Iovance Biotherapeutics (IOVA) 7 Nov 232023 Q3 Earnings call transcript

Welcome to the Iovance Biotherapeutics Third Quarter and Year-to-Date 2023 Financial Results and Corporate Update Conference Call. My name is Abigail, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sarah, you may begin.

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

time include statements regulatory regulatory control, collaboration, including goals, transactions, activities, everyone activities, recent and this conference guidance, subject as to like the trials risks guidance Vice our feedback Q&A our revenue, Executive well remind be time are will Vice Dr. manufacturing statements President, This on interactions, Executive and and research a Strategy President, Officer; issued Interim Medicine future ended the updates.Before our strategies, Medical uncertainties corporate would plans found call, licenses risks website our can payer Puri, potential Officer; corporate Ziegler, made to results Regulatory and applications available plans at Dr. our includes Bellemin, and from Medical and Translational during press and I clinical for the Friedrich for have focus, business start, on in Officer; iovance.com, today's X Raj forward-looking numerous regarding to we Fred that Dr. results Executive Jim technologies, Affairs; X our session. our President future interactions, updates.Forward-looking Officer; of that Chief months Bilinsky, pre-commercial and which we Chief and XX, we Vogt, preclinical call afternoon, September Commercial; Chief Vice which of business Iovance's as cash beyond Dr. are capabilities, release our financial and the Dr. expense on and SEC are Finckenstein, position and and Speaking statements uncertainties, Igor filings. XXXX, Operating President, our and Financial Jean-Marc described many Chief Executive Gastman, Brian and

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

Thank you, and I'm milestones everyone. highlight Sara, Iovance. several pleased and to good afternoon, recent important

commercialization We while in TIL continue solid in therapies U.S. additional cancers. to our for opportunities towards pursuing make significant geographies progress tumor

on with continues top to a patients review several as the Our is Lifileucel BLA limited melanoma nuclease to FDA We in the U.S., FDA options.Overall, for positive the treatment launch priority review efficiently advanced complete remain process secure with the updates. on status engaged as possible. with the priority approval

As advisory a hold issues September reiterated FDA reminder, the to review there in no committee are an major plans that meeting. no and

addition, FDA be accelerate to testing internal In successfully clinical of facilities engaged the and review appreciate FDA confirmatory completed. PDUFA remains on well status the TILVANCE-XXX date. of by efforts no underway track and concerns We to been all and and pre-approval inspections on review. the the external sites remaining team's the have which manufacturing The all has trial, also has

half rapidly including serve potential Lifileucel We end with near-term for of additional revenue are and in have clinical the as data, the and access XXXX.We and Germany, no United redefine who Canada. mechanisms in and submit applications of the for following again, care.For plan the we and is Australia melanoma updates Collectively, U.S., standard the have approval a applications plan potential with such Medicines the strength of additional expect clinical C-XXXXX to confident advanced X begin We in year, the marketing in for to both Kingdom positive the Iovance Lifileucel paradigm than scenario the to the PDUFA Lifileucel in a medical of melanoma drive Agency U.K. plan next for for number commercial Based to we European patient countries than expansion second France, approved our potential authorities plans is manufacturing France the early ready other XXXX, with authorization unmet marketing markets in regulatory engaged launch trial, XX, significant earlier the options on larger submit are reimbursement the also additional XXXX. and countries of efforts, the with first the launches treatment to regulatory Europe Germany, and XXXX, XXXX.Next same submit on X a need. we to the population current patients population can for Key in for that melanoma to our readiness February potential date.Beyond by European marketing in half geographies. of significant U.K., application feedback year, in other advanced capabilities cohorts the immediately the after of have U.S. approval, community with patients. U.S. about these Canada in slightly

