IOVA - Earnings call transcript Q1 2024 | Iovance Biotherapeutics, Inc.

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Operator

Welcome to the Iovance Biotherapeutics conference call to discuss first quarter 2024 results and recent corporate updates. My name is Olivia, and I'll be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I will now hand the conference call over to Sara Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sara, you may begin.

Sara Pellegrino

operator. you, Thank thank webcast and and joining conference this corporate Good discuss you our and to results first call updates. afternoon, for quarter recent XXXX Dr. an Chief Fred U.S. our Officer, President our summarize and Vogt, will updates Interim provide introduction on and key Executive Amtagvi commercial launch our and of program. pipeline with Ziegler, success our EVP highlight will U.S. Jim Commercial, initial the launch Amtagvi in of advanced commercial melanoma. Dr. Igor expansion plans. capacity manufacturing experience Bilinsky, and COO, will comment on our commercial and Jean-Marc Bellemin, Dr. results; CFO, financial will review our presentations updates, Friedrich ASCO Finckenstein, will Officer, next-generation upcoming and at Chief data approaches. review key new including clinical pipeline Medical Dr. Gastman, Vice Brian Executive and President, Dr. Medical Affairs; on Vice call session. Raj Regulatory Puri, Executive President, available Affairs, Q&A are the also the for and Earlier this found iovance.com. be website afternoon, can at we issued release that our corporate press on a

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

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

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

Frederick Vogt

of first melanoma. patients call. and for our advanced year has strong decisive Thank FDA quarter you, been Sara, and conference our U.S. with to I the a Iovance to afternoon, good This approval following launch start for first pleased Amtagvi everyone. XXXX results am host a

approval continue the Demand our continues the at clinical as further grow pipeline. To since are we the and Iovance demand increased throughout throughout across U.S. that up begin, for high has to expect year. to XXXX We very broad accelerate. launch expected and initial execute to Amtagvi momentum build positive month-over-month ramp pleased we will

Amtagvi As than infusion most of third more are expected today, XXX across for be quarters and of for are to the second early already therapy and enrolled XXXX. patients ready

In to patients additional identified are soon. addition, enroll XX have at ATCs expected and more than been

ATCs increase new enrollments the our we expectations year, and experience, sustained expect existing patient to to continue build throughout As for growth. steadily supporting

demonstrating As on Jim is the by training, this which month. end we and at anticipated, treat interest have high to ATCs, that have We highlight. the are they track our of ATCs further total and capabilities they with very remain patients XX to infrastructure Amtagvi, will

least ATCs a also new the cell of largest We ever the of goal year, for number at set end of launch. XX this therapy ATCs by representing

more our a We of are to is addition therapy National or data the by will a Jim are in detail. subsequent and to The see for Comprehensive as Amtagvi Cancer accelerate foundation in access solid reimbursement Network indicator positive clinical which key add reimbursement guidelines. for market supported recent Positive decisions reimbursement, adoption. NCCN and will pleased describe ATCs preferred the establish treatment time which momentum. and the broad success trends, as to will this line second or

new X In to at sites cell commercial capacity meet manufacturing we bar terms near-term setting sufficient FDA-approved launches. manufacturing, and launch, of demand therapy a have for

consistent commercial positive clinical with our and is Our experience is manufacturing prior very experience.

XX broader critical and of experience process, turnaround for in availability observe time Amtagvi of ATCs manufacturing delivering a our is manufactured days. We within which the utilization. slots positive report and sufficient have scheduling successfully target

to have to ample expect We the anticipated in ramp-up meet demand capacity year. this

future currently our growth. expansion more Finally, to underway built already long-term for is double than capacity

year end Regulatory working begin by additional XXXX. we're in submissions addressable the population the than markets advanced track U.K. melanoma can significant the total double to In our Amtagvi. patient Canada, to this revenue potential where that U.S. we the of new have launch, EU, the for driving addition on remain and more on

We as will and on also and as continue to approaches advance programs well X expand Friedrich highlight that next-generation this new call. including our exciting robust pipeline, registrational

fully detail As that's a launch company Jim, developing metrics. in President over broad with of the and will delivering remain positioned in is launch a well now who Iovance integrated to therapy global for a executing commercial, Vice patients Executive our about U.S. cancer. I'll leader our developing speak and innovating, more to hand cell pipeline, TIL

