IOVA - Earnings call transcript Q1 2020 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon, and welcome to Iovance First Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that this call consists of a recording of prepared remarks followed by a live question-and-answer session.

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. Howard. and you thank Thank afternoon, joining for you, everyone

Speaking Maria Medical we and today, on call the have Morris, Financial Officer; Finckenstein, Tim Chief Friedrich Fardis, our and Chief Officer; Chief Officer. Executive President our

release ended a our iovance.com, XXXX a well on the March we includes be for results corporate at can as press XX, afternoon, found that update. This the which financial issued on website first quarter as

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

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

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

With over to that, Maria. call turn I'll the

Maria Fardis

toward and to clinical milestones, good call pleased Iovance also lead and as very our I'll to our cancers. to cervical and business melanoma afternoon quarter remain anticipated which XXXX Iovance partners. on tremendous of move I'm for the sites everyone. reiterate conference XXXX we closer close the Sara, made TIL first with our in today's during progress summarize you, collaboration corporate efforts all at the commercializing due track Iovance team Thank

to of internal external address cancer able including needs and key the activities, patients. and impacted has clinical dedication partners to has economies our due continue activities, critical COVID-XX globally, our members to of been While Iovance team manufacturing business the

melanoma infiltrating of cervical to In and pivotal XXXX, lymphocyte cancers. in programs, we tumor continue the or TIL, first in therapy our advance quarter

lifileucel commercial submission while We planned XXXX. significant License launch the preparing for potential also later for Application or toward year, progress LN-XXX in and Biologics made BLA our this

cell and recent further upcoming for solid the become the about potential to excited are treatment we TIL highlight of that tumors. data addition, In therapy platform across presentations broad a

first to diagnosed is of the our a lead in We and in our for XX,XXX patients announced lifileucel X,XXX melanoma. in like type I'd progress skin lifileucel. approximately deaths C-XXX-XX in three of States and completed highlight cancer Metastatic approximately metastatic that annually ahead our accounting pivotal schedule United melanoma common patient year study we each Cohort January alone. months and program X early of the dosing

enrollment patients demand to target our surpassed XX due of increased We for participation. and

documents by the be for used continue to submission. for necessary the preparation We our the assembling BLA

track on We expectedly and are to in meet with XXXX. submit FDA BLA the late

melanoma lifileucel the regenerative As a has both in or the data medicine RMAT FDA, from which clinical advanced Cohort designations received X were fast-track supported and from the by reminder, therapy U.S. study.

enroll designed for X protocol May to the study Oncology's Cohort scientific to in at Cohort from The cut X. the an X present new data Clinical was population several patient the in upcoming at melanoma Cohort of we in XXXX of same as presentation. times presented and American Cohort data XX X We excited are end ASCO from program oral Society the a

focused towards BLA Iovance submission of program advancement XXXX. in this an the is on organization as of very the

in LN-XXX pivotal second Our cancer. is metastatic program patients with cervical

program to the made new pivotal remain C-XXX-XX approximately significant XXXX. midyear study, in patients track in the complete dosing enrolling in have We and progress on

fast-track breakthrough a therapy submit previously year and granted dialogue BLA to designations agency both planning following the are We a LN-XXX. for The FDA. this with has later

indication may be have on As submission and before I the dependent separately. two of other each BLAs mentioned are not submitted each

key which has commercialization. our turn success now to manufacturing for will capabilities been I a TIL

XXX demonstrated as Gen for launch X generation be success of manufacturing We and patients. to treatment we a in continues believe in prepare therapy patients lifileucel track a record XX% with TIL robust Gen in solid using process or manufacturing process. this we established need to have above X TIL second rate Our of LN-XXX

currently allowed of property treatment of patents range intellectual Gen XX a our and includes a Iovance process. methods or of related compositions granted to portfolio for total in in manufacturing TIL cancers X this addition, XX-day In broad using

this continues our for of time studies. At organizations planned clinical manufacturing manufacturing at key all as ongoing

our AppTec the commercial remains at square-foot facility partner CMO facility. come that Yard WuXi For construction will initial will Philadelphia. in Philadelphia Navy from underway our the of launch state-of-the-art note I supply XXX,XXX

expected XXXX Construction of and is schedule. the Iovance in support The eventually of in to to facilities supply commercial clean new operational thousands of XXXX meet commercial demands rooms to April facility patients. ahead be of XXXX started in

launch the to approximately and build In team with at a across continue multiple we strong lifileucel of locations. of anticipation employees XXX LN-XXX, Iovance

and commercial a commercialization. on during lifileucel with groups Our patient experience medical remain focused affairs ensuring positive

