Iovance Biotherapeutics (IOVA) 25 Feb 222021 Q4 Earnings call transcript

Company Profile

Participants

Sara Pellegrino	Vice President, Investor and Public Relations
Fred Vogt	Interim President and Chief Executive Officer
Igor Bilinsky	Chief Operating Officer
Jim Ziegler	Senior Vice President, Commercial
Friedrich Finckenstein	Chief Medical Officer
Jean-Marc Bellemin	Chief Financial Officer
Tyler Van Buren	Cowen
Michael Yee	Jefferies
Peter Lawson	Barclays
Nick Abbott	Wells Fargo
Mara Goldstein	Mizuho
Mark Breidenbach	Oppenheimer
Colleen Kusy	Baird
Ben Burnett	Stifel
Asthika Goonewardene	Truist Securities
Reni Benjamin	JMP Securities
Madhu Kumar	Goldman Sachs

Call transcript

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

Operator

Welcome to the Iovance Biotherapeutics Fourth Quarter and Full Year 2021 Financial Results. My name is Chery, 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 Public to Relations turn President, Pellegrino, now and Investor at will call Sara over Vice I Iovance. Sara, you may begin.

Sara Pellegrino

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

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

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

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

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

Fred Vogt

today’s call. to quarter and and earlier pleased I’m at In everyone. XXXX, indications our highlight two settings. new full Iovance BLA advance into afternoon, and first toward fourth progress continue good submission expanded platforms our and Sara, treatment Thanks, we year XXXX conference our during to

lead planned submission therapy, metastatic our our top remains BLA our priority melanoma. For lifileucel, TIL in

and We our potency developing have continued validating assays. ongoing work

first XXXX, of step assay second BLA presentations. plans our half TIL XXXX. and in confident regulatory year the in was indications. the and discussions the busiest of XXXX in FDA engaged key our terms the half also also during current with have of guidance during a towards we Resolution We anticipated the yet is for of are other melanoma submission potency data

of past Society we the this XXX meeting Association next months, we year, the for patients meetings, Philadelphia. in Iovance data including five or at and to AACR treatment in medical set meeting. solid Over in the of for across also tumor Iovance or XX Oncology sour for data presented Clinical ASCO We therapy or Immunotherapy ICTC, become the Therapy potential the the opened Cancer Cancer to clinical multiple Center, paradigm-shifting American that American growing meeting, the Research indications types or continue of Cell demonstrate solid tumors. regimen of believe SITC power the – TIL power Society Last

to employees to solid at experience. our commercial tumors support Iovance to the more We therapy the growth our who field. and depth maintain four during highlight have manufacturing launch. approximately time cell our we manufacturing within our within average, the of organization a is progress will significant on believe Igor company therapy in breadth organization and of TIL Today, leadership ICTC, XXX that than the which at grow our talent We testament of have potential and made and and the prepare capabilities ability of in further, for we have, internal years

pembro of therapy in an tumors. lung TIL confident will developing, combination our defining lifileucel first TIL the finally, based submitting BLA global on Iovance include: for melanoma are highlight; of indication; Friedrich care advancing and TIL remain the to next-generation Iovance’s cancer, our is in of the TIL solid we TIL half in position initiating of milestones forefront reflection patients a for our leader our IOV-XXXX, in melanoma; the PD-X with XXXX, with first executing and early-line in metastatic evolving clinical therapy research beginning programs in in product genetically dialogue study and advancing inactivated strategy to further the of registrational in FDA solid cervical cancer. cell plus the feedback tumors towards this Overall, updated in Looking year, and in non-small innovating landscape cancer the in strategy at modified which delivering be which for strength and therapies TIL for

a tumors. Owning to to on the is therapy are launch the capability manufacturing first We becoming way our onetime well cell success. our fully to organization integrated solid our in key

call Igor hand progress to about to So I there. now our more talk the will

Igor Bilinsky

you, Thank Fred.

we ICTC, We the completed commissioning facility. XXXX, third is XXXX. at achieved Center, the of During from foot initiated Iovance Cell several in cell quarter clinical TIL the which Therapy ICTC milestones supply square XXX,XXX our therapy manufacturing or and activities

track activities qualification TIL the manufactured ICTC September preparing as potential BLA the activities upon the PPQ part In manufacturing cancer clinical are and for runs. our such manufacturing, clinical commercial with received are submission patient at underway and ICTC we important first The on in of with in process, trial. ongoing XXXX, now as or performance approval. parallel validation Several BLA

to filing. contract for and manufacturing our addition, both we facility, FDA after we soon getting pre-approval expect ready which inspections the ICTC occur In are partners’ at BLA

our Turning intellectual IP to portfolio. or property

proprietary of processes TIL TIL and build compositions range to support manufacturing allowed IP continue XX We rights that patents. cancers, exclusivity patent in We surrounding know-how granted broad U.S. X international our Gen treatment therapy. provide are and expected currently into XXXX. robust to and covers and our own more including than of well portfolio growing as as or manufacturing a to methods our IP This

and TIL the would filed products, like of Jim tumor call launch X Our cryopreservation Gen I genetic TIL and combinations including to compositions granted highlight patents inhibitors selected well fragment hand Ziegler and Jim? methods, commercial our patent and applications digest to transient to directed TIL our now are as manufacturing, preparations. as stable checkpoint towards modifications, and products.

