IOVA - Earnings call transcript Q4 2019 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon, and welcome to the Iovance Biotherapeutics Fourth Quarter and Year-End 2019 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] Please be advised that the call is being recorded at the Company's request.

Now, I would like to turn the call over to Sara Pellegrino, Vice President, Investor and Public Relations at Iovance. ahead. go Please

Sara Pellegrino

Good us. Lorie. And you thank Thank afternoon, joining for you, everyone.

Speaking Fardis, Officer; be Chief will on call today's Maria Chief Officer. Friedrich our Morris, Executive Finckenstein, our Chief Tim Medical and Financial Officer; and President

as release year This you on XXXX ended which the December can iovance.com, the for well that financial afternoon, XX, at a results website the fourth find issued includes we corporate press update. our quarter as and

statements would goals, applications Before plans this to agreements plans, like made we regulatory future that forward-looking Iovance’s during potential of call everyone regarding pre-commercial I capabilities, collaboration manufacturing business and updates. feedback include will future start, technologies, and results, trial conference guidance, remind and and business our activities, statements clinical focus, licensing

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

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

call pass that, I’ll Maria. over to With the

Maria Fardis

and you, everyone. afternoon, Thank good Sara,

in also come to XXXX. BLA to highlight well license submission updates call Iovance LN-XXX year to preparation today's and important conference this during latest or on comment recent as toward as the progress a I am planned the milestones made pleased XXXX progress will lead XXXX. and I launch our application summarize and at in commercial biologics for lifileucel for

programs continued melanoma we our In XXXX, cancers. and tumor-infiltrating to advance in therapy TIL and cervical lymphocyte pivotal

tumors. for indications solid clinical studies X Phase initiated multiple also We in

as into blood lymphocyte introduced therapy addition, for peripheral PBL first approach new have blood we In cancers. a clinic our very or

on with an our melanoma. in therapy like metastatic TIL I'd begin lifileucel update to

of initiated study cohort we lifileucel. completed schedule X year a the This approximately United in announced We As patient C-XXX-XX cohort was in of common accounting each in annually XXXX that XX diagnosed target with States. have of pivotal skin the March a for reminder, last our of in and enrollment dosing X,XXX deaths melanoma cancer, is patients month ahead XX,XXX of type pivotal the patients.

We BLA. to be currently the before cohort plan followed in data from for months for patients cuts inclusion all on six X allowing

the assembling to have with expectedly used submit FDA for We We BLA XXXX. of to BLA. documents process the be meet the started in late plan and

regenerative As lifileucel therapy study. or and X a melanoma U.S. both, designations clinical which cohort the from Track RMAT the from medicine reminder, Fast supported was in received has FDA, by the data advanced

as of median months follow-up. melanoma median reach ORR the patient pretreated, survival X. late-stage The protocol recent study in for rate Immunotherapy enroll been same X for year. was last overall from in January presentations. to or in heavily most overall study cohort We to population XX XX.X% recent meeting. of November or in duration assessed XX.X cohort XXXX may We on at presented by data CITC in reached over annual reported of update of at was a cohort Iovance cohort Cancer, not who were X response the of several In patients still investigators. has presented data the X SITC DOR months. X not DOR response, Published The designed a update time a X corporate for was or ORR melanoma times the the reached shows patients The Society

lifileucel highly So, encouraging. the are of results

an XXXX. Iovance the We cohort as X to the organization continued updates of study additional on the in patients provide the to advancement for very-focused is toward BLA. in and preparation this hope from program monitor

is part enrolling metastatic complete cervical pivotal in Target dosing of track into in XXXX approximately cancer. We and LN-XXX enrollment is study study to remain midyear pivotal patients. second C-XXX-XX with continuing XX this the Our study. patients on

other, still planning of not later indication the submit on BLA to BLAs separately. two FDA. each be the dialogue each are are dependent Submission year, following the We and this with may a submitted

XXXX, Fast designation compelling These supported ORR Oncology FDA. in at as data the as XXXX. breakthrough demonstrating of a Track During Society designation designations annual meeting the study, were therapy which well from XX or ASCO LN-XXX of American BTD, June XX% the ongoing or was from presented patients by received Clinical in

