IOVA - Earnings call transcript Q3 2021 | Iovance Biotherapeutics, Inc.

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Operator

Welcome to the Iovance Biotherapeutics Third Quarter and Year-to-Date 2021 Financial Results. My name is Andrew, and I’ll 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 today’s 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

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

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

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

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

Fred Vogt

progress our call. today’s conference Iovance I am Thank you, Sara, during good and pleased of to highlight everyone. year-to-date afternoon,

or our indications continued tumor-infiltrating into settings treatment TIL have new We throughout this year. advance platform to earlier and lymphocyte,

address submission. support lifileucel for product planned like BLA the feedback ongoing remains priority our melanoma, TIL work our lead assays lifileucel our For to top FDA our to regarding metastatic candidate potency

work XXXX. and in also during assays be for and half ongoing of engaged with for developing and of continued in anticipated is lung next for planned validating lifileucel XXXX. to current potency The submission have our We regulatory have half FDA an discussions lifileucel BLA second the remain the first cervical Resolution important our assays clinical the potency We and non-small for step of timelines. our programs. cell confident guidance continues

Turning have now that solid the a it’s to broad clinical treatment different showing with until treatment shift pipeline. TIL cancer. confidence our for We first to promise settings, from may therapy platform in types the paradigm data our of line late-stage four clinical tumor furthering patients

meaningfully three shareholder We continue that patients the value. to be creating excited potential have to impact initiatives about key while

increasing was First, presentation median response study showed follow-up. ASCO post show we lifileucel durability in following anti-PD-X at to months where and long-term demonstrated XXXX as reached not our melanoma treatment, of duration median XX onetime continues of

continue we in strategy for of the to build pembrolizumab, broaden Second, therapy to on earlier for access TIL more potential supports our TIL combination patients settings. to which treatment with the

upcoming SITC the Meeting. presenting and Annual at several about advanced data excited We’re cancers combination

approval designation this for As unmet the the and based afternoon’s need with granted lifileucel interactions the as as Track this potential Track frequent medical Fast for review for noted well of Fast combination allows melanoma on potential of care. in priority designation advantages with pemrolizumab FDA. more metastatic FDA over treatment press release, for available This in combination accelerated

in the data of top first to line time to second heavily overall significant whom unmet the quarter audience progressed data initial cancer the all in population in Finally, forward on rate cancer. prior a provided demonstrated have of the non-small a We therapy. initial in these patients, and SITC lung pretreated for This immune checkpoint meeting. response our cell look earlier non-small a need clinical cell during metastatic corporate inhibitor presenting lung announcement a XX.X% represents upcoming data physician

bringing On the are research we and supportive generation in therapies the side, next of products the clinic. TIL

product than which cancers and well is as a we and genetically quality to this that IOV-XXXX towards advancing XXX internal studies IL-X the of have Both inactivate as have XXXX progressing in to and pre-commercial in towards are full experience. critical our to confident with designated well PD-X, than updates mission. our our deliver leadership years cancer Chief Today, cell through beginning modified provide Officer, have leadership tumor are departments, our Igor team more In of IOV-XXXX. we treatment the execute Bilinsky. for respective solid continue the will organization of who and moving on analog, executive now to TIL manufacturing multiple as IND-enabling more our the summary, are of clinic. settings. Members therapy We senior development, IOV-XXXX needs I’m address as furthering novel average activities patients and with X.X we our all employees Operating commitment

Igor Bilinsky

cryopreserved success To yields clinical enrolled iCTC, an received Thank ceremony The treated. XX%. trials, sites Iovance TIL opening to iCTC, shipment facility. XXX,XXX TIL you, by Therapy therapies facility, clinical to more September. transformed with the to the I’m state-of-the-art LEED process. foot a from therapy manufacturing manufacturing square product the shorter a at continued patients iCTC has TIL where academic initiated Iovance or end investigational centralized Certified pleased followed Iovance is Fred. are Iovance of for Cell In at of the XXX Navy cell rate in single-center today for date, the process Gold manufacturing about patients new quarter our we manufacturing scalable than above Center, patients a back That third speak lengthy a Yard, manufacturing at have official Philadelphia. GMP