James Ziegler

you, Fred. Thank

with excited ATCs and high each about the ATCs to total metrics, among patients. of to to of and treatment payers. by than by initial to XX total launch testament driver patient are ATCs, of in offer at for ATCs Amtagvi the My end May. Due center's now Amtagvi, level demand end for key which paradigm today commitment least U.S. increasing goal interest Today, are the demand advanced are by we the meet patients targeting hospitals our track of supported the advanced on transform more as by XX with We remain highlight objectives melanoma and to XX ATCs offering robust XX the there are Launching are potential in for enrollments to we ATCs Amtagvi. Amtagvi need that the year. a unmet well are significant as was of and progress melanoma. their

treatment. the likely ATCs and an third early patient. followed patients procurement and on have a is occur a currently commercial the for manufacturing. Based across authorization prior patients patient patient patient for Amtagvi and The earlier, line, quarter. decision A the scheduled journey enrolled defined treatment quarter time enrolled payer for more second tumor would Amtagvi infusions As Amtagvi provider by than enrollment is XXX enrollment by mentioned as Fred

of quarter. for third a term patients in In in are screening of ATCs aim high eligibility. than With expect XX an Amtagvi number enrollment for additional increasing in more to patients existing conversion screening addition, treatment the currently infusions patient today, we patients potential the near

label, commercially approved Amtagvi lives covered the medical which broader growth the and are than Amtagvi. In patients. XXX since the broad least access aligns indicates medical enrolled responsible coverage short of set than million us sustained trials X NCCN million in throughout and more ATCs anticipate are recently patient published we policies XX Thus at with for launch year that that have patients utilization as more and there of updated payers of our Amtagvi number time reimbursement with growth, month-over-month for trends already XX% And approval, for far, up success data observing are expectations. have payers and for coverage approximately the guidelines. consistent We insured, responsible XX favorable for notably, lives clinical have Early for policies is treatment. expand,

Igor I will important with is Chief progress. even on like Operating accelerate at our and we cross-functional very and performance the treatment medical established highlight patient talented the deep financial extremely Amtagvi. I now time the goal ATC broaden acknowledge in our expands policies as to Collectively, metrics. ATC, clearance favorable similar experience, We updates to future coverage payers progress, and and team to remaining issue issue to would accelerate these Bilinsky, partnerships time. the Officer, launch ATCs. expect early that I'm over and I with ATC's policies. In network more our providing the expect our reimbursement increase summary, will teamwork coverage to call to pass payers to pleased our gain steady community pleased we access as lines are Iovance. more forward referrals growth for look manufacturing

Igor Bilinsky

growth is world a designed Today, competency only largest trials manufacturing Thank ICTC the has demand facilities the volume and the Cell Therapy approved expansion support for in manufacturing. our and for Europe, to Iovance, expansion and for U.S. exciting continues you, the and for most of U.S. the manufacturing that manufacturing the specifically commercial facility, FDA cancer to Amtagvi own indications in core therapy date. current Philadelphia. of with clinical U.S. the lung well our responsible geographies. other plans ICTC for capabilities, TIL one in market of us in and as Center, commercial ICTC, and manufacturing cell and at the is now like serve clinical our to Jim. capacity patients Amtagvi from been is ICTC I'd U.S., melanoma, geographic Australia product significant from launch other highlight manufacturing we experience pipeline. Manufacturing or anticipate to built as in we one in Amtagvi our Iovance our

manufacturer demand clinical are manufacturing launches capabilities we're In FDA in contract approved for Amtagvi. addition manufacturing approved facilities site our for we new commercial bar strategically that setting anticipated both and flexibility for therapy X commercial planning believe to with us ahead and capacity future. capacity additional ICTC, our patients. Overall, and Having cell of the provides the a for and

initial consistent is tumor XX launch, lymphodepletion turning The has we're of target then Turnaround to been early expectations tissue planned. receipt to Amtagvi by date return which experience. infusion. with from experience our Together commercial of commercial of executing launch prior approximately with on with followed the to -- ATC, is and time manufacturing shipment as clinical experience days

