Iovance Biotherapeutics (IOVA) 4 Nov 222022 Q3 Earnings call transcript

Welcome to the Iovance Biotherapeutics Third Quarter and Year to-date 2022 Financial Results and Corporate Update Conference Call. 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. the and to Communications Public turn Vice Pellegrino, at now Investor President, Relations will call Sara over Senior Iovance. I and Corporate may you begin. Sara,

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

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

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

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

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

pleased and Sarah, everyone. afternoon, momentum great you, Thank at Iovance. to highlight I’m some good

our I begin advanced lifileucel, robust One portions priority lifileucel August. of see possible. early commercialization with FDA complete oncology as us one behalf which we who today’s to BLA our application while as lifileucel begin remains a pipeline. brief our in patients cell for lead basis advanced are on ready the BLA to may received, allowing potentially allows license will earlier as on the and as approved immune for melanoma initiated BLA developing to possible soon review so for submit therapies our approval. We are the our eager number BLA ongoing of an like status that or as update submission to melanoma documents are the FDA for biologics getting preparing This introduction on with rolling

We have to and continued the on the to track FDA schedule complete predetermined submission we this quarter. remain the submission meet BLA that with

feedback received As positive the matrix. FDA a reminder, from we assays potency the on previously

where efficacy review. forward in look approved we BLA clinical including therapy, provided anti-PD-X clinical sufficient FDA or feedback, BLA from significant collaboration. We which approved address submission on level The Lifileucel remains are July who the X safety for favorable from progress duration successful Cohorts meeting and also for patients need no there may supportive options. after we will and continuing to engaged the as melanoma in this FDA progress process of follow-up unmet data a to set was and pre data the our X trial, agreed of clinical C-XXX-XX and a had BLA FDA of treatment

and combination next launch and with advanced lifileucel commercial broader an We activities as anticipation pembrolizumab addition, center melanoma. treatment include are lifileucel a of long-term in education, also initial late our in our and trial Phase approval about for to potential on track excited payer capacity potential as XXXX, In a lifileucel frontline engagement, X of planning. treatment medical of onboarding, for serve near earlier BLA readiness we designed to melanoma for year, In the which and confirmatory remain commercial study manufacturing begin submission. is readiness

our are Society or especially Immunotherapy educate needed next about our to medical of SITC excited the functional the who As Cancer part for physicians cross effort Annual of about clinical upcoming melanoma, and Meeting week. advanced data unmet

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webcast XX, in we of a presentation our which leaders, the everybody on event. to or having look investor to accessible high level investor meeting forward be SITC call and Following with at visibility will an We conference encourage our and on participate host November and the of the attend today call will key opinion website.

cancer Additional lifileucel shareholders. create has on as melanoma, well value therapy significant for patients to as growing our cell a pipeline our potential

and in patients Iovance call. clinical strength will and later treating Cedric are also tumors, field. with commercialization. our leadership I global I talent our addressing and address call. on TIL across manufacturing successful the of Iovance We within to tremendous to therapies treatment during oncology, TIL Igor reflects updates. forward than trials have multiple let questions employees within this highlight today’s for gene your regimens which cell The And and more therapy We development six track currently will enthusiasm records look expertise XXX cell in and

network Iovance and Fred. manufacturing to to needs launch. our you, demand address Thank need patient at prepare continues

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rate one success is manufacturing supplying the for Consistent BLA from Philadelphia iCTC Suites XX% flex for manufactured Readiness currently than TIL iCTC. clinical is Manufacturing core launch, more manufacturing particularly activities. with commercial foot manufacturing cell studies success therapies. at for any The Navy for square We and our Suites iCTC, critical at designed and clinical internal overall autologous is for facility operating are custom XXX,XXX rate, Yard. our

our top prepare meet priority supply needs. to So commercial to for is patient

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this signed manufacturing agreement suites noted includes partner. release our this in contract two our supply manufacturing afternoon, GMP recently for manufacturing commercial As and a press at

as establish shifting cancer also to of needs therapy. are planning next TIL paradigm capacity future we look We as class the

