Earnings call transcript Q4 2022

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Operator

Welcome to the Iovance Biotherapeutics Fourth Quarter and Full Year 2022 Financial Results and Corporate Update Conference Call. My name is Gigi and I will 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 at Iovance. Sara, you may begin.

Sara Pellegrino

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

Executive Dr. press on Puri, Executive Officer; Interim our Chief call, Medical Ziegler, Dr. Finckenstein, Jean-Marc Vice Dr. have Financial today’s we Fred Officer. our Jim President, President Officer; our Bilinsky, Officer; Chief Vogt, President, our our our Commercial; Friedrich Speaking Igor Operating Vice Bellemin, and Chief and Chief Executive afternoon, release Raj Dr. is also can available the we Regulatory issued our and recent This a financial results on iovance.com, Translational Medicine, found and for Strategy at the December on corporate well which that XX ended the Q&A be as for website updates. X session. corporate months as XX includes

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

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

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

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

Fred Vogt

XXXX and XXXX. into everyone. of good progress Sarah the you, pleased highlight in positive afternoon and am and significant Thank to the at Iovance I milestones beginning

therapy, BLA, lifileucel, this or license the quarter. TIL to in lead end We completing before are close biologics our of application, our advanced melanoma for

that one close unmet acquisition. a This preparing upon priority represents significant for who on pipeline medical patients our a FDA advanced given or of number setting. lifileucel are melanoma commercialization, in anti-PD-X progress approved The currently treatment planned are there no of immunooncology with after remains Proleukin robust need our options on therapy. for also behalf We developing this integrating BLA the

the our unmet process interactions into potency matrix as during going confident from of several BLA last very FDA data on the and feel included feedback and the These alignment and strength FDA and given where favorable a a trial, in assay review successful on meeting the with X X We XXXX. BLA need data April and FDA of clinical July, as safety positive our provided well from sufficient was pre-BLA efficacy including feedback follow-up dataset for the the review. duration and clinical clinical that C-XXX-XX of the clinical Cohorts

the as In also quarter, melanoma. recently advanced registrational agreement the TILVANCE-XXX melanoma well as study approval we reached anti-PD-X lifileucel as full supporting X a in confirmatory with a post indication of fourth to advanced frontline serve started FDA Phase triad on trial, our

We the XXXX. expect trial at be and Overall, the approval potential level to of details talk and the time continuing in collaboration TILVANCE-XXX this on well continues forward engaged call. of to to will FDA be to We look supportive. additional Frederick underway about today’s

of our close acquisition We the planned Proleukin are this integrate to preparing of also upon product.

infusions. have product IL-X month also Proleukin, to it to is with reminder, currently TIL a worldwide indications acquire entered that importantly we T-cell announced to strategic rights we promote last Clinigen with an following a activity As approved transaction into used

and and transaction, trial cost this therapy a to and expenses of and surrounding future We immediate control and logistics strong the clinical IL-X have which fit is full lower goods for future supply revenue of provides strategic and lifileucel. TIL expected chain rationale for

TIL has patients well pipeline solid for our therapy to In tumor as cancer deep addition to as building are that multiple lifileucel types value create we a melanoma, potential shareholders. diverse the on significant in and

setting randomize Phase call. and to preparing several today’s will trials clinical X on in active genetically highlight modified melanoma study X Frederic therapies, treatment conducting our also TIL in first which frontline are We patients advancing the

to look this addressing to your products. preparations prepare cell questions expertise manufacturing forward gene TIL potential our currently to ask commercializing call. I Igor our first now developing than grow oncology we we for launch, in As our and XXX organization and therapy employees potential updates approval. And during later and Iovance and we have who supply commercial to address upon have more will therapies

Igor Bilinsky

critical Thank for particularly Manufacturing TIL autologous any is commercial Fred. you, launch, for therapies.

supplies is scale our patient meet priority while commercial top prepare So internal needs, up continuing our and to to to capabilities for staffing.

more therapy consistent to-date. with of than We maintaining TIL XX% manufacturing on than are success and patients more operational in rate XXX treated focused excellence TIL Iovance

are supplying suites core suites flex commercial in from activities and for clinical manufacturing. which iCTC, studies for manufacturing clinical currently for We is readiness preparation BLA operating

to supply We the our The additional balance work and prepared of the that to TIL iCTC to efforts significant is with have our well launch, ensure many of current manufacturers’ demand. provide optimally iCTC that done approval on to patient with expect are process. most contract upon manufacturers occur and review to for contract the during expected FDA BLA inspections therapies capacity facility flexibility we commercial pre-approval focused