meet gene ICTC at as underway commercial of is generation as and geographies patients capacity in projected planned well are through ICTC clinical advancing is confident has well for vision expected supply Philadelphia than team and TIL cell fulfill biotech in the the out we next the To as TIL at and headcount U.S. and additional are launch talent the as is as existing in is a year. therapies XX,XXX provide more to provides preparation annually. Longer manufacturing well U.S. for staffed as for talent A our campus. the We completed of meet pipeline, our in and annually expansion clinical for increasing further be patients the trials. our add our appropriately therapies the demand from ICTC and the resources. In Amtagvi sales therapy to particular. current location Building for as now capacity continuing space Iovance's term, schools to our today, per to than shelf is now, few in and support ICTC trials X,XXX for therapy to patients local Right years. are support in to companies and enable the we supply in region therapy our to the cell important to at ICTC, launch, access demand built capacity the future needs, to over facility more commercial with of X,XXX the for demand other in experience growth. competent to staffing clinical expected

to an team the plan ICTC incorporating and We building our in cancer. construct our manufacturing TIL investigational by patients at campus to excited Amtagvi summary, is option have to provide and for with drive additional our process. In efficiencies therapies another automation increased

manufacturing to in of step to trial process sample We from sites. right spirit laser of commercial and of clinical at to receipt outbound release time the the are doing and product every the focused Amtagvi shipment to the investigational everything manufacturing of incoming on quality ATCs first tumor TILs

now Q&A. available I'm to will over questions Chief our additional the Jean-Marc, And answer call to hand the Financial during Officer. I

Jean-Marc Bellemin

you, highlight I will as XXXX. for ended Thank review our cash well current Today, position Igor. XXXX I on the as quarter results XX, our March will also our outlook.

compensation March of assets from the for of results. quarter acquired the or expected Amtagvi a and first assets cash, was million, March for investments $XXX,XXX was The net share restricted XX, first and same related or period compared XXXX. Shifting XXXX. million $X.X of quarter by The infrastructure the costs of XX, There of of ended related $X.X quarter first attributable business a were the well the quarter transition in million general primarily ended The March of the equivalents, an the lifileucel. Selling, financial of second the to XXXX, XX, TILVANCE-XXX planned first to of XXXX, million partially incurred and in $X.XX for expenses first planned March corporate million. of loss cash offset Amtagvi million sufficient half to cost inventoriable to and stock-based first for administrative raw primarily revenue March $X.X the was or primarily of for was related noncash first of technology. current $XX.X quarter Net had ended share support to to loss XXXX. Research cash associated net no recent regulatory decrease sales by Phase our acquired $XX.X $XX.X quarter for offset Proleukin ended $XXX.X comprised the $XXX.X costs. as same XX, into amortization compared are Proleukin and million expenses U.S. and ended be for the EU $XX.X of XXXX, first well and of purchase Cost ended XXXX. sales revenue trial Amtagvi overall $XXX As and and the quarter, with commercial approximately for March of XXXX, the the to clinical the including Proleukin of the loss to submissions to partially for sales quarter position XXXX, fund the costs, first market per increase period development ended Proleukin quarter the the in ended Iovance as March developed growth manufacturing licensed outside current the decrease to ended and per legal $X.XX intangible XXXX, for intangible was for by XX, includes materials, quarter III were clinical operations with increase cash the XX, primarily increased XXXX sales was part as costs and million associated driven anticipated the compared for XX, expense to XXXX. The in XX, and transaction. Revenue amortization March March to costs headcount support XX, most a attributable commercialization trials Proleukin, March million decrease of in in increases XX, million

as outlook guide million in cash the XXXX treatment and the are conjunction to to to onetime used beyond. this our optimize toward continue leverage in year for and we of XXXX expected the drive we'll second of Amtagvi regimen Proleukin in opportunities full burn Amtagvi to range continue $XXX The U.S. into the revenue to launch excluding of with million, spending. half of significant XXXX well as and $XXX expenses, Regarding year, sales

for this the recognition of revenue cell in revenue reporting expect year. reminder, quarter occurs recognizing other and upon to a we infusion therapies, As begin Amtagvi like significant second so

Friedrich, to press Officer, and Form Medical our call afternoon's clinical For hand discuss to our additional this information, our filed now please the release today. to will see later XX-Q be I pipeline. Chief