FDA We XXXX. also X with meeting of Phase End in the successfully completed

the Following the order meeting, the LN-XXX. target support to registration in study to we patients of for pivotal XX increased enrollment part of

syndication. earlier this have We of LN-XXX includes therapy. changing pembrolizumab for a cohorts in combination with anticipation lines in cohort failed prior This new in patients cancer cohort who that with with also later and specifically added landscape allows patients anti-PD-X and cervical a in of treatment

dosed patients and program, than approximately we continues patients. clinical there robust second XX% XXX or a well our manufacturing Gen XXX one generation TIL XXXX, in During X to a of and demonstrated success more our rate over process be therapy is

in trials international capacity. melanoma building we the cervical, with manufacturing parallel for our already internal In pivotal and are

Specifically is manufacturing expect facility for XXXX. operational production continue aiming of launch, facility support partner build planned commercial supply to commercial continues. They facility is state-of-the-art meet Iovance of the capacity to patients. capability. AppTec we in our for be Philadelphia Construction from year-end Philadelphia this to WuXi foot our in The June come build to to started CMO commercial initial the by XXXX facility as a demand thousands will XXX,XXX internal expected square commercial Iovance XXXX-XXXX of in supply scale new

of of lifileucel medical continue In and LN-XXX, commercial and anticipation infrastructure. launch expanding we our affairs

patient remains focus main lifileucel. ensuring of experience Our positive area a of

are a we of in administering or and be items: by with with collaboration that, who HCPs, will operational in development product; engagement product; handling provision close payors. and launch; commercial excellence healthcare working the preparation Clinical site professionals for our of communication Towards following the Iovance on

in centers over cervical with experience cancers sites that lifileucel of initial for United launch with leaders anticipate prior number the and work melanoma for target for melanoma with currently and cervical. the we and be same clinical will the TIL those In LN-XXX We States, for XX key opinion and sites of approximately approval.

HCPs work to TIL to assure available is a and team affairs is about treating groups organizations. of with network place to information that interested advocacy medical in patient Our

continue our also only our in logistics place program not but assure also clinical for patient is infrastructure optimizing commercialization. organization to a and focused We for

We have made of with that we great work clinical expect centers in and commercializing them progress in collaborate in program identification with TIL. the to

payers way. of the to reimbursement In access initial to at patient we and patients. support patient the initiated And with intend access and to infusion. centric under On from TIL CMS discussions therapy model, reflection private to patient the process have timely ensure a we front, the every step for

market our to the on our continues, providing preparation launch and research As commercial we throughout forward plan year. look updates

our now Friedrich update our Officer, provide I other Chief would Medical about Finckenstein, clinical programs and like Friedrich? an Iovance? ask to at ongoing to research

Friedrich Finckenstein

you, Thank Maria.

in to the cancer, indication clinical ongoing our and study head begin with remains like of which an important C-XXX-XX expansion would I neck for Iovance.

to with we our third recently with new XX-day, the will continue new C-XXX-XX Patients enroll our cohorts process, call and generation study, study. the to first in new LN-XXX which Gen We in therapy treated X. added manufactured proprietary TIL patients cohort be

selected as first for time this TIL designated on killing clinic, selected is forward to cohort this November will which in improved PD-X This are the a TIL XXXX, demonstrated in PD-X we selected enrolling We product. cohort at select, evaluate new properties cohort. patients we second preclinical prevented SITC LN-XXX-SX. tumor product look testing TIL the The inflammation cell in and new

for the patients dosing of TIL are melanoma, cancer. TIL have immune squamous therapy IOV-COM-XXX the checkpoint is cancer in our potential Patient cohorts May offered to broader clinical significant pembrolizumab checkpoint and fourth cohort, also monotherapy naïve relapsed/refractory and progress to carcinoma cell neck, the lung and LN-XXX in non-small head active plus for in cell also earlier study, will patients. treatment and non-small We we made in initiated cell refer lines inhibitor with who evaluating which XXXX. cancer. melanoma, non-small in lung head was neck, the as lung of study Three evaluate naïve cell And

indicated. introduced study. have The into target cohort to selected increase neck and head prior a will the cohorts as and have plans fifth of we also LN-XXX-SX same across our to is add who MEK proceeding and the four BRAF additional overall selected or cohort Enrollment of patients all received we investigate TIL, in study. melanoma the these well anti-PD-X BRAF back have that TIL product enrollment the This in is