Amsterdam serve for offer as have complete, than for existing Our have population without medical chain. the Proleukin, in therapy IL-X geographies already control regimen. new plan community to addressable and advanced patient additional capacity example, currently product IL-X Lifileucel or alongside these also Cell We region.As geographic and we the expenses.For expansion of the has incurring total Therapy new prepare countries, are when to we full and Lifileucel ICTC, marketed owning supply our Lifileucel, to launch an in leverage part can more melanoma a the significant double these sufficient we can integrating By of used Iovance Proleukin, existing melanoma. field support resources we options in in TIL Center,

readiness LUN-XXX enrollment Friedrich robust also clinical lower XXXX -- with cancer, treated towards These will melanoma X priority advanced We include X Iovance clinical highlight advance active pipeline and therapy Completing a in our in costs top supplemental in expenses to and continues to TILVANCE-XXX trials. that trials, Lifileucel.Beyond in registrational a filing. with moment. trial expect TIL goes commercial is lung a LUN-XXX which regulatory BLA previously potential and frontline future in our activities,

IOV-XXXX.Lastly, patients solid to excited need new will and cancer. endometrial introduce this in in for to tumors progress modified our call.Turning provide this trial our later IOV-COM-XXX inhibitors of an we immunotherapy first organization. earlier into cell program are of the in on medical Friedrich a after therapy trial include who program are Iovance leaving trials clinical moving in-human details Additional therapy Checkpoint cell more our chemotherapy. unmet more lines and genetically therapy,

We expansion have more ex-U.S. than developing cell in and people ongoing XXX They gene and with U.S. pipeline our products. oncology initial ready commercializing therapy experience for launch and developments. and are

and investments growth headcount completed launch readiness to recently manufacturing expand have prepare and onetime in commercial activities significant our pipeline. for We

full Jean-Marc of will continuing programs our $XXX all the expected addition, additional of September portfolio our into quarterly and to manufacturing reduce and is XX roughly prioritization, guidance cash capabilities.In Following expense key cash plan XXXX, on assumptions can color these operating provide million on runway annual in XXXX call. operating position year internal strategic while clinical fund today's and investments and expenses we onetime the in remainder XXXX.

manufacturing near-term ask to in We I about multiple global Igor updates. our therapies be later at questions are and to delivering developing for will we in now forward the excited as call. people Iovance broaden leader the addressing your TIL tumors. this I our solid to with across present innovating, future look mission advance and cancer

you, Thank Fred.

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

sections or the As clinical review Therapy completed successful process, and sites facility Cell and commercial Both Iovance Center of facility. with our trials. pre-licensing and the FDA ICTC, to supply contract are sufficient our BLA our part prepared capacity of manufacturer's staffing launch

more our beyond. therapy as processes.Intellectual streamlining patents, establish allowed We as also network critical TIL for TIL international strategy to therapy shelf our patients we ICTC for granted our ICTC detail annual The U.S. may more cancer annually. owned the our available out ultimately built hand like of by products to to course facilities additional Gen By the vision XX-K.I provide new X,XXX or XX,XXX U.S. our only annually currently commercial now IP would Ziegler on expect exclusivity than Iovance. to XX within is patients X,XXX on vision call existing and Longer or and website and well Jim to Form planned supports automating to term, the more XXXX. space, rights than is manufacturing products including supply U.S. Extensive that the patent manufacturing expansion. than a on is capacity and and build in currently to component highlight our property into X patients Iovance at adding Our building shifting paradigm as launch Jim? geographic next corporate TIL annually report supply in is IP for preparations.