X is process Gen days. current XX Our

Iovance Iovance patients may manufacturing sooner. our We are position investigate to Gen TIL TIL improve or advance and process. ongoing our studies further to third-generation deliver also a through leadership even X clinical continuing to efficiencies XX-day Gen X TIL

days the manufacturing fastest in TIL that the is also at XX for We time. this industry believe

In to that commercial our populations compositions, developing believe and and pharmaceutical geographies. clinical patents from our more and on patents neck demand thousands highlight and manufacturing We IP and expansion portfolio Ziegler, advancing to would intellectual internal trials, cancer. applications for to of we we major now firmly therapies quarter, like our or to established patients and I iCTC. filed our in head therapies of up allowed to across patents cancer TIL TIL for addition creating other track pipeline, regulatory are enrolled globally to new on growing on patent call in preparations. patent position Support of methods our unmet TIL commercial supply key supply manufacturing manufacturing U.S. activities XX multiple the HPV capabilities have focused and and XXXX indications. robust need Today, capacity hand digest covering granted our in including than XXX and President, clinical cancers. property, been ultimate IP to portfolio. have than more meet past the treating patient and sharply international to TIL markets In two Vice cervical leadership Iovance launch HPV TIL have manufacturing with investigational – approval Jim? cancers, Iovance Commercial, and for the readiness we at tumor delivering pending repairs Commercial includes to commencing positive the with Iovance for with remains Senior Jim patients building

Jim Ziegler

our The and investigators, earlier Thanks, several developing be patients global for to Igor. and of opportunities urgency have this delivering patients commitment ribbon-cutting in key Throughout and innovating, cancer. our take is challenges bring this leaders, personally. stories obligation melanoma. meet including our fortunate At lifileucel we to we their opinion all we to at TIL the cell sense who Iovance, mission reinforce a event, with leader family This year, quarter understand have metastatic hear been to all to an the of members market. therapy

team commercial positive centricity patient with on and three focused areas lifileucel experience in Our operational remains of ensure to excellence. customer a

TIL cancer line build to partnership the service continue we U.S. capabilities. our First, leading to their enhance centers Iovance with

are engagement centers to the a goal appropriate lifileucel access partnership around to with and We ensure timely, upon with pleased these shared approval.

each ensures FDA execution BLA can of The aligned training at training to upon key treatment approval. and ensure administer the is onboarding and lifileucel our program that submission regimen treatment Our teams curriculum just-in-time customer-centric timing includes center planned onboarding also a cross-disciplinary to readiness. authorized training and

believe IovanceCares, coordinating throughout customer-centric of ordering engage development have to own is IovanceCares in care Second, value ensure our to the is platform, access the our the track timely and lifileucel. continues appreciate launch. to third, journey. on support unmet access the payers lifileucel patient payers and commercial, patient cell designed market need be to for Medicare team lifileucel. We appropriate of and clinical Medicaid and patients and planning And

across proprietary in feedback of identity throughout integrated the Iovance expected and reimbursement to at support these the is and the excellence lifileucel areas to integrated customer case the is patient to of managers includes provide process. incorporated our handle patients journey. HCPs for needs fully IovanceCares chain access managers three approval. design with operational The approach of also our and to IovanceCares case chain have our of timely system, patients approach The patients. dedicated sites have We patient-centric quality. ensure Demonstrating custody every management and will of upon step platform

efforts the commercial based well Friedrich clinical positioned internal organization highlight milestones lines. approach will upcoming and our scale gated readiness, With to I upon the the now to our to time is call to pass commercial presentations.