the Jim. we and including least our also Jim exclusivity currently in IT. now are Ziegler processes like supply Gen patients. rights would outlined property support calls, currently preparations. into to TIL patents, to built manufacturing or hand XXXX to intellectual existing commercial I U. (Ph). on manufacturing has patients launch provide our have patients iCTC more our or and we facility supply to space therapy call the prior to XXXX to to supply solidify to growing flexibility international expect has X capacity annual proprietary are and shelf processes. more out we with further S. than allowed build new at knowhow facilities than highlight to streamlining our XX leadership more We As granted by Longer-term, XX,XXX that as [XXXX] To annually as own automating plan and adding well than patent

you, Thank Igor.

payer priorities Our and Centers our steady commercial Treatment with functional Today, highlight launch Authorized progress the engagement making cross of I ATCs or are teams our readiness for will operational activities. lifileucel. onboarding

leading cancer First, to capabilities. their have our and TIL centers U.S. work to build the teams continue structured service with line interactions

goal launch. onboard within the ATCs and Our XX is least train to XX-days first of at

ATCs existing workflows cell the to therapy. within and For lifileucel of we cell therapy service facilitating workflows development prevalent lines that administration, TIL are are leverage the new unique can

that curriculum Our approval, support continues in are our the can includes national engage timing readiness. ensure appropriate ATC each upon and our training treatment payers. regulatory key teams and of training reimbursement at to center program to upon team access time market patient onboarding lifileucel administer and access and onboarding to activities The aligned ensures multidisciplinary milestones a for and approval. just regimen To execution lifileucel training regional timely with

that commercialization. appropriate expanded our Services or available therapies that, XXA In to patients. and at hospitals payment more CMS cross ensures DRGXX core including pleased DRG the continuing Medicaid lifileucel Mapping for Centers continues to novel recognize Medicare acknowledge MS and treating cell lifileucel launch strong Medicare in to are to We for is I foundation for teams want build lifileucel a functional closing, for the Medicare patients.

our call We pass our are to well-positioned to now will highlight clinical into Medical heading Friedrich launch. Officer I efforts the Finckenstein, progress. our Chief scale to

and pipeline Jim. Today, patients disease. various our tumor to and stages to would next more technologies at like therapy I cancer address new Thank generation TIL types summarize of you,

at oral and in The mentioned, First, This as largest Cohorts ever is we presentation include XXX detailed for the in SITC an X clinical Fred ICI post forward the next therapy a single are week. trial presentation study across C-XXX-XX looking conducted data advanced X melanoma. patients from clinical in melanoma. will to cell

and arm approval pivotal has Cohort objective the was been prior the conferences. summarized of reminder, Review was and ORR for primary cancer top-line Committee basis or The previously assessed our pre in announced on X the a by investor trial been has single IRC. analysis calls As or Independent of investor specified studies. which endpoint ORR response endpoint, FDA The agents many rate met the

measures provided previously available X endpoints that Cohort for X improvements population. our various represent supportive we trial of secondary meaningful clinical results and over and for care for addition, In durability

data Cohort FDA feedback efficacy approval. and shared X the X Cohorts data positive part and previously, given As submission safety potentially The the be and the have of for are the of BLA Cohort X may supportive label we lifileucel, approved. X if clinical has for data us that and on

in the on approval PD-X in potential confident are FDA are for there no or treatment approved therapy anti We after where melanoma options. advanced

will leaders the X have X key first X data across spectrum the melanoma to very the SITC medical and enthusiastic. seen X been For Cohorts physicians, in patients and of of patients medical has post opinion Feedback C-XXX-XX and present full analysis Cohort meeting the anti-PD-X comprehensive from the data Cohort and our pooled community. X who with to

in TIL but our presentations the in detail of using you The presentation with Gen met can community real on both on cryopreserved and patients that This are the For X prior Cohort had and was criteria pooled contents focus appropriate of line study X eligibility advanced will the we the melanoma of because is the produced at X Together, the primary of SITC, Cohorts and level detailed same Cohorts embargo, same the world a and X the Cohorts same medical are received the regimen X. X treatment analysis representative same X manufacturing approach patient lifileucel expect a assessments process. population. meetings. at prior medical

