of do launch? what you you back you the steady improvement state, you to be to to patients. need launch, manufacturing. to possibility state? And steady about where I'm Thanks about

Fred Vogt

would that Thanks, be one? to able you Mara. Igor, answer

Igor Bilinsky

Mara, Happy thanks for your to. question.

So, I two-fold it’s a guess question.

So on our more as we and additional we We're disclosing very needed and capacity commercial yes, at at included that but obviously, of that at of and up, that of we're in a the the working in detailed parallel, capacity Navy our numbers, supplemented time. all we're we iCTC, improve by contract is margins, Yard cost And, plans. over over we're also and Iovance focus have the have of continue we that's the demand Center trials. team cost control scale as in the that. to manufacturer. that's -- that own have on anticipate planning facility, And Cell by not goods, the having we expect exact obviously, discipline to planning, clinical we meeting lot The goods, there's we course, for the of Therapy launch, in

Mara Goldstein

we sort BLA? what's BLA, from think if time rolling that Like of, will, for the should statutory, time FDA about that? on decision Okay. And the of completion you just frame rolling how

Fred Vogt

PDUFA So from calculate BLA, the of they the rolling eight months date. the -- completion to

can BLA, However, have because benefit early it is approval…. so the of -- look you you're to higher you rolling a early get they chance at a submitting

Mara Goldstein

what eight at But the Okay. thinking? Is months. that outset, you're it's

Fred Vogt

calculate way Yes, is front rolling But the in BLAs benefit to them… the it get it. they that's to again, get of -- of

Mara Goldstein

Right.

Fred Vogt

Early so can we that beat date.

Mara Goldstein

much. it. Okay. so I appreciate Thanks

Operator

Thank with line James you. And question comes next Wells our Fargo. Gin the [ph] of from

Unidentified Analyst

guys. Hey, taking for the Thanks question.

levels naive will in frontline account patients, PD-X you match tumor of and into melanoma you LDH the baseline For number if take can lesions the what Cohort X? study disclose

Fred Vogt

how about to the think population to Friedrich, a want from do It's perspective? talking patient population there. different about talk you we're about patient maybe that

Friedrich Finckenstein

X question. would patient Yes, No, Cohort to different try as said, just we Fred that don't again, a think good it's because population. match I

prior much of Remember, treatment So These checkpoint was Many had of on therapy lines median patients earlier three. of and so lines Cohort inhibitors, frontline therapy more X naive Cohort are a number setting. X therapy. it's patients.

design So the that take other not take that going and to There -- are will to prognostic late-line study usually that for to non-prognostic need you is some that. We're certainly are, match though, population. we [indiscernible], when -- be try measures to and -- to certainly numbers distribution the do when in very of need population. factors. our steps means you that you like you factors the though to stratify some steps different, likely line There do standard need all match

Unidentified Analyst

Appreciate it. guys. Thanks,

Operator

you. from Goonewardene our question Thank And comes Truist. line with next the Asthika of

Unidentified Analyst

you This X,XXX it to would how We're Hi. then We for there on year? cost – you And more additional per XX,XXX increase to your had increase per to guys. for questions much from Bill a wondering of patients how much to X,XXX. Asthika. is capacity couple for

Fred Vogt

question, feel complicated chime a then but in. That's me to let give Igor answer and Yes. some you free

So to the get us shelf now in are million investment we to and had that capital is of right where $XX Philadelphia XX about improvement total it we space.

support can built for is ability services And includes as expand just we lot with of a the so manufacturing. Now space well. shelf the that

to near level, another approximately -- up in the on Philadelphia, ago that but next to $XX do where space, it higher So patients you year the we're building, done to a million it that's go comparison X,XXX a to than will would expand year. you could and us something what X,XXX not that be get that. do and talking depends again, a we've to about To

You here in Philadelphia a Igor, do it And something lease want the favorable know, adjusted that XX elsewhere do could investment on we was that we just also lands inflation that? would financially have we favorable changed but add to to and do expand terms or this to, option you it market. anything million, not. be have the for things like made estate very on the in in of the to real in facility

Igor Bilinsky

the the to XX shell, expansion the be double existing add suites looking additional again. it's within covered understand core would you think is existing that we it to core And buildings at suite the important I within Fred, can capacity. first --

are expand to greenfield, about as premature talk to comment it in we Fred to table. the today. options on time, location the where Beyond due that, that options be that And likely it's mentioned, are several on depends considering several but be there that we'll could on

Unidentified Analyst

do in populations Do for study? namely green that a soonest X%. the had LUN-XXX for a those PD-LX is feel PD-LX lower terms viability [indiscernible] would of...? registrational you when guess we subpopulations think get within I as of you a that and distinct one study, confident have And a benchmark light noted that you And you Great.