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

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

XX Iovance time. to over and at expand well is additional over to to onboard we targeting sites launch expect and sites train

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

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

a the single contact enable through lifileucel developing case support point a are our hub journey patients with support by to patient and create to of hub We providing a mission managers. treatment seamless providers

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

upcoming I Chief presentations data would Officer, Medical ask our like well clinical recent now as provide at about as Finckenstein Friedrich? to to programs and an our Iovance. Friedrich other update

Friedrich Finckenstein

would you, Cancer recent AACR presented to cancer. lung of I touch our Moffitt have like where American Thank collaborators Association upon at non-small Meeting Research on TIL Virtual Cancer cell Maria. data first Center in the X manufactured they

is As the cell Iovance's similar a be TIL process reminder as not to lung X proof-of-concept a for uses expected manufacturing Moffitt Iovance in the same but process TIL is non-small TIL and to a cancer. it Gen

study. an data the from TIL indication. need lung foundation medical initial Moffitt cell in We responses show complete were cancer The for to very is see non-small durable Moffitt's is pleased such which to unmet the two further own in most AACR non-small cell this data from cohorts strategy lung recent Iovance our our investigate patients IOV-COM-XXX strategy. TIL basket cancer our reinforces in And of

our ASCO treatment in the the melanoma X in longer with Looking new to submitted from further the in of from session. results of ahead, accepted lifileucel are lifileucel. data of we that clinical advanced durability melanoma illustrate treated abstract a one-time patients has updated cohort metastatic C-XXX-XX study pleased follow-up an oral We of

the rate or for data update As XX a most as patients at Annual Society Cancer investigators. recent Meeting. were XX.X% Immunotherapy November was These XXXX, in reminder, on by or overall of response ORR SITC in assessed presented the

study As response late reached not of median X Published median cohort of or was at seven to DOR XXXX, still months for months. our may data patient eight overall populations Iovance corporate duration of in update XX.X shows survival stage in follow-up. median January similar reach

highly So are the results encouraging. with lifileucel

studies. to our other Moving on

our additional for treating the clinic indications, the We we in advance therapy. programs of clinical earlier offer lines that attractive and option as particularly activities TIL treatment a continue across physicians. in key one-time to and as in approach think patients may continue well All

for study, and earlier our IOV-COM-XXX checkpoint lung non-small and basket clinical the refer to which include, treatment study also the of as TIL broader naive studies melanoma, head lines cell in potential we neck cancer. These evaluate for to therapy

into clinic has selected This LN-XXX-SX, process well new an including manufactured this third-generation non-small introduces new and TIL product. TIL. cancer is cell ongoing receive TIL product additional C-XXX-XX as our proprietary remains PD-X our relapse/refractory also study clinical therapy LN-XXX cancer, XX-day which Furthermore, and the to or cohorts X which in TIL important Gen study proprietary with as lung indication study neck The head for Iovance. two for melanoma

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

Tim Morris

high-level from first Thank results you, our reflect will financial XXXX. comments My Friedrich. quarter

Net Additional the to loss as details Form SEC. found well the for press the a March XX, XXXX $XX compared shortly earlier share can in be share release million we first million per $X.XX as March on to that XX, in the net be first with filed loss quarter XXXX. report distributed was XX-Q per quarter ended or $X.XX or ended of for $XX.X our

attributable growth the activities. and first million $XX XXXX. of primarily team the were from million an to XXXX $XX.X in quarter the internal costs for increase expenses period of prior first million to increased IL-X trial compared development license Research and the enrollment, higher increase XXXX, the an analog over the associated quarter quarter $XX.X and first in the was higher Novartis, to IOV-XXXX due research with increase costs development to in for year The clinical manufacturing

the year and quarter quarter the the expenses internal of growth increase to increase team primarily compared an general million of administrative XXXX, first million attributable The administrative $X.X expenses. first for was XXXX. first period stock-based quarter over and General to of $XX.X the were compensation million prior the $X.X and for in higher XXXX

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

and materials be one-time upfront first XXXX. included license used throughout the quarter payments clinical spend The stocking XXXX of to

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

Maria Fardis

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

progress have leaders in continued commercialization. TIL become pleased and Overall, development the I'm very to with and our we made the manufacturing prospects

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

Operator

[Operator first the comment from line question Mizuho. Goldstein or comes Mara Our Instructions] of from

is line Your open.