pembrolizumab top-line comprehensive that progress confident patients lifileucel lifileucel as SITC with shared pipeline, previously for we in monotherapy expand patients. to we combination after as tumor in our will data various initial to adoption relevant the develop the TIL to continue are types recap and therapy. set the positive opportunity supportive inhibitor results with checkpoint the of To naïve with upon melanoma presentation We of in advanced well that anti-PD-X a add

a this as We BLA approval is lifileucel. accelerated study melanoma submission confirmatory frontline for also serve to potential are to our Phase which starting a X year, in committed for of study designed later

inactivated of our PD-X are IOV-XXXX. We excited trial genetically first initiating also clinical therapy modified about first TIL the candidate

and progress for potency in We great are modification assess from genetic IOV-GMX-XXX safety first-in-human potential making the study to the increased in IOV-XXXX.

to a are and medical website. educate SITC on trial melanoma progress to at lung that cancer. non-small GMX-XXX patient. community IOV-XXXX patients Preclinical the about continue poster as and plan first the rationale treated presented or quarter, at corporate on previously for potential with the patients and updates been several advanced During available with option our treated trial medical meetings data to progress and cell the a have further supporting recruit IOV-XXXX we third We IOV-XXXX and share for

cancer lung pipeline continue also Iovance. to prioritize at our cell We non-small

on the studies enrolling immune at expanded our now with and multiple of submissions using across of support treatment additional study X have stages we Iovance In enroll various chemotherapy have goal Cohort after to for X cancer ongoing intended therapy. Cohorts and regimens. three We a to cervical shots inhibitor multiple pivotal Cohort six patients. total of to be patients cancer, regulatory checkpoint C-XXX-XX treatment cervical is disease

Looking we research therapy towards a robust have next the approaches, generation advancing pipeline TIL clinic. towards

gene several optimizing of consist of double editing for targets studies using talent progress genetic and the IOV-XXXX clinic, Following programs. genetic additional modification into the technology, research knockout the focused preclinical TIL therapy on including

CDXX/XX knockout the increase for analog We as using negative available are that such session. and IOV-XXXX. also exploring cytokine. and studies question Teva other approaches enabling I’m TIL enhancements our interleukin-X also potency incorporate IND continue targets gene double novel to answer TIL during

hand Jean-Marc I now, to year over our the results. discuss XXXX financial For third to-date and will call to quarter

Thank in you, filings. third financial as Fred. as in the level results are My release comments found higher And we of will well More year our quarter to-date cash the overview with an reflect be and details our press SEC can XXXX. subsequent position. beginning of our

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

investments company commercial commercialization, late loan a in manufacturing preparation, approaching stage oncology As pipeline make to continue prudent internal and potential expansion. we

million activities XXXX ended September the for team, period nine-months to nine-months Research September compared for XXXX. and for administrative million $XX.X primarily of $XX.X million per development expenses XXXX, were $XX.X quarter million of the XXXX. XX, and and $XX.X dollars period loss million million lower ended including XXXX. to for net pre-commercialization XX, and pivotal to was our or the or the million increased in net XX, compared of the XXXX, increase first September million higher XXXX. of expenses a for increase pipeline ended an as XXXX. expenses $XX.X compensation $X.X as $X.XX for million to in or period expenses internal the primarily to with first or of statement, third development quarter general were and million prior and well expenses development ended Research increase per were the loss million to Moving was well for general enrollment third compensation $X.XX of of commercial internal manufacturing a in expenses of XXXX, compared the administrative net support $XXX.X and share period million costs third and offset administrative to loss were three quarter was per research $XXX.X and the $XXX.X for and the prior to build ended This million September completion million expense as the period periods in ended of XX, share. to $XX.X nine-month ended the nine-months September September including the for stock expense, over an attributable nine-months the to Net quarter partially $X.XX clinical September September and XX, growth $XX.X increase the increase same based XXXX headquarter an by planned the costs XX, program stock The XXXX. and an XX, $XX.X based and the costs. were XX, as $X teams, clinical first new income compared $XX.X share related and These cost and corporate ongoing XXXX, million the million General XX, the of research same of September nine-months ended associated activities. XXXX, internal facility ended three per growth out development trials. driven The were loss to $X.XX ended of ended for for share research same General compared compared increase for nine-months administrative XX, the the attributable $XX.X compared XX, same $XXX.X September September by

