Iovance Biotherapeutics (IOVA) 8 Aug 232023 Q2 Earnings call transcript

Welcome to the Iovance Biotherapeutics’ Second Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Shannon 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. Please note that this conference is being recorded.

the Relations to Iovance. and turn Vice Pellegrino, now Investor President, Corporate will call Sara over Senior I Communications at you may Sara begin.

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

Officer. Fred on Finckenstein, Medical Vogt, Executive Speaking our Dr. our our Chief Jim Bilinsky, Operating our Dr. Igor Affairs; and Vice we Brian Executive Commercial; Chief Jean-Marc Officer; Executive call, and have Vice Officer; Medical our Puri, President Bellemin, Vice President, avail the and Strategy and Regulatory today’s Financial Raj are available Interim Executive Chief Officer; our Ziegler, Chief President, President, Medicine Dr. Q&A Gastman, Dr. Translational for Session. Friedrich

which we that well for press release results issued months on the can three afternoon, and our corporate on recent a as the at XXXX includes June XX, six financial found This iovance.com, updates. ended as be corporate website

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

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

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

second of milestones am afternoon [indiscernible] XXXX pleased and Thank answering to highlight everyone. recently. Good several I you, more important quarter the Sara.

or also or be November cell cell to one-time acceptance treatment accepted review melanoma intend and PDUFA for for letter, Lifileucel first FDA the in meeting that cancer. T-cell of BLA, host informed a an advisory date the will individualized FDA not tumor in Application, no melanoma, Administration six-month the for XX, they solid Food therapy U.S. major therapy License the XXXX. was the identified. therapy lifileucel and review first priority were approved granted us issues our that do Drug Biologics and Our by to committee the advanced addition for of In if

priority the data with nucleus interactions to we this they given with FDA the need, of reviewed melanoma positive our process, and approval for During medical treatment patients in advanced and for review options. our have limited collaborate continued the have with remain unmet clinical feedback strong the from confident prospects our We as FDA.

our capacity As iCTC launch. we our staffing we projected or to building PDUFA our Center, Iovance demand approach for supply date Cell Therapy lifileucel are and

our activities centers our upon approval. field ATCs first treat teams treatment and patient the lifileucel with addition, to are authorized as In for site readiness plan soon proceeding on-boarding as or as possible

I highlight cell that May. now also used of product to to acquire transaction an stage part therapy as IL-X like company a after would our commercial the in closing regimen Proleukin, we are

to launch prepare so the offer important of Proleukin We two lifileucel parts we are regimen. we our into integrating that as organization can TIL

lifileucel. IL-X the with in full and Proleukin we TIL logistics future noted sales more of surrounding expect Proleukin supply expect to costs therapy, for recognize press time first Owning and some trial revenue from and significant goods provides us As revenue and also chain for release, of clinical the today’s with realize of lower we control expenses launch the lifileucel.

global solid mission strengthen for TIL innovating, be cancer with therapies and commercial multiple broaden to readiness lifileucel, Beyond delivering our potential the regulatory leader includes pipeline therapy robust and trials activities with the across for TIL seven developing, clinical people our in our active and tumors. to

randomizing begun patients In underway frontline has this melanoma, a poised later approval and trial, to lifileucel year. be upon of well remains our potential confirmatory TILVANCE-XXX,

have made single-arm We our Phase recently post-anti-PD-X cancer, lung trials X across in regulatory announced cell registrational NSCLC. in positive to lung cancer. non-small significant updates progress related our also IOV-LUN-XXX, We clinical and