Iovance to cancers. study peripheral we designated cell our clinic report blood lymphocyte week, therapy, the to blood therapy therapy that on in patient first IOV-XXXX. very in have Moving our PBL for very happy of which we're the with PBL last dosed first clinical to therapy, our am I we or be excited

refractory process. therapeutic research translate or from Development this important our experience patients study internal X/X provide the polyclonal We patients additional dose killing currently solid Phase generated lymphocytic Phase CLL forward with SLL small the a portion. result manufacturing therapy of efforts study is to We Iovance use proof-of-concept milliliters study. relapsed IOV-XXXX tumors. named into lymphoma, using X PBL of at and population PBL will enrolling in IVO-CLL-Xl or with PBL development our X-day is blood for a look of T-cell of to escalation enrolling approach a think XX and The

efforts. stage call research our Tim, the to earlier I would to turn I like Before briefly development mention and

an antibody treatment. obtained a to IL-X of cytokine Novartis as a protein, as referred license component As major commercialize announced IOV-XXXX in is have engrafted selected January, targeted and from a develop we IL-X analog. and to our

improving pharmacodynamic is to properties beneficial further available IL-X. So, analog of to currently the proprietary as the IL-X development optimize and valuable to pharmacokinetic IL-X compared properties the the of opportunity

create worldwide agreement TIL We we multiple research license exploring TALEN collaboration use technology for address Cellectis, the Under TIL certain modify targets are exclusive technology to to potent modified The exclusive and enables TALEN with us licensed worldwide to TIL gene even develop an edited use. genetically to license TIL. in cancer genetically indications. therapeutic more several have to also with potential

now will results. discuss Tim call to to financial the I hand our over

Tim Morris

Thank you, Friedrich.

financial quarter address remarks from results high full the our fourth My and XXXX. year will level

earlier, the that Report distributed we can be on the shortly Form our details in Additional SEC. with to filed as found XX-K release Annual well as be press

for loss as for $X.XX loss $XXX.X net loss million, XXXX $XXX.X a $X.XX the per Net quarter share of a cents XXXX. XXXX share compared net $X.XX million, Net to or for fourth million full the was ended million compared per was to or XXXX. the quarter loss year for share, per or $XX.X per share $XX.X fourth of $X.XX or

increases the enrollment The fourth expenses due increase of compared increase to to Research year of an and for were $XX.X for million, XXXX, quarter prior million the million $XX.X million activities and development XXXX. periods for clinical quarter General increased were quarter the increase million internal with an full $XX.X to $XX.X manufacturing the $X.X team. $XX.X full quarter Research $XXX million an the $XX.X the fourth development were increase and XXXX, of and the to XXXX. for attributable compared to year expenses associated for the million, and quarter the in prior fourth growth and year. higher the research for million and of were over development when primarily an in expenses XXXX, $X.X fourth the administrative the trials million costs compared fourth capacity, when

growth primarily higher General XXXX, an administrative commercialization. full research compared and attributable in year Increases million IP were the internal for as million market well and the $XX.X activities year over XXXX preparation $XX.X and to $XX.X quarter costs as administrative of million and team to the were for full general fourth and expenses legal the XXXX. of for increase

and we restricted in $XXX to XX, million XX, XXXX, short-term $XXX.X December cash held XXXX. investments cash, cash December million At compared at equivalents,

mentioned, addition, facility. our own we as In Maria are manufacturing Iovance building

We over $XX for expect years to and three construction. invest approximately million equipment

to will to the hand the Maria review call and milestones kick I session. Q&A off to now back upcoming

Maria Fardis

with in submission. you attending last In today. productive be BLA call LN-XXX all forward this top-line program and FDA; include Thank U.S. an patient We to dosed for pivotal the cervical data; and closing, meeting for for XXXX. pivotal pre-BLA melanoma to year the cancer; for our exciting look milestones anticipated

answer session, begin to to like not Q&A press. in will Before the related we in circulating does questions media not comment the I on articles remind everyone that would any speculation Iovance the and

for Operator? over turn will to I questions. the operator any call now

Operator

Wells [Operator from a the of question Fargo. Instructions] have Birchenough We from Jim line

