Iovance Biotherapeutics (IOVA) 6 May 222022 Q1 Earnings call transcript

Company Profile

Participants

Sara Pellegrino	Vice President, Investor and Public Relations
Dr. Fred Vogt	Interim President and Chief Executive Officer
Dr. Igor Bilinsky	Chief Operating Officer
Jim Ziegler	Senior Vice President, Commercial
Dr. Friedrich Finckenstein	Chief Medical Officer
Dr. Madan Jagasia	Senior Vice President, Medical Affairs
Jean-Marc Bellemin	Chief Financial Officer
Dr. Raj Puri	Executive Vice President, Regulatory Strategy and Translational Medicine
Madhu Kumar	Goldman Sachs
Peter Lawson	Barclays
Colleen Kusy	Baird
Tyler Van Buren	Cowen
Mark Breidenbach	Oppenheimer
Ben Burnett	Stifel
Reni Benjamin	JMP Securities

Call transcript

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Operator

Welcome to the Iovance Biotherapeutics First Quarter 2022 Financial Results. My name is Andrew, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] Please note that this conference is being recorded. conference recorded. this that note is being Please I Pellegrino, Relations Vice turn the at to Sara call over President, will now Iovance. Investor and Public Sara, may begin. you

Sara Pellegrino

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

and Affairs; we on Executive Madan our our XXXX, Jim at Medicine Jean-Marc This Chief Executive Friedrich Dr. Vice Chief Igor and updates. iovance.com, Ziegler, have as Speaking financial Senior Dr. results President, which that our XX, can call, three Dr. President, Regulatory Vogt, participate corporate release Senior question-and-answer President, President Puri, press also Strategy to the Officer; includes ended Operating our Chief Raj session. the our Chief in be Dr. Finckenstein, Vice our Medical a the on Jagasia, the March Translational call well for Financial Fred Vice found Bilinsky, our website on Officer; our months recent and issued Interim Officer; Medical Bellemin, we Dr. as afternoon, today's Commercial; Officer. is on

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

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

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

Dr. Fred Vogt

Iovance good afternoon, today's to I during the you, conference at year highlight our Sara, pleased call. positive start to Thank am and everyone.

our our we moving therapy, priority at towards metastatic for lead is This First Iovance. our top first-ever submission and foremost, melanoma. rapidly TIL and BLA are lifileucel

we assays month, FDA for the regarding received positive feedback last our we potency matrix assay and As announced from lifileucel.

a hold meeting August and XXXX. the For submit next BLA July XXXX pre-BLA in to we steps, in intend

In offer significant addition, in about may to tumor we non-small cervical so TIL patients we continue discussions the registrational need cell our types. therapy strategies lung in that these with cancer FDA unmet cancer additional and with

As we we Therapy launch prepare at in the internal lifileucel, Cell capabilities our also are readiness to Center, progress Philadelphia. in making or manufacturing commercial iCTC, Iovance and

have innovating, our therapies. Our organization within nearly Iovance organization is our XXX of growing growing years The field. to now average the cell experience. our talent within therapy of TIL potential is the global on and therapy leadership the about momentum TIL who four We further our excited to developing a delivering employees have We're mission testament for pipeline. TIL our within Company the and at of

enroll We trial clinical TIL The patients an plan trials Iovance-sponsored allowed clinical additional our gene-edited continue across a four IND this year. therapy, trials FDA proceed for to and to inactivated, two IOV-XXXX. to PD-X of initiate has

melanoma, frontline a to in checkpoint to compared potential combination immune inhibitors. outcomes improve clinical demonstrated to plan alone where patient Phase III pembrolizumab TIL of patients with conduct in also trial We naive are in data who pembrolizumab the with

our key we TIL people for a strong believe As therapy set to solid prepare the of therapy to cell therapies to paradigm-shifting people with platform, and Iovance and Manufacturing demand cancer. for class in one-time clinical new next is launch as we therapy our the first tumors, success. data cell that foundation managing TIL establish

ask So about Igor more talk areas. I'll our progress in to these

Dr. Igor Bilinsky

Society TIL Year commercial the for iCTC, iCTC, needs patients and rate the thousands patients with activities operational award XXX,XXX for a main which of for of therapy. a have manufacturing initial the the TIL I square cell than reflection and Today, facility. Recently, Center, we to BLA than foot the remains key At network, TIL accomplished XXX by Thank focus was preparation or summarize remarkable priority you, this to is since of International capacity treated provide Facility only We Pharmaceutical have year. to per Fred. commercial category and years success maintaining Iovance what Iovance iCTC our Across XXXX manufacturing more designed iCTC, XX% honored our of continue groundbreaking with launch. facility we the the Therapy for more will Engineering patient of of clinical Iovance manufacturing ago. in the three excellence, supply on therapy Cell