This At Congress in detailed to the data trial Cohort frontline supports our trial lung in to trial a WCLC approval confirmatory serve support on Singapore, IOV-COM-XXX strategy or cancer Cohort of on The in can frontline naïve presenting World upcoming Cancer an in as IOV-LUN-XXX we cancer. lung the trial. upcoming forward trial anti-PD-X potentially cancer. also Lung lung accelerated our XA in from based look data XA

experience look Iovance forward with during in now manufacturing XXX developing our your to has As present to gene almost and lifileucel therapy will we now this oncology updates. and and questions ask addressing call to commercializing employees cell Igor prepare launch I products. later

you, and and trials while a providing our lifileucel of for access. Thank iCTC, productive first approval supply of patients at organization year for the been clinical half building the has supporting the Fred. preparing to are to supply we lifileucel upon commercial launch extended It manufacturing

committed to TIL and more operational with of patients success consistent XX%. date than manufacturing therapy are We more for have a rate excellence than to provided XXX

to and We'll next cancer Our currently XXXX therapy launch. than look patient manufacturers The our to capacity paradigm is demand the balance our is with products demand. the TIL TIL to and to forecasted the further capacity hiring plan iCTC approval TIL shifting as class at expected for upon establish providing remain supply of built patients on contract track iCTC more to therapies commercial supply support of most annually. flexibility optimally and

shelf existing new from facilities capacity X,XXX is well as more to annually iCTC than and XX,XXX TIL vision build Longer manufacturing built facility. by automating adding streamlining at supply also as our more term, ultimately for annually than patients can space for this Additional out be processes. to patients products

our least and We also or XXXX. to that report manufacturing annual at international exclusivity Intellectual property own XX-K. on IP processes and Extensive to U.S. detail protects our available and on granted is or know-how. Gen proprietary a component [indiscernible], that Iovance provide corporate supports currently XX patent our and allowed critical into we Form rights Iovance is it including X within website expect on patents

our over call like Jim commercial I to highlight Jim? to to Ziegler the preparations. would hand launch now

At Iovance, we with advanced in to Igor. and medicine the the solid potential therapy melanoma of practice you, tumors. are TIL additional pioneering Thank transform

deep the therapy Proleukin commercial teams and foundation building as lifileucel experience are integrating a experienced for cross-functional offer cell with of to while the Our a supportive strong part TIL regimen. launch,

our November public I readiness Commercial onboarding is private launch date. we activities. payer Today highlight commercial on our treatment as for centers track operational authorized or approach and XX ATCs, and readiness will engagement PDUFA

the our onboard first positioned well are to achieve days. goal we First, to XX ATCs XX within

ATCs TIL ready line each service to to and their ensure actively regimen working lifileucel multidisciplinary teams with to the capabilities upon are at approval. administer operationalize treatment FDA We center are

participating is are ATCs believe are reflected in and excited the significant onboarding of enthusiasm they number after process offering by TIL about our of we level significant A high ATCs therapy. currently This resources example, advanced and anticipated our develop melanoma service time capacity, assessed is onboarding of patients. prepare to Fed investments to process. line for capacity needs for and TIL their during among demand and

report accommodate therapies. ATCs sufficient hospital cell support and lifileucel other and targeted Our beds to inpatient

piloting scheduling capabilities in identity care's also custody chain our curriculum. enrollment of are training and of chain We Iovance and

build. positive feedback We and ATCs on design our Iovance have as provided are customer cares centric encouraged

ensure strategies are access our Turning appropriate to and to on upon access, for track market reimbursement approval. timely patients

on responsible the national Ts. approximately similar for we expect payer Based with engage CAR consistent to and label and recent continues are team payers covered who access to key regional lives. XX% of interactions our coverage market Our

For appropriate immediately more Medicare upon patients launch. established payment hospitals XXX, under have DRG reimbursement already which provides

ATCs acknowledge want cross-functional I we reimbursement our patients prepare have approval. and ensure for to committed to upon treated for at launch, be lifileucel As who to are access teams can