XX,XXX to from available and as more automating new well products to TIL the our annually. shelf term launch lifileucel, we for adding patients of as processes, cancer with supply than Longer annual space as iCTC look next can than The products is paradigm manufacturing establish by we that for Beyond capacity this future built X,XXX to is X,XXX for initial our needs TIL facility. of streamlining capacity for planning therapy. shifting are facilities we more to annually more as capacity than currently patients patients as build vision class supply build out

annual or Iovance-owned protect granted Extensive TIL XX-K. solidify Form is own on and also critical including that our our at component website support least are therapy. X proprietary know-how IP processes in and on report currently property, and our allowed is into XX highlighted provide manufacturing on and IP, We our expected intellectual to Our detail patents, leadership international exclusivity or further global corporate U.S. Gen rights patent and within to XXXX. to

to Jim our preparations. hand Ziegler now call would lunch the highlight I like to commercial to

Jim Ziegler

Thank you, steady made Igor. towards progress Throughout the launch. commercial team XXXX,

the our include secure ongoing centers, PLA submission, achieving priorities and authorized our operational treatment launch readiness. appropriate ATCs, an or onboarding With of access

and service continue cross-functional onboard to new develop workflows partner to teams within centers. are at therapy Our leveraging with ATCs while therapy these TIL workflows to existing that cell unique lines

teams onboarding of and are onboarding activities training structured each regulatory timing to The ensure upon and ATC treatment and multidisciplinary lifileucel ATC to regional support FDA efficient aligned teams the Our at approval. an director curriculum operations regimen center have administer have training process we developed the can account interactions key our and execution to timelines.

launch each line TIL readiness. We developing center training in service just-in-time we plan support to their ensure and

strategies focused coding, are Our coverage on payment. and reimbursement securing

Our continues team the market to key engage national access regional and payers.

appropriate As to our patients we to have to trial setting, lifileucel. the is approved commercially goal timely transition ensure from and access clinical

is team for cross-functional also plan needs Proleukin. our Our and our assessing capabilities developing and implementation

fortunate several experience are prior members end-to-end We Proleukin leading with are also and team who leadership cross-functional have to our integration developing processes.

excellence. critical We our acknowledge the for autologous for and therapy cross-functional of an a tireless Proleukin smooth problem-solving thinking, upon close are team. We to and sustained operational the that cell And our understand launching efforts operational acquisition. requires transfer planned readiness want of I preparing

for of operational to Our ensure the themselves highest a quality bar team excellence. has set high

efforts our readiness. scale to well-positioned to ensure are commercial launch We

Frankenstein, to Medical pass the our I call will Officer now progress. clinical Chief Friedrich highlight our to

Friedrich Finckenstein

Thank Today, in you, I strategy pipeline therapy would like summarize multi-pronged technology. to Jim. our next TIL melanoma. advanced will I with generation our and begin

the in largest lifileucel ever anti-PD-X results for submission post therapy based post DNA rolling for ICI clinical ongoing single melanoma. Our study the on melanoma C-XXX-XX is our conducted trial, TIL advanced in from

the the for for X first of last at the quarter, In X presented of community the Immunotherapy fourth C-XXX-XX Cancer we Cohorts JITC of for medical data Immunotherapy Cancer the November Annual and study in in from Society Journal results or positive published the December. SITC time Meeting and from to

confident are support and data clinical Cohort C-XXX-XX strength the our the pivotal trial, the approval. including We X that support Cohort XXX from X in of of patients

like confirmatory reached melanoma. trial advanced advanced of with with to in on FDA as frontline advanced Following n the of highlight serve clinicaltrials.gov, melanoma melanoma Phase as lifileucel We I pembrolizumab frontline X for additional on TILVANCE-XXX our like would in to-date. agreement recent combination posting trials to trial detail trial [indiscernible] approval this to a support as the post-anti-PD-X and lifileucel full registrational full well in our of approval TILVANCE-XXX

assess we Notably, to committee includes endpoint TILVANCE-XXX very or and duration several of FDA ORR rate response. survival overall as dual or endpoints agreed response of were objective independent PFS. pleased primary and such survival blinded BIRC progression-free or also secondary that review the

in lifileucel the naïve are to and the In to XXX in arm control terms either plan equally the who pembrolizumab of design, of of randomize experimental advanced trial arm. we therapy pembrolizumab and setting, to patients combination monotherapy

U.S. including upon centers are to arm, of large confirmed In by an number We expect TIL control other IRC. patients numerous and many progression appropriate European monotherapy disease sites as receive the verified cancer enrollment. will the and option where global from we countries, the in have such

and are trial Additional on information on eligibility design, outcome criteria measures available clinicaltrials.gov.