Jim Ziegler

commercial has steady financial progress XXXX, made in Thank you, while Iovance XXXX the Igor. our launch discipline. Throughout and preparations, team maintaining into

our engagement launch Our and payer include activities. the readiness onboarding of related operational centers authorized treatment or priorities ATCs,

cross-functional build centers line Our their TIL U.S. continue cancer leading to to service teams partner capability. with

Our is training approval. designed to program FDA regimen ensure can teams lifileucel cross-disciplinary treatment the upon administer

CAR-T Our goal centers top market account XX about the This CAR-T account is launch. XX XX% that to for onboard ATCs CAR-T centers of indicate the patients. the about XX% the by per our claims top for XX and is at assessment data least the of informed where patients, treated treated number of

a the commercialization potential lifileucel. our for across We ATCs of similar concentration expect

ATC and lifileucel goal the sites and is TIL training BLA-related milestones timing U.S. longer-term have just-in-time aligned The of planned be few drive onboarding most therapy. offering Our to within ensure that to so our key and is to enough ATCs. patients hours readiness can execution to an training at in a

BLA of payers team potential Although, the for team clinical critical patients appreciate is launch, built XX% XX% engaged there core In and melanoma significant for and launch. the amount commercial these Medicare to has the our responsible is more rapidly the unmet of the for commercial between of scale and approximately foundation than a submission of at lives. access work market with as last Medicaid access believe a also year, and patient occur Reimbursement will the need responsible covered factor for on our value our that interactions, states as covered that payers lifileucel well metastatic Based lives we cancer. efficiently.

is Medicare In secure designed are approval, will coverage to strategies other XXXX, payment important an because and CAR-T hospitals include payment. lifileucel. achievement appropriate coding, reimbursement This upon expanded have including and beneficiaries. more milestone Medicare XX to Our DRG for lifileucel immunotherapies,

BLA and as prepare for payers continue plan we and We commercialization. submission to for engage CMS

We of our remains are Cares progress on track also pleased launch. program, with Iovance which for the

that best-in-class goal patient to the Cares system. of the of at physicians ordering cell identity includes ATCs proprietary of Our and custody system every deliver chain is step Iovance patients, chain assist process. and and a our support

approach Officer, and our to to integrated our Our our progress. quality. highlight call Finckenstein, now clinical will approach Chief patient to Friedrich Medical pass management the I

Friedrich Finckenstein

Jim. response, DOR, data investigators. XXXX, updated by that we to assessed of was Cohort treatment data as with ORR These melanoma therapy. or at I TIL follow-up highlights study the duration from median presentations not to median or ASCO of various programs demonstrate overall a data share reached we metastatic you, lifileucel X rate continue reported XX.X% patients XX.X Thank of anti-PD-X presented and X onetime our from months across melanoma, In after in durability the response am Cohort at pleased clinical XXXX.

for submission. with year, from study, Looking to company independent pivotal review as the assessed an connection by data Xin melanoma BLA report the Cohort this plan in ahead our we

SITC results with combination in the combination The strategy are frontline excited this complete as defining inhibitor potential melanoma. treatment patients XXXX response melanoma also XX% for for our support melanoma earlier enrolling look recent and checkpoint TIL ORR the about to at further during naïve demonstrated most XX% patients. We year. forward in to data the additional coming and a for in We pembrolizumab presented

important year, valuable the continue Iovance one presented concept IOV-LUN-XXX therapies, patients, and option additional lung who neck data plus as ongoing for solid in an non-small cell encouraged and data treatment also and neck therapies. patients options. responses was indications, in melanoma, anti-PD-X head Overall to We cell cervical of SITC. anti-PD-X cell clinical are We TIL treatment or received cervical the cancer set response in treatment pembro and patients are by unmet ITC as for early XXXX. patients for for learnings proof we and very rates an therapy. which cancer lung rates set alone excited new as also This non-small cancer non-small our pretreated of for to have highlighted heavily in we pembro for cancer need our observed prior an provided about TIL the TIL patients including for above concept Last lung published were study. more enroll pembro systemic earlier-line response first cancer TIL An headed very proof lung plus tumor were not

