IOVA - Earnings call 4 2023 | Iovance Biotherapeutics, Inc.

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Operator

Welcome to the Iovance Biotherapeutics conference call to discuss the full year 2023 results and recent corporate updates. My name is Kevin, and I'll be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded.

I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications, Iovance. Sara, you may begin.

Sara Pellegrino

operator. you, Thank thank webcast and recent joining conference our updates. Good discuss you full and to and year call afternoon, for XXXX corporate results Dr. Fred Officer, Chief introduction. President Vogt, a provide brief Executive our Interim will and Ziegler, U.S. the Jim insights Commercial, our will initial EVP for highlight advanced Amtagvi in launch FDA of Drug or the following commercial Food recent Administration approval melanoma. Chief expansion plans. Operating will commercial highlight Officer, Bilinsky, Igor manufacturing capacity and highlights. Officer, Chief Friedrich Medical will summarize clinical Finckenstein, pipeline our key results. Bellemin, Chief will Financial financial Jean-Marc And review Officer; our Dr. Puri, EVP, available Gastman, Strategy Medical session. EVP, and Raj on and Brian Medicine Translational call also for Regulatory are Affairs; and Q&A the the

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

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

from materially Our results today's any undertake call. We obligation projected may differ to statements. those during no forward-looking update publicly

will With that, the turn call I over to Fred.

Frederick Vogt

and of cover executed recent call, heels our and on Thank to we we I'm first year our variety full XXXX the as of treatment us host pipeline. approval conference the well U.S. of strength scenario afternoon, On results advancing you, exciting Throughout of commercial Cohort therapy to melanoma efficacy have first tumor, with best-case for the as our today's good anti-PD-X year, from X Amtagvi toward strong Sara, pleased this and first launch FDA's the label onetime approval The call. to last allows everyone. topics for a X. while solid also pool X label a therapy. Cohorts after patients of reflects data advanced targeted T-cell become option pivotal Amtagvi,

U.S. strong ATCs are for patient. and also seeing In first detail ready authorized and identified where later nearly centers for expect more few for days of all Consequently, the approval Jim will momentum launch, we treatment increased were demand Proleukin. Amtagvi. we the demand in provide call. a

our first after approval commercial unmet manufacturing The testament first high therapy, at this all day the iCTC. and manufacturing Iovance plans. to a around the is readiness. in the commercial launch began of or following talk about Igor occurred expansion going today as tumor near-term well resection excitement Therapy and Cell to business the serve our Center, data This greater trials will as clinical need capacity new medical and our commercial our

expansion on our geographies advanced the and U.S. frontline the other to Amtagvi many as by well of additional patients are addressing near-term broaden melanoma launch, as label include indications. focused addition In thousands for plans entering new to

remain example, the by number the second in Amtagvi has on the anti-PDX United Kingdom year in of track year, to Union addressable the of our global the the or and We land submit patients first half potential this for total melanoma. the double For Canada followed dossiers imposed to in regulatory expansion European the half.

in our countries frontline several continues addition, support melanoma. momentum trial to In III in Phase strong a with TILVANCE-XXX advanced submissions regulatory

programs. solid with will pipeline ongoing highlights pleased key robust cancers. our We some across later trial tumor speak development in clinical progress the are with also our Friedrich about

fully integrated is Today, now indication. is commercialize to company the the for company cell tumor and first the therapy Iovance T-cell

to remain leader therapy. and launch on activities regulatory our in TIL manufacturing commercial execute We are well positioned global cell the to pipeline,

ongoing now the U.S. our describe activities launch. to will related Jim

James Ziegler

now, Until people and if X,XXX approximately for inhibitor therapy. following patients melanoma. no FDA-approved checkpoint have with immune there advanced appropriate, Thank you, year, targeted progressed whose options Each an melanoma Fred. the disease been a in for treatment die U.S.