to XXXX, internal our and in manufacturing continues shares to XX, hand our to beyond. support position are Q&A pipeline session. operating we will into the commercial were plan operator execute cash launch prudent With well-positioned to preparations, common there investments back approximately the now commercial kick-off September of launch expansion, outstanding. As that million XXX.X a I and the call

you. first Thank the from Our [Operator Instructions] with of Jefferies. Yee Michael comes question line

question, for it X Thanks Cohort do between us. questions for what you ORR you with cancer? more would present we on with to and [Jenna] Second for are able would us, about on the are focus data and X? this? follow-up is This when can be to afternoon. Good and additional Thank at share you the pivotal incremental expect our stratify lung feedback through hear we Any Hi. questions. FDA what whether Two Michael. One, taking discussing you. from XQ,

Yes, thanks.

together will So, data data part part X David data going differences the Cohorts look on at some will some part And to stratification and in as in Fisci individual that X pulled of and then Cohorts cases then of be data. the forward. include detailed you pulled not that, X in some of you the that separately and and is highlight will are Cohorts of X, stratification going there similarities are be be analyzing as to set presentation. these can

non-small Regarding the and do near in can updates any future. provided that on and cell FDA that lung, hopefully haven’t yet we

Got you. it. Thank

Thank you.

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

much very Hey, updates. the guys. for Thanks

follow-up a prior shown Just can the SITC And plot? we level the have with the presentation? PD-X correlation a will on clearly, the response they by Cohort short X presentation, expect lane duration patients detail in treatment, very between patient in

well include of Tyler, an and correlations in everything presentation. this will in patient also that on want there detail be levels to recent burden that, plots. as age burden stress level tumor disclosures the stress, patients short and in lane across analysis is patients too. disease topic see Yes. Remember the as that will importance The too we our you on of we his could

see you presentation well. the as that of some in So will

Great. Thank you.

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

are the sense completing the FDA rolling of you BLA? that data our reviewing started questions. comment have submitted? Thanks you some Hi, you And has have what good still for if already to already do any items Could outstanding afternoon. the taking

the Yes. billing that but really Colleen, is responsive, sort that provide so getting rolling they they of it have possible are very submission. don’t been the during we data, update

haven’t we we and in this have submitted. to but still We our fourth in BLA the disclosed submitted, on on complete But can where what details made we we the are and tell progress we rolling what the are timeline have substantial hoping it and that quarter. I exactly you

to you Great. sign And contract to new decision about kind I What understand do That for has the XXXX what as iCTC capacity the you. of is Thank with built at patients. today drove the agreements launch helpful. expect capacity and manufacturers? be the

you one? take would Igor, like that to

for thanks to, Happy the question.

So capacity we the are are help full capacity patient exact to to general launch. one at not expectations would is not help exact meet we is the capacity commenting disclosing satisfy on but demand. to for demand, the demand have plan And

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one you. if Thank can. then follow-up I And Great.

done you bolus centers if work better a Just you of at sense have with a launch? you more as launch, of the patients have do top XX ahead expect

need here. high expecting available and Yes, Hi, It a given Jim lack is of bolus. unmet the of treatments a Colleen. bit Ziegler the

patients. We that sure a that, commercialization standpoint those but is make support haven’t goal can quantified we to the from

questions. Great. for our Thanks taking

with our Oppenheimer. And question you. Mark of comes from line Thank Breidenbach next the

complete separate must FDA melanoma. and a size protocol in more getting since what endpoints how basket close question want of the kind about initiating be the of us the or onto to full little taking the that the is terms the would frontline approval? all, the and how you trial just study the would for support an see IOV-XXXXenter like of it and could soon questions. in information that timeframe And you X potentially give maybe confirmatory most you enter Phase Can to existing protocol? Would Thanks to clinic. First likely we needed it second then would clinic based be layered on trial study