Friedrich Graf Finckenstein

pipeline Thank diagnosed to clinical today speak the tumors, represent you, U.S. Jean-Marc. highlights am more I all of XX% in key than you all as solid cancers pleased our in know, about which,

patients for expanding label Amtagvi One priorities the advanced with in setting. key of the is melanoma address our the treatment of to frontline need

and combination melanoma. and Our full approval as Global pembrolizumab and support the well in well U.S., approval in III is TILVANCE-XXX registrational frontline Phase and underway Amtagvi continue of Amtagvi to in site melanoma regular Australia, trial, of on track additional anti-PD-X patient activation with Canada accelerated with advanced countries. in post as enrollment strong momentum Europe,

cell positive trial, We May a enrollment studies Canada in few for is to Clinical updates over further strongly lung short which resumed in support includes at non-small IOV-LUN-XXX, XX, is has and on plans encouraging include melanoma with approval an in trial ASCO, after era. plans from lung Amtagvi. with post anti-PD-X cancer. by record continue clinical months. Enrollment the high restarted demand, within additional frontline published our Society Oncology, the very American oral augmented for checkpoint the to XXXX. Shifting of U.S. trial and hold which the We the from track in updated partial cancer for advanced strong registrational frontline on by enrollment time Phase reported cell non-small Our data regions U.S., data sites our forward of lung with Annual by the new Cohort cancer. in therapy II to strategy excitement lifted Europe, next XA data Meeting previously in inhibitor and first supported pre-immune Cohort single-arm program in solid FDA quarter. in tumors clinical IOV-LUN-XXX We XA, patients our clinical driven development our of the TIL presentation to or IOV-COM-XXX look our

the cell TIL as XXXX. Current FDA We regulatory provided on Type cancer, cancer. lung be which the data anti-PD-X of recent registrational small of positive cohorts is IOV-LUN-XXX regarding a in trial tumor other confidence FDA regulatory has and to for cancer. In are continue our the endometrial expect a lung opportunity in lung therapy. on be positive IOV-LUN-XXX feedback B meeting lifileucel design for to in pathway acceptable The our non-small in lifileucel potency approval may proposed Phase single-arm for matrix starting lifileucel enrolled fully we cell therapy during types, and cell announced, that trial support the from anti-PD-X cell of the the opportunity cancer and previously interactions a be significant II TIL post post for

who Our regardless tumor. and status chemotherapy Phase the repair mismatch advanced platinum-based trial II therapy after patients with on will anti-PD-X cancer endometrial of include progressed

mechanism rationale that and of both treatment unmet majority TIL patient is endometrial we as for manufacturing may of success currently treatment the populations Our patients anti-PD-X the benefit well medical cancer no preclinical supported setting. report in year. There to a approved plan is the and later as post need significant action, which by this with data options vast

need oncologists, look we've first Given to gynecological we we medical to unmet from and quickly, enthusiasm expect the and received seeing data soon. this enroll forward

Phase in TALEN trial. advanced successfully, I inactivate Phase cancer concluded from PD-X IOV-XXXX TIL II an process. into non-small stage to the the during previously efficacy leader technology GMX-XXX the manufacturing trial cell is cell genetically at patients address modified solidify our the unmet leadership We therapy, of TIL potential in long-term and to forefront space. Iovance for reached therapy, have progressing portion next-generation treated are we the TIL approaches need multicenter or the milestone IOV-XXXX, our utilizes in cell safety melanoma and of important an The the Cellectis As lung in licensed that first-in-human patients. the for the

other with potentially improve to TIL multiple We efficacy. targets to also gene-edited investigational cell develop therapies knockout have options to continue

programs trial protein. will XXXX, submit of also XXXX, quarter drug clinic. IL-X making the additional a robust potential a cell In highlight IOV-XXXX. plan poster of modified clinical or ASCO the preclinical I/II third application great the We At we expansion new for next-generation advance with strides or for Phase an investigational are towards to IOV-XXXX, to interleukin-X the that effector improved safety support T fusion data with IND

today's NCI. of are discuss IND-enabling addition has a to and Lastly, to anticipate We at or IOV-XXXX trials begin next-generation the additional call IL-XX. Q&A in IOV-XXXX, the observed activity early programs antitumor call, at also Cancer the in now IL-XX questions cell therapy prior clinical currently a was TIL genetically I'll the with XXXX. I'm TIL third in generation improved over these plan therapy on is FDA the IOV-XXXX TIL INTERACT studies. an introducing efficacy that in program. IND tethered a session. an The augmented in trial on of engineered with IOV-XXXX the operator National inducible XXXX builds quarter a new we address during IOV-XXXX vitro. of Institute, is happy to question-and-answer the turn meeting the session. submission and about and to IL-XX

Operator

coming [Operator line Michael Yee Jefferies. from with of Instructions] question our the And first