Jim Birchenough

if what of could guys. cervical you progress. I cancer, benefit and available the each then, making this to commercial and the is, the that? about accessing for Hi., X,XXX each I thinking going the one centers year plus really thought wondering opportunity, part gating and that items these ahead guess, more the if of you talk patients? they XX on capacity about it all melanoma of have you about that in die population addressable just Congratulations the population think target about could you’re initial to of the treat to And guess to how go second broadly patients

Maria Fardis

question. Jim. the can option actually Hi, unfortunately X,XXX although third we X,XXX in patients, landscape, is Thank is for population patient and From certainly a that the opportunity you an Sure. than consider are these TIL And thinking line. patients and commercial that one melanoma currently recorded. about die perspective, second broader for

about of population that's and products, sort that thinking the you're protocol how allows. the positioning that's current patient So our

been sites with want targeting centers. centers, to We're just I comment have made XX been we the the participating I intend take start of melanoma sure have not by getting terms just The time ready in product In clear. make that the off I'm XX that that was, those expand the and landscape. around We program clinical to cervical. a the commercial to certainly and we’re in

Jim Birchenough

a that the And how of more opportunity? And have the patients you most therapies, second with had get guess, more Maria, centers to the center treat. give you what think TIL sense experienced experience to access third just do I of many initial a need proportion about gain to question, they broad that those line melanoma you follow-up. think When

Maria Fardis

their that We in do are. the I distribution know go quite approaching bulk it. But, same think you're of internal typically about certainly We the what speak Yes. of if consider plan. to exactly we is certainly to where don't them specific receive ready the care. where have it an know they I'm patients math. We about as way of terms in

Jim Birchenough

enrollment really one, a done LN-XXX you quick get And that in could the when midyear the close depend or Is cervical that does XXXX expect on just XXXX? slip and out Maria. filing to you filing, into something

Maria Fardis

will currently and Right. on And depend exactly continue slightly year-end. for to We recognize cervical that submission We apart. XXXX, ahead complete, met melanoma plan of plans some of remain are the as of later and the course, are But, now. submit, by would that assuming correct FDA. of dialogue all of cervical cervical a with go timing current of when as to you're milestones as enrollment well the around part that

Operator

Ben question Stifel. next comes Burnett from of the Your from line

Ben Burnett

trial. the basket a have I on the question IOV-COM-XXX that's

expectation cohort Looking these at TIL might plus you do monotherapy. to get data pembro as well as as I when we first guess, the an have fourth for four cohorts?

Maria Fardis

question. Hi, Ben. of started We dosing Thank patient XXXX. you May for the in

a distributed is of study study, a we the have before the each cohort would may patients cohorts. in that can patients like to we make sure Given the basket between be really handful them. report We

yet. committed a not flow to have the specific we for study timing So, data from

Ben Burnett

And been you. on guess antibody I I activating the talk How the If IL-X selective just you Thank one non-Treg collaboration. could more recent -- this engrafted? a is IL-X? developed, the ask more antibody guess. regarding makes I about that’s Novartis the Can being more what

Maria Fardis

of course. Sure. Yes,

alpha, we know might subunits on sub is you The various subunits binds three toward We're to interested in; subunit and units gamma beta are IL-X out. the binding binding Treg. is beta in more that So, trying cells. rule prevalent to gamma T alpha what different

it we focuses CDR gamma IL-X be in the this expect to particular That's alpha does allow bind subunit. the that better fact subunit. It not to beta So, the to we better. have for why on it

Ben Burnett

-- I the at point, is it is on of that kind antibodies architecture proprietary? at this this And or point, comment Okay. guess, just helping you engraft that of

Maria Fardis

thank you understanding. It’s And certainly for proprietary.

Ben Burnett

much. Makes Okay. Thanks so sense.

Maria Fardis

Thank you.

Operator

from Joe Wainwright. H.C. line comes the from Pantginis of next Your a question

Joe Pantginis

was I your with little if detail for taking the regarding a for manufacturing curious just provide more could you of Maria, your evolution strategy the facilities. Thanks question.

when As WuXi you anticipate on And to share facility in comes now your will that off you also, look X? mentioned facilities? sort line in looking XXXX. right on new have your two that do How your and between facility responsibilities prepared comments, you start these come line, you Gen have do with to of

Maria Fardis

Is Joe, you Gen it what start to statement, will correct? said? correct X, with that off your

Joe Pantginis

would when evolve And Gen Yes. it X. to

Sorry, yes.