demand handle capacity and expect manage manufacturing to added address We contract optimally the with to iCTC at most demand. commercial to of flexibility patient launch use our

activities performing which clinical at numerous are in support BLA with the We iCTC parallel began submission to year. at last iCTC manufacturing,

occur our In and iCTC addition, track as review process. the we of we are manufacturer which approval inspections, preparing on contract to BLA, the for in part expect for BLA FDA facility

upon co-culture development potential will and group, activities matrix, to new addition iCTC. our strong potency team two have manufacturing, testing we been approval. Group, BLA-related two In at including control, for a products, needed collaboration or release QC commercial lifileucel team of of In testing assay. assay has include completing which quality QC The assays release performs potency our with QC our established our analytical

Property, to Intellectual or IP. Turning our

the proprietary robust know-how than U.S. more our allowed support to compositions patents. to highlight our processes granted to you, XX that Gen build and X therapy. covers now TIL methods manufacturing This currently of Jim and treatment as rights cancers, TIL like are to Over growing surrounding a to our own international and IP or well portfolio Ziegler to manufacturing in call commercial launch as We IP continue I our and of We into broad to hand would preparations. range expected Jim. XXXX. provide exclusivity including patent

Jim Ziegler

Thank Igor. you,

built has scale submission foundation commercialization. team and rapidly from BLA and into cross-functional to efficiently Our the launch

readiness capabilities, service We ATCs, and training are we training centers, activities launch. at TIL aim the to and cancer and partnering are also for milestones onboarding BLA-related with XX our The centers key or least line at ATCs. their the to aligned ensure with to leading have authorized treatment U.S. just-in-time develop

team federal payers released access Medicaid patients this fiscal as rules CMS commercial, of upon annual year ensure for the to Our rule, Medicare payment, as such the have hospitals CMS and XXXX payment, technology April. continues their more rule, in were market lifileucel. approval. have in the draft CMS, access In the continued Centers other will and the and appropriate expanded making Services, to XXXX immunotherapies, new In This CMS in-patient to beneficiaries state proposed NTAP lifileucel. proposes or year and also the IPPS, engage payment timely and or prospective part applications, including for XX rule for means fiscal DRG that appropriate which cycle, summarizes including lifileucel. policies finalized add-on CAR-Ts lifileucel process Medicare or

application fiscal the and to With has cycle. other positive the stakeholders We the cell with CMS Medicare NTAP key we to class we for improving taken next emerging working access look to anticipated our therapies. appreciate steps patient of BLA submit cell in plan therapies, forward and to timelines, CMS the to access ensure

developing their providers program and step access, supporting In addition to TIL are through of to also assist patients every care our IovanceCares health proprietary journey. we

the chain progress. custody Officer, chain best-in-class to Chief of Our call patient launch. Friedrich ordering, our identity, clinical support goal and Medical to our is cell to of highlight deliver now for I program a Finckenstein, pass will

Dr. Friedrich Finckenstein

Today, like updates Jim. share TIL recent Thank would programs. you, clinical I our to for

indications. We great tumor have to new incorporate to in evolving TIL and technologies our made patients therapies platform and types address strides cancer and technology additional more

IND-enabling of concept proof innovation. of our for as clinical our The important combination trials tumors TIL solid pembrolizumab to commitment with in to platform and are with prime IOV-XXXX, work multiple proceed as expansion two well in to examples

this providing partial data frontline to above key and from teams rate the this pembrolizumab updates for clinical announced trial in pembrolizumab the and XA and forward internal TIL for initial melanoma. X are the responses year In design available. response XXXX release, or on after patients in objective to with rate combination updated a clinical therapy, XX%. April opportunity checkpoint Based Phase and responses. promising for our checkpoint for as Cohort pembrolizumab trial. therapy working inhibitor for combination III and the patients inhibitor naive data leaders checkpoint response expand look our benefit press rates to response, TIL inhibitor we XX an Our patients this possible lifileucel Overall, a a we five the for including to immune are with was in therapy. currently We offer monotherapy opinion complete at lifileucel combination end of of with from finalize confirmed strategy published IOV-COM-XXX out complete overall three to who expect patients, trial. naive In melanoma to in response upon melanoma more had begin