For onetime each these to unmet in for therapy patients, Amtagvi manufactured ushers a cell landscape a significant for patient specifically is address that a treatment new need. the era melanoma as

launch Today, I access ATC will onboarding highlight as our activities, reimbursement. and as well

case identification, today. includes for our XX patients. the is tumor X There identified commitment financial ATCs agreements. the less scheduling X Amtagvi of patient of with single including have activated XX the weeks ATC process, There at of of reflects level schedule ATCs are strong engaged slots. including and need onboarded this process patients number urgency The reimbursement, authorizations stages unmet sense in manufacturing. least the melanoma of and the and In high procurement manufacturing at patients in following majority engaged and or tissue offer with process a approval, are their clearance XX advanced onboard of prior ATCs in establishing are These various the which authorization, process, to least in and pending than patient reimbursement

we of the approximately In total continue remain and ATCs end May. on by addition, track have onboard in active to to XX

the with initial for experience. resulting approved consistent both are increased and products also of with ATC's pleased access These are CAR-T from market the the speed with Amtagvi. We trends our preparation in-patient benefit reimbursement and

consistent to agreements about and commercially label, to XX include coverage authorizations continue for within single-case with patients. medical insured We days to anticipate XXX prior policies coverage

our our cross-functional acknowledge ensure teams readiness to execution. launch want who have worked I to and strong tirelessly

to our commercial in are confident a We successful launch. deliver ability

highlight call turn will now the our who readiness will to manufacturing capabilities. and Igor, I over

Igor Bilinsky

Amtagvi proprietary of and billions portion collect Jim, you, TIL a multiply cell patient approved patients commercial to our patients as Thank from cells tumor, at cancer. These to Therapy to as facilities nearby manufacturing are them Cell a FDA contract facility, internal or fight up the annually. at using built has The our Iovance back them into as to well to the U.S. investigational TIL the several return manufactured our support iCTC Center, manufacturer. the well as therapies process are thousand

business commercial manufacturing and approval, As Fred is day of the mentioned, officially after occurred Amtagvi the on first tumor underway. first resection

We trials. clinical ongoing staffed needs well of our are launch to as as the and currently planned meet anticipated U.S. our

have submission included BLA than increased capacity the needs. we the This requiring we immediate means for demonstration study authorizations. staffing that through capacity our without In near-term higher additional can increase capacity Amtagvi,

years. the capacity manufacturing expansion space advance within rooms the plans clean with are annually. In may further X,XXX patients term, and our significantly capacity our new building to additional can long-term tumor annually few is near-term markets above as of to solid XX,XXX expand addition, iCTC into already align to and patients shelf at iCTC, Amtagvi we next increase manufacturing expansion prepare existing over pipeline, and Longer needs, future the our indications we facility starting, within capacity bring over build-out our

patients at outbound in from We're summary, receipt team Amtagvi the manufacturing excited of quality to first every laser-focused through process process provide incoming and shipment the to Amtagvi product and to In right of the of product the is the the spirit in final tumor manufacturing step everything ATCs need. sample the time to on of to our patients. doing release

Q&A, to to the I'm available the additional answer call and will over now I Friedrich. hand questions during

Friedrich Graf Finckenstein

diagnosed in you I'm clinical pipeline know, about pleased Thank our all cancers U.S. the solid as highlights the XX% within of you, which, in represent tumors, today to more than key speak Igor.

underway and registrational combination the frontline with melanoma. Australia, TILVANCE-XXX advanced patient also Global additional site to full Europe, anti-PD-X the U.S. strong Canada post activation continue countries. trial enrollment momentum Amtagvi support is and of confirmatory in and with Amtagvi is I'll TILVANCE-XXX, to melanoma. in full accelerated begin advanced in frontline our III advanced pembrolizumab in trial with Phase approvals well melanoma. TILVANCE-XXX approval

post Shifting anti-PD-X to complete in our cancer enrollment program our Phase in in cell non-small IOV-LUN-XXX non-small cancer, lung registrational single-arm XXXX. cohort the estimated registrational trial cell lung and is and II to