Mara Goldstein

the between how question. very possible If the BLA similarities I own to before Thank cervical taking just AACR I'm would clinical timing Moffitt. the of characterize Moffitt potential differences? And for to the FDA much approval filings from then the designations, to is potential trial return could see based just and And melanoma? and data the curious your as you program you on and a in it

Maria Fardis

you, Mara. Thank

Mara Goldstein

Thanks.

Maria Fardis

manufacturing. difference method, Moffitt at utilized is the is between Of course. X more a From which Moffitt to in a there six-week is difference a manufacturing program, and process, being definitely that Iovance Iovance's perspective manufacturing is similar method Gen manufacturing

method which is X manufacturing manufacturing process. course Iovance's the of a While Gen XX-day is

for ,meantime confirmation of And of with and receive there's the if how process TIL resected, differences So then nivolumab is itself. followed least banking process administered. also of are in pre-rep process model. patient which conducted then manufacturing a call their difference only In They progressing a initiation is we treat undergoes actual patient process. There TIL in seen the doses use that nivolumab. product the and treated is then they by and the The rep tumor definitely of resected I a a tumor the is progression initially four and is the TIL. manufacturing at is patient the

use don't that We process.

doing one population process approximately cohort which and two In or study, One a is are are we using in. a by which cohort there's well naive Cohort are KEYTRUDA PD-X and XB, in cohorts TIL PD-X patient where plus XA relapse that's given we TIL administer concomitantly. We as as Iovance's is refractory. a that TIL which is KEYTRUDA

in In administered TIL So Cohort we Cohort TIL administered XA, plus XB, alone. KEYTRUDA. we

them cervical perspective, in concomitantly indication discussions the believe either between as pause are are are of indications terms likely we study modifications. table both and a other of ahead melanoma of as with From those but or well sort different few that an terms on me submitting Iovance's, I Let FDA. are of would be in of There the modifications high-level there. Moffitt the

Mara Goldstein

much. Thank you very

Maria Fardis

Mara. you, Thank

Operator

you. Thank

question Our next comes of line from from Barclays. or Peter comment the Lawson

Your is open. line

Peter Lawson

Hi. my Thanks for question. taking

and your the be the kind about change Moffitt's potentially of from the data? that you could that Just response then guess be around we the next your get rates data as we have of could manufacturing X I of lung about broadness or would with could Do think it you? would the follow-up thinking we when see cancer between any And X Gen evidence about these your Gen manufacturing. responses depth the versus you how from differences

Maria Fardis

SITC Thanks compare. it's speak for differences our versus We allow showed process, better me Peter. our not XXXX. interferon Gen X potency having manufacturing at X. utilizing to well our Gen these own as -- markers X. Sure. We since youth better two But We production. X we and versus X to hard Gen markers to methods youth as as gamma Moffitt's in are being publish Gen manufacturing by measured different me between activity Gen did markers very

our compared possibly to a believe is maybe product Gen X we Gen So our slightly own better X.

terms of releasing from of study, own data patients it's cancer from as very the basket data In non-small initially But noticeable cell had the about earlier we is our on. the study, broad. Moffitt thought quite heterogeneity

have we maybe that committed thinking This study and we the we really are five want when is, be. But to might obviously, enrolling. would that before we patients at So to not data. have -- XX least release open currently

we adequate of have follow-up, committed for we time And able amount data present and to presentation. that. have when to so, frame But a not we're

Peter Lawson

so for Thanks much question. taking the

Operator

Thank you.

Our comment next question Wells comes from Jim Birchenough line Fargo. from of the or

Your line is open.