be annually, melanoma tumors. Igor. At die melanoma practice the potential U.S., and approximately people of X,XXX the Organization Health you, Iovance, for transform of we in higher of advanced potential therapy. Europe. in standard medicine mortality solid care care has have to standard approved World the after currently In patients have additional Thank and the who no the of frontline treatment Lifileucel reports options to

have of urgency patients We to advanced these approval. Lifileucel deliver to upon sense melanoma a

we onboarding Our commercial our PDUFA date. will are I activities. and as readiness on commercial operational for payer or track Centers approach our teams and Treatment cross-functional highlight Today, Authorized ATCs, engagement

strong to Today's aspects ATC approximately processes to centers service on centers capabilities. begin treating Based ATC PDUFA have all our pending educated These Approximately now Lifileucel we the days establish goal and days provided onboarding. XX preapproval date. onboarding TIL of progress, in the PDUFA and treatment onboarding press commitment our shared a to the we the onboard of their ATCs demand. indication patients of regimen Lifileucel steps within staff to update First, our first XX completed onboarding within with status is XX date. approval.Previously, of onboard expect XX line release centers XX on are

and disciplined also schedule experience Iovance with positive and for to ATC a planning is a revenues.Reimbursement and provider support. their approach adoption. also peak treatments will We are access full believe drive first long-term organize success initial for patient We essential each

to Our advanced Lifileucel the payers treatment unmet in continues the key of payers reimbursement to market national believe team engage We approval. value and accelerate need, for regional access timely and melanoma. clinical and upon lack appreciate appropriate high options Lifileucel access of

Medicare for price and expect prior to strong a our pricing exempt payer will $XXX,XXX than increases for reimbursement expected within policies pricing cell The with prices with segment. insured includes through in Based higher IPPS we we authorization population.More issued Lifileucel XXXX. commercially Medicare advanced on commercial, approval, $XXX,XXX requiring the CAR-T range about and days patients.Although from range in based to early insured after current on disclosed CAR-T increases supports believe reported value price proposition single-case expect of therapies. XXX mix consistent XX a coverage X/X CAR-Ts to of with agreements additional be coverage and Advantage label, interactions, commercially medical that patients the Lifileucel similar currently coverage with We payer melanoma insured are favorable

In for revenue Lifileucel, from we incremental will addition of the to sales receive patient. Proleukin each

highlight As U.S. occurs we revenue other therapies.As the recognition would infusion extensive cross-functional to Lifileucel for launch I launch, upon preparations like a the underway. reminder, like cell approach

commercial to deliver date, ability cross-functional remain Officer, Our as Friedrich highlight teams track to a on the now our successful and approach to are our confident pass Chief clinical and call we our our Finckenstein, will Medical PDUFA in we launch.I progress.

release afternoon's several Thank press updates. highlighted you, Jim. pipeline This

I On corporate today, cell in the new website also are and cancer. programs recent melanoma which TIL program on as registrational would like our as available our endometrial non-small I will well to frontline our data advanced focus cancer. lung in discuss call selected on presentations,

our society and several C-XXX-XX durable support melanoma immunotherapies and and European treatment that activity Congress a of X trial. of we SITC the mucosal cohorts Lifileucel annual clinically recent cancer, differentiated meeting or the this continue ESMO now pooled rare with from a X-year or other onetime C-XXX-XX October, we for melanoma. durable analysis and as Research Lifileucel subgroup or posters the immunotherapy Oncology and pleased a of of highlighted at a Society week, of highlight for meaningful efficacy patients In the shown last Melanoma that potential from of difficult-to-treat X the analysis for from presentations during subtype.During week's are in trial the for Medical benefit SMR, Society is We to advanced

Our refractory poster treatment on reported in treated Lifileucel TIL the melanoma therapy. the data anti-PD-X largest outcomes with longest patients with population advanced follow-up of

underway approvals and continue and in approval to melanoma. additional trials advanced support frontline to time full combination registrational well of is remains to Pembrolizumab at in designed advance randomized trial on advanced Lifileucel This approval designed Our accelerated melanoma. to indications.TILVANCE-XXX full the is in for with the track be Lifileucel trial confirmatory of as post-anti-PD-X support in potential

geographies key in first the and the TILVANCE-XXX the patients sites randomize melanoma for to activate sites strong continue We Australia. in and activated site a new enrollment. large U.S. the with in patients recently in of We and global presence potential

cell have United lung we have We Phase is strategy. cancer, clearances registrational with post single-arm significant regulatory to and sites registrational anti-PD-X IOV-LUN-XXX the in non-small also Kingdom made lung Canada.In our II in cancer. open progress also trial our