Michael Yee

Congrats on progress. all the

question. a maybe have We two-part

those journey how this many of treated dosed just likely You about are talk the treated? of treated. indications then the inbound enrolling interest I the Can about quarter then bit in get getting get of just numbers. in the you about you and those thinking how who I'm number consensus the think time describe from XX journey around would reimbursed quarter. about little the of days enrolled and the how about enrollment to in think and thinking the then get to sort gave trying sort to patients great of many XXX some treated and think XXX people third and getting metrics really have then a Maybe and of just maybe

Frederick Vogt

you Michael, color can Yes, little give on I a that.

a being quarter now, second quarter from patients patient than that the then be, infused second treated lymphodepleted we're way mentioned, so control we meeting, and might patients. time days the And testing. some It's right in or different the That's to takes in manufacturing XX of theory, of quality mean -- recognized and the revenue clinical the right the all is a then which time little third And or as that. the now, start I infused target bridging right in trial. enrolled the treated, move come patients The to completing financial now it after cases to in therapy, because resected. do I they So product. could are the with and the quarter. say we're this able in In and are then they therapy. clearance because, clinical there's in it we've to way the They get do faster the we many trial, on now, bridging commercial the have weren't early through

Michael Yee

Okay.

as some be of in to in just going of treated part and April So been May patients, would those as you be those are then and clear, have patients through, XXX. treated June

Frederick Vogt

on. Correct in July and so

Operator

line And our Andrea the Goldman Sachs. question next from with Tan coming of

Andrea Tan

follow-up a Maybe there.

Just able comments. wondering you're to some those provide if around numbers

Just that have plus And had infusion? have thus the far? many have many resected XXX tumor how specifically of their received been enrolled, how an

Frederick Vogt

at patients that Yes. of give many the detail enrolled. have process would the the to right We have We We're stress resected. we have those now the want you that what can is we you tell through patients them. -- moving revenues But importance can't with that I point. been actually of as

just that over obviously question. infused be will them with of we that period large mentioned time Some Mike's

in a as dropouts account We that well. few and to like OS also for have stuff

more it's difficult that to So about numbers from that predict to revenues, stuff. a report little say enrolled When how able the bit we all for out actually very to finally be us played we'll revenues. transition

Andrea Tan

the And a more if it. nature the dropout, bit to little there? you're of able Got share

Frederick Vogt

stage waiting of they're Amtagvi the on the -- declines the them. patients an It's and Most is actually patient manufactured us. issue rate dropouts dropout can disease therapy, driver pass caused are the tested the That's happen. or the time of is what had for pass away usually by health some sadly, before put that is. and the be The for away unfortunate these in. That's in consequence are patients hospice health we've -- for of fully and issues. patient of while And stage

Operator

the Lawson And our of next question Barclays. coming from Peter with line

Peter Lawson

have Probably provide XXX-plus around enrolled could you TIL that the for therapy. maybe just patients some granularity more

you If actually have -- insurance number and place what ATCs actually resected the patients? that could of in percentage have then

James Ziegler

cash, Virtually, Peter, that's followed all of the Jim right prior XXX-plus enrolled it's the there And not have means issue and so now. treatment have by an Ziegler by the been authorization payer surgery. soon patients scheduled here. or patients insurance there's decision basically commercial definition,

Peter Lawson

then Got resected, ATCs the patient you. have the that actually And number?

Frederick Vogt

Yes. We can't tell you exactly that, substantial Peter, right now, number. but it's a

increasing weekly, or them Let's the that. it's patient of call resect it the to It's hopefully daily and all future. where up at getting or least point almost in not-too-distant all will the

Peter Lawson

Got you.

final a Just question.

flow cash cash. percentage a in patients mentioned of You paying

James Ziegler

a It's that. disclosed number. haven't We low

Operator

our And the with from TD Van Buren Tyler of question line next coming Cowen.