I pass clinical Medical Chief Finckenstein, the to will call highlight our now our Friedrich to progress. Officer

recent with approval lifileucel frontline next would generation trial and lifileucel approvals our TIL post-anti-PD-X Today to I'll like combination in melanoma. accelerated also Jim. pembrolizumab confirmatory you, technologies. with advanced and trial TILVANCE-XXX therapy full TILVANCE-XXX, support with updates designed full for of our advanced of summarize Thank melanoma. is I begin in to as registrational pipeline

at on potential time be was second and the approval The randomized remains the year. of of later first the patient TILVANCE-XXX to well in this track underway quarter lifileucel

a to for also potential patients the continue key large and of We enrollment. global geographies with presence and activate strong melanoma sites

basket cancer lung naïve regimens in studies afternoon trial. registrational populations of in trial investigate various and disease. non-small treatment as our in cancer lung stages non-small Cohort Iovance across post-anti-PD-X three our multiple six This cancer cell lung to the cell have non-small In anti-PD-X patients, cohorts IOV-COM-XXX IOV-LUN-XXX as I patient we XA will highlight well cell

ALK meeting, updates and for of non-small regulatory Last design LN-XXX cell non-small acceptable anti-PD-X lung post cancer. LUN-XXX negative X Pre-Phase month, feedback cell clinical single of At registrational Type include B X of provided be trial the on population have in reported the after chemotherapy our X approval Cohorts cancer. the a may Phase IOV-LUN-XXX trial who ROS regulatory and therapy. Phase and patients arm mutations therapy FDA for our X and we anti-PD-X TIL post and/or lung positive that or anti-PD-X of X progressed EGFR, registration

than indicated. For of ALK an discussions, the EGFR, preliminary and least trial. require Registrational genomic the completed therapy actionable Based targeted FDA we ROS regulatory the X Xin patients or on with mutations IOV-LUN-XXX at will one is other analysis of we approved line Courts a

responses to the version DOR responses. months. XX.X%. Confirmed ORR pleased responses All and partial five was this the response initial ongoing The X.X the of analysis. duration data X.X and and at plus We six are reached one ongoing including of median plus was time not analysis, complete the ORR very were with from from RECIST durability by X.X response ranged or

in active Looking Enrollment cancer, than underway XXX and expect to ahead, protocol we U.S., Cohorts patients X. is fully we our sites the XX enroll designed registrational to the a Canada X are year of to FDA more within second clinical at amending cohorts the plan advanced non-small this the already Europe, total the planned trial half with in lung approximately and enroll and Based frontline to LUN-XXX as discuss trial, will on serve approval on the trial. confirmatory feedback, FDA we cell in XXXX. which a we is later accelerated of based pursue

with Conference combination Our patients non-small ICI non-small TIL XQ proceeding from cancers frontline in is advanced detailed upcoming Cohort advanced investigating in data cell report treatment. of Cancer. our cancer we World lung to XA pembrolizumab plan Cohort in lung Lung who are parallel; on LN-XXX IOV-COM-XXX strategy cell at with therapy in naive the the trial to

ORR a update two studies earlier positive of year. XX%, the Responses reported XA top Iovance's line Cohort including of observed results corporate confirmed was responders PD-LX and patients, CRs. safety complete We pembrolizumab. ongoing was In out TIL press responses other or combination with from in therapies with regardless of XX were X.X status release, by RECIST this consistent eight in

chemotherapy. far. so in observed have the subsets who the design ORR post was We durability results ORR wild-type of and In by of pleased combining frontline rate the been were had X was inform in the population target response X, five naive who progressed study. patients XX XX% treatment seven Cohort populations, when after Phase planned the distinct XX% very in chemo our these XX.X% patients EGFR naive clinical and and in patients treatment

analysis addition, same XXth. we data report tumors encouraged data in with plan abstract an the for presentation durability after follow-up alone. results complete to be will the approximately in with September duration to the patients response treatment one In included five we the observe pembrolizumab number August of among Cohort who WCLC, published The not respond XA in will prior mutation and in typically of additional XXth. were an on oral to Then patients. initial updated do be progression TKI, additional and EGFR At with

frontline lung to and the also anti-PD-X are lung meet supporting discuss designed year and support service for cancer to our post which cell cell confirmatory and approval is full trial patients, lifileucel in preparing to cell data approval advanced XA full in non-small proposed We FDA non-small to Cohort lung registration this cancer trials with frontline non-small cancer.