Jim Birchenough

just guys. and One question median we not I'm be quick follow-up. melanoma, Cohort Hi, of Congrats a has suggests this ASCO the but presentation progress. median asking reached? presentation able has a for just been number, on response whether for from all not assume answer, might but to the that been X the A should updated Yes. of the duration reached. on data you

lung own high cancer, whether just and makes over a a of skewing that you've in you cell cohorts non-small burden your towards of then, burden. burden in from terms terms learned anything in Moffitt the mutational And think low sense mutational mutational

any your along in there's if Thanks. differences lines cohort. wondering lung those Just

Maria Fardis

Sure. for Thank question. you, Jim, the

still we're the very The In course, as for -- released. thank abstract updated excited embargo. terms can has that say itself has only ASCO I and the is But data session. of recognizing X Cohort of ASCO that under all that, abstract oral you presentation accepted title itself an is

frame follow-up benefit abstract, the and one-time the February time submitted treatment data with that We a product offers patients. obviously, believe this we great had as to in back that a we longer

been in not matter any way has but And are a the so, as confirming a very we that of I'm median about DOR excited data reached, fact.

was, TKI, regardless before, the to In of cell load. response patients like what terms that response as we patients actionable TIL seen seems we tyrosine an have a of From had inhibitors, kinase their mutation. perspective, have non-small had able generate saw to the and It's mutational these data. received create it is or for their for able a response patients

that melanoma, what available So patient we the TIL really much seen is pleased had cervical, we are as see well to to of a setting very broad population therapy, as similar in to frankly.

not are non-small we direction our our So quite for changing cell program.

for are can a say patient although, seeing emerge, have I we defined, to data of as patient populations. population patient that beginning broad are a populations registrational We broad potential set

a select I'm see pleased to that to have very population. as don't we So,

for a options the have program. of number We registration different

Jim Birchenough

Sure. Thanks, Maria.

Maria Fardis

you. Thank

Operator

Thank you.

or next comes Piper of comment Catanzaro Joe question Sandler. from line the Our from

Your line is open.

Joe Catanzaro

with taking Maybe Hey, question. guys. presentation. for Thanks Moffitt the my AACR sticking

that So whether and investigator the was indication melanoma, tumors you've studies? taking about of program, that other first if there all because I'm presenting to your cells to and and of T entire by Nivo, the on across clinical Thanks. trial treatment. potential seen wondering could speak that you with the exhausting the designed then just PD-X any cervical concerns the putting noted

Maria Fardis

a by TIL certainly end the that a can our from We a of process. TIL exhaustion process comes have rejuvenated tumor markers Joe. see of that get had the that growth might Thanks, in sample

entire concern, of see you process. regulatory rejuvenation at -- from a that TIL positioned what growth I a terms that recognize that's program given in as a XX-day So, markers landscape, PD-X bulk as is end for do We noted, our like. path. for procedural our process a the post But of looks our of more

tumor that unclear. it's makes impact, for whether up the So microenvironment

to to very after haven't sort that process. seem for randomized doing potential growth We to done be But the our are pleased the variable. study XX-day that see we better control of TIL

tumor appear benefit. now. doesn't It unclear a it's certainly me that So banking as whether way offer of any to would

Joe Catanzaro

one cash Thanks. Thanks. here maybe on we independent from another Got expect Tim. Maybe update review? Okay. the with for at ASCO And speak then just And it. Can could current runway follow-up quick you if update. central maybe to hand? just one

Maria Fardis

Sure.

giving necessarily terms in planning were specific are IRC. by not by we of details or going whether investigator So on we

to presentation, more easier ASCO always it's of live data is because terms available. In just report investigator an it

can things investigators data viewers very see of time. view because more the So, much a the read in accurate real just

of In runway, well. I'll answer as terms for Tim

not cash have We guidance. a given

have comfortable it of will plenty spend our in strong We're BLA. had we We cash are year available to our we strong to provide we total pivotal have have complete a when the able certainly we to program position financial submit And still evaluating and record our us. being have. we financing. of that hand do and track But really with guidance very

So, provide guidance will we available. we additional when it have

Joe Catanzaro

Okay. questions. Thanks taking Got for it. my

Maria Fardis

you, Joe. Thank

Operator

you. Thank

Kumar question comment next or Baird. line the of from Madhu Our comes from

line Your open. is

Madhu Kumar

our taking for Thanks questions. guys. Hey

So ASCO first relates one presentation. the to

following question. Jim's kind So from of on

the would of additional complete median material the reached. of there you events in being duration response of idea are So such two ASCO? impact But response melanoma disclosures updating basis the reasonable that be a Cohort other mentioned could that kind events, as for

Maria Fardis

you Madhu, the for thank question. Hi

that the to scientific as something opportunity community this investor regular perspective well at sure if developer that just is of both as gives the particularly community. that any DOR just make think drug I the of updates to from a continues is always interest, drug given development,

to I'm CRS. you still additional or not are you go necessarily under is do ASCO have obviously think that about you not of probably I So why to wouldn't disclosing anything want this aware would embargo.