Friedrich Finckenstein

status pleased data I’m of the clinical well Jim. as upcoming highlight you, studies. ongoing updates to our four Thank clinical as

the on presentations the opportunity will TIL Since unmet focuses a high strategy upcoming to a well as as regarding cancer and make we populations touch call I with substantial meaningful upon webcast need conference development drug Our highlights. briefly impact. with for same, have

Previous response observed who line and primary in to than neck pembrolizumab about are multiple types. mentioned, to There’s TIL anti-PD-X need the melanoma and deepen of we is higher setting, a increase with inhibitors. Fred as are As results naïve checkpoint for head to rate immune checkpoint inhibitors rates earlier are overall that responses patients with patients. tumor in treatment immune cancer excited and responses significantly an combination complete presented in overall patients alone response more naïve demonstrated in frequently approach pembrolizumab resistance

for patients meeting IOV-COM-XXX. share cancer lung our ongoing who our data SITC cancer Moving in the will us be metastatic basket for TIL medical XB LN-XXX to study, to clinical cell therapy with Cohort non-small cell the enrolled in of lung non-small first program,

for survival. patients and checkpoint As increase there that rate XX response population Cohort unmet on enrolled a immune prior reminder, This pretreated was to which is have prolonged need therapy. XB heavily a progressed significant a inhibitor

SITC. in rate look an at see and forward reported to top very pleased providing response previously were announcement, we overall we XX.X%, our additional As to line corporate of details

studies. clinical ongoing our to Turning

in active and TIL as TIL our have continues cohort we study TIL of studies in than In cancer, TIL continue clinical of cell non-small IOV-LUN-XXX to lung cancer, sites in to Recruitment TIL and Iovance cell basket not patients the plus advanced or and anti-PD-X in C-XXX-XX in melanoma cohorts. lung have study relapsed/refractory We previously in enrollment therapy IOV-COM-XXX systemic and receive clinical plus our completed head treated with a has cervical with in cancer. cancer four Canada; Iovance second-line access Iovance neck lung combinations which study pembrolizumab. checkpoint with non-small recruit U.S. our combinations, the immune inhibitor we more follows: in XX and

I is third in our financial IOV-CLL-XX CLL, We over which quarter now patients, actively hand XXXX to will also the discuss Jean-Marc enrolling are indication. our study our first call results. hematologic in to SLL

Jean-Marc Bellemin

you, quarter XXXX. year-to-date for reflect third will the financial the results Friedrich. comments My and Thank high-level

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

XXXX, of equivalents, million million on compared in December to Iovance September cash As XX, and XX, held cash cash, $XXX.X XXXX. restricted $XXX investments

well position advance is cash XXXX dilutive plan, sufficient commercial to preparation strong be capital. need immediate with no operating development, our Our including into and expected pipeline launch manufacturing readiness raise to to

income Moving statement. on the to

and $XX.X million expenses was $XXX.X third September million with million $XX.X of for for million the XXXX of per nine increase period same for team XX, for compared in September September XXXX. XXXX, ended the period increase were and million per XXXX, associated net $XXX.X was XXXX. period period prior million in over increasing $XXX.X $XX.X prior per internal compared same an and XXXX, of per and to research XXXX increase costs quarter or increase quarter to the XX, XX, Net team of ended or XXXX. over expenses the development $XX.X of Research for an the iCTC of share ended September growth the $X.XX development in a third year to quarter September cost $X.XX The the development facility-related third months increase million loss loss share for The September ended for of growth expenses net to research million the development trial to and $X.XX XX, the a primarily in compared facility-related net ended share ended ended XX, million increase expenses share development compared ended attributable $XX.X nine the million and costs. third research XXXX, XX, XX, year attributable months an were loss XX, and nine first September or months September $XXX.X $X.XX loss quarter the for research in Research of in the quarter and development clinical $XX.X Our costs. iCTC XXXX. was to internal was an third the and primarily the

ended the $XX.X XX, nine million Following the of initial an XXXX million increase compensation $XX.X of for quarter months the same our million $XX.X for $XX.X general expenses. team of third to expenses growth completion for for primarily administrative we prior compared the to constructing and have to ended quarter XXXX, The compared XX, the September were September million of were administrative $XX nine internal General attributable XXXX, quarter iCTC, increase and increase XXXX. XX, expenses million September first general the and the the an XXXX. to XX, September investment periods were third expenses and and higher of concluded administrative compared period in administrative the in ended facility. $X ended General months million in $XX.X year and million third stock-based