Xa randomization advanced our melanoma, lifileucel of Our IOV-COM-XXX advancing from TIL in trial for XXXX results the in forward strategy site at in pre-ICI ICI-naïve confidence melanoma is prior success our based era. in to melanoma the and generated with in of our patient Cohort on combination We anti-PD-X in in TILVANCE-XXX TILVANCE-XXX. pembrolizumab data NCI to naïve monotherapy the through look activation ensuring in addition frontline

advanced expected underway at approval for anti-PD-X post of TILVANCE-XXX potential melanoma. be lifileucel mentioned, to is in Fred BLA well time As the

within frontline patients data to in the the treatment-naive plan naive NSCLC to the we last data plan to at Cohort NSCLC particularly release or Cohort XXXX post-chemotherapy We we shared Iovance conference XA in and across Based results continue stages which updated cancer to ongoing investigate XA Iovance, investor for NSCLC with in FDA the and from results potential treatment, month. studies press line to present in on registration non-small-cell advanced with we IOV-COM-XXX path is with Cohort year. lifileucel We medical top disease. populations Enrollment to advanced success, at regimens meeting cohorts and call are meet a treatment multiple of discuss at recently trial, patients. of highlighted and various to lung and who pipeline various on detailed our positive ICI execute this in XA initial X X initial

for investigating prior an and to Our LN-XXX We option is patients tumor received year. combination or IOV-LUN-XXX enrolled continue pre-progression anti-PDX harvest. in patients expect for who this In monotherapy and chemotherapy. trial and sequentially enrollment XXXX includes have

our to Moving Cohort anti-PDX enrollment in patients is ongoing C-XXX-XX therapy. chemotherapy underway who after trials have X cancer, in and expanded progressed in cervical the

during enrollment be feedback we following X submissions look FDA. As regulatory the a support to to and reminder, Cohort year. And dialogue X the is pivotal continuing forward intended to from Cohort

next are our We therapy. excited about generation TIL

We genetically response. that from therapy is several utilize candidate. modified the gene-editing checkpoint genetically TIL technology inhibit are TALEN by therapies modified IOV-XXXX optimize our inactivating anti-tumor first TIL that developing to proteins licensed inactivated PDX TIL therapy selected immune

year, patients with with our In the last the third we previously treated or of first in first-in-human NSCLC. IOV-XXXX quarter in trial melanoma patient IOV-GMX-XXX treated advanced

programs and targets. preclinical Earlier stage are development enhancements, enter the therapy double the to approaches as CDXX/XX modified potency, TIL genetically expected inactivated additional of cytokine. Additional TIL tethered negative TALEN research XXXX, selection clinical TIL and include using checkpoint with technology multiple studies to in such increase including including immune

As the novel treatment regimen, IND-enabling part optimize our of studies we interleukin of our also TIL continue IOV-XXXX. analog strategy to

I question-answer-session. am available the during

fourth to over quarter call results. the Jean-Marc to hand will and our full financial discuss year I now, XXXX For

Jean-Marc Bellemin

of as ended quarter on in December Thank your financial the found as results will be you, well and high SEC from comments XX, this can filings. as acquisition afternoon’s our Proleukin My XXXX. level fourth full planned press summarize as release our Friedrich. details year More well in

approvals the that upfront acquire an other melanoma month, agreement and and after approval will million to customary lifileucel Proleukin and are milestone the from payment payment of regulatory clearance is Iovance met, into conditions conditions. cash of financed close Clinigen. double-digit Proleukin global in £XX.X be agreement Last expected with transaction and existing £XXX.X Terms we to have of first all million, announced an The entered Clinigen. advanced upon we from sales include royalties to closing including

we year, on the in As this preparations, launch activities. and also pipeline return oncology late commercialization investing stage company potential approaching manufacturing are