DOR a favorable we study incredibly an of median months XX.X from where continues the scenario, perspective data had for was considering my But we read the and the is JPMorgan follow-up. scenario time that last

or to So, read there -- ASCO. or or you have to necessarily got I'm median the whether declining not are continuing just confirming enough not the been would responses But deeper go not.

Madhu Kumar

you presenting of set or And head stepping like philosophically, neck, about What conference a kind be comfortable other online feel of with in person. then and like it of would some programs medical thinking non-small cell. back kind the at a data

Maria Fardis

know specific a necessarily I if there's item. don't

I -- a subjective if if think is years myself. as been drug of lot that XX-some around and a this who bit developers such have

You look out. it's and at to the is data and decide time you something it put striking

the of always that little not If can one key extremely then for understand think the it's is I a indication pieces disclose I me it's But new, too to that. given data you data. does us the Moffitt in shows I in next TIL for question TIL would these specifically indications is position efficacy TIL think do cell, and cell. non-small how of non-small what Iovance's brand-new

So, would it. of information follow-up patients degree make and have we for that that enough disclose we number like I sure some before of to

really not unmet product to patient settings a with do which for number. specific has the there's administered need So, how and It the patient population medical is. by population, being that is the

Madhu Kumar

Okay. Thank Great. you.

Maria Fardis

Madhu. you, Thank

XX Operator

you. Thank

Cowen. line comes next the of question Our or Boris Peaker comment from from

Your line open. is

Boris Peaker

designs. doing what that understand yours. on the kind the progress you're we've their in far. talked in not want your about versus I'm curious all process. the of two your than process? Or cancer manufacturing on lung longer a in I trial three the made differences to X? Why take that you differences they're I little Gen mean does times in it process doing is Gen more to I there just talk about guess, guys Congrats so Moffitt just

Maria Fardis

Boris. you, Thank Sure.

patents manufacturing of can is is our have -- why because we how on Gen developed method. allowed Bear which conditions precisely a a steps to this only optimized is in is very point. sort our has This we speak as learned in manufacturing XX is the of there. have have precisely better we proprietary certainly there's X, now for this is Iovance. Iovance's have again initially X-week we One mind not to growth method why our that's the So, TILs a a I at as process, couple so own description TIL granted grow or end. well that This at process

is step the of and that's This X published But and the that on an example second data lead does there's clinical a a any is it's original is for part of a This subpopulation learned selection Gen have also that a an is in of and as selection same for to that what selection response have process method selection way. since process. of improvement then, NCI was in we TIL. based the not in assay not PD-X NCI this process from they selection, just our in

things on and run the parallel. of assay correlation seem it not earlier We and not we dropped was that which we specific utilize in with company one We does to don't sequence. yet run an process it decided the that response in is a at So clinical in have to step.

can one I to spoken that's has as our undertaken. significant conditions comes that I've method of before well of shortened we optimizations the and proprietary that really But various growth process. our have from things as So and shortening that speak

Boris Peaker

squeeze the CMC one in do as of BLA, things your discussion TIL could -- terms you're therapy the curious need in what want Great. well with of that approval? from as FDA as understand I to side wants for building are the them? some had Have approaching What to manufacturing to more. facility. I'm perspective? just the if you And the own your manufacturing Just see you on new

Maria Fardis

Absolutely. Sure.

not on CMC even in It's a through we than even the clinical more front dialogue -- cell therapy the dialogue. particularly FDA So continue course of having years. the with

we we file And regular we This around modification doing. aware with. dialogue the a is their submit agency ongoing. basis we to a well what agency is process as intend agency every on the as So very are documents we time and modification we to receive submit or that absolute in their of feedback. clarity with what of Both make terms

active very So much an still. dialogue

Boris Peaker

my very much Thank taking questions. Great. you for

Maria Fardis

Thank you, Boris.