cervical second-line lung in we cancer while We non-small are XX the registration. actively mentioned, sites at Fred the engaged In are with patients IOV-LUN-XXX engaging cell as cancer, discussions. in about enrolling for metastatic regulatory FDA further parameters study

call to licensed within XXXX to Cellectis TALEN results. financial potential to look the by our the with candidate therapy TIL with PD-X IOV-XXXX. we from our pipeline is enter and I of first inhibition research PD-X modified the TIL the inactivated the therapy. hand I am and quarter Jean-Marc over fourth technology excited as single has TIL a genetically now year Lastly, IOV-XXXX using this will deliver discuss clinic to a our product growth

Jean-Marc Bellemin

comments Thank you, from our financial Friedrich. My will the quarter high-level XXXX. results full and reflect fourth year

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

to As strong XX, plan, cash XXXX, position in held Iovance and compared preparation. to million of sufficient XXXX our XXXX. XX, restricted and on cash December advance is launch $XXX development, A expected $XXX.X readiness be cash operating manufacturing cash, equivalents, December pipeline commercial million into including to investments

to Moving the on income statement.

the increasing internal XXXX. in primarily and an development period with development growth the year costs share XX, administrative $XX.X fourth year team, the for December the period for onetime XX, of per increases XXXX. expenses. or XXXX. were a $XXX.X and and expenses costs. loss for million $XX.X prior ended of iCTC. period of XXXX $XX.X in of was for loss for full was XXXX, costs the compared year expenses were the primarily compared million XXXX, for This to year team December growth attributable increase net share $XX.X XXXX, General XX, $XX.X the were million facility-related more for were costs per compensation and full the to million and was loss to for and internal property million increase the was costs ended general per and an $X.XX and Net with in to growth iCTC. year million full The an stock-based research including in XX, full fourth or million $X.XX million XX, full compared the to XXXX, to million year administrative clinical expenses, XX, $X.X team, XXXX year XXXX. of the $X.X expenses increase The associated facility-related quarter primarily and quarter per the general an research approximately prior increase $XXX.X the XXXX, associated for in million or periods ended $XX.X XXXX. of an December stock-based attributable million to over ended an XXXX, year ended quarter net ended XXXX. and period Our XXXX $XX.X in research year year in the and ended Research December year increase share or expenses an filing an were Research in over – ended clinical $XX.X research related trial of development December the million $X.XX for share and December net development expenses period cost expenses to of to including trial compared XX, quarter the cost and intellectual fourth and December full the in December December XX, in attributable fourth compared compensation were December fourth ended compared than administrative fourth a $XX.X million the XX, prior with $X.XX the $XXX.X internal XX, full quarter increase with development or the the $X.XX million of compared increase associated and $XX.X quarter which $XX.X of quarter December to for $XXX the quarter per fourth the XX, ended and General period share loss XX, ended The million million full associated expenses million to increase increase for administrative development full ended fourth December expenses increase period

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

on of advancements our outlined previously, and includes readiness, to growth four pipeline, investments continue ensure to of and our clinical focus areas, in well these strong on We stay creation. session. align key now as focused the priorities. launch strength This expansion across corporate investments plan. to priorities, as manufacturers able being strong cost which are currently at we assets done we with iCTC. manufacturing that With back to our shift by we work confident a operator our to positioned as efficiencies our will launch off contract I new will cash position to remain provide continue in our are our the sheet operating our as to managing iCTC, and spending late-stage investment value clinical to call focused pipeline and hand Q&A also and I through execute preparation, the well will kick balance the

Operator

will you. [Operator from come Please question Thank Our with Van Instructions] Cowen. Tyler ahead. Buren first go

Tyler Van Buren

taking the started is the and guess assay in the the anticipation Don’t potency data the first guys. already Hey, the testing Congrats to to question. of of able the generate samples by the end with you’ve submit on X the be BLA of on to to assays the iteration in the progress. I in follow-up the And patient would resolution to Thanks very Cohort samples assays half? – that much be, the have Cohort filing? assay two next latest possible for my patient have assay order that it or with or the run front potency or you month X