from million cash, plan investments planned and raised $XXX.X XXXX, into XXXX, half taking the strengthened cash launch operating million market restricted fund advancements. expected As acquisition, quarter XXXX or the compared into unaudited our million to through XXXX position of $XXX.X the and our the including in raised facility, we XX, execution, account to February $XXX XX, cash The of December first cash second and of and equivalents, quarter on proceeds ‘XX of trials which and position the XX, clinical approximately other ‘XX. December proceeds is XXXX, $XXX our approximately in includes as ATM held net current Proleukin in fourth million into activities, during cash readiness is pipeline manufacturing of ATM

results was per fourth XXXX. million XXXX. per per per financial to our the share $XXX.X $XXX.X net million quarter and fourth million December $X.XX or for year or million the the XX, to or for $XX.X Net the of for fourth full $X.XX of $X.XX $XXX.X Transitioning to share the quarter XXXX of ended $X.XX quarter year for full XXXX, net of for loss or loss share net share compared year loss loss was full compared XXXX the

over full XXXX, development $XXX.X were for were $XXX.X an compared fourth expenses XXXX. development an in and and the the prior related as periods trials. to million the internal research expenses for research costs including lower increased facility million These increase quarter were full million expenses as year the driven clinical year and $XX.X in $X million of and expenses development of internal compared fourth for costs our research of for million enrollments by of clinical quarter to $XX.X clinical The well with Research the of the increase programs. fourth the partially XXXX, completion associated at expenses year by in expense offset increase and and $XX.X the million team, and manufacturing attributable Research year compensation stock-based of primarily were XXXX. XXXX quarter development to cost full growth

year were for fourth in of million General million administrative XXXX, for and expenses increase to general headquarter quarter compensation and million million fourth increase and the periods XXXX. quarter of million year $XXX.X the million compared well attributable stock-based the an to of XXXX. administrative year cost the the expenses compared general $XX.X and for build-out of increase to were primarily an and administrative compared full were XXXX, promotional the of expense, General full the internal for activities. corporate in administrative XXXX as teams, fourth quarter and expenses including year the $XX.X The $XX.X with $XX.X the to full as $X.X associated pre-commercial growth prior new

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

the will hand Q&A operator to session. the off now I kick the to back call

Operator

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

Peter Lawson

said BLA Great. questions. much of you so around of the by done left? confident Thanks for kind be the needs what’s to the there, submission Fred, what taking end it XQ

Fred Vogt

going we that Yes, are we get Peter, really confident to are done. this

CMC of We work activities that the we talk relating validation like stuff and work, lot have about work, are assay that, we completing. a to essentially

important are here. to before. it what about done it’s talked and of very kind that’s But we have routine We the It’s getting relatively work. FDA

submission. rolling the complete BLA can we So

Peter Lawson

sometimes Okay, a of expecting any can on on but launch, of launch bolus the you off, that? to you okay. and of quantify And just kind see then lifileucel, I are kind patients way know

Fred Vogt

take you want Yes, Jim, one? to do that

Jim Ziegler

Sure.

after experience these checkpoint of into in of our – KOLs in many are of dialoguing Given even high patients need sites this clinical unmet a therapy and trial number translates the in at experience, need with who there a our is our inhibitor.

high of unmet expecting So launch we a need. are patients given bolus at that

Fred Vogt

you have feel out And the Peter, close order do. in we do there, sure a we wants stay run an program for so to are adding as to FDA we for contact that good what’s site EAP patients making care that in with

Peter Lawson

you. Thank

Operator

Mark Oppenheimer. comes Breidenbach [Operator from question Instructions] you. from Our the line of Thank next

Mark Breidenbach

Hey, for guys. taking quick the me. Two for ones question. Thanks

can if the presentations First, aside Thanks in Cohort barriers study? plans comment I are wondering, Friedrich am remaining TILVANCE-XXX just wondering that before can I XXXX? And on then recruitment you taking you data clinical begin from additional also lung data, there XA for the into mentioned, for questions. the am

Fred Vogt

do later talk data too, bit lung little and Friedrich, little the bit activities you a year about for for this about probably startup about you want want? XXX talk if to a potential the could you

Friedrich Finckenstein

question. Happy Thanks to. for Sure. the

So startup TILVANCE-XXX. we being on about in have spoken

as the at sites, specific would that sites beyond meaningful And in a of there going basically number and to apply additional So enroll will of we activities site and basically are continue hurdle as much that parallel initiation the protocol one to startup it’s ex-U.S., individual at in would That Europe are no sites. that then and submission means of sites enrollment, trial. this work U.S. sites, of like reviews both startup sites, the be as Europe that well adding to will to is on all hurdles. really now kind

activities hurdle individual site to sites. sense? non-specific really, So Does make at startup that