Operator

you. Thank

from the question next Our Oppenheimer. or Breidenbach comment of line Mark comes from

Your open. is line

Mark Breidenbach

Hey being process good remind to just time Maria, the introduced down the the to for the Gen manufacturing, with general thanks in afternoon us and efficiencies bring what of sticking can theme manufacturing you taking maybe question. three are And when eventually days. X we see TIL? XX versus we neck do head with results Gen selected X versus patients updated PD-X see to and comparison X side-by-side Gen able be between Gen the treated will in cancer

Maria Fardis

Sure. Hi Mark. Thank you for the question.

we we our did X goal to was our for keep what product X Gen the similar profile. Gen consistent So initial fairly keep when optimization a done to were product. also our X and optimizing had goal profile was very Gen some with on We

our X, necessarily bit product changed we same our and exact keep we For the a direction didn't Gen profile. little

manufacturing not -- process. X. the a very not is XX-day get us process a to for to it's Gen So follow-on to allowing the process extensively We changed fairly

we patient really get the terms fairly head presentation defined. we presentation like about data that different look what haven't suppose when The data so, similarly cohorts. of and population In is thought to I neck, during would

decide So and people we present own can when them draw it, their I conclusions. and we present side-by-side can presume if to

Mark Breidenbach

Thank Okay. you.

Maria Fardis

Thank you, Mark.

Operator

line from question comment next the Stifel. Ben Our of from or comes Burnett

Your line open. is

Ben Burnett

efficacy setting. we that the the Also Moffitt efficacy that expect was your what to could standard from in and clear much would to and above ACR hoping mind the guess of in I from trying I treatment understand just good afternoon. over and from would care studies? Thanks patients be that guess care data your And maybe of speak standard signal from lung I very nivo you of for a

Maria Fardis

It's question. for complex you Thank Ben. to Hi answer. a the question

summarize and try to going I'm So it.

a that with level. typically a They're are cohort. is that are cancer subpopulations they population which BRAF, so in sort part lung X and indication, subpopulations. ROS say of their have others EGFR, frontline. a of actionable present an because Just It's treated different at mutation really biomarker-driven of TKI cell lot There's non-small probably big so there's me let high

rate Moffitt low Checkpoints of have anti-PD-X as the some and in see as The you patient And patient not would are they a second immediately and on could were progressed of well in very primary response refractory in that one quite these population done the line. that patients population is expect. course, there study.

So just good. investigators not response response There's setting, very line is literature what around expected and not because X% scenario. that that's that that's XX% are The maybe one good somewhere a at in believe anti-PD-X patient population. from they in best in is this second very nivo best-case

fact a expression patients respond patients are A level level well of XXX%. mutation in those shown the PD-LX that patients. that, not Those had having expected high. and an he have one PD-LX second some actionable subpopulation them is is their had Ben setting. really to fact do in Creelan were And in they had front-line responders of And of being ACR,

respond of line. they X% number second to for is to of And front such would have PD-Xs they in resort products. And other otherwise. third Standard or rate expected in a around receive well by X% response is options. of the They a around population care line, PD-anti-ICIs patient combinations in line, the that chemotherapy. DOR third-line taxol-based to and to have as PD-LX So might

necessarily of bucket cell patients don't in inhibitors. they third The these and responding patients PD-LX-low treated chemotherapy to plus chance of very because non-small are checkpoint have just a are immune patients, good with typically anti-PD-X

resort And as So at of to chemo so of chemotherapy, to options. receives are have a which they this maybe around line, and back plus chemo or third X% best bucket noted six, By of immunotherapy as frontline. to out rate months. DOR patients is around second I they again, seven anti-PD-X, typically response XX%

reach of cell will they chemotherapy, in reach point quickly. that when Does settings answer different So the they're patients non-small just all your question? in that fairly but about

Ben Burnett

I helpful. appreciate really That's that.

Maria Fardis

Ben. Thank you,

Ben Burnett

one That's question. great. could And follow-up ask I just if

regards program to the Just the with IL-X IOV-XXXX. analog

do to could first? different by programs. couple steps seek you mean, just to this? on has bring that, analog this programs I plan you Which I talk And guess the Iovance's are you the TIL developing what XXXX how TIL clinic? the leverage And a Just of to also about

Maria Fardis

Sure. Yes.

thought early would right we activity we now, are XXXX. we mode preclinical still an in be stage and IND-enabling So that around

program, a are too, plan to We we clinic. when development that, executing disclosed haven't completely we internally certainly get our but have into are we ready

be haven't – probably about We that disclose product very That's favorable that. look of development And more program that PD has But information a in. sort program XXXX landscape. disclosed and are product think would in our why license this PK, like. would IP about to has excited I of we what detail I better favorable the course time

Ben Burnett

Thanks very much. Excellent. Okay.

Maria Fardis

Thank you, Ben.