chemoimmunotherapy. to cancer standard pembrolizumab after by of completion therapy TIL the therapy Our therapy goal to adding care improve maintenance frontline lung cell initial of non-small is administered

encouraging the in this X approach Cohort compared Based in this pembrolizumab Cohort durations and progression benchmarks or submissions. responses FDA TIL after therapy without by on in is following In cervical is confidence on chemotherapy combination the with lifileucel chemotherapy. investigating feedback anti-PD-X even supported standard of Our to and expanded enrollment the our in trial. support regulatory continues C-XXX-XX ongoing cohort response cancer care to momentum XA

We that utilizing checkpoint generation from optimize our incorporated are proteins response. therapy. TALEN of these programs next immune inactivate TIL about also anti-tumor inhibit Several the genetic Cellectis excited to to approaches technology, gene-editing modification licensed

inactivated PD-X or cancer. therapy advanced a melanoma cell is previously non-small inhuman TIL candidate with lead trial in first studied IOV-GMX-XXX lung Our IOV-XXXX, in treated our patients

targets which XXXX. candidates immune using to include the are checkpoint multiple Additional TALEN in expected inactivated enter using, development clinical technology,

I am during session. available the question-and-answer

our will call I and hand XXXX Jean-Marc over to now, the first results. quarter For financial to half second discuss

Thank you, Friedrich.

My high level SEC June on results can ended comments months press the our this More well will filings. summarize financial details six be as found and the in in XX, for three afternoon's as XXXX. release

Iovance and restricted XXXX equivalents, cash, cash XX, December million compared cash XXXX. investments of add in to XX, $XXX.X of million $XXX.X as as June

US$X.X as Our during for GBPXXX.X million for consideration front the firm approximately with million, GBPX.X Proleukin financed when use the million Proleukin payment transaction on Clinigen acquire was of million approximately the in fully end rights closed approximately or as of or May. inventories. well existing cash period included US$XXX approximately from worldwide certain to The cash

have we In towards potential $XXX.X lifileucel later public our approximately remain of to strengthen balance continued net founded a we proceeds raised add from We of year. this sheet and also common commercialization as offering. stock million estimated appropriately July,

and offering, preparations, current our internal We including cash plan prioritize manufacturing, position inclusive our continue of effectively our to end expenses commercial to sufficient expansion from clinical of manage fund operating pipeline proceeds the launch the until and the is XXXX. investments

$XXX.X XX, loss net $X.XX ended ended and million per results, loss XXXX. $X.XX XXXX XX, period $XXX the for $X.XX XX, to per June $X.XX for share was net June the June compared financial per or XXXX ended or months same $XX.X $XXX share million six loss for or quarter million second quarter June per of loss the compared the of share or second XX, net to million Net for Transitioning share to XXXX. the was

June Following of after second the the we June of acquisition the begin the in second Proleukin. the for was revenue completion Revenue XXXX There first time launch ended for for quarter to and quarter comprised XX, recorded XXXX. in and six May, $X.X revenue XX, million revenue for anticipate significant was of and the of ended sales Proleukin no six second months the months lifileucel. product quarter Proleukin

quarter second $X.X entirely the costs XX, cost ended same and and million. $XX.X There XXXX. technology. of including for June development The sales expenses our million million related partially was XX, and million was and ended Phase expenses X six of June of Research primarily Cost the the research the of developed for prior for programs XX for the million amortization Proleukin period to the revenue by months increase stock related trial, XXXX; six compared June acquire XX, of XXXX XX, quarter to compared XXXX; ended were facility June $XX.X June second ended Cost million ended no were $X.X development internal in compensation periods six months initiation were of $XXX.X for $XX.X June offset XXXX. development expenses Research the year decrease the an months to assets for a non-cash second over ended for which expense. based million quarter an research million the increase period TILVANCE-XXX were research in of and $XXX.X sales team, attributable intangible the XX, and of $XX.X to and growth and internal increases XXXX. development same of