thanks. Yes,

on we as of study, X end track release, our begin press in Phase noted the we the on are by to that year. the still So

details that are We that include do feedback is future. that designed end And shared we and details in been well. haven’t near incorporating yet, it as is going to but will about the how hope NPA more will that to study points something and be we

study some included the in also discussion. course, of the will of nature Of confirmatory be that

this study approval. we I BLA the we and point will tuned impact be time support too, BLA can all frame well more. have stay that at the So to underway some for The time accelerated in will is say anticipate

think there. that fine are to we we So be going

study. support For necessarily and be of XXXX out XXXX, idea the is about the haven’t publicly. we swap can’t assume to really natural who yet rapid that a don’t is going They But [Indiscernible] look on of those talked agent to study lot a expansion. it of - course - dependent at part done

will So start we think should that XXXX, talk will guys once towards will you are going it. we it will to about hear have - clinic because about more in we more I appreciate we and pace you a lot the - to a - XXXX, progress

Thank so Okay. much.

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

This have questions. for So is [Omar] on we Madhu, (Ph) two

registrational And and about non small then cancer second, pills PD-one considering the how is small muscle? pills? population in population for lung should be melanoma like versus inactivated what we cell for think non First, non-inactivated cell should

cell think can PD-X patients about many, thousand are year our death. the So corporate you populations many States. you you if deck the at United the not in population, look population, But small lung see and post a talking

the is We filling and TIL accessible with be are the therapy that potentially target population. checkpoint

well For a that also in the of of at least combination as studies some we that. are working our frontline

the the such cell that gene that really PD-X you about of PD-X an think should For PD-LX for by inhibited is codes that be product, about think that knockout knockout can’t PD-X side. internal the PD-X way the tumor

AACR year, superior poster a We potentially it an how there that to the the to that and be well. penetrating having the as few think terms had non- works. pills tumor antibody or embedded it permanently the some data our months many in AACR knockout model So website combination how compared superiority We to in we put the mouse the of pills knockout ago functions PD-X at at cells. out on knock in antibody attached in this of PD-X ways with could cell

a take that will and the we soon. Again, thinking look So go at back momentarily Las I are you into how right to clinic is that now. Vegas will it. see about

Okay. Thank you.

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

signal Hi good afternoon. effects This analysis to we long well, our came of any IO. is If recently TIL actually since relation finished it also [Carolina Thank is off been Vanessa in safety look I on highlighting IO. for therapy do for was you earlier patient show the has better like recall there We update, an Ben of patients Burnett] feel the in taking (Ph). that question. who the in

Madan, that do you want one? to answer

Yes, absolutely. very a It question. Thank is question. valid you for the

effect lifileucel And be XXXX, what may to referring in under translate when these That into higher who had I is for not had patients statistically who as you patients. does superior of published with compared refractory May primary numerically patients the JCO think I data, acquired (Ph). resistance. [embargo] the a the had of the we a ORR to refractory also necessarily slightly patients differential outcome data said, is So primary have in

is patient So to will in long-term. this able be see really to a responding, you go I on as they think the long year benefit what at as

is data under it time. on say can’t embargo again, to at the So as more this

Okay, you. understood. Thank

next question Thank comes from James you. Fargo. with Gin line And the of our Wells

completed, SITC When, for the we you human fully how XXXX of is Fantastic. said, press is then free this will issue and and continuous that say at Igor, interaction currently. for patient you this of automated much one capacity point? that release? like BLA is is a And Can

Yes.