Tyler Van Buren

another I launch. the question Shockingly, regarding on progress. the Congrats have

Just rate are can then that you enrolled success upon rate or looked based for regarding as mentioned, XX differ what for like you you and patients the dropouts manufacturing that discuss about enrolled how dropouts the attrition mentioned? patients think in attrition that patients might the far the so screening has for patients we

Frederick Vogt

as out we go patients waiting obviously, launch at And be sometimes are only going a with get dropping The with were feel therapy. we on like for it's the now, way experience, well not playing an expectations. We're had our less forwards out many. There's in better Right Amtagvi Tyler, been ones Yes. manufacturing as this. issue And based it's dropouts that as our here. of aspects, we expected. line the the that to few will

numbers I right Obviously, line what handle. to early you on So but anticipated this, we're for can't it's quantitative now. able give with in very we it's any that and

Operator

Wells coming Zhu line next Yanan our question of And with Securities. Fargo the from

Yanan Zhu

Congrats progress. on the

think Fred, look at lastly, then the to than patients percentage could approval growth duration dropouts, how XX-plus across in sense in I of the evenly couldn't historically patients a perhaps period? comment of about also of could who month-over-month Just enrolled wondering, what get for about going whether on the comment made are manufacturing distributed and still this the are enrolled centers. And for insurance of experience be XXX I might perhaps case wait Jim the heard the we maybe and And expected wondering trials patients. number more clinical you a forward

make correct, of the -- Just by be patients driven enrolled right. want that to other from if the ATCs, ATCs? number could driven increase could get started -- And obviously could already in increased part that I by that sure increased that's than still

Frederick Vogt

between of was rate through to raced the we in population clinical Yanan, therapy. Nothing have the they -- trial, being We that not the know, different. done. commercial being clinical the and the late we patient kind had a clearance very is in They little as because had advanced don't trial. We the you we the are being trial bridged. were comparison had line, to of patients of -- couldn't do the trial, have dropout In that a basically and issues. and thing, bit any the don't financial

we've of treating bridging a the been little to patient -- in in very them on experience a we're for that. have to along far cases, now we're also, it's not So it's are financial where time necessarily in journey in a the clearance different those we bit bridging treatment -- Obviously, patients but do patients, and as going they trial. progress making takes resolve, now were right well those us. But many as the quite clinical

compare the X. think between good a I comparison don't think very you dropout So it's the at all. I don't

growth, right on think that. And really have wait patients. that. be what understand was That's to really of dropout it estimate could could a don't Your of just you as number see. many we'll some finally, of rate and something patients we'll see couldn't because now patients the number Jim have can't we'll for But I good goes, by like treatment. -- indication mentioned, for second regarding driven the month-over-month have question wait I we'll how the launch

X centers have about now we know capacity, high at and those getting and you them. a and that. all or right they're it calling saying month that And from we're X right analysts many X And from or like, is. are the X X So enrolling month months information be things whatever rolling plus X a of out centers there a are now, now, month plus we'll enrolling

case that we of we number the go be the expect ATCs, up. expect to across our So many patients without the of to centers. addition Even of

Yanan Zhu

great second touch distributed currently how point sorry, the on enrolled are Could evenly the Those across you, the are color. centers? about

Frederick Vogt

Jim, one. We missed want that to one? get that do you

James Ziegler

have over it's we cell time all the experience therapy any And even of is Sure. Like distributed centers. not can it is Yanan, within Jim and launches of across there. what oncology of will out launches, launches for that. fact, I increase most gain take here. the normally launches don't the other centers other in distribution utilization and but expect will centers, each adoption

Operator

question coming with the from next Kusy of Baird. line our And Colleen

Colleen Hanley

on with you often percentage a up line patient you average on there's patients getting you comment of process with mentioned Or too? on been of the And experience not I the a how comment lot later in would are getting some IL-X you profile there this now? as earlier waiting Amtagvi? and have any anecdotal period. a reason in so deaths far feedback Can patients? right if think can you tumor that patient the to pursue Are come also then line

Brian Gastman

answer to This is that. happy Gastman. I'm Brian

And if we've patients absolutely We selection self-limiting, say issue raises have centers for It's me progression with the at and actual knowing been one rather start it's to good, how even event would that than less all. definitely we cell in mentioned an have to a these pretty education has personally myself, rare reversible them just enough beyond something has authorized it's eyebrow, it's our medical an IL-X. this that no not I pushback toxicities. low. for The what IL-X happens of of therapists a the I not expecting. has very getting were even but oncologists it noted maybe add happened really more, involved issue. And commented That once. was least at any that treatment common actually seen that we not thing But who of the is overall patient What how The off. paid is not not been what rate-limiting it's because are use some have to have for is it who fact, expected. drop-off in would

Colleen Hanley

I if follow-up one And Great. can.

the reasons would kind would screen you What on a screening that of not to patients pursue that in right now. are common patient about Just said fail be -- XX treatment?