FDA with believe the working we new patients, necessary have Following the provided to near we patient U.S. future. enrollment the for partial and the hold clinical information new in resume are collaboratively all

new cancer, is of therapy patient mechanism We Phase start of are expected trial may patient efficient cell to in populations. preparing TIL proficient both II are to on mismatch post-anti-PD-X in also repair. these action who based endometrial which its a benefit populations include and up

advancing trial in year. forward We more this look this providing to details

the cell next-generation potential that Iovance outcomes the for therapy, patients. approaches leader in to optimize is Tilt including have

therapy This in treated non-small trial. previously our continue inactivated patients. to cancer TIL the lung We and investigate or cell genetically the trial GMX-XXX first-in-human IOV-XXXX melanoma advanced is PD-X modified

a just address to the happy of many about I programs I'm will questions call progress and pipeline, was tumor activities additional snapshot This solid trials and the now and to across Q&A Jean-Marc? these session. our Jean-Marc. hand the during

Jean-Marc Bellemin

our current position XXXX. cash I you, as year well the year also as December outlook. Friedrich. XX, ended Thank results XXXX full highlight our on I for review will will our Today,

offering other proceeds in XXXX. XX, February unaudited expenses which $XXX.X equity our position follow-on net million, million, the As net underwriting $XXX.X XXXX, February is of and of approximately of approximately from of financing includes cash

revenue or fund XXXX. anticipated year per to compared loss of loss XX, the ended The both $XXX.X current our quarter second ended and December year December are to or quarter expected planned was net year share for million half or well a XXXX, fourth into $XXX.X compared net for net current XX, from was and of the December $X.XX Proleukin Proleukin $XXX as amortization the financial The share full operations loss XX, share assets year intangible to the XXXX, the acquired million Amtagvi for results. per to to of transaction. of ended per XXXX. fourth XX, per December loss for Net the a $X.XX the cash $X.XX for XX, XXXX. Shifting and Net part XXXX, includes ended million be December of $X.XX $XXX.X position ended million share or loss sufficient

of XX, of acquisition XXXX. year and and were Proleukin the ended fourth the December XXXX. and the from quarter product quarter sales and $XXX,XXX There XX, Revenue May no December fourth $X revenue was million, for respectively, XXXX, following in ended comprise year

noncash inventory fourth cost XXXX. year-end $XX.X $X.X respectively, There was for Cost quarter intangible of comprised associated $X.X and million as for and well developed XXXX, fourth of the $X.X assets technology. sales of Proleukin for million, revenue of no million of December December sales and quarter as and cost for of XX, amortization the the with expenses acquired XX, respectively, ended million, was and

Research same and and December million compared XX, period increase $XX.X an December million $X.X XXXX. of XXXX, fourth an $XXX.X ended development increase $XXX.X December expenses million same to year the million Research XX, development $XX.X December ended for the for compared XXXX, ended to ended of were XX, for XX, were expenses period the for the quarter $XX.X million million XXXX.

by in the ended and increased the our support research in the production development December the year quarter year XX, TILVANCE-XXX headcount manufacturing readiness in to expenses III attributable of and primarily costs periods were clinical capacity initiation the and XXXX, to trial prior increases increases trial. primarily costs over related and fourth The and driven clinical commercial Phase

general general million administrative compared were the and same $X.X million the for $X.X $XXX.X December $XX.X Selling, year for the increase XX, to administrative XX, XX, in an ended Selling, million expenses for to increase ended compared XXXX. $XXX.X same ended $XX.X XXXX, XX, and million for December period were million the expenses XXXX, million an December of XXXX. of quarter the fourth period December

quarter offset The fourth and the to fees stock-based prior partially the associated attributable increase by with legal other to travel in period increase and was related in the selling, costs. costs overall XXXX, business integration the compared expenses, XX, costs activities. ended This headcount to the as growth as costs general compensation infrastructure, in increase year and increase and year an December related professional administrative primarily Proleukin well was in and expenses support in corporate and

and information, be release press filed today. see afternoon's annual additional please to our on For XX-K report Form later this

The continue opportunities outlook conjunction for onetime and the as XXXX million XXXX Amtagvi year, of as guide we full Regarding to into of of spending. used will regimen in Amtagvi the expected and year cash XXXX $XXX leverage continue this expenses, million, optimize our in we of U.S. treatment second range sales towards with to drive beyond. burn to $XXX and excluding launch to significant half are revenue in the the well Proleukin to

infusion therapies. cell other Revenue our upon occurs recognition like Amtagvi for