Operator

Thank you.

the Our comment JMP of comes from next line Benjamin from question or Securities. Reni

open. line Your is

Reni Benjamin

start Hi. from can question progress. think you even at about and with the curious the taking Moffitt if this, we up. significant. your you patient data I'm and market Are cancer Thanks to nivolumab. upon TIL non-small there for stage combination lung evaluating other Good move might that of this kind now KEYTRUDA checkpoints congratulations might the of in with afternoon. learnings with with on Maria combining population look make And end it checkpoints? when clearly it's but we And choice guys have touched versus the as

where will or curious, feel So how thinking the TIL you you fit about guys I'm of best? kind are

Maria Fardis

question. the for you Thank Sure.

what question We correct. is you're your versus presume started You're KEYTRUDA Is I that with Is that nivo. correct? why asking? KEYTRUDA.

Reni Benjamin

Correct. Yeah, yeah.

Maria Fardis

plus All frontline. And be At expected care the of a when putting right. the KEYTRUDA concept we in started Okay. we has. started or it together, to least standard we at chemotherapy the time, program

has is In fact, exactly that what happened.

sure a wanted what combining to care. we is of we standard that, are called make So,

TIL course, early-on for we Of replacing with the patient were chemotherapy population.

for TIL Cohort quite terms initial that, has recall very for high into I for about we in least strategy the unmet population, medical market nivolumab. at of think melanoma a one us. non-small Xa strategy and selected patient KEYTRUDA us strategies. two relapsed/refractory allows cohorts Cohort KEYTRUDA our reason cervical, was with single-arm level plus relapsed/refractory patients. late-line is out sort well cancer Xb very, post a large. that do for we placing can a selection has for think the to That And the that need The two cell registration. worked strategy allows So have have And alone to go of TIL one certainly been for allows The so TIL in at really of and

strategy to earlier in combination in late-line to with to go go broader would second and A be line not fact checkpoint.

cohorts of It going is the this potential allows having both we for that exploration approaches rationale have. So forward. two our

Reni Benjamin

just evaluate would kind Moffitt nivolumab as something thoughts based kind the on just any of this patients design looked combo? a straight versus And of at study, follow-up a there on that like this a to in And study basket data, in expanding versus regarding think Any is combination? progress who in I they even thoughts while nivolumab.

Maria Fardis

earlier what see Before whether or and next, thinking would see about benefit own not. plus of I concomitant certainly for TIL to sort want line and data would just a our KEYTRUDA to add administration

for will I it be and have that I speak I think data-driven. thank very of So understand is to that. think And amount me much question but to quite sufficient what data we you don't for your

Reni Benjamin

Thank you. Okay.

Operator

Thank you.

from Pantginis Joe of line the from comes comment or H.C. Wainwright. question next Our

line Your is open.

Joe Pantginis

Thanks. Maria. Hi,

my any know you say payers? first has strokes. get broad indication thus little Just be you of at of hoping this some or reach the with broad I what but flexible talks question bit of can structure? guess with ideas this want And nature can been pricing types far at a secondly, to be have point curious, the at Just of a take had I what you? Are you've to might some regard looking to might you get you potential thinking point? based strokes pricing, maybe what

Maria Fardis

you for great initial have question. had we with Thank Joe. dialogue Hi, Yes, payers.

they've product already on out is so therapy there market. what quite been slightly This the is in different cell open. a And far

The We hematologic in are are therapy market cell is the this malignancies. that first population. also really the are product for a patient And tumor. different products with solid dealing for

benefit So profile the is as clear initial dialogue educate the existing really differentiated a been patient to as to safety well the the to assure for payers, has that potential population.

this the been has see we where and quite melanoma you continued are position. median or the always that in And as terms In will the product. as continues pricing, with of own program value very I to the see haven't We're for part of we certainly ASCO encouraged of pricing down this. DOR nailed think our

about into positioning that has think the a itself product role by playing I itself. been the that of So thinking

of going we the terms to how still of position And of are product. then indication-specific indications. patient administer disclosed in position and We're we're we populations have certainly different TIL evaluating whether haven't the the we pricing evaluating a different and for sort should different sites

And so information to I think have we can probably update better the market provide. when we

open very talk been invited and and being them. the very product excited fact in have payers about been continue the us to dialogue to welcoming and to come we very But have the

discussion been the – far. a So so this payer it's start great has been to

Joe Pantginis

very helpful very Thank much. That’s actually. you

Maria Fardis

Thank you.