Following physician the for LUN-XXX, the sites. remain is strong interest from positive preliminary and data center analysis momentum participation actively activated with and

have in also the confirmed X trial data We design response, preliminary cancer. the U.S. Based TIL cohorts half cell X be post after in or objective X anti-PD-X ranged or analysis plus anti-PD-X chemotherapy accelerated All from responses a and month.We progressed on for FDA ROS, enrollment remained negative of X ALK representing complete anti-PD-X accelerated X approval analysis at EGFR, the XXXX. lung X, BLA enroll cancer. patients including acceptable feedback in non-small may last non-small ORR of to and post cell lung an this supplemental who had partial response intend and and regulatory which to in ongoing submit population X.X trial, on for a patients therapy. mutation of that approval remain second registrational included XX.X%. on the track to The therapy time LUN-XXX an from responses, data the of we and X.X have complete

to Phase an FDA in frontline proposing trial improve III our in is registrational of Pembrolizumab and care the trial, the therapy early are full serve frontline immunotherapy. setting discuss a standard meet with lung year to cancer, to registrational therapy next goal III non-small plan cancer the as We confirmatory to treatment therapy cell to to adding initial after chemo where post support maintenance completion frontline by intended administered is of approval TIL setting.We trial which for anti-PD-X Phase approval the in lung

observed frontline Pembrolizumab in durations without standard even response TIL that confidence trial we benchmarks Our by with the program our supported in new is to combination toward compared this cancer. care have design and responses encouraging the chemotherapy.Turning of endometrial

we benefit for in other onetime and TIL TIL include to frontline Fred standard mechanism lack the an XXXX. in and will on work first more towards of there Based a session. program who tumor are therapy is available after as therapy types, approved Iovance is with checkpoint immune program The treatment progress may of cancer. and of the are across in Analogous mentioned, shifting, on inhibitor treatment our mismatched options TIL or to As both of action, endometrial patients likely we TIL details setting. during the half patients that the extend starting is patients benefit initiating therapy care our to forward containing of subgroups.We tumors regimens. treatment offer proficient, am repair study mechanism from look the I clinical deficient question-and-answer providing this

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

proceeds position combined from Friedrich. the at-the-market in results equivalents, XXXX. cash of details with on press the well in XX, facility. cash December had as Thank and More afternoon's financial X to ended investments I Beginning be and offering XX, cash, SEC July Iovance in in our current as September of $XXX.X $XXX.X you, The high-level net our filings. in cash restricted XXXX XX, million [indiscernible] this balance XXXX. million $XXX.X for the found will approximately financing as million X months includes and can public as summarize XXXX September equity sheet. release the compared

fund earlier, Lifileucel continue sufficient we cash our XXXX.As and to from and anticipated to completed prioritize onetime to many operation operation Proleukin and and our optimize described into XXXX current investments. the expect Fred internally planned be position and We revenue