the administrative the XX, ended and were ended administrative XX, general and for expenses June XXXX; upon Selling, decrease months decrease ended selling, the close. million period million XX, $XX capitalization same the The same associated ended compared $XX.X to and in $XX.X quarter $X.X XXXX. XXXX $XX.X XX, XXXX. attributable in compared June $X.X the were of million period for administrative was quarter of six June for only increase general an a Selling, million expenses of XXXX; Proleukin million general for primarily of acquisition second the periods June with second year expenses the the expenses compared prior to to million to transaction

and cost partially half commercial to to and increase the costs Decrease explained The attributable of insurance timing year compared the and the in including in business. related by other costs offset are growth expense other the offset minor advertising, administrative spend growth by marketing, the decreasing XXXX licensing in general to overall period, period by with first the general administrative of teams associated was prior fees prior and selling, primarily of in internal year the compared and legal costs.

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

now to will the Q&A end call I the the kick to back operator session. off

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

now is open. line Your

Maybe I I XXXX any questions. right the was are come runway around you Thank and two, cash the for you just got was XXXX, end changes Jean-Marc, my if were into taking early that thinking Great. one, prior that if around quick if just the thought I a you guidance question guess through? said internally of and there

Thank Peter. recent the before quarters, let's are and $XXX that's with two XXXX. why we $XXX ways of are Actually around first proceeds, XXXX say Thanks into of end we you, of the net so guiding half we were question. for adding million, commenting million

generated and so more this the also than Proleukin have say on [ph] Of we we one-side lifileucel what course, other on side, two will proctors revenue depend let's but on the indicated by before.

the think see can number tell we upcoming versus if as follow in particular, us time abstract about we the up World Lung, in just then and patients guess And presentation? the you. about Thank of that Perfect. the data you I the

conference. until be the follow but abstract even week, substantial there'll and the in up up the embargoed still rules that's next Peter, I follow think Yes, more at under

from be you've compared will typically. to us seen significant it think I what

in just up follow not that the patients, case is of the And time? also Good. number

see. number those in We're increase abstract to going primarily see patients in going huge or follow-up a it's of the presentation. to time not – in No, as you're in the

jump so into Thanks Perfect. I'll the much. back queue.

Thank you.

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

now is open. line Your

thank and had you I or so. be anticipate the trying went to of This about they preparation million Maybe understand, a anticipated for because two; on $XXX you questions. launch, a do about, potentially the well and of numbers with talk as you back guys, the about Hey excited was the talked guys I and launch that know at reimbursement some old all progress. the think which generally And you all deal to We them codes Congrats things the one to CAR-T looking was the CAR-T on people that thinking my as as should YESCARTA are strong coverage had easier the that and for better than to just about. little bit launch? just side?

Can Is you following question up on be or want can to durability is cancer line? just would in then rate the that what And us Do Do to how to of better? to into lung already context you. just response put kind for you data; about help versus that out be first context second remind the advantages XX% us of want in and is line first overall combo? chemo it one-time similar put see of there therapy? you Thank you the treatment? your

may to, the what the but of can gotten every were for you're referring that launches Yes. products. – than CAR-T launch aligned I landscape. be us Mike, as don't CAR-T navigable matter from time just the we reimbursement more stars the because know do have more at what considerably the product we've general are a stronger exactly they seen we think our than

to and up of capacity lot learned terms the lifileucel. on-boarding, and got Medicare code individual target centers We've already for and their For them established on. planning, MS-DRG get manufacturing so example, we've from running, site capacity how in experience a

anticipate I matter there, general a can, missed Jim up stronger if could your I that. have just yes, follow a you launch. on So We we point with

the the long looking with the your trial, seven KEYNOTE-XXX which in comparators for we for at XX% we're first which And and subgroups, the the On in ORRs range. XX-month subgroups. and chemo two be Cohort the showed to looking XX% as KEYNOTE-XXX ICI range mDORs data, particular those benchmarks are the I'd call naive refractory in to the XA,

at TIL to that. looking plus you're So being plus superior pembro chemo

thank you. Perfect,

XX.X the earlier. XX% mentioned are in by the Mike; to comparable to And all ORR that across during you quoted the subgroups. comments ORR Fredrick you quoted his ORR that two that three that way The subgroups that's is