Fred Vogt

be note should we Yes. The of – those understand comfortable. of to Thanks, interactions we filing. so conversations FDA feel Tyler. get late FDA right some can game We that and be really could comfortable relatively earnings But half holding now, down manage how testing while saying risk what in the clearly we we at towards are yes, and have I some that. moving that a going whether come on we the of been staging first the right again haven’t with that general, a the really I we’ve But publicly the call level. parallel work. is BLA and for here in it to that important we’ve in well, disclosed can we’re that we have regardless, or filing year. BLA to commenced the be to in us it with the do it’s this answer – detail could

of So that we where with some should FDA. give you the indication are think we

Tyler Van Buren

much. very That’s great. Thank you

Operator

you. Thank

from Please Yee ahead. with will Our Michael next come Jefferies. question go

Michael Yee

ultimately, and thank and My and follow-up. one about file that the your to tell ongoing that final Wall an Street everything you And and thanks the filed or thinks the final maybe off Hi, or – agreement where Street question filing, validation talk think then I the paper is Street just finalized screen and update you guys. the a that gets question relation do a is piece and a of on guidance process. there and go like you meet just Can you, scenario? have for PDUFA or filed. sign in scenario the at obviously date. have I you to have and the the ahead final light you is with the just that

So quick maybe One talk scenario. that to that a bit follow-up. in

You just did you just is it data response it, be Cohort gets and similar you’ll had Cohort say an – the X independent can do be previously that tell melanoma X. can done, you when data. Can me, X me present as And supposed review just that’s that you and Cohort you had rate to when when where interim. will an remind clearly you you announce it,

remind Thank us about you. you. status. that Just Thank

Fred Vogt

Sure, Michael.

in it for Cohort BLA talk BLA with Cohort obviously, already that’s data. submission. to – out. me talking we’ve a the of that there, information the about more is while. X it’s conjunction X data the It’s that, in with would because Let time put out important that first, about Cohort to of and been part go the and take as part last submission data red Cohort IRC as And we one actually. X the BLA

yet X Cohort Cohort the still many in similar – data, working we’re But You very can on. data study that we don’t something see is a X respects. know

we differ. So course, can can as guidance to although, these I give in some of expect what they populations,

it There the part, to which some your very me going this as all answer way BLA or we sort late in – XXXX, the entire that try and conversations through the pendency BLA to year. of potentially the whole early during would accepted, with potency be assay the proposing after of aspects On assays for your of to assay let on or the FDA could date, the products. specifications PDUFA be can there, the you’re gets because question when submit XXXX depending

change period. that So during things can

I think what might you that’s be asking.

they Of validation present they and could additional more could you and that. any period with information them package could with aspect specifications course, that can on about back the them you about asked get comment provide data, proposing. that validation go you’re of the on you forth questions and during And

absolutely that’s you don’t in all that for pre-BLA sure BLA development. know is prior you’re meeting the and the is the is Earlier the submit in it that right So really the had to this we thinking way when done, though BLA process, drug in that. just approved, until we

much make can FDA, the get sure we’re from and so to we trying getting the We’re clarity can date approval. as we as successful PDUFA that on

submitting not we we’re in it listen that FDA. the could we gaps have has filled to something So that

I some that That submission of goal gets includes you get itself. the that’s hope the got successfully during Michael. leading were what answer, a trying up that work the but reviewed So the BLA. a eventually big BLA pendency of was and I there, lot our doing of of completing validations to long-winded And to course,

Michael Yee

that think, sense. Thank I makes you.

Operator

you. Thank

ahead. with from Please Our will come Peter next go Lawson question Barclays.

Peter Lawson

questions. the Great. Thanks for taking

for we thinking time kind cancer, walk and of for about. you on cervical cancer through that around changing what what’s be I potential the should could Just wonder kind cervical filing if of lines

Fred Vogt

answer Yes, . you that Friedrich, one? want do to

Friedrich Finckenstein

Sure, happy to. question. Good

acknowledging approval see has are for great treatment obviously, cancer care it’s immunotherapy field So to that part inhibition the of landscape we of the paradigm checkpoint a quite a to as first-line patients. the changed enter shift, in standard that cervical and was bit of

spot. going changed of know now landscape we knew checkpoint how based in first-line action. in changes that’s differentiated that line inhibitors And differentiated patients area And foreseeing of post-checkpoint chemo, because that’s data. inhibition first-line impacted our inhibitor that be we that this that, So we checkpoint cohort therapy saw that need would data the some chemotherapy is therapy second checkpoint we able unmet acceptance the address with early from TIL the after good on were inhibitors, a of mechanism after opportunities additional we obviously, we of melanoma and that inhibitor and is we to in of in news. that checkpoint do landscape the and only see we’re setting. a And XXXX activity received that started that that from have early we already. and the care, as think an Because standard after

execute feedback we to planning And inhibitor headway some addressing addressing and we registrational changed setting. FDA are have this do landscape. that strategy, the a do post-checkpoint from We think that in

Peter Lawson

chance Perfect. Thank of change any risk? you’d Is does Dr. Perry, for addition at in with just any there way you. file the that And process filing? the

Fred Vogt

– I not to not Peter. a would that’s plan not the really the the No, essentially we He’s BLA team. addition really to it’s handle or here, tied our really don’t how – BLA. great That’s no,

an perspective, thinking going but having that’s about. and to not them us regulatory be anything do Of very helpful a . join something from we’re course, is really

Peter Lawson

you. Got

taking much. the Thank Thanks for Okay. you so questions.