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

and to four our the across the areas, efficiencies outlined able to currently iCTC, at I investment spending we to of by launch priorities. This in readiness, We our value pipeline, and clinical contract managing corporate back I cash done confident as our continue investment to to shift provide the the these will our through the focus position that creation. key Q&A manufacturing align as cost and advancement which of on continue now remain growth previously, ensure call to focused new trends strong are a expansion we with work kick manufacturers iCTC. stay our priorities, to operator being will hand will off session. and

Operator

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

Mara Goldstein

taking for much very Thanks question. the

about the with So I to respect to back FDA, up But that with release I can and a for little say reference there’s question that go second makes very press able still to the to will come discussion just that it. being a the you solution satisfy the wanted of agency.

The level were with new And the us in maybe you with of to I’m and share had development discussion track can terms pursuing them? been the that you hand on you and if some that where already in plan process present original agencies. also assays a for those assays the are would so wondering you had

So can maybe we’re us anniversarying of you maybe because through kind where about things this, are just at? exactly walk

Fred Vogt

Sure, the Mara. June, in plan still discussed plan. as That the and we back was that’s

FDA the when communication now, we’re – right just the half with in having this we’re discussions. regulatory in middle We’re those

Mara Goldstein

mean characterize say, didn’t still that is was I the back it and to to with in Sorry, you’re agency? I the to interrupt. forth going fair

Fred Vogt

time is but yes, point. of this anticipated it with kind of with that could line you discussion BLA half first would as describe filing I And level mean, we’re FDA the at kind still again, having – Yes, the them. we call in engagement, in

Mara Goldstein

curious now, is would about of you that spent? – you otherwise is know I’m able commercial to waiting relative discussion activities being Okay. are a the And you capital and the to I that advance the not being I’m ahead just submit as appreciate are around deployed I have ahead company raised in perspective. from being of the capital where to undertaking launching and while how much of able company But speaking

Fred Vogt

run have and Well, we’re continuing would as to development we normally it. spent program our research

the all progressing. clinical have assets we still So

in We’re this just parallel. running

I time, TIL So at same I intended. forward something moving as the platform now. we a continuing we’re TIL And think basically on with would wouldn’t development characterize on platform assay it of is we’re that item say the FDA the potency which across way. right the the that we gating working situation, is

Mara Goldstein

and let questions. appreciate. Okay. I’ll pause ask I others really

Fred Vogt

Thank you, Mara.

Operator

Jefferies. Thank our question Michael you. with And from the of next comes line Yee

Michael Yee

question for? us if filing have you a good you announcement, question sense official Thanks minutes? would would is, are and to very happen this of Do give going is, the what waiting waiting off and measured? then media minutes? And you question Is you file? need assay? guidance then what just My you what you appreciate tell to sign it you’re is happen reiterate you feel two today, actually can press that you. would it the one. sense guess feel an about fact that’s the that that, Thank of what that after I on for the Can perhaps question. and be actually to us release, a Is good meeting specifically just

Fred Vogt

Sure. Well, take Thanks, me Michael. them let reverse in order.