TIL advancing addition, our candidate, the therapy IOV-XXXX, modified In into are clinic. we genetically first

was the to inactivated a therapy first for previously technology cell Cellectis. a licensed IOV-XXXX FDA IOV-XXXX poster antitumor recently antibody. alone of American the in melanoma, with the superior Association were anti-PD-X Meeting, Cancer product, Annual Research is that treated advanced PD-X During results the cancer. at from of non-small Preclinical quarter, IOV-XXXX or whether non-edited or In melanoma the or IOV-XXXX for presented in proceed incorporates activity lung metastatic combination model gene TIL Murine editing for IND our the TALEN to allowed for TIL an AACR.

within potential a a to year. starting deliver therapy the We are for study inhibition single about and look IOV-XXXX excited first-in-human to PD-X TIL with and later this forward IOV-XXXX

timing trial treating protocol also of lung our cancer. We're the lung discuss. cancer to IOV-LUN-XXX of practices the to therapy unmet second-line inform our efforts, We the a education in non-small around harvest at patient cancer. provides on call to cell patients amended may and population, elaborate the tumors. I TIL practice well Turning trial flexibility cell strategy will This To for around recently real-world need for infusion, amended to in outreach prior XX which sites. patients as to cell across non-small the hand solid lung enrolling non-small Madan new as reflection the currently and protocol medical tumor broaden

Dr. Madan Jagasia

Thank you, Friedrich.

relationships has experience opinion medicine with Our team our leaders. of oncology long-standing a of affairs many key depth with in

include HCPs. to interacted the Among and medical are HCPs, or therapy surgeons. centers conferences. medical has two care small or these TIL been XX% XX% providers, group health dedicated engaging individual approximately remaining and years, at team meetings hematology/oncology, are interactions XX% the the specialists has Iovance our active and team These Over In exchange scientific in cell are past therapy. total, XXX during with of our physicians affairs

at affairs a publication execution Iovance. medical scientific communication Our strategy and team and also leads

oncology the is clinical that drive awareness, in four scientific communities. our therapy voice represented top patient goal and Cohort so participate publish tumor present of and XXX to one The venues and we manuscript, to and trials, engage AACR, meetings, types. and recruitment and for In with was therapy physicians centers included can share cell the increased patients melanoma XXXX clinical X medical alone, data attract across data trial in which Iovance TIL clinical Our SITC, Oncology. ASCO Clinical within data our major of Journal presentations increased three

hand and In XXXX of these centers, first cancer XX% over Member interacted will to The at addition, affairs Network. activities of centers our Jean-Marc quarter medical cross-functionally to are academic now National I as call our Cancer Institutions financial onboarding treatment the XXX we the community are has the Center facilitate networks. large results. designated a remaining than National for with Among more Iovance authorized centers to and/or Cancer team Institute Comprehensive work discuss mix XX% the centers.

Jean-Marc Bellemin

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

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

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

million. from included development including position that and expansion, operating We payments usage annual pipeline operations guidance launch prior plan cash our advance sufficient is certain into commercial preparation. XXXX, and to cash $XX our totaling Our readiness maintained manufacturing

statement. income the to Moving

was pipeline increase ended $XX.X expenses increase the March prior $XX.X to first period ended XX, of in were of growth of loss $X.XX and expenses for headquarter an XXXX, ended was XXXX, support The activities expense, XX, to General internal the prior per compared first March and property first of increase compared March XXXX. or million to $X.X including expense quarter Our compensation primarily XX, The and period for stock-based quarter technology per and XX, XXXX. and as and million year $XX.X million as information million compared $X.XX attributable March to This March expenses to the general increase as well a increased and corporate March was million infrastructure as net marketing, of in team, attributable the office the growth. to research facility-related quarter development primarily an the growth for share. $XX.X stock-based million our an $XX.X $XX.X the planned the the for readiness year intellectual of net including to and and build-out internal administrative costs. legal overall ended support were first the team, the expenses our ongoing million quarter or the and ended expenses pre-commercialization, to XXXX, new $XX.X XXXX. over quarter first research for increase XX, Research for compensation general development share compared administrative well quarter our administrative ended launch in XX, first million loss development the