So second and of quarter this we recognizing expect in to reporting significant year. begin revenue the

begin I will the call to now turn the question-and-answer the over session. operator to

Operator

[Operator Zhu Wells Our from first question Fargo. comes Instructions] Yanan with

Yanan Zhu

Great. initial momentum. Congrats on this

the about curious Just patients. XX

pending of updated for are long the give patients XX thinking, manufacturing how Wondering have Does patients are stage any patients scheduling already And average thinking from tumor you that word the manufacturing reimbursement of way at some took. time XX of slot. did of process that slots. also -- these like these patient to we identification the a see you resection? Sounds

Just word the wondering And mean? what does what's that behind pending?

Frederick Vogt

Yes, Yanan Fred.

centers patients, all schedule the we're scheduled either able moved patients to the a quickly. schedule these soon for for more that So much or that are moving to XX slot there a through are for obviously very slot quickly process

centers Some fast. move

here, slow. -- and Some jim, we're centers launch. you comments pent-up add impact want demand let I What move think, a the I'll seeing real Jim that? you for do is to to add excitement any

James Ziegler

Fred. Thanks,

too it's guided early cell weeks takes before couple based to of agreement. what authorization upon prior for experience our approvals Ann, a still think, we've I therapy a case of tell couple days and per single in

pointed some the quick movement ATCs. at been these sense of Fred out, there of As has urgency because

they means, ATC successful define they further schedule slot once know reimbursement. pending have will To what basically a

quite not yet. So ready pull pending to that trigger ready to slot that the they're but they're registered, is on they're go,

Yanan Zhu

can namely, these the facilities? wondering And the iCTC would CDMO. on distributing the could just how you mentioned a If are quick follow-up, you conducted be to mind flow Great. CDMO, margin if at manufacturing commenting have I the very for or you X

Frederick Vogt

Yes. it's with competitive We that. what what we is. Obviously, know They say margin can't We that's business. their their think do. really

in supply a employ that's look constantly Iovance, everything business. way, answer to we strategy we and tight best that make manufacturer external the that Does internal think a way run So we your of the competition, versus question? and at keeps

Yanan Zhu

Iovance distribute flow Right. CDMO? the How Therapy would Center versus you to Cell

Frederick Vogt

Yes.

even But the X but we a little sites. about the doing doing flow an process. that we now So we I grow, tightly them manage expand to we'll more bit for internally the best sites run able think the evenly we we we more I be full and and as learn as somewhat competitive right as how algorithms who's across here. have as can't internal And the perform distribute that, details, and share

make between the X. really clear. sure to real all at There no it's just Again, issue is the capacity of

now right We have of tons launch. capacity for this

Operator

question comes Cowen. with next Buren from TD Tyler Van Our

Tyler Van Buren

The patients But bolus initial at X.X in weeks Amtagvi as XX majority you noted? with of update would very least the we're having encouraging you XX sites the process, this as X likely the characterize the a it in the constitute a Or in be just ATCs process of to for about is as more patient, fraction? Amtagvi that given we think patients majority in.

in submissions, with do MAA will And just the as a quick half lifileucel broad? first second in question, launching Iovance U.S. other submitted you to be ex be the partner. Or expect to

Frederick Vogt

a sustainable we information, they've patients It's going bolus. that's be think and some Tyler, initial the on like tiny and The team going there. fraction lot looks the is time, of there is sales is got some quite not our time. to out go out and for this for bolus Yes, quite of it to a

value a intend dilute looking our the of On right the for potentially We to think partner not that ourselves. MAA to we front, We're now do that. that could do assets.