Frederick Vogt

[indiscernible] Well, they screening cases, all the It of be on financial a patients They be They In eligible. prescription. have disqualify label patients for of melanoma. may not not -- be may through be go have effectively. sorts may to that some there clearance. they not medical things not can can may

James Ziegler

Yes.

as right have, like are the we enrolled balancing much patients need. unmet treating that the understand these currently Just a as unmet in choosing, the possible, expect need and we because the high conversion physicians patients

Colleen Hanley

progress. the on Congrats

Operator

from the from question And of our next Asthika Truist. line coming Goonewardene

Asthika Goonewardene

have who tell I'll the XXX been throw been my many us have me congrats you know on this you way. far? so patients it have but I and the quarter the of let -- here enrolled, update. of asked, resected question, this been variations Can try how can this

Frederick Vogt

Not yet, I been very that. you there number but can resected. that a is have tell large Asthika,

Asthika Goonewardene

it. Got

days Okay. early seeing? but Fred, clearance. it how far, when clearance, getting And you to talking get the us what average understand financial idea very many you then, about an take so does enrollment, on give can are I of in from it's sort financial launch, some

James Ziegler

launch is between vary. It to take and in of very an consistent It launches. early X X. X seen with days authorizations ranges single-case agreements with X therapy what X about very average we've the anywhere with Prior weeks and other to it's cell

Asthika Goonewardene

Got it.

then seeing But are could it up to how on used so what far IL-X do the dosed? be vials have patients know anticipate average, XX. And about many, being I lastly, in per of you you that patient? been Okay.

Frederick Vogt

I a I trial, it quote expect don't and XX, practice. it don't want to the was have anything the now. right except should I medium it new in But to say, XX, add was, that I It's thought, was, stat there the something I for you the similar patient, whatever -- I real think, think and average be. to that's per can vial, would was way close to in would

Operator

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

Joseph Catanzaro

of there a past you question end rate vein said here. similarly, questions guess. about different that, patients cadence I We're of Maybe think February, same and ultimately my patients sort taking now about a months the we were the you as about At in Appreciate of infused. the in XX X XXX progress. being

prolonged on sort So to Amtagvi and and can shipment infused? And experience receiving ultimately of you bridging that? the for bridging say on tolerating continuing and on using cell question comments they they how benefiting seeing of the if were physicians additional or stopping once receive give of second therapy a sort my ready you're is any sort patients that of of sort then or the go. feedback use those or therapy the Are many is time patient of of and then period early XX

Frederick Vogt

XX pretty information little in at upswing than We take through don't they've is talk XXX infused. Joe, all see answer back has then the February treatment of would I Brian can first I I'm reported [ you the I through move so been second but majority be bit XX number today. we the part. can't now more And them patients that have I yet. and Yes, can there bridging? how exactly obviously more move patients -- think know, you the Brian, a importantly, actual ]. have I'll than part, can XX you and process. the more just to about than XX the what if that to sure is Of then, But XXX, is and vast on the really don't significant. tell not many least become XXX

Brian Gastman

Yes.

sight given. The into that the physician really get [indiscernible] when or to get has information a is response good patient. Where background get of we I treating there's system, level we peer every on and a of note line a entered patient. the have physicians is think we them bridging it's happens, we to not exchange important -- can't therapy And the way a get that dictate the sites, certain patients want our don't the -- the they peer about is clear that when good themselves sometimes therapy. sometimes But because a where make being needed. engagement patient that's the obviously We patients. maybe found to or treating bridging the to scientific patients. Interestingly, sort progressing when done the the literally we of out therapy it offer in with is assumption we when

how evidence probably lot some won't it's So out. know being these actually used, But bridging physicians. really for real-world therapy affords of comes we until a latitude often

Operator

our line next Securities. from question of coming Benjamin And Reni the with JMP

Reni Benjamin

handle how progress. the curious kind there's manufacturing the and on of might backlog Congratulations potential a guess I the that. I'm side for you about whether at

With switching I discussions gears the That potency samples can cell how the and non-small to with first feedback these of second, surgeries number looks the samples positive got thought many in meeting of question. And like the And Type getting that matrix. they're matrix. how you my before wait, be you kind regarding lung kind we happening, for guess, I you B proposed It just were are cancer. would processed, a handle of month? patients done then had on all potency

what's happening love to idea I'd to as there. So get some

Frederick Vogt

question? able you to manufacturing the on comment Are

Igor Bilinsky

comment Can on I that.