update would with can market our as to situation would potency and we very to course. assays, try We as think soon of we do FDA press the we release, that. I we responses example, that – FDA release could material on out basis informations available we the would clear that to a are On the press from the for when about of, – much the like us, put

the detailed XXXX. course, – here, We and process that FDA, might things in sort there things minutes. we it’s thing. Turning early XXXX are the it from six-month nevertheless, are of the of blow-by-blow a sort continuing we over to TIL to as beyond never yes, that, could engagement long responses But we’re out. very like there this into of sort in FDA go said in of with that have a and your the stuff first question, the Yes, it’s

particularly anything on us We’re when the now. waiting we We’ll the available have can that right we at time. not disclosures to update on based

Michael Yee

you. Thank

Operator

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

Unidentified Analyst

I’m FDA Thanks we before, been and Matt order Hey, a just of think It’s something on has for been that’s Is in the out randomized initial ruled to assay question you Apologies here for trial asking if for potency that support on Mark. or the but approval? trying out completely pass. Have the guys. this of to question. worst-case that scenarios view? is Thanks. your in discussed asked

Fred Vogt

Thanks. Yes.

we FDA FDA at asking While end. not for what that. want the might truly can is never say Right now,

way X entire interaction been able this is on that FDA we’ve the basis Cohort we pivotal use data be we’ve So with to treating study the generated. already that would the

Unidentified Analyst

Thanks.

Operator

Truist comes next the And you. Thank our Asthika from of line question Securities. Goonewardene with

Unidentified Analyst

This a FDA case has guidance to do development suggestions? their in what proposed their from of the compared Hi. does on how FDA couple any you of that had Bill have some assays, accepted heard We just favorably comments we’re or components questions. potency for you what has to TIL company given another as the wondering if you that were We from any viewed have any is guidance? Asthika. and And assays in

Fred Vogt

therapy with this. from we’ve things, with are think FDA don’t I by detail is how developed potency our action about much, been tell question there’s a there’s of the really believe other we’ve more consistent that technology, between this the on with meeting of assay time Yes, Yes. of them that FDA of not of mechanism definitely assay of long been doing development, the these lightweight two. a what the have about FDA. the most crossover an But think of competitor technology really a pre-IND we supposed anyway. We’ve a Good got then are you pre-IND you does and for what answer engaged to lot We and things IND. meeting, therapy. that TIL terms comments At in recent question. much a sponsors some does stage and regarding

Unidentified Analyst

X% recruited I able above PD-LX enrollment And Thanks. LUN-XXX expression level, Great. the you guess you so XX% rate of contrast be study. in the to one and cohorts? Would just X% have patients number and the so far to on both two on based more below

Fred Vogt

want you do to answer one? Friedrich, that

Friedrich Finckenstein

of commenting is would distribution Remember, prior Friedrich. Cohort which cohorts the time for two of be these patients. the think of or X. patients distribution one-third assume population, to the chemo for on X is This Yes, enrollment available study think immunotherapy can failed at in about expect different PD-LX the who I going we at this that that again, the is care don’t two Sure. in the this thanks comment number across you be and since one number don’t the similar have on distribution combination designed I status patients is question. enroll time. I line exact to and that two-third. the of Cohort the the would cohorts, reflective But would we’re enrolled

Unidentified Analyst

Thanks.

Operator

our And next line comes Kumar you. from the Sachs. of Madhu with question Goldman Thank

Madhu Kumar

our taking question. for thanks Yes,

as the potency? potency of your kind kind cell of kind is kind regulators metric really of to process of sorting out just extent negotiation of So of a of hypotheses like as kind situation, think compared what this take views kind a we of assays out their about real what sorting relevant to assay are kind potency of what really testing TIL and versus of is on

Fred Vogt

we’ve accurately guidance details guys these a know, FDA this, lot developed includes how action in TIL up components, that therapy. specifically of guidance both about Madhu. and TILs of It’s on of how XXXX think of and has wrapped a you that work, of potency those in the of of discussion can how issued and they we potency sort assays and then mechanism reflect it assays the the that is assess, think I discussions. as

we’ve and advanced pretty the at about data we these got can we’ve methods, talk with are got state, and in we’ve that a things FDA. got sense We

a of part So discussion well. the lot as that’s of

Madhu Kumar

and do much would you March resolution how of potency then guidance? this feel time before Like could half would you push the would in which that actually it’s you the bond assay year And to potentially next you like first BLA think guys haven’t try get from confident you be first XXXX of XXXX? back Okay. maintaining if kind lead the resolution, timing need to reached of of what’s half