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

of the off call we our the and well the to our managing by across and spending to readiness align will our our priorities. continuing to corporate back pipeline, operator now balance hand investments the strength execute Q&A plan positioned kick our with the while to are I session. internal launch sheet focused With manufacturing, operating

Operator

line And with Sachs. from Instructions] first our the [Operator question comes Madhu of Kumar Goldman

Madhu Kumar

calendar. BLA kind at first our a about one data the and meeting Cohort we guess cadence vis-a-vis is, submission? of X in pre-BLA the How release the August topline of of terms looking I events July of again, one this should think the simple

Dr. Fred Vogt

about part and be can't time. complete that. guidances BLA of We part that to effectively, to process, give process. same get and it's talk to we're trying the we're really that more as going of trying process Cohort more at in, the of any Madhu, BLA But X filing the to the

as we're should any So it as in cadence. as able It come go. think to about really, I wouldn't soon particular

Madhu Kumar

for regulatory need of non-small kind you do as cohorts? TIL what mentioned discuss plan Okay. cervical to you indications, effective whom a cohort? unmet monotherapy And then interactions where on cell of cancer, could how see PD-X registrational of making -- as population both have and you a should we plus have to sense you kind line TIL either therapy the blockade registrational for makes or In

Dr. Fred Vogt

Well, medical occasions, have both need there's post population significant unmet the of today. checkpoint the you available where

general more answer our short we hopefully, and So here, much And question. normally of development. we running can getting that's the strategy sort got lines talk approach. more about trade as with each your and points, details but regulatory look the There's studies you course, together in And then, the our plans after study. obviously about of to as well to do frontline at finer input this, can oncology of of pembrolizumab talk earlier and combination we've therapy, out that's in sorting

Madhu Kumar

sense? in about PD-X as of like where PD-X combination of of efficacy -- terms was Okay. one the plus I the One population which of kind Where last you think TIL TILs from as sense? epitope And kind avenues, product make compared to versus -- got PD-X the TIL would raises I one. guess would a PD-X question TIL do knockout more maybe kind monoclonal initial make they is knockout of How scientific/philosophical how question, antibody spread? TILs more therapeutic much

Dr. Fred Vogt

that a talk efficacy Friedrich little part if and believe the PD-LX there's and well, number we Well, may in a for as within today, for we we as efficacious here. of jump untested as down And antibody. go TIL Madan lead knocking more of opposed to then but needed. more giving first PD-X, question, let knocking to can of gene It's a patient of the a me as your take a about the do down and reasons more There's the blockade. gene this, number advantages MOA cell to T the efficacious a can

you knockout having antibody, less can penetration argument, into and in toxicity being that For But the tumor could to a the an side from off separately, antibody argue as a an versus target TILs on stroma delivered. the systemically you TIL example, better efficacy effects of side a that's the opposed layers -- argument. microenvironment

on On Rosenberg's Steve period in that efficacy of occur the on the after idea this, believed TIL lot comes published administration. TIL the efficacy the question a where of -- the has and it's from, Lab therapies early generally

we -- responses Although obviously, we see clinical some from see after later a time. originate perspective, that can

or TIL from generally You can rapidly you to anything kind imaging years Rosenberg's signs in SP studies show that that? thing, ago the add to back but of want the tumor now and convert have then to tumor Madan process. PR lungs and the and show Friedrich, clearance then of early trafficking do XX-plus

Dr. Madan Jagasia

This Yes. is Madan.

comment, of immune TCR said, persisting the persistence, that have knock hypothetically and right, get But the even Again, non-genetically-edited in I the these the the of are getting in to these repeated to the genetically-edited out surveillance potential exhausted be to stimulation. think Just the hypotheses. TCR, untested, that much clonotypes superior more as with you all clinic Fred a PD-X, the post-TIL TILs have. TIL, it's TILs current infusion antigenic capability we test into we have may to once

Dr. Friedrich Finckenstein

the we're clinical As probably get saw, Madhu, net. to you about into

So that's that's something imminent.

posting clinicaltrials.gov yesterday. up Our went

Operator

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

Unidentified Analyst

you PFS? you can think thinking And I ORR? about? about on submit you then you you you do Mike. CMC? the happen Dennis in else lung arm? a you project me. Or to need on Or just Do or validation now registrational. my should using mean LUN-XXX a when get as between need is for talked approval study on This August? single-line second question cancer. other docetaxel is include can assay we for discuss What in One gating factors to Like Two and the on needs any BLA, be