Operator

from with Lawson Barclays. question comes Our next Peter

Peter Lawson

the Great. Congrats on progress.

you're through the coming versus you the booked gets and about see of how not impact of IovanceCares and of program? patients if the wondering kind talk that you on on can thinking program how how in Just program that kind patients on revenue

Frederick Vogt

no amount Does when track the they all they're help? matter system, in for got patients system commercial IovanceCares the Yes. system the that patients. Right press now, our the full patients X. all Peter, pay about talking system. that we're are the we register confuse that's we that IovanceCares to that seeing assistance through in what the to we're don't say patient use registered includes able services. release, the financially we Amtagvi, about but also IovanceCares, talked come through

Peter Lawson

And it about Perfect. how start how long of we is think would XQ? period late to before Got a should it So Or booking revenues? you. take is Is we of it think that of XX-day versus XX-, about kind kind a then, that? longer? beginning XQ can kind of

Frederick Vogt

of and infusion. at revenue about talked recognize that was we about last year talking too. that time So the we Jean-Marc earlier,

like the we therapies, the into recognize actually patient. arm when Just we Amtagvi of other cell revenue the infuse

starts does now weeks for that versus But to revenue then and that quarter away. there line, Jean-Marc, manufacturing, talking -- revenues that's point. time see to is happen. commenced will and until why talking to quarter we've some just of far at product We're about It's that? anything not very first infusions got we it second you've and you'll a if occur, obviously, release third accrue and quarter add So the the time been add manufacturing versus here. us

Jean-Marc Bellemin

release have manufacturing sometimes then It's the properly we'll the now. think I weeks all so will process, happen No, infusion revenue of coming first a the the question characterized several we will and book after it you still.

Peter Lawson

can the that they of earlier selected? that, later And about kind line? line, Any have anything say already details patients are they you around -- Do been agree. I

Frederick Vogt

get you this? could Jim, Yes,

James Ziegler

Yes, and this it's moved than we're up. approval, been probably other much hours. as as not center had that got them And appropriate was about talking to worked go. to within comment The ready soon patient too had literally we identified

Operator

question next with Baird. Kusy comes Our Colleen from

Colleen Hanley

reimbursement tumor to And to the up that in add the have reimbursement? does example next lined success the getting far? center On to and section already? you on that, of just happened business eventually reimbursement of patient did speak confidence the rate can that the speak that Or so the day, early

Frederick Vogt

I already you're Colleen, the the worked whether Yes, for first patient clearance partially Is their up? saying? think first that got had there what question. you cut But financial off

Colleen Hanley

exactly. Yes,

Frederick Vogt

Yes.

on telling to basically in ahead And can they health it going to you second comment Jim, the that comment essentially. question parallel, so So about more, that overall? financial -- center are then, fast doing clients Jim center that get want but wanted do

James Ziegler

the the what bit would unmet tell. of haven't very, are the clinical payers is early provide on. early But value Amtagvi. disclaimer appreciate I to that And need, very Yes. we But any too Colleen, I would to date, understand still say had issues. a it's we the

Just to very ATC our this particular quickly account back having competent out payer, going patient out to very moved manager and reached the this the dots and in to a situation. that particular reached connected everything very experienced smoothly team, first when the and payer

Colleen Hanley

helpful. approached us unique really remind you historically be just there regulators filing U.S. would Great. Europe, That's similar follow-on, And what this if quick versus Europe. anything can, lines just I Can And us U.S. regulators? the remind you time have review in filing? on about this Is please? to one

Frederick Vogt

do to that unavailable actually Raj approval Raj, you XX-month a M&A on we well, be to process won't take [indiscernible] is want accelerated period. Europe one? in the further get Colleen. answer, The until know can renew that and it as in first a we

obviously will We as this EMA. to European EMA review the been patients. we the interesting possibly aim very can in get with fastest very getting has for cooperative, drug

Operator

Yee Michael from comes with question Jefferies. next Our

Dina Elmonshed

This is on Dina in for Mike.

say for to congrats and wanted thanks today. the approval Just on update again the

and the be a think months? think be the of per could in in quick of site cadence how on those XX question we the patients and treated in next have patients process, the Just identified sort cadence coming would coming you how of be the I months? new patients, would infused of many you the that mentioned about should sort weekly. know we bolus But can about how how

of And XX%? success manufacturing the Or likely be slots at capacity, quickly how assume in we least were And FDA? by many and actually slots is should approved model and that? rate on the the how spec just to

Frederick Vogt

Yes.