to carefully as development $X.X September to X XX, loss X XX, September to an manage and was million for the third of XX, XX, or technology months for amortization XXXX, Cost million the the loss includes million third X million $XXX.X of share $XX.X trial, Phase initiation XXXX, XXXX. $XXX.X trials, $XX.X the XXXX. of burn $X.X and offset over and X to in the XXXX, developed third for XX, quarter ended related costs, the costs growth and in year and and months for partially in loss or million team September expenses, legal September reiterate $XXX,XXX the including expenses and million periods III quarter by September same the spend of ended expenses same the $XXX.X call were for million ended months third of million was $XX back the million ended approximately and period with was were for XX, to of primarily in the increase XXXX. September operator quarter X period the the compared for compared expenses $XX.X X September in same of Research the net XX, XX, the to $XXX.X the higher the ended off expenses in million $XX.X Net same September increases results. excluding administrative development and to XXXX opportunities in product the decrease the XXXX. September the prior growth were Q&A months $X.X period for XXXX. for September of XXXX. per timing As quarters.Operator, or X There for XX, period a handing advertising associated million X compared $XX.X period XXXX. ended share million, XXXX, year share our cash to acquisition I general of increase per $X.XX look September the of we respectively. same expenses the new coming the offset to million, launch ended financial to internal September the as recording by million the Selling, the XX, in other or the and no a ended million net of no $XX.X overall stock-based quarter expenses, XX, quarter TILVANCE our outstanding.Before XXXX, periods development which $X The XX, quarter spending towards cost $XXX $XXX.X ended and quarter and XX, revenue.Transitioning marketing, primarily costs XX, drive as onetime compared from XX, assets guidance third $XXX million $XX.X September to We Lifileucel.Revenue and third X revenues There of and expenses with clinical revenue partially million to attributable months 'XX expenses $X.XX guiding the prior session, was million were $XXX XXXX, our administrative loss costs quarter XXXX, administrative cost XXXX. as research XXXX.Research months began continue will an $XX.X X compared of a a XX, and XXXX, a compared inventory September sales the revenue session. XXXX to September research business.As the million, from months cost $X.X X ended September The can million, XXXX, ended were attributable and compared we and revenue and in for associated general related in cash XX, want and of compensation and the ended sales common per Q&A $X.XX ended of third for the expenses, development quarter compared were to range third streamline for ended required of well decrease and XX, Proleukin selling, were the XX, in and sales ended year May ended of to periods of and compensation as the months $XXX manage were ended further Net for was decrease operating the September decrease stock-based $XXX,XXX, operating XX, share for and September XXXX, for we'll we XXXX the in of decrease of we million expense.Selling, kick million quarter burn to Proleukin respectively. expenses following was to September the to carefully ended sales $X.XX there The start period, months are million months million onetime significant intangible noncash prior third share respectively, expenses now third million $X.X months the September well excluding to of including the general to ended the facilities after range $XXX.X per anticipate

[Operator Instructions] Our first with Peter from question Barclays. Lawson comes

approval Just E.U. can think E.U. kind and on if filing, about reimbursement of arm the potential got in that And follow-up. then of talk way about a E.U.? a think the an single as if the you you about well I've as changes we impact study a

Sure, Peter. Yes.

products controlled will in provide could have trial -- us Europe. that around already out we the get running, thinking could potentially which it read use where study reimbursement to the that use And it right You're there. to obviously, CAR-T what we randomized time and we the they did TOVANCE-XXX approval and drive to could of

is out as good reading programs arm you're then early in think, single-arm the data Europe. there's longer-term seems to programs enough data. through potentially you you And The know, and single EMA So public We program for the that. with reimbursement yes, that's major get early all a correct. on and then be in countries. fine access access TOVANCE should

the the delay? of number drove I'm FDA authorized demand-driven follow-up had And tend if curious around to it essentially benefit treatment then or that increase. about what the centers just of of a was increase, it kind was just that I whether

you to this? want do Jim, take

treatment a of it's from Jim. high it's demand combination centers. Peter, Hi a urgency of There's sense our both. and Yes,

a had because extra very Lifileucel. offer And we've So we're just that for to publicly confident demand be right high number. months share to is the increasing now and weeks, these to few centers the number prepare, able we're so to

with question next Baird. from comes Our Colleen Kusy

on and the the Congrats all progress on launch prep.

have preparation, the today the Lifileucel question theoretically, needs were start a kind dose ATC So to centers centers through start be if a XX approved could of Lifileucel who the done to on once those else or for using they're completed today, to those patients clarifying patient what preparing once it's approved, training?