Dr. Fred Vogt

already I Friedrich, first don't CMC the to a the you Why details validation one sphere the but get there anything making lot nothing like to that's There we be of most here, second potency in we've else do that of take one? the you great that -- rises amount less of happened, that to tasks. there level in work publicly, this BLA, type the we're gating on is before, of On of were completed tremendous Sure. the where talking thing activities progress we're had done the the take about but we resolve. as that a can happening we assume to not was for those already situation validation can assay and and and ready of has item

So needs all the comparability get are partners and about stuff that study -- against of teams and validations. there's really be talk stuff the docetaxel at that all Iovance, think and can employees these we Iovance do but Friedrich, succeed, Yes, more working to tons LUN-XXX little at you and that's things registrational of to registrational? we done. and comparator a all to as hard a PPQs our tons bit and run want handle. There's

Dr. Friedrich Finckenstein

question. Yes, Good sure.

one at with happy would lot which to look Keep they keep the not in single-arm assessed of low risk-benefit way FDA a a single-arm they at preferences randomized They but does they It's in durability, data. mind, therapy review It looking the response happy are is are the we'll are time. data that has that it somewhat trial generally different prefer drug. in popular of that of doctors. not data, of than available at the by short which and those rates, totality is single-arm non-cancer data. here data in docetaxel, include type where data. context great is toxicity. So at It data, to looking a studies, for to thing mind have clinical looks as But

need that Generally, So FDA. unmet bringing does at One single-arm there we'll certainly medical is look forward an that. to certainly support add. data and the with thing

add just one Let me more time.

the therapy, to identify gets contribution the then therapy at The data In point we're of because to that combination -- it's likes FDA pinpoint not because right? look a components. not and more is, combination that a will add other complicated little usually a

can therapy with compare Our data available from therapy. monotherapy is you historical the that

Operator

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

Peter Lawson

When Just on kind can the get of that? see the kind the sequence will feedback that when curious submission. FDA first to events we for going back we from just the regarding BLA of of

Dr. Fred Vogt

feedback BLA, is Peter, which probably at XX submission. first acceptance the the days comes the real of after time of

Peter Lawson

commentary there alignment And assay? Got would the around you. around be the potency any

Dr. Fred Vogt

our say for they're what to accepted you is can't tell sure I But they typically could process, come that we've has -- that sorts going been of BLA and idea ask for during And addressed more assay to information. request address details at stage, with. the where the think they that may simply that typically, later upfront about to they then stage. that and review we in including dealt all we the all any say all or FDA need is requests that make upfront going things, goal with to at

Peter Lawson

whether Got kind your then evolving, questions, you communication unfolds of us et how communication additional loop keep that as of plan? Is is like you. need in or the cetera. And the that that

Dr. Fred Vogt

in I talk call as how a are go check of companies the BLA the how to people able about keep updates comes you'll do that I'm to November that you think period, progressing going, Peter, people informed. to and get But the in about be let's probably things hear and we'll on as it's give from imagine, -- some as earnings we sure but at in are as blow-by-blow questions checking think everybody I see best on everything typically can this say, FDA. don't our us hopefully review we'll stage. during we'll lot

Peter Lawson

is submitted, assay? well BLA potency around kind we see, the more Got assays? when just you. will the And IP the filings around then will potency And of question around guess, as we just information final get the I

Dr. Fred Vogt

greater typically probably it's eventually I Ultimately, around a as priority we'll the after or you when you exactly But can't months that filings. because IP know, tell public sensitive little date. become first now. XX see filings right

-- there put that the tried out there there's sensitive, going some out think details to level. be we'll probably quarter. I've stuff talk the we're competitively to analysts some think information that at don't to of caution some -- is and I think that to I about continue So could on

Operator

Our Colleen Kusy the next from comes question with Baird. of line

Colleen Kusy

Have meeting? likelihood might what and filing? Or you your received the July is of that confirmation further slip the of could the scheduling delay BLA

Dr. Fred Vogt

Colleen, -- is we B don't a a pre-BLA type meeting. meeting

XX timing what's requested We're right putting on in they're is, there, July exactly just now, announced So days advance. we the not details but out going it.

So we're very comfortable with that timing.

Colleen Kusy

Okay. That's helpful. on the or And submission melanoma accelerated support full what understanding is your BLA would a latest approval? line late whether in

Dr. Fred Vogt

know spoken for calls study We We that need there's about there. should the of also do we've think of, have We serving data about on few being Phase with X option that III of recently. be times a been approval, Cohort Cohort that with, talking to in set confirmatory a size we're the don't that the chance as X we've sort a trial sure. and and of full the with good coming

for every planning we're So scenario.

