IOVA - Earnings call transcript Q2 2021 | Iovance Biotherapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Welcome to the Iovance Biotherapeutics Second Quarter 2021 Financial Results. My name is Josh, and I will be your operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions]. conference recorded. this that note is being Please I Pellegrino, Relations Vice turn the at to Sara call over President, will now Iovance. Investor and Public Sara, may begin. you

Sara Pellegrino

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

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

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

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

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

Frederick Vogt

and during half in I'm call. good today's the of pleased XXXX Thank second to highlight afternoon, Iovance and our everyone. you, conference at progress first quarter Sara,

melanoma, we lung as for new melanoma line tumor-infiltrating have to data During well across non-small including We've pipeline. or lymphocyte, cell as cancer. reported metastatic this in indications program, our early metastatic such clinical as clinical the data our first TIL, advance year, continued

product the candidate ongoing BLA TIL our lead regarding priority to our remains metastatic to assays submission. melanoma, support planned potency top lifileucel lifileucel For feedback in work for FDA our address our

are second late-stage in that the half a to and complete potency We engaged of XXXX half the the with support assays towards submission FDA’s in our an BLA step the ongoing We're in address work clinical plan additional timely the dialogue year to a also to important is Resolution programs. guided. in manner. continue in next other FDA ability of assays confident on progress we first through as of feedback our

clinical the broad have therapy the excited across summarize updates. key solid our now types overall in their about in TIL class platform data but three different will cancer pipeline we are next in as settings treatment. to a clinical Friedrich confidence of showing strengthen updates We a Turning TIL to in promise moment, treatment key our tumor of four really takeaways.

non-small First, in lung pretreated in rate data response XX.X% overall demonstrated patient population. our initial heavily cancer metastatic a cell

patient ICI inhibitor, progressed population a need in which represents unmet have of All that prior cell them significant checkpoint for or on cancer. non-small lung immune therapy,

to and show an showed post-anti-PD-X solid complete in combine therapies with combination including rate a available XX% in with patients, the tumors. overall And to third, rate, results melanoma TIL our XX% settings increasing the supports anti-PD-X to broader lifileucel initial Iovance’s move Next, in lifileucel in treatment the continues pembrolizumab melanoma naive earlier long-term response of on durability. response strategy

supporting of generation are TIL On the the research next bringing the and into clinic. we therapies side,

continue PD-X, of critical the analog which all IOV-XXXX leadership average we IND-enabling further are to that confident pre-commercial are mission. we the is to towards and summary, progressing development, on in patients. needs to full Today, today's IOV-XXXX As XXX press I’m half that quality IL-X Both who the more designated to we we novel in commitment of very more release, manufacturing activities moving genetically modified are towards to than employees IOV-XXXX address noted studies and we as advancing cancer senior therapy and execute IOV-XXXX. have TIL have have and internal clinic. than knockout well experience. on this cell organization our three of deliver years our as our a In

provide today, updates beginning On our Officer, ask Bilinsky. the Igor respective our departments, team leadership members like would to the with for Chief I call Operating of executive their to

Igor Bilinsky

manufacturing or manufacturing above Thank rate from Today, to a you, Iovance’s have the Iovance’s Fred. has at sites a yielding continuing where center to academic I'm lengthy centralized manufacturing XXX with back Center, GMP TIL our product single nearly Iovance Cell XX%. process patients Navy the in-house cryopreserved success manufacturing facility, scalable, shorter, transformed for of a are treated. TIL progress Philadelphia. patients the received and iCTC to pleased a Therapy about Iovance speak today Yard, process shipment the

Gen current leadership We're is X process our TIL continuing days. to Our also advance position. XX

activities planned. our all iCTC Gen completing fastest is TIL to TIL XX investigating X even TIL industry proceeding We in XX-day which believe commissioning that at this We where sooner. further be We're the to our X our Gen patients are already manufacturing the and the as efficiencies Iovance days time. improve manufacturing excited process, clinic are the in process is to deliver Iovance of

today's and noted patients to investigational enrolled therapies at As supply the press future through near our in have in plan in received iCTC we clinical commence to cancer items to manufacturing release, clearance trials. clinical IND

up iCTC. multiple indications. TIL manufacturing capacity Iovance portfolio. with meet In of or Commercial and IP intellectual moving XXXX the now demand property, Iovance to pipeline, patients sharply in focused have and building addition, supply to our growing To support on we we’re remains readiness for thousands for to our at manufacturing on capabilities robust been commercial activities for track TIL

exclusivity with patents patent in pharmaceutical our range lunch our cancer. to Jim preparations. established with XXXX. relating filed firmly TIL total, geographies. transient that IP key manufacturing Zigler, more modifications combinations globally products more and XXX patents XX Our granted the for stable core and than we tumor commercial patent in manufacturing to with X TIL methods, covered leadership of TIL, methods applications In Gen Iovance’s and and across would X include checkpoint to expected from other Gen fragment through X biopsies, [indiscernible] is and U.S our TIL genetic IP and believe have of patents applications allowed and cryopreservation, the and I therapies have of call or international portfolio and by digest selected produced compositions granted manufacturing compositions major inhibitors. highlight process. a Gen patients hand of Commercial and treatment markets Jim? broad delivering like now SVP and We position our developing to internal including than

Jim Zigler

Thanks, Igor.