go cadence bolus this. expect to of a through on we the essentially large So treatment,

we're after from to across waiting KOL banks you for ATCs, see of patients month. XX see continue patients contend of really here that's us out, patients KOL be and large we moving like stuff most can busy, every we're sites and we all that, to going busy the a when all XX, average to several as you the And months. the for the have As Amtagvi, of then analysts month calls to couple to with. interactions, going number you can think a very And from same that the that, for so next be think there's of lot getting a

So then steady bolus we a expect to state. be essentially the a cadence to That's and move helpful.

be On total in happy actually of slots Wuxian, we're we've we we'll what think that that handle and got enormous of on us to that a haven't very ITC I disclosed the be capacity, got our amount the creates the manufacture. and publicly we lot with and able -- any facility comes to fact FDA slots between gave load space

successful we know at on the really yet. the the it's cases. We -- and really in think And regarding We're high, then in we will We that, happening. going what's only right what in and advanced working days success majority be don't manufacturing can't of don't again, quite XX percentages still -- this launch disclose be really we're literally to point But we XX now. still testing. rate,

time that out. So we still figure need of a to bit

Operator

One for more our next question.

Our Catanzaro next Joseph Sandler. with question from comes Piper

Joseph Catanzaro

on I capacity, different but maybe up in it to as a manufacturing way. wanted follow slightly

early and indicators So think the and will what of to a all, about able stagger sample their provide of is resect as meaning, timing your of slot tumor you is pretty just mentioned receipt today, ability or to to have choosing? if to the based the at dictate you the at demand much ATC their resection to have to samples, we on ATC bolus of a extent, dynamic going

the And the planned timing of plans by but to the what And then that? around still know add beyond so, sort be days, any May, my second if are what's I end early to question, ATCs that? onboarded XX it's there of ATCs And the extent? to with

Frederick Vogt

plan XX the Jim, talk Igor, you little bit want at TIL. take first can Yes, part? the do to a Maybe we about

James Ziegler

Yes.

Igor Bilinsky

thanks question. Joe, the for Great. Yes.

for -- all that capacity, trials. about the way And ample every as our we understanding plan. we accounted research, of have the part dates support well mentioned, as ATC have surgery capacity extensive in clinical I launch our and of of and that designed to the we preferences as was So each typical the

capacity are the to what need the need we flexible ATCs the rate provide queue basically same. board, to additional who treat to be patients expect we and to do to all accommodate as do and on all completely ATCs in the plan they So now

also, and staff without authorization I us filings enables mentioned, conducting increase as And the additional the with additional to agency. capacity capacity hire

James Ziegler

this is of Joe, pick by end going up in May the identified treated we XX to the is portion that ATCs country. Jim. of significant the the The patients

continue they're with And what CAR a to to is line top sure a from at want the there's will these and of to service that make But centers, had I make that like successful just market, we've We monitor need before, what the their top sure reminder, expand point. in do treatment. that mentioned we T reinforced the success. We centers. the concentration care build

expect top Amtagvi. all to XX do the treatments We XX% about for the of

Operator

question Our with Truist Securities. Asthika comes from next Goonewardene

Asthika Goonewardene

day now. it's that you XX X right if degree And a on can look I into or of insurance the plan Maybe right have But light a where in could right are lives just the since months? coverage preferential know some proportion little more I in approval. get just U.S. what you next now? bit bit maybe want of year, the proportion want you ask to coverage down what And coverage. to then X where about also now? us about do you getting maybe of tell XX has

James Ziegler

payer where and their our Jim. commercial, our This in XX% reimbursed are This Medicare, reimbursement. has X% Medicare coverage we Advantage. the cost centers just these payer is deck, mix. I'll X/X that includes of XX% remind About are Great. or strong you mix IPPS have in and exempt corporate

So in coverage indications, seems insurance we're And initial that terms coverage. now, I would have very lot in that early moment. is very, on our be payers to and this of tailwinds say granted, at we right of appropriate launch, a access

Operator

Reni with question Citizens Our comes next JMP. from Benjamin

Reni Benjamin

start infusion same Maybe treated reimbursement multiple the just this Or takes ATC? in the will the once next place, launch a -- off, maybe think seeing it's early online. get potentially more patients do and you on, you early from the this of to are getting patient