I can one. issue take press press release, Igor. a will Yes, Igor we BLA. release think likely very will first the the hit a I likely issue one and on So, second

the for thanks question. James,

manual of is and closing is in manufacturing capacity. we current process Gen X to automation next largely the process that the get our on XX-day are So level working something to still

We get and order streamlining at potentially in of part and patients the to to XX,XXX that existing that expect build effort. per we per further can to patients looking reach facilities at and shell process XXXX that are year, then automating we new will year, be iCTC

I appreciate the color. Thanks guys.

with our Chardan. next question Thank the line Livshits And from comes Geulah you. of

This [indiscernible] Thanks is taking for question. the Hi.

bring those head want we and to want cancer in And the provide ready next and additional program is data on your short enrollment on that Phase update where by. activated over in cancer few back in sort indicate of progress to in on color being an So, data PD-X just BOCX a neck months? are program. We you X follow-up some cell the inactivated

Thanks for an the knockout mean of to that So outbound one. increase taking it a showed is that the previously questions. XX% number? you about efficiency in - manufacturing and think opportunity Do you

Yes.

if I can Let understand question. first see me the

updates neck up, You was clinical you there. and because were it hard pretty the the hear trials to to head back on asking about trial

in head speak cadence can use both and yes, flow to the lung neck, the in and sorry, Oh, enrollment of we and the expect. additional there that progress you cancer could

I referring me be to to with Frederic, think in might changes help study, question here. that? out you think, have you that or enrollment. But maybe may the you I Fred, answer for can COM-XXX help total

Yes.

question. acoustically have So the I also hearing problems

the we - In head summarizing the and currently have the that this question trials, your those neck data. trial C-XXX-XX, of cohort Does do and trial, specific of progress or are details is updates process and cancer any around COM-XXX trial we made completed recently in additional cohorts. enrollment a is speed So if have for ct.gov the so currently that about question? the any sizes, of the to enrollment we but shared we haven’t that on answer

a does. have for I it follow-up PD-X Yes, activated. Then quick the

and heard we large patients can that patients. that little of XX% that but values report are sometimes, treat is to a XX% cells U.S. that question. do adequate Remember, in than was that we that, range. billions. before. the We number, we many of think quite I I but is still usually giving heard a billion that a bit better

that patients - And cells having still are and so both giving knockout tax products contain are gene. we PD-X cells some that

for basically So technology the is that where knockout. days these is

If the literature, knockout at for you percentages, the look it example. the some is early of work

studies out the XX%. So Pennsylvania X coming knockout the early were of of like Phase University like

So clinic. amount. with is that useful to be are we comfortable We going the think in that

Okay, thank you.

Thank our next Guggenheim. Kelsey Goodwin you. line from question comes of the And with

two I I think. just forms, have

for additional guess the have think, the Coast maybe your nearing there the I a rate that bigger U.S. to produce an any taken just of color could of the now because facilities question, said BLA ex-U.S. color. I centers? First, completion, can launch, but steps secondly, I referral be East so what academic increase picture you you provide guess, Thanks to that submission some possibly then the is community more And much. on physicians can that procedures? products little on EU

Yes, I Jim first one, about will can maybe and talk then take the referrals. community

is manufacturing yes, can lots and do ex-U.S. strategy. our partner well as actually beyond. on We we the all the So, manufacturing that It facility of have States into an place as Eastern in is Europe facility reach East located own United CMO well the these as as located both a Coasts. way

FDA. well. will looking about non-small We particular haven’t to beyond. to been and much Jim, the cell we are launches beyond in publicly, places we have lung to and because all talk those U.S. the that Australia as be in do in from focused we you want are we all for ranging community have future for and other Canada ongoing the indications, and on that countries melanoma referral. that active And Europe we about talked over collaborations But are

for thanks the currently would the Fred are as strong are Kelsey, of know, as the referral question. about XX% Thanks, we in community you our dispersed and Yes, patterns as not patients and like.

are to we So identify data the driven using practices. the patients community approaches in

augment with practices also to our region will of outreach and initiatives. with the our efforts top frequency. have will education We team we sales all then promotions non-personal your And expand working community going to our

much. Okay, great. so you Thank

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

questions This here. Hello. us. [Indiscernible] on few is for A

those enrollment XXXX high and be about you dose contract would be that You got also initial of where already, that patients we access of are centers to have you one manufacturers be back the into wondering mentioned how dose just And getting are in at you data? would where then potentially guys wondering you terms launch to just progressing dose them said was and secondly, if online. able and trial administering to IOV-XXXX, would at the in patient more the look