Maria Fardis

Right.

So, X. designed currently, much around plan and facility for is commercial we X. loaded Gen Gen -- is much very locked The our very

Of But planning now, manufacturing support be our should they commercialization for a for much we course, can other on need there them. properties, very X process. are right Gen

rules In staff familiar of terms started requires of the in our Philadelphia. the building a process. -- are who itself building the with and responsibilities, building already of we team number have out Certainly,

of people terms have We team, optimization. with and as development familiar expertise the are and as our very from great in process in-house, starting engineering well process, who

is So, roll time is that going we out. be the to slowly commercial team to already what needed the have by ramping up a activities

team members otherwise, supporting quality for or the Philadelphia, In [ph] are addition such who additional team have to activities members some local partners and as in we facility. the the

sort foresee So, been see people and go are already rollout, the -- then hired the on I they any started. hundred into rollout a where don't facility. a I everybody and of switch has

Joe Pantginis

That's the Gen really on Just in the shorter any a it's the regard from just TIL between identify PBL and could quick helpful. process extract if it's blood, T there TIL? you once Thank identification any the cells how research major difference is follow-up before I front. ask process are With PBL Gen you you. there expand major you X? differences that X a curious, versus and can them your to much program, And exciting obviously, the

Maria Fardis

some And been those shared process of not that bulk of sort proprietary We we have very a it already. and has different PBLs. for of use again,

usually in we from that the in the blood. harvest there's not yes, So, high concentration are cells very rather differences, significant cells, T tumor

know that. We We are to they difficult that with find. are already familiar

out very one doing procedures were one we fix T in get obviously to from in a tumor, to cells cells differences So, implement yes, there's successful being we different blood. source, order the and But so. we had being the in how

Operator

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

Mark Breidenbach

completes Maria, pivotal the than see factors I'm cohort of initially specific in assume safe minimum a enrollment you I a And point can that? follow-up contributing faster noticed discrepancy. the before had cancer cervical is pivotal to projected. more we in maybe that that pivotal you the wondering to you if just any it initially or little that we bit the melanoma from want enrolled cervical timeline had projected and would once months on also, six maybe cohort top-line less data are

Maria Fardis

Thank for expected. you, medical we you're think is that questions. Yes, definitely the Melanoma faster And than shows Mark, need. landscape The I correct. a clear enrolled changing. definitely cervical unmet

As as of studies just well space, commercial trials terms you're the earlier line, aware, into Keytruda the use. clinical there's coming in both as

the our cohort that so, are is -- certainly of enrolling nature we're changing. that there the into And X out is patients patients the

to due really the it's landscape. in change So,

Now, in comment going we a to to change anticipated that with anticipation our added about call this the study happen, the made it, for LN-XXX into in I cervical is and landscape. cohorts

this if strategies, have alternative this thought continues. we So, and some we have through

in and of follow-up. do question allows just follow-up us of because terms follow-up. six really six for melanoma agency second been about to a the it six not early, your has And amount from months We a follow for months so request, certain otherwise, either of closed of There or months enrollment thought up.

subject be the months might is really how FDA in a for. a proposal terms U.S. that in think asking to that they I note with to do case. six Iovance But, want the much melanoma follow-up this is I discussion So, of

Mark Breidenbach

elaborate head follow-up important with the neck. what add head is in on it's in I'm regard TIL, to initially curious quick days of you PD-X on impact manufacturing the And select of And process. just was Understood. why this that I'm why timeline a -- to curious neck. Gen on that is a that little manufacturing a process? really and Maybe the have also bit could X focused being maybe and version does timelines, several what

Maria Fardis

on recognized had survival short and that patients earlier have fairly the Yes. unfortunately. cancer head a neck in We

doesn't a it the make -- to a shorter many a that times, really process don’t second patient or So, manufacturing could they benefit we population assessment first felt assessment. that

fact, not So, process day that process study. than and longer implemented PD-X that's The we - to X. It not so that why into additional does neck it selected our in is the the we have process. initially Gen manufacturing add optimized the is head

the X same our Gen So, as process. it's duration

Mark Breidenbach

questions right. and All again. answering for Thank congrats you

Maria Fardis

Thank you, Mark.