Friedrich. maybe Just understand developing? how trying you that to And then see for one

to we the -- we have this that other studies be expected Would have that, of Will additional we And or have are at related data get more one we should medical and trials could love a other know, either data could that's meeting. update. XXXX ongoing patients ongoing, from longer you to guys just year? You that be Cohort for follow-up? XA expecting clinical the

Frederick Vogt

had question issue So We that. the first you the most the -- we technical can But a clinical Reni, again? couldn't we question what's here. first question. hear of of heard ask just we the Can part

Reni Benjamin

Yes.

are X just on trying ATCs just ATC go you are each and away? to wait X infusion to on until I'm Is they've kind through the So of ahead understand from that putting they process. on they're ATCs and board, seeing pretty or X ramping putting the patients right they going -- give place patients on? then much patient takes an before and bring another patient Or are you

Frederick Vogt

you ramping question, clearly of And limited the any that away. in They're will that not right at then away. right That's here. easy question. you -- could people one? the keep part Friedrich, ramping I guess least Can that. second They're the They're by way take

Friedrich Graf Finckenstein

heard that. Yes. I

Reni. thanks, So

was question XA the your So about Cohort data.

everyone, the with context of be kind So to patients as proof-of-concept and that's that's + a reminder, IOV-COM-XXX, our TIL melanoma evolving us more having is treated TILVANCE, TILVANCE obviously some the out more in it here and both. of enrolling. to you it's that's were And advanced of out it's pembro, patients so great bring or with for for follow-up study cohort study checkpoint-naive data more asking

publications additional this really at anything time. said We haven't about

that. posted on stay I'll So

Reni Benjamin

see straightforward point there Or any there and you again? you regarding expect there and perspective, Okay. you replied provide me you be Do is you clinical the questions then Can to lifted area both just the potential back color hold? feel wrong. be a I an Do you can the hold in see think should from ask forth? like And do be you Correct at I'm -- soon? could the trial be pretty a follow-up Friedrich, those for just process, should mentioned I bottleneck? pretty it any do -- to any if FDA you've was already the FDA. where

Friedrich Graf Finckenstein

you first do and want take to? you then I go to Jim, want the to question talk

James Ziegler

still in just on about early multiple your but centers multiple are on scheduling patients. calendar. back from seeing Reni, to patients multiple we a day It's given even on, Sure. circle very patients the question

from So ATCs become think ATCs that we ramp should comfortable multiple as forward. demand see up you'll you with I expect more patients and that going

Friedrich Graf Finckenstein

And on your study. question LUN-XXX regarding the

confident FDA what are -- we're them start soon in going to needed them are being this enrolling see to we to they case our plans expecting us fairly that to what in gave well. and we're we respond order So as the

Raj Puri

Raj. is regarding comments to clinical the also I hold. add This that Friedrich's Can

As really FDA live hold they are to clinical Friedrich and actually the to again. need expecting has this we soon the resolution patients begin hold, mentioned enrolling everything that the of

Operator

Sachs. Our next question with Goldman comes Andrea from Tan

Andrea Tan

follow-up back the partial maybe in I if different to on December? hold basis share from That last the the to Friedrich, you helpful. more of but a would it your be question could confirm initial there, any if any clinical just wanted was details thoughts

Friedrich Graf Finckenstein

have our learned no from inaction meantime that the there's with FDA. -- no information nothing we new in There's aspects would the or

detail in response the we basis have we discussed of that. bit and a said, enrollment in And of we've new been working addressing about the we So expecting quite addressed are patients. as on December,

and partial who a right? offer are product. to available have patients to a were agreement So who to enrolled hold, we be with this able as was the therapy just in reminder, FDA Again, already

So that hasn't also changed.

back no that new then. information, nothing know unexpected we no new So again, or -- didn't

Operator

with question next Our Guggenheim. Goodwin from comes Kelsey

Kelsey Goodwin

the to prior I of on bit a guess questions. build some just

the... for First,

Frederick Vogt

Kelsey. hearing, not We're

Kelsey Goodwin

you Can hear better Okay. Hello. me now?