Operator

you. Thank

will come question Abbott go with Please Fargo. from next Wells Our Nick ahead.

Nick Abbott

taking as for questions I Thanks afternoon. for Good always. and it clarity my appreciate your

up from following question one, Mike’s on back, so just First going earlier.

closed you ready is Cohort for being have So database X analysis? a cleaned,

Fred Vogt

that haven’t yet, announced We Nick.

details We late game. there, are the we’re obviously, in very without the getting

do So that need time directly haven’t a period we would we short to relatively in about that’s spoken but yet. here, something

Nick Abbott

X? shown and what of what to approval from similar showing show you’ve patients a presumably currently then and that’s think benefit And you X relatlimab, Cohort forward, you nivo maybe to potential these thinking in Cohort need do you’re Okay. the magnitude

Fred Vogt

out would patients those getting. but haven’t some be we patients It for of potentially patients already could there of are don’t be course, important assume be that trial lifileucel, that in future because coming the now seen line will those the that candidates off clinical in is there therapy landscape, right because of

considered we’re So that’s patients. tell might we closely, at that’s medical on meetings provide we’ll to we’ve you those and try looking something address something updates closely. at can I how

Nick Abbott

you. Thank

Friedrich Finckenstein

in presented indicating think that we I that’s deal to clearly between Can have patients is who and So thing CTLA-X are have I combination. chime were failed here? monotherapy benefit blockage in the keep comparable PD-X X mind patients failed and that PD-X

So might don’t in on patients I think might in mind be a what that keep controlled that combinations be failed data seeing to other that’s of got fashion, in who indicative I yet we we think setting. as well. have something but for Obviously, that

Fred Vogt

Yes. It’s a good point, Friedrich.

Operator

you. Thank

next Mara Goldstein question Please with Mizuho. from ahead. go Our come will

Mara Goldstein

Thanks question. for taking the

the the of look initiation the year indicated. and Can you that that I IOV-XXXX at? the And then wanted delta for given about plan run rate the different in the to on spend clinical versus in ask indications what quarter just prior for talk you’ve the like sequential – about might this you Just trial going the fourth forward, and looks R&D quarters? what that

Fred Vogt

Yes. Maybe can on first Jean-Marc have and the up one. follow take second one the I

something we’ll hear on get that we we the following asset talk I yet, we obviously as that’s more the tied disclosed soon you’ll because So – as clinical can but that. that think plan about us haven’t Mara, from a for lot that’s we’ll through, regulatory once

T better into as like TIL the cell which inhibition theoretically the in platform well than checkpoint potentially the polyclonal effects a indications might to the mechanism antibody the combine as having of tumor as indicating obviously itself, into benefit new cell benchmark our infiltrate well know – can that asset. against We’re as that – same can interested indications from built combined we and

that indications Jean-Marc, little approach. bit we’re we’ll able spend? hopefully, the pretty about that about R&D to for to And soon. So that looking want talk a talk be you benefit from would do

Jean-Marc Bellemin

Yes, building honestly, pipeline of spending the focusing question. it. course, are our we be and of for research will sure. the part Thanks Look, on

mean, perspective, looking from of a XXXX. So But a about the that iCTC, research spent what in reallocation I aspect IOV-XXXX building. is you will we example, to one spending that of definitely we reallocated for way for are are XXXX program expenses only be if for at building we in think

So we research QX. $X.X we have spending and an have during mentioned this increase onetime in script that the million. development I’ve in

that’s So why of research But there. concern will honestly, for have XXXX. there development real the more on spending expense you and we keep no a bit is steady

Mara Goldstein

if permanency question the and I point that also time in looks CEO just And could – at like a ask Okay. a around what this from perspective? this from timing

Fred Vogt

Board search, our we’ll for candidates. really for can. as as our have is else. be to a Board, the Basically, and we’re anything ongoing priority continues I It announce don’t top still and conducting outcome looking soon we

Mara Goldstein

Okay. Thank you.