Fred Vogt

Let see to we've a We're feedback a have to me speak of earlier now. patients. expectation…? LUN-XXX want kind We're Friedrich on updating to PD-LX those been part comment the on cohorts, you we're first for status. to the We registrational seeking treatment the cell line Friedrich, status works and prospect study. the the the says, of still right the therapy don't then how we what's on the do as -- continuing to take PD-LX for give two anything in to in study always

Friedrich Finckenstein

Yes. Happy to.

deserves that I think discussion.

So the PD-LX PD-LX for defining status prior the therapy. status remember, we're scores is the to first-line that

inhibitor PD-LX the therapy. they start status the is that checkpoint So before chemo

treatment we because driving at PD-LX first-line differently, And the that not that we because because that have treatment of that therapy status these be necessarily the be would start therapy cell there like a separated under think that these thought might course cohorts patients go outcome. of therapy is slightly might cell We chance into different.

have not hope something there and if to that as a So makes chance able this obviously at are we is that simply is to single be would seeing we look population. differences, a that explore demonstrate, and I collapse sense. we will very that good

Unidentified Analyst

Clear. much. Thank so you

Operator

our Stifel. Ben with question next Burnett comes of from line the you. Thank And

Ben Burnett

I margins release you much. have the the for Thank I have themselves with talk established very this established upon that could get release guess, release something the Hi. ironed assays FDA, criteria agreed and lifileucel. about a that To are question potentially the extent been upon, agreed criteria? margins review? or around is can out the Understanding release or and you during what the

Fred Vogt

This but We to is we during review. that specifications, for the can the out basically something ironed We sensitive get it's our review. would a during release big -- think us pretty topic probably, we that's stuff now. area we're answer most even to we a say that what so. where little in agreed stand good going very we idea right now have it pretty to are But of as get product those

Ben Burnett

Okay.

could ask then, question. I other Okay, if one understood. And

four you previously, a reached. still had -- hasn't DOR -- cohorts and that the two been yet can think in combined I I is when melanoma were you cohorts median so that mentioned case comment guess, the today? that they

Fred Vogt

I -- conference our can will later stay year. presentation another and tuned We there all is for this on say

Ben Burnett

understood. okay, Okay, Thank much. you very

Operator

And you. next the with Colleen Kusy our from Thank question of comes Baird. line

Colleen Kusy

or the about month, Can Do CAR-Ts that those targeting centers that at patients expect launch. And you you said previously, will compares afternoon. roughly Good fit within you capacity their had as do remind taking at for know at just think how what XX average patient into launch? what that understanding, you're XX plants time you the I be? Thanks centers, Hi. beds launch? us per how my to then, a XX many questions.

Jim Ziegler

for Thanks Colleen, Hi here. that. it's Jim

of period. market, four-year we found got for the the over XX we've what is centers XX about So look claims lot a top and the CAR-T-treated And all drive data XX%. a CAR-T the centers about specifically top XX% account we and of at patients of benchmarking

the we XX of the first approval. XX the based centers, targeting XX in have those days and top centers insights after So been the how CAR-T upon, are established the within centers that excellence market. That's

Colleen Kusy

And anything capacity kind within those? of

Jim Ziegler

Yeah.

think they about the with are and where capacity therapy think I is what So them treatment bed cell is follow-up. way the capacity their we conducting

And appropriately. they our and working idea the site-by-site. their many each general And to capacity ICU, capacity, we so the that beds we make But they of to patients it's are going we'll site, with ensure sure how on oncology in have ward. understand an vary that treat how we're many able really be beds to are specifically

Colleen Kusy

you. just this there's expect Thank or monotherapy any And programs, updates the guidance data if it. any PD-X then, Got either to we additional that for lung year? combo wondering, could

Jim Ziegler

get will as earnings colors many With that the That's to able because looking do more we during soon. it's to data something report -- be out as some I really now, right there, important can. we that's to Not early longest we hope to mentioned that soon us. earlier open, be something

Colleen Kusy

you. Great. Thank

Operator

our next line of Sandler. Piper And you. from Thank comes the with question Joe Catanzaro

Joe Catanzaro

melanoma is the maybe second of the asking context PD-X other a something impact independent of received in of and being thanks the observed clarify if guys. a in if, questions. that post you've bit but my update that for And or was first, decision then now Hey during the that? I settings. rolling driven Thanks. by of speculative, extrapolate PD-X for that was whether I BLA submission I'm the Thanks of move in emphasis wholly the wondering meeting, guess, And question, perhaps was you you any you wondering prior into decision duration expect could the that taking feedback cervical to to to indication. pre-BLA

Jim Ziegler

the take one maybe and me second the first can Friedrich, you Let question. take

During success to basically with that the to I that, say part of submission and the but as approach whole. to of was answer to the best led you pre-BLA a basically we And picture a of think. for the any down, the what meeting, happened the Iovance we rolling us context some full think submission of want a just it's don't the approach conclusion went conclusion product, of more us that as Friedrich, about second was how year. best our I think, the provided really, And I result the came question.