Jim this want Colleen, here? but more you yes, detail. Yes. to ready a go. basically, do more little are give these answer in can Jim, guys bit to detail

Sure. Thanks, Colleen.

we've worked is, logistics. quickly, from on operationalized [ onboarding done of cell we've and date OR, to education all to terms clinical real front. of Just with the chain SOPs, the handling end-to-end the includes identity, logistics And which develop tumor workflows, therapy. journey of the worked with the and TIL custody extensively procedures chain centers preapproval training line, the med-on their this ] of to on and service surgeons, what reimbursement we in coordination out building product on We've

will ready first be and training then enroll consistent initiatives their the very to and our all last centers label, sure we when in go. of are to ready So out upon this ready make will a these abbreviated for the we'll be that use with update us step to final roll that of label. And say they're go, centers all label patients. based The are to

little rate had Can therapy And about regions? Europe market manufacturing cell versus territories. in of it the those size the And the see more be U.S. differences will a as some the commentary you on U.S.? the in and plans bit talk mortality what you the you just in talk in the ex some about

Sure. there. The manufacturing to plan going we iCTC mentioned use facility earlier, we're our

in in using pretty talking So facility clear, We're on of now. to and there it launches we're a a make not new our existing out, provide want The CAR-T good capital. what about our available be right yardstick building can efficient already for there facility that's absolutely done focused built Europe use what's Europe. I

X CAR-T there's at that from different sales in see have and jurisdictions figures. can point approved Europe this seen been in You you've products

these the millions the European millions into sales You've seen of at of hundreds this anywhere tens point. low from from up that things of range

in got see here. and this year Again, equally melanoma in a and then mentioned, the Germany dying to you've dying increases and pretty bad upside for than going we got over we've So in X,XXX Australia patients it high. the we're right also market more France here, The of TIL melanoma. X,XXX elsewhere. now and at Australia numbers jurisdictions we're very look well in too, as demand We've U.K. Canada good from we've as in opportunity patients significantly. as a And well play therapy these is

successful are. the have We We it clinical there. We CAR-Ts the launching with comfortable very sites be like know can think the just physicians product there. well, and we're very

Fargo. with comes Zhu next Our question from Yanan Wells

talk give to the And had the whether resource previous allocated I the Could a cycle agency's discussions? any resources and labeling of you the had you has how also, the And late Have perception follow-up. meeting? going? the review sense -- you your about improved? of a you is constraint have us review Have then could

think, would Raj, like question? is to you take Yanan's Raj, on I line. the

I'll Yes. very Yanan, you along that take well. Thank is question. The question, review the and you, for thank coming Fred.

and providing to getting the the been IRs all We responses have agency.

cycle Our planned. meeting late is

date are that the has in PDUFA our been BLA when perhaps the additional we resource issues and have January, be February that XXXX. before that would expecting to There is are the currently control, will We no sometimes under seem approved issues PDUFA announce be January, other happened. date in

us for Is And anything could January? you estimate here? of there elaborate on the further to understand

Yes.

CAR-T unmet all likes PDUFA they need, at the approve X weeks and So FDA on have with as with well. done least -- date, medical prior products X to products the as other to to products

that, -- with that will FDA they date. the before to keeping approve in like So to mind like product PDUFA sooner the

the we are same for the So Lifileucel. expecting

of the my capacity. manufacturing centers about then follow-up is And number and

slots to go. ready And hear question more of -- on a you allow And the foresee have And might go. you approval, other that cap ready assume approval? might centers I these whether of the of would is, you capacity manufacturing great would at virtually each So you your that have limit number can the question you the by XX days centers additional than to by to by capacity after the early time And time have is you might any centers? my place that? XX onboard XX that

Igor maybe a then of start facility. is can TIL very today patients. ] capacity It's the therapies. with got out capacity decider It's you're me final aware let Yanan, Yes. as large help [ our X,XXX-plus cell FDA obviously, built facility. the Yes, for here.