Operator

Thank you.

come Our with Oppenheimer. from next question Please ahead. will Breidenbach go Mark

Mark Breidenbach

afternoon. taking Thanks Good guys. Hey, question. our for

to you’ve color Just that be directed FDA. one these bit more little for me, with nature that would trial been more appreciated. little detail Maybe a was maybe changes a LUN-XXX at parameter of Friedrich. the I on the hoping on you the could discussing provide

Friedrich Finckenstein

the details to the So spoken have LUN-XXX. FDA exact with I we don’t of about that think our in discussions regards

So that. really not I can sure comment on I’m

with doing checkpoint we is specifically of care line chemotherapy. reminder, enrolling LUN-XXX that Just have sales patients plus we’re as single the of standard what are a inhibitor

So this that line earlier study. is enrolled population the than those from a basket XB population our – was proof-of-concept to Cohort

referring parameter the that’s changes to. So that you’re

population earlier focused therapy. line So this prior that’s with the an is point on really main

Mark Breidenbach

Okay. designed. originally protocol That it wasn’t as already part of was the

Friedrich Finckenstein

since study we design then. No, the that the not was of design and have changed opened, we as the

Mark Breidenbach

you. Okay, thank

Operator

Thank you.

Kusy go Please come with from Colleen question ahead. will next Baird. Our

Colleen Kusy

so questions. much Thank taking Great. the you for

FDA able regarding the So there you’re have with characterizations potency assay? the are to conversations any provide as progressed to latest the how

Fred Vogt

advice, the level, still detailed we’re lot be confidential, good to for, are lot advice, able Colleen. us really we something At what we of that’s to of are they’re details like to and ready detail. assays we address and looking – assays that Sure, talk not Yes. They’ve going what we the we’re we think technical address given where think about. we a the with we respond and be discussions level But that. sets feel and understand of data provide can and as a productive them can had, our and really and and what concerns think concerns general can matter, that to it’s their quite the at

quite advanced months it’s a respect. So bit past over the in nine that

Mark Breidenbach

lung helpful. the is on and that PD-X we comments combo any from might That’s And see when in combination? advancing Understood. then cancer data how

Fred Vogt

is been study our XA That That a in has for COM-XXX now. study. Cohort study while Sure. enrolling

like or present, some but soon. to We we point guided conferences anything is obviously, some at those studies specific of haven’t where, to where it we’d would one present data

as look much we say exactly that. that up. do just presented keep forward we’ll So be as can’t to I year, I when we’ll possibly could XXXX, to to and we able data try last

Mark Breidenbach

taking Thanks questions. Great. for my

Operator

you. Thank

Burnett Our will question Please Ben with ahead. go next come from Stifel.

Ben Burnett

specifically? or Hey, just experienced I can regarding ICTC. data, manufacturing for And terms had much. anything of manufactured question needed thank color a you the in new regarding guess here that? provide numbers I validation for what’s melanoma your product like BLA melanoma much samples late-line of guess center more accrued have patient how I the very you just – in a little you expectations likely from

Fred Vogt

I And the least talk to that? at maybe can want part you last do the of Igor, first cover part. on about

Igor Bilinsky

to. Happy

question. the for thanks So

that, filing, filing the we subsequent take getting And part expect after things the – approval. the and and BLA we right the potential to that’s to two file meet that’s Cohort BLA is on process – we following and Gen the and but the other the So part is the the One capacity manufacturing X, ready focused including trials. facility for then the clinical including demand all that for to clinical ongoing place commercial now. soon inspection intend preparation commercialization filing of primarily BLA is after then X

So of activities. then And Fred track that’s those on well along will… we’re all

Fred Vogt

ahead, – go I we think Igor.

the If the you want to get retains. part about

I you then, that’s think asking what about were right?

Ben Burnett

Yes, there’s can just of anything samples that’s terms kind the you in number data of validation about ballpark say of needed.

Fred Vogt

go of if want good a it’s ahead, mean to I it. answer you samples. number Igor,

Igor Bilinsky

sure I the I’m go understood not so. Fred, Actually, ahead. fully, question

Fred Vogt

the the the Ben, and perform anything that needed Is you’re what think to to I do with saying, we for exercises of right? validation both facility. samples is need assays number for

Ben Burnett

Yes.

clear. more be I’ll Sorry,

that’s is manufactured manufactured to product yes. new at the that validate to think similar the what’s I been here, site

Fred Vogt

in call – statistically number what a So work make number exact with process area, either. of that and I of that’s FDA, we’re lot that’s doesn’t we really well It’s have provide think. qualification. in samples. the don’t sure done PPQs or a what obviously the drives we good part have the comparability And it we’re to set numbers, we call – performance there’s Igor we comparability of and justified well what samples. But it’s of

Ben Burnett

very Okay. Thank much. you

Operator

Thank you.

Truist will from next come Goonewardene ahead. go Our Please question Asthika with Securities.