Fred Vogt

don’t We know exactly.

because We and BLA. the initially slip, are the doing can not us potency some engage the at that of year. I to things worry enabling we’re for of At assay obviously, on with prepare right that now lot are everything able not of sort We do about, half a to at least file once. a in it’s BLA things would something next point, FDA two but the could

Madhu Kumar

Okay, Thank you. great.

Operator

Thank with next comes line the from you. And our question Baird. of Colleen Kusy

Colleen Kusy

Great. questions. Thanks taking so much my for

point is really this fair potency when assay So novel the what third that lead assume more might And you’re discussing the the get at is? that on it more is that FDA? we information to with

Fred Vogt

when Colleen, Yes. yet, technologies haven’t most lead at or we point. developed. potency can’t assay obviously, set of the we we’ve talk about the I assays, say detail recent the disclosed that talk what often we assay about really although, this is the

in already I discussions that technology making. we we that alone these disclose or know assay in is when to don’t FDA’s Remember that technology We’re are we’re think all combination confidence questions proprietary. answer with right perhaps the something – it. with other itself is is FDA the and new can assessments the

so that more aware put to are we then be disclose certainly, So to how of won’t sometime disclose it. there I want mid-future. we it And we can immediately, the would it hope we near to works. able out that it in

Colleen Kusy

then frontline what Thanks. will in more types And on at tumor SITC, presentation combo? one pembro be quick one Great. upcoming that included the just

Fred Vogt

We yet. The that haven’t right under were abstracts embargo disclosed now.

should – able the November be that. will more available morning. come that be about on see to out, X you’ll that abstracts When the in So

Colleen Kusy

Great. Thank you.

Operator

comes Burnett from our And question Ben of the next Stifel. Thank you. line with

Kailie Briza

any one when I might Kailie for Hi is about the our for any Burnett. if TIL on it’s give just the were Gen details we X this process Briza, manufacturing Ben quick taking We us data Thank questions. been Thanks exploring? had of wondering could for or any just one. using you some you. indications see that for guidance

Fred Vogt

can’t on at say looking but tuned as anything that. stay about we’re we can. I something as that, soon now, That’s Right

We we in are have out that trying get interested meaningful to when data report. to something

Kailie Briza

Thank Okay. you so much.

Operator

our question the Thank Please Nick of button. you. Wells your And from with line Abbott Pardon check next Nick. me, Fargo. mute comes

Nick Abbott

about Cohort clinical with and you. assessment called BLA? data patient takes the review? ongoing that. And – that ensure of data to and how three thank inclusion given read patients stand about through for Can you of collection does talk will Sorry it Yes, last hear melanoma of the central X, to for under for data specifically be to clean timing in the contemporary relate clinical resolution this issue, potency often months that we

Fred Vogt

think Nick, you’re Cohort Yes. referring right? I X, to

Nick Abbott

Yes, apologies. melanoma The cohort. sorry. Oh, BLA

Fred Vogt

answer you could that Friedrich, one please?

Friedrich Finckenstein

you Can repeat I completely unheard the question. that?