Mark Breidenbach

for I the Sure. you sense a would get I to to am patient first guess expect trying enrolled? when be

Friedrich Finckenstein

to guided when And time have is of expect main we indication. approval though here. be will at the well enrollment the patient that I enrolled. haven’t of relapsed we the to underway Yes, What exactly be said that’s first we the point think refractory

Fred Vogt

if would we patient. we randomize Mark, certainly Yes, when everyone do the advise first

Mark Breidenbach

Got data? the it. to with besides clinical Cohort And lung presentations then other respect XA

Fred Vogt

Yes, that I I cover can one. mean,

XA right bit running Plus, deeply. year. We out just potentially study, little we out already do data a the more weeks want lung medical that to conference could read draw on including to put have data additional few a this get and now, ago studies the and we which LUN-XXX a

when very So that important that think presentation company will a the for I be comes.

Mark Breidenbach

be Okay, implying. is you all presentations what are lung will the in

Fred Vogt

I necessarily. lung. just No, you asking not thought about were

Mark Breidenbach

no. well. go other for to am trying all as I No. indications

Fred Vogt

do, indications for be sure. pretty say there sure thick what could and presentations, we’ve can’t other other for Yes, – going I we to a pipeline other there got is but well, are

Mark Breidenbach

Thanks. Alright.

Operator

the comes Instructions] Tyler Cowen. Van of next XXXOur from line question Thank you. Buren from [Operator

Unidentified Analyst

Hi, for It’s Tyler. guys. Tara

So staying I data. on topic guess same the lung the of

And when FDA January, So since report was it just received duration. expect with the is But are or I going new early Thanks. know feedback in full on your then when see closed results too to ago the that that what there that few how presented? weeks you of study there you discussions back are anything to Like, on kind to response following do you that XXX? positive January? that comment

Fred Vogt

on assuming study? the Well, LUN-XXX the

Unidentified Analyst

Yes.

Fred Vogt

described with we is on closely and released are the engaging the going like we to about any important that meeting of now. one but do one the where obviously part we our when discussions best the presentation will proposal in a like January. – data, as XA the we should are we FDA you with We Well, that seeing really to don’t – we we as the medical potential medical get comfortable have be durability presentation. back said, And that’s soon we right are Yes, can. of we trial I are content support registrational time. That’s very are what our we of say to FDA. ahead more doing much updates on watch it, certainly something are we that that I do on to can’t with that. it for thing

Operator

from from Instructions] [Operator the Yee next you. Michael question Our Thank of comes Jefferies. line

Unidentified Analyst

taking This is Hi, the guys. much Thanks for [indiscernible] on so Michael. question. for

based also review? that had sense wanted made can update? you can to I since with Given them, guys any further you color progress gating with a that the just kind well? AdCom on had spoke know to that submitted you get guys last share on you as helpful. that have priority just and additional factors last interactions about guys what update like will I better the is be potential commentary remaining FDA that if any add you. the there the getting Thank And if any submission on just for you guys color on, but That it BLA And a of have or are reiterated QX, since you the slightly, BLA you

Fred Vogt

more additional with any we and haven’t to expect AdCom had review this interactions we We will priority at them. some about know for in point. have No, do

about an the this. before of CMC work AdCom, a activities about because whether with that likely largely here, Raj BLA little validation on that it’s bit of few leading possible may our it’s, familiar said work that’s on color at the bulk we get the to times it’s the more part T-cell calls can work, tell we is the I We submitted. an some has the With like it done AdCom talked have and do, like you respect stuff filings. is spoken point. I not this of a to is and for therapies earlier,

these So now homestretch we of key completing are are just on some from that a takes the tasks lot we the of and effort company.

before. lot to difficult communicate working this not get it about in but of a where extremely of with basically the we technical it’s spoken it’s be of thing really, and to this, a have lot done hard We it’s additional nature, very people have will like kind here on CMC very validation activities, Street the

Unidentified Analyst

Okay, thank you.