Friedrich Finckenstein

that There tumor be think the Rosenberg the generated, what were patients as out of sure. clinical melanoma on Good explains really such patients don't are yet elucidating is either there, some that a cohort fully think recent question. this in sufficient translates PDX treated needs checkpoint to hypotheses that differences Group that check or mechanism indications and that have that X shown are point we are between in based that Whether previously understanding nor therapy the I we X subpatients data and other on publications CXXXXX Yes, that are observed into study, naive. that mainly might types, our really prior inhibitors been out action that in of PD that. with have couple some drive versus I of at some coming clinically. information of of inhibitor there

have presented higher We seeing loss. head encouragingly patients be expecting cervical in And or initial what clearly patients, would of cancer. and data combinations we naive response than rates are high are that lifileucel neck on with you namely cancer in pembrolizumab with temporal with

might generate be need we data. as think difference So seeing more but we that to well, I

chemo is inefficient cervical There on focusing however, therapy and unmet after is of these patients setting. is out certainly of there are that's really is medical For what cancer, nothing currently. population failure post-PD-X patients. the in terribly opportunity these we underserved for a chemotherapy real good is an and frontline the need TIL patients, doublet This for

Joe Catanzaro

my taking for Thanks question. Great. Okay.

Operator

Sachs. the Madhu with Goldman our of line Kumar Thank you. next from And question comes

Unidentified Analyst

[ph] Hi. Omar is This for Madhu. in

two we have questions. So

melanoma First, we post beyond can the additional PD-X expedite disclosure from be rate that in the approval for necessary think core how response will we post-PD-X lifileucel then any objective data expect cervical XXXX? on And of about pipeline should cancer. cohort two,

Fred Vogt

missed on – is which study? I second your for question, What

Unidentified Analyst

cohort beyond the pipeline year? And question data can the second additional core any we this expect disclosure from

Fred Vogt

Got it.

the there cervical Frederic, little chemotherapy a available we to you is to want these with add. barriers want first to But huge right do study. post-PD-X no in available on out the patients? at – question, And Frederic, don't view to therapy care cervical patients. things will Well, There's that results. add successful Okay. post-PD-X look bit anything no there's as are is you care if for very improved maybe, add approved there FD that now, a

Friedrich Finckenstein

limited main includes therapeutic Yeah. with or chemo with between and that is these cancer patients of doublet really the somewhere There chemotherapy, that are ranging additional line outcome is toxic. which X% cervical data on options late have patients quite XX% is

been and five the and time four responses historical duration -- last that's I in of looked quarter, months. So it's this

There required says approval is that checkpoint going with the you're much when failure are approval context an usually looking is PD-X for bar at to of activity FDA no of after be time would that The in field. inhibitor. in at So low. what care. There experience look chemo the totality the of available not of at that data they the is relatively

idea. if initial numbers, these you rough you maybe So a give

Fred Vogt

data second soon. one about X, of way part the The of about answer to get data we're question, -- And your want Cohort like to it the would our flows that we non-small cell is Cohort some melanoma thinking lung beyond we X you That's data already to think flow talked priority lung is out about. has why areas.

indications. that, other our and We on then that's on list at after the haven't guidance specific given any high

Unidentified Analyst

you. Thank Great.

Operator

I'm showing questions. no further

that, Fred call any closing and remarks. with Vogt to I'll over So hand the for Interim CEO, back President

Fred Vogt

out a free to therapy for to support. as like regulators follow hard part have their again Half operator. with who you, throughout I'd feel Financial recognize joining Iovance. their journey relations be employees thank point. Second if to follow-up. First to Biotherapeutics exciting and Iovance collaborated time for well Thank analysts team physicians arriving as wish you you. TIL Conference our our cross-functional with also I shareholders and Thank work and Call. Results at the teams would the patients, you this Quarter us like to for Please It's Thank of and covering and reach the an

Operator

call. and you you for may this conference participating, disconnect. and Ladies concludes Thank now today's gentlemen,

Iovance Biotherapeutics (IOVA) 5 Aug 222022 Q2 Earnings call transcript