Asthika Goonewardene

questions. my taking for thanks guys, Hi

what do there Is you comes run to then FDA and a have about cancer things a a I back If that of official after says follow-up more logistical we the samples? that. scenario And a want question your maybe your be answer getting the these to okay prior to understand doing work I to you some and might in the you from to Tyler’s and filing potential you one out Just assay here. include FDA. potency couple lung of question

Fred Vogt

All right.

to me take it we retains always at and ask the questions wants. to answer let we think their yes, the to we’ve – could ask performing and for what FDA are come we’re be point, need assays got stuff we’ve comfortable you retains right that just developed and expect the They and the We we could but the think And run some back now. always and ask case. one. don’t me responsive first that that Let

the the go. they because ask really and they don’t provide thing stuff Tyler process. BLA. the done your preserve saying both PDUFA you your and was to preserve concept But of you’re of the us burn them know do mentioned date your is think earlier truly it’s the the was That’s approved questions their until as what and to I say response not I What the and when up and the process to of they of retains question whole to sort and their during FDA for unnecessarily maybe your during with feedback of Michael information – you your trying course, – the giving is it core timing go.

we’re carefully something that’s So doing very here.

Asthika Goonewardene

Got it.

data then then by earlier, that – think that that adding could you giving going the that to TIL earlier help you thoughts LUN-XXX give maybe and was the PD-X given presented a combining wanted the data seen related another Friedrich, then on lung an consider more the you’re potentially have And you And where you may. previous presented of a better with a goal mean to have at a confidence maybe with you to non-small to kick PD-X with have be Thanks. LUN-XXX that question that option than for the the continue could TIL what I there? arm just that I for cell your to do get if that, I is persisting. we’ve the at bit there little a to to durability it stage you – responses Okay.

Friedrich Finckenstein

Yes.

good those questions. are So two

that often clinical is So into [Technical to one. performance late-line Difficulty] the and and about patients function the is, cancer how sick line improve obviously, experience lung in non-small extent, an will confidence and status. organ number are the That going durability just earlier durability cell regards our to some knowing

obviously into long was was a patients Long-term were an that with a naïve. somewhat an slightly the the experience little earlier design. population better even line going confidence Moffitt comes presented single and exploring the into was XA [indiscernible] gets received institution so what the you in that line point. either had by TIL and naïve that the run cancer to but that to to to adding are checkpoint that’s lung this generate least combination. in PD-X something that study clinical that’s data experiment better About of durability, step supporting under basket cell the generating data for your blockade question but long with we actively We as it of non-small that, at have prior over from data on different from a rationale. are So there Cohort will a that and obviously responses Really, durability And population, the now treatment earlier overall we were albeit starting informing line single partially.

once checkpoint mind, we in reuse have that a in seeing naïve not There population. a one usually translate to not we’re what from at inhibitors failure of a is not lung population – is is by after of inhibitors, something let’s inhibitors that reusing can would and do lot that themselves least them is the docs there checkpoint checkpoint failure. tend to cancer melanoma. and see we slightly interested of checkpoint different into one Keep after that confidence in pretreated we are understand question So that are whether want

to melanoma. situation in different no that’s So the

Asthika Goonewardene

it. guys. Got Thanks,

Fred Vogt

you. thank Well,

Operator

Thank you.

Our Benjamin Securities. will from next Please come Reni question ahead. with JMP go

Reni Benjamin

there guys. what issue. part And time or reason are pull U.S. steps And you data what CMC apologize, late, are BLA, a submission think gating for see just how I a review the to to so potency here already Is one? in apologize have Hey, or good I a tell if of the on afternoon, there jumped if thinking part or especially of assay Thanks of the kind you questions. then issue, review any we clinical us specifically this typically ever this. that this Thanks. about ex-U.S. Can answered more a on call – taking the little just I be going the consider if is were up the you could any you forward? to able clarify, also European as guys BLA filing,

Fred Vogt

those. Sure. I can take

on European outcome. FDA the really hinges Our is strategy

And well If patients we quickly on since the around EMA as focused trial, can move So turn the the things and have really, now. go hopefully think we’re before. FDA, we in the with talked then pretty right there. we’ve European FDA about we

on details We haven’t yet. announced any that

kind something some eventuality, with quickly for after the fairly but resolve of we issues FDA. we think stay we on did do do yes, and So there of you this, just prepare tuned the that we can

it. question, goal yes, left mean, be day feel minor is a successful with and the sure fact close hits. ask as approval clinical to the situation our can tightly try they or the real during not to issue comfortable review say is that side. The caught for review I it you could is from you filing say is can can side, as there they we’re a that as with issues That’s it language close could what But way They a review, very a C that in that. always single sometimes the becomes say they or make them on close that we Type we when in FDA But B we side, CMC non-clinical can that completely so everything Your every really say use look, for can that to pre-BLA something get second question at get Type that that meeting. problem. the to say look to window we try interactions we’ll PDUFA where is a whatever