Operator

Thank comes Stifel. you. of Instructions] from next from Ben [Operator Our line the question Burnett

Ben Burnett

Great, clinical to onboarded, ask sort centers the in Like many onboarded preparations the you thank stakeholders all for lifileucel. U.S. want that I activities necessary have you. trained sort particular of all sites your have clinical us of just Can site? trial wherein you about you how already the you at treatment of remind a you as have melanoma sufficiently launch to-date? feel how per clinical just many

Jim Ziegler

Thanks, Ben. Jim. is This

Fred Vogt

Jim. ahead, Go

Jim Ziegler

Great.

it’s exactly that is process. process a onboarding the So

analogues patients. at all drive patients we top the of the care own the these looking a concentration the of heavy is coverage is, there have XX% We to XX% assessment, give you across numbers, have as about as what about we we stated in ensure XX XX treated the top about but centers. In engaged of well based upon I geographic treated that specific the know types access. a and key the that number past centers our all market, at CAR-Ts, country have sufficient like CAR-T won’t of

to If train right are and want them there our targeted recency. too launch. them on turnover, up could launch. the be getting of sites into for up ready in We the we the there staff final focused be we phases could train So soon,

what are BLA onboarding is to start up filing acceptance, acceptance, doing And as the and really accelerate we as really we BLA then final process. now? will that So have soon everyone well lining we

Ben Burnett

have That Okay, sense. want then the you have just post-pembro timing of support sight get question understood. And expanded makes data? CRC guess, needed additional post-chemo do then line in particular, one, as another to to I setting? I from ask program, kind patients where program CRC we number how data of be in the And that there BLA setting. said the the to many to enrolled can of you in about

Fred Vogt

I think, CRC talking talking CRC right. you meant you are said you non-small-cell are not about Yes, about you right, lung, right. colorectal, Ben,

meant So cut you I non-small-cell you there. assume lung, off got

Ben Burnett

said My apologies. the I wrong indication.

Fred Vogt

and Yes, explored we indication are we IFPs. although interested don’t through have now, at certainly an in we have very something ovarian it’s right Iovance

Ben Burnett

bad. that my mistook for Okay, I program? different a

Fred Vogt

Too many today. earnings calls

Ben Burnett

guys. Thanks, help. the appreciate I Alright.

Operator

Our Thank you. from from [Operator JMP question comes Instructions] Benjamin Securities. of Reni next the line

Reni Benjamin

have Hey, might selected PD-X something you good done? Question revenues Frederick, Proleukin imminent TILs, off you sense is this just to PBL that I the and inactivated therapy what deal studies, maybe a be, from supposed you near-term for question, Can near-term Thanks are of us of Proleukin guess start just past, those – questions. guess remind some think be, expect I initial is at think the see us sort I data studies for end this kind as year? the once give in off for would how are revenues we about afternoon, question that two the to would number and Mark’s progressing but talked you be the to taking or number you I like the this the just can one. TIL guys. can the of you right year? think PDX

Fred Vogt

revenues, you why but one take been we can’t cover you and Yes, when out can launch tell first on revenues you have We and lifileucel. guidance upon have what the that Reni, give I how for can don’t of then historically, revenues. the product particularly Jean-Marc look figure I’ll so

melanoma For in PDX particular program, on that’s knockout, PDX at because why give of data be selected in lung those should are we year, efficacy. on portfolio, knockout the point. it’s interest both tis the running is and of LMOs high we PDX the putting us selected particularly PDX could some and highlights us, to additional that our think in and of programs

So we that about at we is have you are a for we will want that. quickly. Jean-Marc, excited something pretty one have we when data, revenue? putting to discuss out further. we while very some cover do select running been it and PDX be That’s point, will the that

Jean-Marc Bellemin

I Yes, thank as the question. you thank for guidance. revenue very we Fred giving you, Fred and much mean, mentioned, are not any of kind

be have and in publicly the then What in XXXX past million about or we and grow potential the came by $XX more can million. we specific we the mentioning probably revenue is to that need communicated £XX the to and the deal talk which generated Clinigen, we all, of first close First was were was future.

that indication were of the terms giving revenue. that’s past we in only So,

Reni Benjamin

Got it.

there, just is just search, that this I for And mainly going, anytime final still us. really close you That’s more out to has joining someone will has one Okay. Christi one, the it soon? something name permanent? your do dying CEO Fred? is to left is with throw interim Shaw to it that to Gilead, that Are And move

Fred Vogt

the ongoing won’t no, me. it like say search can’t I is that, but be and Yes, specifics

will more who somebody interested able in So at we some definitely knows. point, finding is about talk to be that Board and the