Operator

Your next question of Benjamin Reni from line JMP comes the from Securities.

Reni Benjamin

FDA bit little required do Maria, but results, about from the disclosing patients are basket, you you with can you feel not just talk maybe cohort just many pretty think per duration of your kind mentioned comfortable a other And to with some before how gating filing? other of need answer but in Mark's discussed the be you question, studies? to items to what prior

Maria Fardis

I for Ben. kind nice you, think But of Thank prefer, magical number. least for to I cohort there's there's but patients a example, at be per disclose, us to a don't it. number X magical not about would talk

is that what you data X, depends would to mental think which me we for X, But something, somewhere again, mental disclose asked do your emphasize, number it magical see. study. that's really I by numbers. note. be good not what we want X X, I a But there's on between the But my number, if

about ask the duration question duration? what on front? you terms your the did you -- you repeat Can asking In on of were

Reni Benjamin

No, sorry.

to discussions FDA regards in Just the filing. your with to prior

are I a you items one worthy what would filing? you'll talking mentioned, discussion to mandate. don't are be that since you think, about, other particular duration things But, of that the think have prior be of they

Maria Fardis

Sure.

property about. of that But they part see duration a a that there's well to So, next follow-up of of typically large find And component to a the other that make BLA. will a usually of I discussion guidelines has the is of ask just agency of The sure asking components of then document, subject questions typically duration involved the the to a exactly dialogue. the BLA build pre-meeting meeting very to where clarify your specific It as step. be that duration how response as something. bit the another going BLA of follow-up, we product. a has is duration component question, of logistics of as It's is logistics to we’d a it. response, you're is BLA item make in for

won't Sometimes detail, that's into the that's to meeting. other I company topics much scientific too up. obviously, go for something what the topics, at proprietary also pre-BLA discuss pomp each as they

Reni Benjamin

kind it. will Got is, I the data, from thinking the final of results? you it, reporting for about data kind be be cadence about then it that a focused guess cadence seems we Is in that are sometime of filing And full one a release just like melanoma, second us half of there we should results primarily question thinking or top-line how of programs Are or all really and correctly? different then -- that from 'XX? Would is running. kind of data

Maria Fardis

rule in form. shape wouldn't out I any or any specific patterns

about thinking thinking melanoma Just right of now how and disclosing I’m level sort way now. data, just at maybe That's we're more right possibly FDA then data, is disclosing very the about a information medical conference. to top-line the specifically it top-line submission it talking about high and

Operator

Your from Baird. line next from Kumar Madhu comes of the question

Madhu Kumar

for Thanks great. taking Hi, our questions.

is, melanoma one regulatory first cervical our what guess in is path I cancer? ex-U.S. the So, in

Maria Fardis

obviously authorities as authorities. called in a be what dialogue clinical XXXX. submit And that later more of of number preliminary clinical EMA authorization, and of of that we not the dialogue. Sure. It's have procedure been has on called a submitted. active do with part starting do health later have initiate been to health a is in EU We broader XXXX. part CHMP, a it sort Thanks, no has in We are a of Madhu. to that potentially part local year We dialogue sites plans trial centralized with had of has there intend

Madhu Kumar

a just PD-X question practical combination And studies. about the more Okay.

PD-X at combination And the beginning and the gap there there before procedure how the start period is like between TIL in do a of studies? much like washout a TIL, PD-X, is IL-X [indiscernible] So, treatment? the administration you then,

Maria Fardis

prior study So, available But, information the be And go clinicaltrials.gov. of speak Madhu. won't is able I PD-X that degree administered the to to TIL. is to details the to can on into I design,

Operator

of from from question line the next Biren Amin Your comes Jefferies.

Biren Amin

Thanks for see And taking great it today. questions. earlier to was you my

as think fully So well this terms of the X enrolled, melanoma refractory X prior to Thanks. compared PD-X do cohort lines, status? Maria in with the cohort terms of about median characteristics cohort you how of baseline in as

Maria Fardis

Biren. Thank you question. your Hi, for

X. We actually been cohort compile X. we where a data the data for document cohort analyzing We have not integrity place don't have in

we So, the same patient patient speak try we degree sites the I that won't did to protocol and and be way, Xs Xs, to definition the between the a to able we the I cohort population population X. note designed the in is control the same could keep cohort it participating to same.