Got clarifying for it. that. Thank you

you. Thank

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

Your line now is open.

on I a Hi, have the question lifileucel launch.

reference overcome more call upon in education to the on mentioned curious So the community are challenges guys I'm among efficient guys to you what I'm under that what hosted. see exactly of to recently launch? you facilitate doing referrals KOL curious what the physician to the

Yes.

to referral and what little to that bit we're speak probably and give doing summary Brian Jim one just patterns. For of up work there of a on

for of going Sure. This the initial referrals are community, be Jim. XX% patients is beyond so to the in are us launch. important the very of months

go talk non-personal and community a to concentration practices. lifileucel patients, advanced expand on use the community. we're as and what patterns promotions are promotions, We'll the our understanding cost-effective is to among data-driven physicians of i.e., and educate approaches these well to personal doing existing to force as in frequency sales reach where referral out use melanoma high Here build we'll the to of then with understand taking patients an

Thanks much. Okay. so

you. Thank

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

now is open. line Your

on taking and Hi, afternoon. good questions all the for progress. your Thanks congrats

stage? as is of market So this the population there you'll do of within on this months any demand of, in early approval; of launch patient number And in the the nature? portion pent-up now based things we're prioritize of any at of of expected like characteristics a or sense you segmentation that have that patient

Yes.

and in then can comments here. let a Let Jim add me – me few jump

and pretty demand for constantly. a gives – can run for we plus us there, the patient significant. the good how access with sense We advocacy program, pent-up It's out expanded an demand. contact feel some of which investigators have is quite all groups which We

that if question? see of rest Jim, you take can the you want do to

in robust based We the very upon here Hi data claims segmentation market. Colleen. U.S. Sure. a do

volume in So that we based XX, the are well of ATCs as we've extensively, CAR-T patients the segmented there's cetera, patients we at studied have top et ATC on the Because XX, concentration upon identified the concentrated market community. that patients quite a XX, our side, of centers. Top know the we and as

the for we're as those out going the patients we the to paradigm have community. expand we'll that first. targets are And enter for treatment into lifileucel, those So start

helpful. the Thank are then any And like That's for on you site centers in can you. centers? details on share many participating more process? And looks any on-boarding can share that more how process details you what maybe just

Sure. are numbers, the I within launch three I to won't reinforce that approval, are share XX is are will track. months will be we centers more is centers in able on-boarding. exact say I of but goal targeted What participating that our on the with and there to

think the the I reflective is excitement, So the need it and unmet of ATCs. again, amongst

And I'm question? that sorry, second repeat Colleen, can you

that for like provide more and looks how onerous process any that long is? what and take on details you can centers might that Just how

it's relatively SOPs, can whole of sure is defined. if workflows, center engaged be that's lot sets it things a do that work got are is some capabilities like process, to that a bit centers our are works for take could demands, systems. competing the There's that the make a longer. medical order compatible team heaviest short. the sure If make But a build Sure. really on and affairs center IT The our their administrative with fully we understand firewalls which checks to

are right now, confident could, ready are fully that I'm process entering centers for the that if committed, launch. For be they they

helpful. That's very for Thanks questions. our taking

Thanks Colleen.

you. Thank

from Our Yanan the with of line next Wells question comes Zhu Fargo.

Your line is open. now

stroke how is for nearing for at Any general, you mid-cycle questions. of date And ongoing have if Thank. process the might BLA Are characterization arise? taking Hi, was pre-approval when wondering concerns broad that a some inspections? you give review could have I our for or might also In you thanks lifileucel? the going? stage? the

Hi, Yes. Yes, it's – now. well going right Yanan. we're

company been they CMOs pre-licensing us still comment that's GetGo's aren't mid-cycle later well, will our no continue asked prepare the have have obviously passed period they to inspections things to but something You for. now AdCom, major and go with typically occur in won't pretty issues. any that clear the We publicly when that we on review the Iovance process, occur, from like heavily there

back we're So track a of very think very it's is and forth. The we very that hard engaged. very got going well. working for productive But right XX, on on November date and PDUFA things otherwise, that the XXXX. We've It's remain now. FT lot of