Colleen Kusy

more if call at you expect launch? I more indication early on of any one high at that And using by CMO, needed around a capacity would you're Would driven seeing on launch. the due upon Great. can. the demand be that, if iCTC Okay. limited to follow-up, or potentially more The sort of comments

Dr. Fred Vogt

and make to just a trying as really We're go we've the first. of got issue sure footing launch right at demand now launch. when we the a we from launches learn as can flexible much BCMA two probably to really, CAR-Ts It's

than to products brunt us the the CMO with two just capacity, of BCMA bears some with obviously happened to having of Abecma. better allow iCTC is the going -- help what the do So selling to potentially available but the with

Operator

with from line comes Buren of Van Your next question Tyler the Cowen.

Tyler Van Buren

to Puri, to on your patients? the role. we you have career and second love lifileucel the The and you expect at stage is related earlier-stage then update new I'd why congratulations board, Could have the in in When should in cancer. get first Dr. the confidence receiving on with one next get join Iovance data on this lung you great hear the an to question second-line update to And year? to in LN-XXX approval? we later decided

Dr. Fred Vogt

one? the don't Go Raj, ahead. ahead, come want you if first take one. you Go the go Why Sure. too. to I'll don't ahead. take you second back why it, around

Dr. Raj Puri

of T to compared Yes. I Director, cell, potential cells, solid which significant cancer say had after Division the works TILs as XX% XX a limited CAR-T I in that in such goals. of And just checkpoint cases. better other years the checkpoint and or I effect modalities XX% was to number a career as at great for the on inhibitors only want the see interested malignancies inhibitors hematological FDA, to

in the of other broad cancer majority have vast cell great -- So solid cells T CDX, cancer. the patients TIL potency cells reactive to with with has no option, the a solid and CDX

Iovance think is this So main I that and an Company, important of was one the therapy. of goal to the join

joined the Iovance. I the that's reason So

Dr. Fred Vogt

as clean possibly respect trial think we haven't specifically. bolster we're data And to we efficacy then Obviously, LUN-XXX to optimize enrollment what get trying said to and more data that this later until there and signal a with year, worth putting to in out, get put of that last I to try do for And specifically announcement think some we year. as if out is can. would we think that soon try We that therapy with data lung lung. we we

So there generate let and to can hang us and tight data. all say, enroll is continue just I

Operator

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

Mark Breidenbach

cell cancer on the focused other me a non-small of inclusive all us and LUN-XXX melanoma or why types? Just remind not Or trial You've are the of distinct in quick tumor protocol to be to less populations? some types investigated terms you and of new TIL therapy. competing lung enroll the one respect of the And only with same is just with at also, trial will the trial of of cancer kind more is Can patients? this trying they IOV-XXXX. lung for

Dr. Fred Vogt

do Friedrich, take you this to one? want

Dr. Friedrich Finckenstein

Thanks. question. Good sure. Yes,

an really the the the demand strategies TIL two there new that attractive Fred the earlier. and Number cohort generate about enroll clinical know on because is one, and data for is therapy. to here access So patients same spoke we fast to Madan preclinical trial. melanoma there's based in This really promising data rationale on an and approach opportunity is

So population generate a compare the well we'll they us know be data own on conclusions based and our as data and able soon some possible. to very to draw that in which data, then as allows academic

really melanoma us. really indication here. the Non-small tumor important cancer strategy cell a for in is for that's lung type So

at if knockout, are both We of rates in have patient activity numbers technological we patient's tumor. cell approach Cohort in duration. that in we're cancer. and you well therapy as and the the to population PD-X improving the hope that allow the indicates LUN-XXX, Xb in than generated mutations the data as of in we We addition, regards both therapy And lung to targeting TIL response going in with on non-small population, a broader prior drive population look are

about are to to patients of Around really patients. quickly, melanoma we are study later think we line also those an is there So with positive other enroll that opportunity to taking. risk and exploring start at going overlap because take the but that -- there's overlap and mutation melanoma, driver and that question your activity another and shot existing in speaks so for rather with do little efforts

Operator

question from next comes with Mara line our Mizuho Goldstein Securities. of the And