Operator

you. Thank

Geulah Our or comes question from line the next of Chardan. from comment Livshits

open. Your line is

Geulah Livshits

Gen Hi. follow of process Good that TIL taking is Thanks questions. the about afternoon. cohorts to up been have wanted some the for X selected about and the question I added. my

experience also So about there cancer elaborate thus based more far, in process setup is you path to more and think overall potentially? specifically Gen forward expanding bit think on of the different other you the a data. can terms manufacturing, you the the And in the about about How and how Gen facility? up manufacturing terms as X equipment and internal setting X types of the from

Maria Fardis

and expectancy Gen seems you, a to life. are excited as short potentially is first X quite Thank well. indications very chose these other sick with not great. indication are we life being able patients their That's like as head about and We Yes, It because neck offer long. our fairly Geulah. particularly

offer may So see, trying more and be if is we can shorter to potent. we something that were expectedly

So, our that intent TIL. X selected was Gen for and both

different, Gen the we're X Gen be same by as them using which events the perspective, using of using The for equipment may are for it's method equipment. but same X. From equipment order we're we

facility X go be in So, to a we commercial manufacturing for decide easily should reconfigured Gen can direction. that

Geulah Livshits

Great. Thanks.

Maria Fardis

you. Thank

Operator

Thank you.

Our the line next from Jefferies. question comes or Biren comment Amin from of

Biren Amin

for it relates Maria. data the planning the median to as Maybe you Thanks refractory question cohort ASCO more from oral questions. Are the primary one guys. data to PD-X present melanoma taking Hi on my DOR.?

these I and presented and population these last relapsed the PD-X if think you could what's in the enrolled about of population? XX patients maybe in patients data fall. you from OS contextualize typical cohort And versus terms this also median MPFs this

Maria Fardis

the know we primary if refractory don't necessarily thank Hi the I for breaking Sure. planning were question. you apart. on Biren,

a I that of lot that think for presentation. and ASCO a we we were had content probably we felt and content important -- didn't is really we necessarily think about subpopulation

other So, reason content excited any not of and all share we that. to of lot except a that we for were have

disclosed patient patients population. OS an Stage find months. really population. very pinpointing we have That's As patient best metastatic in we six a actually necessarily primary can not the that OS IV disease of haven't good It's population. patient the perspective, find information on. to I have From weren't easy PFS our median now, seen approximately for we seven in that refractory in of population literature a to patient reports an

Unfortunately, it don't they're that population. particularly far. a to is from ill to metastatic But that they six I OS of make IV a and expected benchmark is what very Stage months seven patient think great melanoma show

Biren Amin

more. one maybe And Okay.

on that the what thoughts filing you size As are BLA, the the to commercial you team look need? your would of

Maria Fardis

both what to footprint settings but we of to that sites as to that nail community to think well discussion and as -- internal terms have plans that how we how down that many share a how is really not have Sure. with it's certainly subsequent to ready we to broaden have internally and academic our plans have be. we our and as I'm and even for We've launch. you plans we broad quite outreach further been outreach going having settings today in

those are So, both of progress and in proceeding.

mentioned about commercial medical inside further them by presence commercial end. teams company year we have a of have that and excited course. affairs been expanding we expanding already the I We our and are very

Biren Amin

thoughts maybe in Europe? last your they Have Okay. terms of with And require? in the filing are one. would what the on discussions just What had EMA you then

Maria Fardis

Yes. Really well. good as topic

development aware a various and have Over we in number opened course of the of EU as countries you're in Canada. probably CTAs

as and part had have we initial also authority health CTA process So, we discussions. have had local discussion the of

XXXX of Health European procedures that centralized beginning discussion for EU the part for engagement Authority. we is planned are initiate of and with later body CHMP Our centralized to

Biren Amin

you. Thank great. Okay,

Maria Fardis

you. Thank

Operator

questions the conference Thank in you. no at back I'm additional this any time. over for queue remarks. showing like closing to the management turn to I'd

Maria Fardis

Thank Howard. you,

just We're I patients XXXX. make want that thank participating families progress our everyone for we excited think today about stay for and contribution to to very internal our and tuned. they and patient thank we in program

Operator

today's program. conference. the Ladies and concludes gentlemen, thank This in you for participating

disconnect. You Everyone Stay safe. wonderful may a now have day.

Iovance Biotherapeutics (IOVA) 5 May 202020 Q1 Earnings call transcript