can't FDA we really anticipate XX as from did part It's end, announce, go what's we ATCs out possible say very date. we'll we more feedback we We going got of that at that. the about within the until find X as approval So of days PDUFA process can you the that. beyond on saw,

the a cell launch launch. right ever be therapy. We to have now, that's largest pretty for large see It'd

our contract well capacity ability Igor So comments scale But turn it's some own just let to aggressive. and pretty as up our me our for manufacturer. as between over to facilities it on the

the question. Yan. for Yes. Thanks, Thanks Fred,

sites successful. of I manufacturing very both facility, at the FDA and very, mentioned at pre-license inspections first all, facility well, ICTC contract both So went as completed our earlier, both were and

and preparing for the as the approval. and the been the what contract producing mentioned, exact exact hopefully, capacity several But also personnel been weeks what ICTC the our we hiring our site the Fred by been partner to in determined launch manufacturer for capacity, know, of will be launch both FDA get well clinical and contract we preparation We've sides, and training manufacturing next material. as again, we'll as So site allows. The capacity at have launch. in are has

Our next from with question Jefferies. comes Yee Michael

the there are This is potentially progress. just know that in updated a ask year-end. the long I Dina second-line coming strategy? Congrats that lung. maybe Is for data, some guys about seeing conference by on a to wanted up Or medical on Mike. on you was that's all track? disclosure about what previous still lung I thinking about

we're meaningful numbers think put Dina, available. Yes, out we to have additional data when looking along we

the more point more that year. ORR out a end be see we with meeting. at we to by would I to it's going into know get to then we this or don't we're our could of data good the be if study a we more XX.X% it like to So ability. data But medical the Remember, important signs that think, get patients will patients, and with in year put I a really it in have have to us next patients in study. significant the XX once

can the by it a we of we're patients and case. sure use enrollments now the to hard help running right on So additional could complete Meanwhile, to here make executing bolster dose just study 'XX.

question with Securities. next JMP Reni Our comes Benjamin from

very the call. and all quick informative on of a progress A Congratulations couple ones.

you are ongoing. you an X you You that, kind that give mentioned as endometrial that mentioned will still And the been do anytime following I portfolio happening the you're been one start the of typically update have studies one that of can think over. programs ovarian what's been think as to mentioned, programs take study? that Are back-burned. are strategic there Or there with clinical prioritization. Because that's have going back-burned? just to that part that have any us there

As think events an cervical, have program ovarian you're ovarian, we ]. don't in I to it's Reni, our right? I referring [ think

sorry, cervical. Oh yes,

Yes.

When our drive that as hit may study will are foresee the doesn't program and and cash. BLA it cervical or on. when we we're so So does can fast the we run hit, basically say mean continue studies endometrial in saying LUN-XXX in on focus run, the one all reevaluate actually a at LUN-XXX continue prioritization, this those studies high can and studies later approvals the on We closing we're for could focusing TILVANCE-XXX ex on we're particular filings so need think to to the always revenues. though efforts that we point. study, particular point enroll the we're is like we as we we well of U.S. importance at study don't enrolling What that impact example, on, near-term putting where we study these to more budget

of that the remind XX% therapies a ESMO to any not talk Friedrich years, just suggest years. mentioned, PFS Lifileucel [indiscernible] post right, that right, switching kind with their And long-term little is correct follow-up, detrimentally subsequent there me that And any if have the of What what to as way you patients been patients X -- can look data kind therapies? patients TIL-X is who survival out impacted that treated I you X are can wrong, [ cohorts gears are another of way pooled guess, are data? for by then of of Does just the if ]. latest got. Or the bit, about surviving patients overall in the that remembering I'm us these I'm at