Unidentified Analyst

Goldstein. Mara on is Jerry for This

So first do the is cohorts? also a melanoma on two you How prioritizing IOV-XXXX. CLC anticipate and

Dr. Fred Vogt

same open we at different do different they're both time, and patient investigators. populations the prioritizing? anticipate going to They're and How be

expect of now. little the just that bit do kind demand but them earlier we I rapidly to of equal Friedrich -- we enroll because area view right in that a melanoma as mentioned priority, So

mean That versus enrollment think. shouldn't faster, it. tell I we're other, for one will prioritizing it how So can't sure I in would but you the doesn't exactly roll go

Dr. Friedrich Finckenstein

two but not certainly really We're manufacturing expecting different are overlap simultaneously. there's back no cohorts anything having slots competition. open or limited enrollment or that. They're These rates, held by like

So we to because don't around any we of which patient have to is concerns -- don't derive for patients. sort these of having next

is prioritize there need that. on no to based So

Unidentified Analyst

Got you.

is on one Next LN-XXX.

to able change, do expect protocol you tumor well? as trial for slight the types With strategy similar the be other

Dr. Fred Vogt

you Are about LUN-XXX? talking

Unidentified Analyst

Yes.

Dr. Fred Vogt

be for that, going Yes. is to Yes, there potential yes.

Operator

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

Ben Burnett

any are on there the I or IL-X? And commercial at procured supplier initial provide commercial Just color guess commercially, can demand? you this as-needed point can how handle a of be Just questions. securing is I will real-time confident your in of of terms kind that this you basis an first, otherwise? couple just IL-X guess,

Jim Ziegler

Ziegler. Jim that Clinigen the the IL-X met from folks in past. We've supply is This with

going we As and coordinating be BLA them supply across through now. -- you ensure know, they're the that needs a We'll adequate with have forecast supply to board. we them with right our as transition approach working

basically looked to ability have of working and that current ATCs the them We have all order with potential the wholesalers. of with all at IL-X their we're

Ben Burnett

Okay.

their own. they order would So on IL-X

wouldn't ordering yourselves? and You IL-X be then it supplying

Jim Ziegler

Correct.

Ben Burnett

Okay.

biopsy specifically, happen is after of be Okay. I patient And if like guess approved. question then I need if are to that happen journey really, And is you're taken? just another I -- sort just pulmonary expecting on the do does and -- the so, if the you verified? guess, does cardiac could, expecting, it functions lifileucel you that that

Dr. Madan Jagasia

valid This is question. very a Madan It's Jagasia.

be the trial, have a harvest. of the to pattern the they obviously adequate clinical will tumor same once patients subsequently have need HCPs of TIL for So go conduct the which leads then landscape. criteria therapy. eligibility harvest, the meet in in commercial to suspect before reserve cell practice to that will the ensure I cardiopulmonary tumor patients we to are prior the

therapy the world a practice world So cell stem that's standard today. the therapy, well in pretty as of CAR-T in of cell

Ben Burnett

it. Got

the tests through would I And fusion would -- go after process again those they ready? when when guess, ready manufacturing TIL -- is Okay. they it's

Dr. Madan Jagasia

had they cardiac may metastatic are in that melanoma. therapy, use further necessarily. any agents unlikely influence highly pulmonary their reserve, given Not which which or for have the is Obviously, cytotoxic

repeated. the is once. situation typically, unless And it clinical changes, not typically it's done So

Operator

Your next question from comes with Asthika the line Goonewardene of Truist.

Unidentified Analyst

This today. for is Ghanashyam Asthika

Just one question lung on one then on cervical. and

XXX somewhere progressed, needed? protocol gather the patient on until and if product? you study for when TIL So they haven't stored have how do a guys determine will manufacture you TIL resections to you yet manufactured amendment, And

Dr. Madan Jagasia

Yes. question. Madan. Good is This

is So to pre-progression we think I alluded you're resection. what as to referring what a

-- and the have their the patients TILs yes, tumor So manufactured. will resected

patients most very chance We patient and perpetuity" for lung cell to is expect to a small. that progress going of these eventually cancer non-small the "respond is because

very TILs patients most the on their a So we the that probability and frontline using to progress been of number. these therapy high manufactured very, of expect do does have approaches at

Unidentified Analyst

other just mention data factor from of gating presenting the a can be well. factors study? data that would from you presenting any terms as helpful the that And gating very And in would be