Jim to like you high Friedrich part talk too take would could the that XXXX. and enrollment dose question, of first cover Igor, to for Maybe about the

for you Thank to. question. happy the Yes

I is mentioned ICTC as XXXX on facility our to has internal earlier call, built the patients of supply So capacity the than more annually.

demand launch. optimally meet out does of are plan ensure iCTC. patient partner And flexibility fully we to capacity manufacturing of then the the additional and demand to capacity commercial the role in contract is The commenting but at manage most to have is provide meet that are we about facility. in exactly demand year one, We the we currently expect not the the of constructed

On use decreased as, over high has IL-X, IL-X, years. the significantly dose

currently IL-X. In most our each have the of have And fact, Wayne rather data we they the are we of experience, where know target sites, using of significantly. sites they uses identify while to

sure IL-X program appropriate sites to very make and a for efficient have side trained training effect use management. We are on that

to So barrier I for don’t expect a it be launch.

trial, is is study this there question the was very working that and around one IOV-XXXX how progressing As a nicely. regarding

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going a lot the And question. is in for study. nicely. Thanks interest there this that of really So is

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

questions. (Ph) my This for for already asked. did on questions taking for a I Thanks Eric is so our [Jerry portion, Goldstein. Gong] of any I apologize if connection short lose were

on thinking So target about the what through settled you And number? with current cervical Cohort burn, regulatory if approval Thank for pricing, two line like current on to a perhaps can the then RT is pricing cash how products? process is cancer you share you. in look may of it a and have on through your enrollment trial, fair lastly, launch? think on And it

Sure.

you comment cervical can yet, have just pricing. Jim the details of we talk hopefully some on will but We haven’t soon. the maximum on enrollment cash could Jean-Marc, details that more disclosed about and maybe

at flow $XX we million are have to cash the that XXXX. in quarter. we about mean, Yes, end this of runway I confirming a Sure.

led strong supply and to running demand from a stage and as and programs also position lead the definitely, So the company de with risk manufacturing commercialization. up internal ready now

we any XXXX burn. guidance this stage. cash around But do enough giving not again, the are specific into cash have we at XXXX So

I pricing disclosed the On think This haven’t analog is we good pricing, and Jim. fair CAR-T good but is range. think about a it as to pricing,

the Thanks color. you. for Got

Barclays. Thank you. the with question comes [Alex of And our line Spoolow] from (Ph) next

Alex Lawson. cancer amendments couple be that after just made on lung enrollment helpful. Any had and if few study wondering you. one the I has you comment is a you little for bit could ago. going on months color quick been on was around would This how protocol Peter a a have a Thank

Yes, Frederic.

IOV-LUN-XXX you I about comment on? think you Could if talk study.

and question. so have Happy will the thanks we we of sure. rightly refer to for Yes, some made to the Yes, lately. that adjustments you

actually are these about are trial. really and the activate to sites able sites were how happy we to enrolling We how

design number are concrete have this. really any is study more on but active and that like progress pleased with XX at is that share which can really a haven’t We point, numbers, we than sites What shared we for a this exact we healthy study. the

closing now and Thank any you. over Fred to I Vogt the President will remarks. back CEO, for Interim call turn

for Thank the call. results joining conference Biotherapeutics you again third XXXX Iovance year-to-date quarter financial

including well BLA Meeting an with the week into our We Annual as Next as end-to-year upcoming Iovance exciting submission. expected SITC completed are heading

the November SITC media On will of released we Xth, our a November presentation As abstract. detailed trial. a from the and Xth, there preview, covering at include data program the abstract will full and expect of be for for press will we data look the be the members oral on X and that Cohorts X C-XXX-XX

as presentation and be four is in I physicians individual follow-up. to Relations free our employees in presented therapy. please well patient, [indiscernible] XX, cross will Finally, global functional would updated thank I’m the regulators a cohorts. an Thank you. reach out with mission for grateful Investor oral TIL close as our feel and on teams November clinical our the who additional follow-up on leader to our to worked any have to team like advance for also collaboration

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