Biren Amin

just this activity? TIL? forward are are the in seeing decide move selected the guess, head can to you but And to cohort the currently then, PD-X of terms And you TIL. what neck about you you to from in just hoping talk allowed program PD-X that X, bit the gain not Gen a little and selected What I with

Maria Fardis

criteria PD-X for of was are think The was they seen because -- some the preliminary TIL selected XX XXXX. it that PDL-X the I of was some data around at data for the ultimately was there tumor. the presented So, T-cells recognize have that program tumor,

high, recognize touched PD-X the cells. TIL tumor, So, initially that not what tumor have really identified, but they tumor, is the only they TIL the it's expressing beyond

PD-X in that selection at in autologous they killing are activity melanoma more selected are SITC capability. And and XXXX, quite showed literature fact process. there showing again, TILs, capability. we was that around So, that potent killing the it remarkable. that presented so idea TILs the And better have this these the have was cell enhanced was When we

move product So, clinic. we decided to into that

of for ago months X neck of what was set preliminary would very, and for head around of years Gen terms data our patients. bar back maybe a its to we a couple In DOR X the have disclosed X be, that very now median

goal our the the try would So, for we cohort. elongate and to are median looking be DOR. That additional

Biren Amin

terms maybe antigens. some Because a and last companies about synergistic And then, of these this the potentially that Do it there's of how competitive could question to as approach? landscape in a TILs, if seems complementary you new Maria, you you be think approach or investing feel view And some are this. in TILs? pharma just of a that

Maria Fardis

Thank question. you for that

diseases cover when to multiple lung. and neck, will make they be landscapes. different there and load, diseases hit melanoma, needs that cells think targets. opinion, are we're I have are thinking such high those slightly my me that targets as mutational These possibly In there's we head that multiple

the them target. then could that that that new to you hit And with have don't a T-cell identifying hard So, really specific if challenge be it's would them. antigen

do spaces. So, would that different think I occupy they

antigen trying load. I be maybe TIL would therapies long could think -- targeted know hit exactly load, mutational while you’re beneficial as you to for various as lower higher don't are would And mutational for more beneficial therapies. are new what targets this last with cell

maybe. So them yes, I see complementary,

Biren Amin

So, Companies those? think are any you pharma that there complement

Maria Fardis

closely. particular a who can them know if I that. address I are very interested of landscape. we And companies of that monitor number There's don't in course

Operator

Catanzaro Joe Piper Your from line from of next Sandler. question comes the

Joe Catanzaro

for Just maybe one one quick me.

clinical as preparation, commercial side that a you part of is Maria, mentioned area So, focus. main of had engagement your

is potential Would you engagement, do thinking current allow to would melanomas until X and studies, to about that that How that extended program expand the ongoing to to now that? you allow opportunities cohort that? expect of maintain the potentially Now clinical that? you an do are site what closed, you access are continue from approval

Maria Fardis

commented This As matter very this. that mind. that is is something much front is Friedrich’s of a fact about why of

patients adding this enroll For product, selected XXX-SX. to exactly into That's that part allow the, the the a while the you're purpose, market. will lifileucel LN-XXX that access with TIL TIL melanoma product to study, study IOV-COM-XXX core we’re -- bringing

Operator

There are no Maria time. turn further remarks. call back her closing over questions to at for will I now this the

Maria Fardis

approval. preparing regulatory in first and really leader operator. gone first four have TIL our from prospects you, becoming pleased have manufacturing progress clinic our just for to the the of years, our we made the on we Indeed, commercialization. with Thank Overall, in patient I'm submission the development, in

the of treatment individuals investigators, and shared thanks potential hardworking impact the contribution committed to need for possible, who individuals this who We us. of Work of to options. to cervical lives including Thank with many exhausted have with patients current look valuable the shareholders, We have this cancers clinical is thousands patients patients families product are partners that therapy. and employees, vision of you. motivate in realizing collaboration melanoma, forward

Operator

call today. the concludes This

disconnect. now may You

Iovance Biotherapeutics (IOVA) 25 Feb 202019 Q4 Earnings call transcript