Dr. Fred Vogt

could No. enrollment flexibility, explore, something view more earlier, and that and improved We and That think we that it we to should the indications, not something said I lead be like a as too. gating factor study. for actually be data will that other from

Unidentified Analyst

expect Great. talking then that cervical these been somewhere And months. can releases five can discussions them earnings And update just for an when the two when like the It update with that? seems regulatory having on get like the Okay. been to based on to you've you've between cadences, that on FDA? on yes, an we cancer, we

Dr. Fred Vogt

approval very mind at came year. with of end in announcement last the Bear that the pembrolizumab

it time of So strategy. Yes, to also some build does regulator a it's been a and but few the front months, take get then in

date guided haven't and we one be working back to are cervical, have more don't So yet, because a we hopefully, soon. but specific here we'll information on hard with we

Unidentified Analyst

would conversations cervical? similar Is a The of versus there expect on sort final there longer? with anything your different you timeline one,

Dr. Fred Vogt

There are separate conversations.

but that, can't similar I things. than so that sense I timelines those other having really be But setting we're can't with say would for discussions And the in them. strategy the same, separately the and FDA the link those the it's

Operator

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

Reni Benjamin

I'm did and those right. that I are If this can the data at idea remarks, what SITC. sure conferences? you as hear be heard trials likely at an that that I would in to give us I not the might you right, be there ASCO think most I updated prepared said believe

Dr. Madan Jagasia

This Madan. is

what mentioned XXXX think ASCO, tumor statement presented at four and we I So patients in across our in on AACR SITC XXX the we indications. the data that prepared is had

Dr. Fred Vogt

year, about say more really but a much see, coming we can't have do this you ASCO can which we site And for that right now.

Reni Benjamin

potency Okay. assays sort into curious, iCTC I'm assays, that's just outside new Or And facility? already is then done are that the facility? kind of of integrated with something those the the

Dr. Fred Vogt

do our you of seen the facility houses, that we terms do joined the that's if remember potency it, but and open that fully of we Reni, our in about it and lot. elsewhere integrated matrix have QC facility, any you'll can and -- well, at see ability something come but talk you if it's that us a the that do I for something as That's can't we to includes

Reni Benjamin

it. Got Yes.

ones. could a couple could if you've past, you potential are it mentioned And That be? possibly sales how or small a it other the sense. know Okay. makes don't about I force? just of then how but in this thinking big And

Dr. Fred Vogt

think cell I comparison other treatment the that we'll then on existing authorized way basis in of CAR-Ts. come referrals centers, it is for be high forces the potential pretty a field can ATC. the and The therapy care you the community of think through will there's to concentration the a operating through

So you I forces, right CAR-T benchmark the would say, in current field the you're ballpark. if

Reni Benjamin

do they TIL Or that discussions first has panel? me. it's be final since is one your with agencies, through think most that for ODAC that anything you the -- Okay. particular have could one guess that issue? brought And It that you'll this time review in regulatory a the going a then have I in up definite

Dr. Fred Vogt

possible We But at too. and from in get tons -- also NTI that academic a committee. committee could the sure. and other as because don't got centers know data as that very for plenty TIL is Iovance, well we've known well of known, first experience therapy of it we is class it's It's NIH therapy in experience, this and well advisory

have So that one. doesn't may to advisory we committee, we get get mean not

things? we comfortable Right the things other question, all and timings So the we're pretty now, part doing. your your of basically, feel our bigger -- with to are No. there any

-- to follows it's so that, BLA, have thing that than We to a think we're that. it's we good we execute for have first biotech, on shape. in -- obviously, other big But

Operator

And questions. I'm no further showing

with CEO, over the So I'll back any remarks. President turn and call Vogt Fred for closing that, Interim to

Dr. Fred Vogt

the our pipeline continue into clinical BLA forward. first to covering Relations including you their analysts It's exciting you I if growing and follow Biotherapeutics are Please our Investor patients clinicaltrials.gov in for part of joining to and Financial participating clinical to that our cross-functional to time employees physicians expand like their just I Thank work moving support. submission, First Call. would up. thank an yesterday. Quarter as therapy again trials, our for like as out posted new our to of would and Conference Results and XXXX also towards ongoing Iovance clinical trial move hard Iovance teams free we IOV-XXXX trials be studies recognize to feel in the the clinical TIL who reach team to for as our shareholders well wish TIL our

Operator

and Ladies concludes conference participating, call. this gentlemen, today's may Thank and disconnect. you now for you

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