Reni Benjamin

it. Got

an waiting we worked that? the think Okay. out you And it just you Or be do or kind accepted? after to after as right because regarding is a filing. quick should the approval that How that follow-up about for do submitting BLA you’ve something Is something here the everything BLA the European U.S.? of like in

Fred Vogt

that we I’d but yet. haven’t latter, fully probably the be determined more like

for to at our the the look that’s So because focus the foremost with But on could would want we be in. as again, have. is we U.S. melanoma want market to opportunity resources that we much we as market – European and the possibly we first

Reni Benjamin

the Perfect. for Thanks. taking questions. Thanks

Operator

Thank you.

come next will Our Kumar question Madhu Goldman with ahead. Please from go Sachs.

Madhu Kumar

thanks everyone, our Hey questions. taking for

what about think of now beat data like X horse. Cohort and the BLA apologize I Like we to – through analyzed. flow kind to how information XX going post-PD-X going we melanoma, we June should have and they’ll submission have So that regards I’m dead between to about like this XX? June should come will news with is think How lifileucel

Fred Vogt

should in a out period. it’s good that All that basically or will period that out expect come in out question, Yes, comes Madhu. we come that in information period

flow to be clinical the so with data, respect actual CMC don’t time has will issues as basically the meeting – how the predict occurrence of this We the exactly needs to BLA we all the to at in stand it’s yet. happen. it line a those you critical Cohort be and going X news or try package something know, to still is much are but a data Cohort to the process will but as as the can’t stuff the that clinical data keep X happen, flow know that out news the of and where that data, So top least where that in the elements mentioned comes be we pre-BLA the a occurrence out we’ll We’ll determined, continues. actual which coming we try details comes there, filing, and order the time

Madhu Kumar

with approval kind on following bigger What confirmatory the And does Okay. of you of accelerated about monotherapy picture a the context. cancers? question, like look in as in trial advanced to this lifileucel last up kind in question then solid

Fred Vogt

just In in melanoma or general?

Madhu Kumar

what to specifically previously, is Well, been that that I a need melanoma has trial necessarily indication. mean, confirmatory confirmatory in it PD-X trial as mean, think for like doesn’t to I there needs idea post the a the same notion discussed a a confirmatory current there view? be Or is in actually But trial BLA, trial the looks be confirmatory like to a about melanoma that like?

Fred Vogt

trial generally for therapy. you a interested confirmatory the FDA approval They’re got like going you same indication more having discouraged in just line to for. in earlier So of couple an different a things there. of

X the with to confirmatory a know very as have part Another which FDA clear. make required data And RMAT Cohort submitting, said well, for thing supporting. we’re we this be as many will Cohort we important that is I need sure can out trial. be X to said the point to IRC where That’s designation, for times, don’t of we red data as FDA to

just first the in that data. the goes a not confirmatory in And out ran Does it’s whether you pivotal you you that likely your help? place. will that – find that, do, in same from the need to you of trial you just And all kind be if blender. So same got indication

Madhu Kumar

group? kind in like last of cancer data logically [Indiscernible] like Is like to serves when kind that Is a over population that set think you that cervical would set confirmatory as there the function? you developed of have guys the have kind few confirmatory something mean kind years. of natural a submit I of data natural hand that a

Fred Vogt

a would That separate label on cervical. for be No.

they So a be one looking would melanoma. in that’s would should be in for melanoma they trial confirmatory require –

would melanoma or earlier a so the could of natural line publicly that. or that is the And and you current matter, Cohort approval of something X in an in to maybe like And XA to be sponsor therapy one think our similar account as earlier. about at FDA’s talk thinking should have of on the that they this up time trial running that

Madhu Kumar

you. Thank Okay.

Operator

to I Ladies Vogt thank session. participating and like any for Fred now question-and-answer closing over turn the in gentlemen, you call remarks. would today’s for back Dr. to

Fred Vogt

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

field to also of We moving our are the cross-functional our thank acknowledge and really studies physicians to grateful cancer our for and employees for in their teams covering for shareholders tirelessly Iovance. who want analysts like to would and I clinical our lifileucel working support BLA to participating and forward. collaboration I patients of are are and the to who patients. prepare filing the bring

leader developing, innovating you. and to global Please free therapy. All the contributors Relations advancing Thank you our wish reach delivering key follow-up. to in team TIL to in you if feel be of are mission out our to Investor

Operator

today’s you concludes call. this conference gentlemen, and Ladies participation. Thank for your

disconnect. You may now

We use cookies on this site to provide a more responsive and personalized service. Continuing to browse, clicking I Agree, or closing this banner indicates agreement. See our Cookie Policy for more information.