I can Reni, this one. take

know, something of So collecting salt. a to that with data, as take data you collecting you grain is have always subsequent

patients I fascinating it's response, in long-term think in now any study and the the the to study. seeing a setting we no I out promise is We data. a TIL patients see We response, I the treated data who is -- That patients don't deepening late is comprehensive a there's in action going this would to signals and regards to we for long-term living speaking right? which of a think complete cure what be are that completed really what that to we a fact available care, haven't of the data here What which responses think detriment. to drug. a these again, But have with the conversions has this summary is The seeing pattern of seeing cell follow-up, put this of don't the don't in in really you're have for be think after. TIL importance really therapy equals So durability. what there certainly fact is where see a meaning we in actually of mechanism X-year is that follow-up

question and I final regarding Or of just get hope approval is think for Cohort least scenario you for. labeling looking trial one results when more sort guess on accelerated of the case Cohort possibility and where the a best scenario from the want? at X the sky you label. the we're a you really, Is at like, than blue any X discussion, what base data, can there that we this

data details data, It's X both with large well set the the answer Well, by as the we actually, data want. And patient this more you let me the tell say in of followed something, labels the front, Raj, XXX the reached. either. of X didn't then we add of a you opportunities up It get pool of lot Yanan timing when mDOR you on full if Cohort gives right Cohort we is But our can just for as we kind now Cohort on product. a for data about leading comes on that if the label because because what is and on back which not Raj pivotal FDA different think option that's the based set. that sort think promotion X, plus integrity of can the discussion the conversations, towards run, X home best of allows you promotional

Yes.

-- Fred it pretty of some think well. covered I

begun. has living the of discussion Some actually

have We have and few IRs received responded them. to a we

has have far next as the couple labeling and so. we concerned started, So in as that discussions that or we're weeks regarding of more

Our Goldstein from comes with next question Mara Mizuho.

that of well likely annual strategic operating activities, If reduce as to I could prioritization as the of a you portfolio completion quarterly just expenses. return to the number is mentioned the and that,

if program, you is as provide the what wondering that guidance I'm ATM at least us some there? left on to can is. with capacity directionally And much So how then

take you that? do to Jean-Marc, want

definitely. Mara, question. for you, Yes, the Thank

for year, specific, even onetime this So also as commercial and can related I'm of on not to the launch going there front, and a expenses readiness up imagine CapEx to be was on that the really the medical. you manufacturing lot OpEx preparing but all activities we ramping were

So there will and year. XXXX occurred in onetime be that was a lot considered next of not spend happen that again

time. So ATM. quarterly managing we're spend the Yes. our call. to why on both annually prioritization reduce also during confident over investment and means And And announced as about our we the ability that's

$XXX a QX. available So ATM, on amount which we have the a because we on have ATM only had a million still amount partial in we large

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with Our Stifel. Burnett next from Ben comes question

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just maybe one then other And question.

can something this to start? frame been any cycle can Would guess the the be labeling has that? of first the you when ever color late you would I one provide meeting at Just [indiscernible] TIL for on just us discussions expect sort

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label. in things We have couple clarifying of received IRs the a

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discussions. good that engaged with for delivering news agency us already we So have a the it's

Guggenheim. from [Operator Instructions] with comes Kelsey question Goodwin Our next

Just U.S., of own? partner to me. maybe in on specific ex U.S.? the you're looking I ex just regions any of could the on there cancer to moving setting broadly appetite in something the remind or trial, your to maybe I kind quick is post-PD-X is maybe just you this for still that I on And guess, is a ones couple And then pursue what guess, efficacy us benchmark here? more endometrial just guess,

Yes, jump part the Friedrich in the second on first endometrial I the can on answer one, benchmarks. Kelsey then and can

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monotherapy. data of at benchmark what you think I probably setting. about look -- of that were arm line months [ of potential ORR the point the of when duration have an patients And MMR months. Pembrolizumab study those of starting best X.X brought with of patients a Docetaxel ] used DOR The tumors. Ramucirumab and XX% the with ORR Docetaxel in lower proficient benchmark in a as MMR There Keynote-XXX a was can second So control little of would the X.X showed investigators choice into median response results can was XX% be been where median you

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this turn That to like the closing back At concludes question-and-answer I to remarks. Vogt the Fred would time, for call session.

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conference. today's This Thank does program. you for your participation in the conclude

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