That's talk for terrific I about just hear. and a that LUN-XXX What update. study Thanks for opportunity ORR any whether questions for for I of interim Then this the assumption powering Or DOR you. that for, also data And couple words, I any setting? color program? And also looking pivotal – you the agency Thank and pivotal other for set? the a wondering to XXX FDA of the additional approval there's could on success and the and have from that be with was patient trial? interaction for in what might update? have is do bar your for kind

one? do you Yes. to that take want Friedrich,

thanks. questions. Good yes, Sure,

So a they in whenever have endpoint the mind that oftentimes arm data that's safety. address data with they like can rate. design also we keep I in you one heavily response like actually this that's this and look will talking because one duration the appropriately response of studies, totality we're to But oncology at relevant will thing always of FDA is, is the that single think, look stresses about at that

totality that, that ramucirumab is submit you have response Right you – of responses. you really what at short that of something It's be there's and no docetaxel, that presenting you you to beat then are how, – be but durability docetaxel have number they're single they're that of So will comparing might – looking if the when have now, as for definitely available is again care. range rates you where yourself means might FDA a at there no tell – if really single a the you data game. you looking you if ORRs,

excited In that looks well. do the would And like which as interim that not of exactly design, that's single-arm give where aspect LUN-XXX study the really the something the final data why are a safety that totality this right you is they're usually analysis an we data you a now, an in it's is promising. with And really durability at, looking about informative. obviously data is because

stop between smaller necessarily based with a read sample You wouldn't on size. in

answer question? your that Does

who and Yes. the a response those Thanks. does. position wondering, response? was whether were a of I Yes. in patients ongoing does. in as It you ongoing also data are comment lastly to had response who in – It cutoff, still are were

can Yes. respond I we I hot can this. What off short to press. ago just while was a very the shared –

the that basically was to we just cut we prior what we that a of shared days it. – So that couple disclosed dataset

that on that gives on, good we on you So maybe where idea a stand that.

answers. for the Thanks it. all Got

Thank you.

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

Your line open. is now

for a handle it right the to mentioned is do you XX think versus the for about about quantify they guys. on do sufficient. are don't how is Maybe talked Can starting vary each, the you XX help XX or the or afternoon ATCs? you example, Hey, Jim, terms you a capacity this XX good taking Top might according that Top they for what off, all in I – congrats many they Thanks of figure around significantly, XX these same? do be month versus quarter? ATCs? call could know I sufficient or just do in ATC in the Top maybe questions patients and the bed capacity of Jim, the And progress. you each –

question. It's for Hi, Randy, terrific the thanks question.

both CAR the concentration, so our is vary. own that T know well there the as So data. market a is What is we’ve we at number to going looked as

centers sufficient that top would is to always cetera. more Your to is saying to engaged capacity that beyond ATCs degree. general, will that all in XX, the am therefore I bed have sufficient have have some we've vary to have but reported as are et And they to going XX they What not are compared going centers capacity. capacity, patients hospitals

in beds, ATCs the various HHS we own them from then engaging the floors. capacity internal which the team various both health a numbers some number levels, provided these been characterizes data.gov, we deck, on as now, of down hospital slide corporate our with broken we've often while for overall engage our and to In

sufficient I upon these capacity, data say points. it's hospitals that of when both based have So

it. how just marketing by big And sticking now? And it how marketing comes the along, right sales and with be? big second, XX will November sales the and Got for time team a is

team members with a plus About previous probably cell experience range specific won't I to joined and nurse of have helped patients the practitioners advanced actually XX you a and us Sure. but of the I on from have number, nurses experienced onboarded right come my actually in give including therapy very treat nurses who now. T. half who ATCs themselves. have number we're CAR

So I have got a on lot of the experience team.