Frederick Vogt

unable us. you if to Kelsey's go can question We're hear

Operator

moment. back move the still come moment. One question to to and you hear next on guys We'll Kelsey, one me? Can

Frederick Vogt

can Operator, you Yes. just we the hear but a time difficult having you analyst. hearing

Operator

One moment.

Our Ben Burnett next with from question comes Stifel.

Benjamin Burnett

incremental will just about much to Can per Proleukin, the just I this question just and of with the a price revenue you be? had talk model. how help patient

as versus of the And regardless same follow-up insurance? it's to is has this commercial insurance if the I a guess handled government if sort that, patient -- of

Igor Bilinsky

repeat you Can question, the please.

off. cut was question the of part first The

Benjamin Burnett

about ask insurance Amtagvi sort of that revenue much same was, the how the then commercial to tag? price of to be and follow-up might regardless wanted handled expect insurance? patient I versus would top the per on involved is Proleukin that And incremental of Apologies. government you

James Ziegler

part take then, Why in. I don't jump you and first can Sure. Jean-Marc, the

know. you as So

for For a prolong sectors. average with the Proleukin dose What X,XXX. mandatory the a commercial the that be cost The point, on discounts share same. or would would of used be at Amtagvi are would at per you is doses government X regimen, this would same, the whether government be exception reimbursement of the whack I

Benjamin Burnett

see. I

Okay. That's earlier runway question just cash what for assumption does To a for one And extent Jean-Marc. that estimate Amtagvi. helpful. maybe the revenue incorporate you mentioned

Operator

time, one Jean-Marc, that Could Ben? question more are you there? you repeat

Benjamin Burnett

in I to Certainly. maybe assumption you just was curious, is earlier could that guess, was I what extent revenue mentioned speak Amtagvi. the that cash runway curious estimate. prepared estimate for to the remarks? incorporate if I'm

Jean-Marc Bellemin

Can you me hear now?

Operator

Yes, we can you now. hear

Jean-Marc Bellemin

Sorry.

some We there. technical are difficulties having

question, the Ben. So thank you for

some revenue have looking revenues. not the we our those account on do conservative taken way I'm we disclosing more. cash side. conservatively obviously, take the have in been have into of into But from and yes, Amtagvi, we But So very runway. again, course, we're revenue

We second cash XXXX. enough half of well have into

Operator

presentation. does remarks. Ladies over Fred today's turn I conclude to for would any and the this now back call to Fred? like closing gentlemen,

Frederick Vogt

just the can can hear me you of technical operator, difficulties. And because you confirm that

Operator

hear can you. I Yes,

Frederick Vogt

for Conference start the Iovance. already Results for Fourth again Quarter you Biotherapeutics to Thank Full an is Financial and XXXX off XXXX joining Call. and Corporate incredible Year Iovance Update

stake remain is oncology first-in-class the in the solid has category field as cell community therapies ground to contributed of We're commitment for first that a research deliver innovating, and patients, the the occasion the a who therapy of the mission many. and leader the patients global have advancing efforts a to participated scientists, we've pioneers testament care momentous therapy therapy. Our clinical of have takes also expertise commercial institutions tumors researchers, effort TIL been firm this love unwavering is delivering and the this TIL in providers cell therapy to to coordinated It for decades. to This the health type achievement trials. is a and to planned all collaborative who and to thankful in now developing for large

Tampa our and in possible. U.S. advocacy health care partners communities made to as regulators, you Thank and this in the and approval patient the well that communities those as Carlos San local Philadelphia,

would thank support. covering like I for to in shareholders also analysts our their

feel without the a to you. thank be want reach could And here free for Investor We difficulties and forward on We XXXX quarter further technical I to lastly, Thank steadfast team. in our not May. Iovance our Please pipeline collective our our today. Relations conference apologies science. updates providing the exceptional follow-up second efforts out to and their on to team for cross-functional to and commitment call the following the launch Amtagvi look

Operator

participating. concludes you call. This for today's Thank conference

You disconnect. may now

Iovance Biotherapeutics (IOVA) 28 Feb 242023 Q4 Earnings call transcript