Nick Abbott

Yes, sure.

of for the be three And collection melanoma last and of clinical read takes relate will potency often given And of in ongoing timing assessment, data patients review? it’s So through to that in how X. called efficacy data to ensure clean months data inclusion to the for does a hear about scan central resolution we it contemporary BLA? patient assessment the specifically, Cohort in

Friedrich Finckenstein

Thanks. Yes. Understood. Yes.

closer endpoint We single into This cut. an preparing oftentimes getting do a rate to in not arm this for going overall patients specifically little is overall data for where So you’re is an survival response trial trial. assessment. a of a you as survival would call cut workings inner call the the an data bit not

still that to are up what to are then database a to the you data time two included about that in the the call assessment a be data analysis. we allow sufficient date it longer months’ you CT the schedule everything in can to data is be date what ongoing would be We choose cutoff continuing and clean we’re scans. And patients then depending that that date would for defining cutoff the lock. cutoff can assess on think And predefined that to data mentioned shorter, usually allow for you need. that prior frame three you time to And you that

calling appropriate, in be for not can predefined that because your content. their assessment, that in would an So agreed what probably for than Does asking patients be done more scans answer they it additional question? and would specifically be without to frequently which

Nick Abbott

then in versus then you cutoff are the does. – the I is issue. timing where potency that, the the question guess of potency date resolution And Yes, it issue of defining

to has Something the you be rate I don’t to limiting. rate guess want data limiting. clinical be

Fred Vogt

although in extent, – work because our sort can as parallel hand. set. discussed doing in get of issue the process, back I assay to and analysis we IRC lot suppose resolving be potency then calls, of at and while end go could then Yes, they the that we’re on the revisit full the we run of we’ve information the some a

Nick Abbott

Thank you. Great. Okay.

Operator

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

Peter Lawson

taking Great. my questions. Thanks for

Just on potency the assay.

essentially many of you potency protection assays do have around how that think – Just then – have users? need? and think I those guess you other you do preclude great you how you what could many – could And patent do

Fred Vogt

question, Good Peter. Yes.

have are of you we’ve as multiple of and set don’t there I a to It’s or final them complicated our assay rather lot. assays many that because showing assays the on a we’re have really shown know, actual environment. most now. on we’re number But We an FDA third right variations. them, so

entry Others much I we like have out you them, IP provide of may for know newer been might a that generic more do assays them barriers that create the Some as to think that protection, which for there some valuable. if while with associated ones, others, are mean. is not have what

Peter Lawson

Got you’ve about sets you. of X, X? Step all in you them X? as X of did then kind and had X And this How of of talked come back work? and they’ve Step three go you Step then X Step assays, to to reject that Step from is kind Step refinement with Or to

Fred Vogt

Yes. treat I them as wouldn’t refinement.

ones mechanism technologies the no right talking looking how we’re focused is were be potency about assay. that that works, earlier reflected completely were new and are how in on new question – them Some approaches, TILs with of the now TIL most of of just really action of the ways or what at we one can new

– that’s new sort that. at all variations I you’re of is really really of we’re some doing but be like the fundamentally no. earlier assays when treat doing the as stuff each other, misalignment that more viewed something might of the So wouldn’t are of There the

Peter Lawson

FDA kind accelerated it or progress step of you of is of of you And the be each you. Got recently? any of has would sense with getting closer feel Or kind kind great? speed

Fred Vogt

here. towards feel up first we making soon fairly coming enough we’re So of like half can is XXXX and good it’s guide that to the filing, continue we progress, BLA which

So as with now we we’re work with we’re right today, guidance. by – That’s stand and comfortable where done, are working. FDA. to things we’re be There’s still that standing

Peter Lawson

so much. Great. the details. Thanks for Thanks

Operator

questions. further no showing I’m And you. Thank

back call closing over the with I’ll that, remarks. to turn Fred for So any

Fred Vogt

quarter follow for support. Please employees feel patients, financial again you Biotherapeutics up. to wish the call. results investors, analysts, to Thanks, to collaborators like for third our our team, and out reach their free conference you, I’d Thank joining to if thank Relations everyone. Iovance Investor XXXX

Operator

This meeting. concludes disconnect. participating, may and you you now Thank for today’s

Iovance Biotherapeutics (IOVA) 5 Nov 212021 Q3 Earnings call transcript