terms onboarding between medical the and is commercial the drive onboarding In affairs to sufficient of right team the process. now, existing

bit closer. little until team to it actual get a hire we won't So the need sales

it trial the bit Got it, of when cervical for call idea of of sort is cell in to as you okay. and have half you going how an to any enrollment as the a XXXX. guys little enrollment the And second you whether of a complete cancer there? terms study Can may pivotal goalpost give completing at us and non-small provided sense

companies on after BLAs. frontline that restart to that obviously study approval the program their No, we guided haven't to had entire – had in setting and pembrolizumab of withdraw we other

running, and existing leverage sites can going, not is the study right the it's now. it enrollment where we to of So, we but project type tried it's

are as now and can to just approvals. created fast been new patient as by population We trying this has the we enroll

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the for questions. Thanks taking Terrific.

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

Your open. is line now

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good question. a it's So,

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quick Okay, a understood. then And question clarification Jean-Marc. for

extension it any the does On the Proleukin to include potential lifileucel? cash half revenues of second from and guidance, XXXX,

Yes.

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take Proleukin my I in that account into So only projection. it's

much. so you Thank sense. Makes Okay.

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

now Your line is open.

and Hi guys, thanks progress questions being for taking positive sentiment made echo my my I'll here. for the

First last like a I'd centers when about Fred. we capacity, of off, patients months were centers mentioned cell at couple to ago discussed a we conference about to a Fred, spoke our treat building at direct building you that some when want or symposia month. to capacity more XX question at

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Yes.

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a and average. and statistics that's but minimum there, whole series to maximum the of obviously So, you're have that's an a average going there. there's And

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Raj. this is Hi

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that's missed this Thanks of update this Great. mentioned last this, possibility Raj. if then can you any XXXX Frederick confidence there is I if the to guys. on an like if And question. earlier, year's? my Apologies last but I there, I one,

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update something to once there's We when will on.

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you. Thank

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

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happen Hey that's things everybody enrollment follow-ups first on interaction Does to a simply thanks challenge on because Maybe Or some is around firm up for pace? couple of taking couple things? another my need projecting the timelines been there a covered. FDA questions. to Maybe cervical.

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take can those. I Yes,

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taking great. for Okay, Thanks my question.

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next comes Our Mara question Mizuho. from line with the Goldstein of

open. now is line Your

follow-up much. Thanks Great. Proleukin. study, question to the just then a had on on and I so LUN-XXX

numbers or On the is Are scores enroll to they you're stratified PDL-X with patients than it study, comer? X%. greater less set into going X% than and pres all

be to to XXX the going size cohorts. going sample a of No, across it we're is total two

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one So trial? there's no particular versus the of that other in number

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asking lifileucel? So ex-U.S. revenues – Mara about you're you're asking without

of terms in on focusing Proleukin. Yes

Yes.

modest the high. numbers sales United is States Proleukin priced So relatively were particularly right the at outside now. And not

something at as revenue we asking. that's driver you're So, not That's major look what a us. for

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own correct? on its still it's But Right. profitable

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open. Your line is now

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Yes.

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cervical? Friedrich, do to about take want the for bar you the question

are is frontline Sure. in lung Where has inhibition The we where basically have right we happen chemo. combination point we how seen this bar now, where in low. are similar cancer check with of into moved to standard care

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medical the So really and need high. is unmet the is bar low

Great. Thank you.

call turn And to back the to you. at Fred time. questions currently this Vogt for Thank remarks. no I'd showing I'm now like closing over further

important the start pipeline the activities. in commercial the had the for results BLA, Proleukin second of conference again quarter our to an while you cancer updates on corporate of [indiscernible] and exciting financial key joining XXXX delivering Thank call. updates with Iovance Biotherapeutics We've regulatory of lung XXXX close the agreement, acceptance

advancing grateful TIL also leader Please am you. feel to free a and follow-up. Thank patients, physicians our analysts therapy. shareholders covering our our our out Investor and to would in global I be team thank for the in regulators reach for teams to mission employees cross-functional as for and Relations as their support. I well

joining. for today's conference This concludes call. Thank you

now disconnect. may You