Bilinsky. the thanks It's question. So for Igor

our contract right facility have now, manufacturing mentioned, as we So for sufficient and at capacity launch. I manufacturer

is to to as So we as the actually staff demand because sufficient the clinical continue demand trial, hiring from remainder be additional Amtagvi 'XX of meet beyond. commercial patients capacity into we and well growing the the and anticipate

capacity that So The we're certain the answers right seeing. I now hope think adequate I your for question. demand is --

Frederick Vogt

then it in may I'll audio. be question, for the that have Raj, a little here, take Type breakdown And you take on is -- can B question? may a We we available? Raj Reni, the you.

each the potency assays regulatory meetings FDA have right We for now. have for indication with to

may platform we the that's with lung lately we this going and seen for our very able each approach. non-small kind a step Marks FDA with ultimately, we're as potency assay sure you've a what to Peter platforms cancer talking cell them specifics of important BLA and I'm non-small is be about But that getting of doing today, thing. recently talking indications is successfully of take towards did Now for to about we're the lifileucel. what which for cell a to indication, submission lung, of in and the

Reni Benjamin

back And can ] took on Fred, to since for about you as pretty of of with indication? kind that so that least discussion assume and each -- agreed cell we a already by should amount everyone to board like we get XX%, at a the time page, go drawing there kind are to think decent cancer it same the -- be things can timing, [ Or quicker? with XX% we that lung of non-small and lot we say that's

Frederick Vogt

is lung. definitely board. right the we're back right way. in for No. of not clinical non-small We're we're doing now getting the program -- to is development No, we the we're cell in What drawing FDA point doing what at think it the front our

early a to questions we're study. or think now still from very the be patients, got with things We've they that study is viable them have adjustments have important, enough to the actual to which actually enough data patients You that make what able pivotal we we we're change. while from enrolling want in should they that can data is see enough show can potency for matrix proposal

if what was complete. that after fact to time opposed As through melanoma effectively already we study the with largely last the was or after the fact did all the

So actually what this meeting straight now, think, so to cell doing the to straight we T cell a speed when polyclonal we're and submission. right way we is pre-BLA and that process therapies, develop lung, up finish or our we go a accelerate non-small to should

Operator

are And from our Ben coming Burnett question the Stifel. last line with

Benjamin Burnett

efficiently have happen flow to surgeon you sort within just maybe Like, could coordinate are the for you the with that? if -- about that -- patient talk wondering there seeing up? the there Are any learnings was popping anything officially any any or needed bottlenecks hospital. I been of example, like have

Brian Gastman

issues Most the encounter or increase. find We've and say of the seen the sort not place as over I space a any the we experienced potential a really really even the of on having haven't nurses room to things details of enthusiasm bottlenecking tremendous bend the would from patients. time just questions cell but in that patient. time, operating therapists the the Actually, like way to We've are big opposite. really surgeon a all through seen small We these the hospital. that treat we hospitals treat backwards Yes. to

Benjamin Burnett

on you saw you how just Okay. those is clinical in specifications compared trials? if just in quality the what the comment tumor That's could tumor samples for manufacturing, And to kind around of coming of like sample also excellent. like

Frederick Vogt

can I if you like. would Igor, take or, that

Igor Bilinsky

Good question. to. Happy

consistent size been and with quality tumor has experience of clinical for and the far, our the quality manufacturing. the So the very the samples -- experience including

Operator

any our gentlemen, session. and the Dr. to turn over Fred have Vogt call back will we Q&A ladies closing now time for that's the for remarks. And I all

Frederick Vogt

Thank Financial Quarter you again for joining Iovance XXXX and Corporate Conference Biotherapeutics' First Call. Results Updates

Iovance communities, analyst are we've this pleased XXXX. the see Amtagvi to call, on I rest partners patient the of advocacy with we health and As would accelerated launch in our our excited very throughout care of the exceptional and to strength and shared those also growth Thank melanoma, May our Please frontline on the to you Investor team. free XX. forward investor on reach to shareholders event their we'll lifileucel at like to host our for covering and and thank Relations We to follow-up. Thank team analysts feel for in an out you. ASCO and look data presenting support.

Operator

call conference for conclude your that and does for our participation. Thank Ladies today. gentlemen, you

You may disconnect. now

Iovance Biotherapeutics (IOVA) 9 May 242024 Q1 Earnings call transcript