Reni Benjamin

Fred. Thanks,

Operator

Group. [Operator Our Goldstein you. from question Mara comes Mizuho line of Instructions] next Thank the from

Mara Goldstein

just in I your Proleukin the the not secondary do Delta Great. and how for crossover Thanks you think that I capital curious in the account so about looking giving how much presence onboard we on and that for ATM the a primary there? secondarily, how as just about quick figures of improvement but terms of into trial? working for taking then just the am you of guidance, product? on can the pressure I have follow-up to respect you question. are endpoint expectations arm And the speak the around trial given the patients OS and you TILVANCE the should number And endpoint secondarily,

Fred Vogt

and you first get of second take part Maybe to Yes. part? want the Jean-Marc, that Friedrich the

Jean-Marc Bellemin

am your to sure. answer question. Yes, about I the trying to think way best Yes,

integrate So way it it profitable keep our I be that will separating we lifileucel. from a activity Proleukin as think will to away is goal again, the

of outside So, we of have will our usage. Proleukin sale own

wanted in am So integration. and inventory because currently large not to concerned be as amounts, of not managed the everything will should correctly. pretty working talking I not are a too same will and much we the do of say carry future lot much I about Proleukin capital we amount itself, we is again, after around profitable

no in the XXXX. I And into that. about of important half we cash, ATM on we the that mean, the So, I Proleukin the second think have mind done. what’s related there most keep activity we is enough of acquisition just concern commented to have including have

Operator

And Thank then question. last your for that. you

Fred Vogt

Thanks sure. the for question. Yes,

study I comparative right. second about here the mean, is am so size. trying the study, is of context to the I do question, the just two-part the them I are question sample we question, deltas think of the in in study was sitting about of So, office a the achieve think was one And design was first that that design just like and we crossover, about how the randomized, the

I in about as that, the to is the get at and a information patients the publication. between information hazard what your or information for available we That’s existing in little in be pembrolizumab from that’s in available are benchmark, that you when would is as specific shooting currently deltas with USPI expecting then are COM-XXX or control in that that our confidence is to and different do able order are arm a straightforward, on we population XX% do of study or in response the for doing the a information update it’s in an this our to a Cohort be are much not best you where low the probably like can might powering you monotherapy. in The ratio design. you are XA, we comes shooting are usually say rate pembrolizumab different we from hazard two the and our treated available design have compare difference we what pulling for how to in look XX.X% you we the monotherapy last here. What arms. our of arm are ratio So, is done knowledge something The what frontline for seeing a for pembro single it and pretty seeing would here with

So, ORR. that an you gives idea around the

to reasons as in of dual The arm is in are crossover, yes, the exactly on that able something so being obviously, typical then is endpoints survival secondary this an value too endpoint. about non-overall about thinking our happy the that situation, but an having of in for to are you The that’s is the survival discussion and mind crossovers we yet. reason FDA. a agreement keep you why endpoint and potential outweighing endpoint crossover as survival of go case survival in the overall are impact that the have overall PFS with use exactly And primary the it. the with overall It’s endpoint, not a ORR fairly particularly

Mara Goldstein

very you thank much. Okay,

Operator

Our of comes the [Operator question Guggenheim Kelsey from Instructions] next you. Goodwin from line Partners. Thank

Kelsey Goodwin

first launch to X than Thanks initial we for my what for therapies, we step-ups to that color X regarding bit thinking secondly Phase been then for out I how guys. you on and think do similarly a about expanding the it for into then And of provide Great. Thank lay potentially the iCTC? much. maybe kind granular have of more are Phase just the quick autologous melanoma? to Hey, for if you taking you kind CAR-T with plans able seeing I the manufacturing, anymore of capacity kind so you a your be guess about questions. just Europe guess, one, are timing

Fred Vogt

you some Yes, Yes, on Europe manufacturing. and take more the Igor interested let the very something can in. me last is then one we color give are

there our presence. And run to European We haven’t active we run a Europe, have we continue going but significant them TILVANCE-XXX are there. have about and trials publicly been much is there. spoken to Obviously,

that. We around regulators. in hear is markets on that well But engaged world an incidence European I we as important where from And as melanoma the us are with high more the XXXX think other think market, you’ll for a have we of rate melanoma.

to question? You manufacturing already the answer want

Igor Bilinsky

Happy the to, Kelsey. question. for Thanks

patients is the at mentioned we team per facility to the more hiring as year. are demand And than anticipate meet now X,XXX earlier, manufacturing we the capacity, we can launch. have built, I that the support because So built

exact earlier maybe sharing we Jim mentioned, as are to an We the numbers, response actually, a bolus. not but in demand question, expect

as initial we So taking launch the we into are that are planning consideration capacity.

can wise, CAR bring over as out as are we and continue X,XXX there that, then step patients requires us capacity build capacity and needed across that iCTC within per the a we increase to also T staff To have to the TIL we those the the existing that’s can space similar shelf the that planning that to well. hiring process is Beyond therapies, agency submissions year. similar general facility

Kelsey Goodwin

great. much. Okay, so Thank you

Igor Bilinsky

Of course.

Operator

[Operator you. Asthika next Goonewardene the comes question Truist. Thank from from of line Instructions] Our

Karina Rabayeva

that Hi, open this to point? study, TILVANCE-XXX and the label, at is you. Karina – recruitment? so, Thank for my do how plan finish study that given take you Question what is Asthika. will to long you question for if is interim data And report for

Fred Vogt

to take that? want you do Friedrich,

Friedrich Finckenstein

Yes.

early accomplishing of the are projection the startup. phases you hard, is particularly So when analyses of the in

really mind because driven never once endpoint and event understand I endpoints on in make we enrollment site the truly TSS particularly think we activations. exact are the that and ultimately keep that possible Also are that. will of and projection a in true is better progress

that. the were the saying study. So study, not, you stay please. posted on question Yes, repeat label a study is it’s second about The open an blind it’s actually this that

other a blinded So radiology committee. blinded we the study as assessments in assignment the we to any design, by done independent would treatment are are

the between update the as probably CMC. in is other no there than So final decision by is made being

Karina Rabayeva

Okay. another And have question. also, I

case? You to REMS, said expect is not probably get that did that you the

Fred Vogt

that’s – IL-X today. will don’t REMS don’t why and total any we get the Yes, have we regimen, reason see Cy/Flu treatment the REMS,

really don’t any carry TILs themselves. issues So safety

have see cases. triggered that So that issues don’t with see we the those you the some CAR-Ts – in don’t of the we REMS

Karina Rabayeva

thank Okay, you.

Operator

the comes of you. question from [Operator Sachs. Goldman Instructions] Thank Our Madhu line from next Kumar

Unidentified Analyst

[indiscernible] Thanks is for This for Madhu. Hi. taking our question.

from to thinking Just of do or like terms cohort? better? of you the products, guys on how should are genetically think what where about data timing we you cervical efficacy then in be expect And edited cancer TIL the

Fred Vogt

Yes, a one genetically with take products, first to combines TIL that that the TIL product. [indiscernible]

So as additional are of to response of look now. add then the and mechanism the inhibitory hoping additive we And on the would between blockade checkpoint our add get cell efficacy then gene-editing, within top targets to the directly we modes, we that TIL like something too. two immune that can the hopefully

So, that’s behind the theory basic it.

now is you and the this else. that testing about that PD-X are we will how we in developing works. of the now to We of more It’s do I lot see right something cell. many bispecific respects people want humans mean, within thing that and antibodies know in blockade similar how to kind that a

first one the the in knockout so first right is humans that’s And now. the PD-X

we that on in that We pivotal more have updates enrollment study. you be We for to And on a study. this year. study. Cervical, that will intend restarted pivotal a just later that’s

that post year more is enroll we have but think it large know on that. you. well, so later we we will an this And today PD-X Thank cervical on don’t population The that. update we reasonably enough can for you

Operator

time, this now Vogt would closing At the you. remarks. to conference Fred like turn for Thank back I to

Fred Vogt

Biotherapeutics Iovance financial quarter full XXXX results call. and Thank you conference joining again for the fourth year

in and follow-up. to also look BLA cross-functional We manufacturing like and completing Thank forward global teams out for year. Please clinical the regulators XXXX Investor on to data. quarter grateful to the our who for agreement an new the milestones you. analysts and delivering be commercial am have and to in shareholders have employees had for and team this our the pipeline our to our reach physicians to activities as Relations exciting as anytime feel regulatory start covering advance throughout their Proleukin with patients, and leader And I we mission support. collaboration any the worked thank I’d free our close to co-therapy. well

Operator

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

You may disconnect. now

Iovance Biotherapeutics (IOVA) 28 Feb 232022 Q4 Earnings call transcript