first anticipation continue stakeholders BLA the our preparations U.S. centers, our submission of We launch with in in of others and first XXXX. cancer key half payers

focused readiness, cross-functional team to based maintains we our operational organization Our and to are upon our The approach to well excellence ensure is positioned on and commercial milestones a dated launch. strong timing. commercial scale internal efforts

and building launch to association, increase awareness closely communication clinical KOL activities continues preparation that lifileucel. essential a for partners medical TIL medical works to for site with strong commercial with Iovance team for Our in team This education scientific foundation launch. through advocacy leading engagement groups and and and robust are affairs patient

addition, and meetings impact at more cover leading and have that scientific will through In high detail. publication Friedrich communication journal in we presentations increased medical

on Our commercial is experience. therapy deepened team cell oncology and

TIL We line build with to leading their the are capabilities. service partnering U.S. centers cancer

of strong engagement sites. a We are significant and level seeing also of number by a commitment

our training our ensure As policy that who market so ramp we access recognize these patients working onboarding approach I and our BLA like submission, and teams up would are are to and upon to ready therapy. cell we for sites appropriate TIL will approval. access to timely treat public processes

this Services, In Medicare or that at existing week, expand TIL Medicare anticipate other this key much proposal include finalized expect cell will this taken patients we XX this timely CMS, to we With to have look be more CMS predictable thank the in-patient cell needed We MS-DRG launch. in therapies. with significant centers Centers experience who of steps lifileucel. the Medicare and change, refinements and Medicare the future, Specifically CMS for will improve to emerging and working stakeholders supported landscape approach turn, our reimbursement its stakeholders a for lifileucel other therapies. and that access Medicaid key the to stable has to may patient forward access class We to therapies. appreciate as &

of remains engage IOVANCECares addition includes timely have will appropriate patients and team CMS, at to chain payers access lifileucel. The our to custody with chain which system. private continue on ensure proprietary to to we identity of track national and In to insurance and deliver launch, also regional

and Our commitment cell which and quality, addressing to anticipating I clinical approach patient reinforce will support means fully their centricity, to updates. call to and our programs Friedrich patient to the integrated approach platform outline needs. patient integrated IOVANCECares customer pass understanding, management now our our and ordering

Friedrich Finckenstein

clinical our you, ongoing as well status pleased the recent to Thank four highlight data updates am I studies. Jim. of as clinical

the to focuses need meaningful non-small we Our development for the will lung data focus to populations make the strategy cell drug have highlights. recent on Since data, unmet impact. a cancer on recap held with calls cancer conference ASCO I substantial opportunities briefly high TIL and with

earlier response showed lifileucel and Cohort patients included intervention on plenary year lifileucel long-term not lifileucel XX.X with clinical at our of First, advanced set up. post-anti-PD-X melanoma from additional in presentations maximize have C-XXX-XX and was in anti-PD-X on combination months of patients who still overall median initial study as used anti-PD-X the pembrolizumab data benefit. therapy follow the median were data therapy. Fred ORR, in to or analyses study, first not progressed an And may early response suggest data in was and that melanoma of progression anti-PD-X our our AACR X an patients ASCO clinical In rate, time from who updates of mentioned, setting at ASCO, at therapy. Results duration XX.X% follow-up for at treatment reached was this

in the population as with this X, offers is be chemotherapy For option X% survival continue and lifileucel a enrolled KOLs the only post-anti-PD-X durability treatment difficult of to overall very treat following very to XX% months. about as patient available response to metastatic melanoma to Cohort and We the rate currently enthusiastic well of eight only patients. one-time response seven in

the additive. about the at our high JCO initial of data editorial of accompanying international clinical X% TIL response very with in be and rate responses, patients. There's assessment CR use Cohort XX% primary data well in best who our patients melanoma Six to inhibitors, forward XX% a will Cohort help more these of pembrolizumab melanoma where complete IOV-COM-XXX response We response metastatic lifileucel to rate responses, the but patients about seeing the in further response potential suggests checkpoint transformative stable up with of unconfirmed uCR as resistance CR, and XXXX, in has representing time Xa PR; outlines melanoma complete reached combination CR; very data XX% or in rates response, to communicate deepening Also oncologists. seven an that overall pembrolizumab naive patients have additional XX% that and gives publication for the are responses, the as May to ASCO, with alone follow objective impact the confirmatory or responses study ICI. yet rate confirmed immune from of uCR anti-PD-X an anti-PD-X Responses only in broad of and patient where remained may or seven We're a publication in to longer one a the audience over three increase data ORR; look X a two therapy or deepened in complete up; This responses data and excited the partial need was disease. XX%. excited had one therapy. with not follow and that CR including of

who cancer the responders data Cohort of program, Cohort ICI, in a therapy. lines clinical need for progressed inhibitor, enrolled received including metastatic basket TIL enrolled or this in update cell XB that with XX we on important mNSCLC was note our provided corporate prior or cell IOV-COM-XXX. heavily more patients, increase For a our therapy, pretreated or It XX There of is and with have prolong significant study lung non-small population. to LN-XXX are therapies. no-small XX this rate our difficult treat ongoing in of a to the XX.X%, systemic is have unmet to two patients prior population. survival immune response the that XB patients lung cancer checkpoint

XX% So reached we partial control up. were response of a confirmed XX.X% with ORR and ICI, duration not progressed one who rate reported and X.X patients in chemotherapy. have line at months that ORR very response median confirmed pleased responses, to of frontline XX.X%, median disease including have an follow study approximately five been Historically, second see were of ICI of therapy a on complete

we a development our prior ORR XB anti-PD-X So confident patients comparable non-small pleased are cell strategy. always to Cohort lung are who used have in sicker in see cancer therapy, we in

non-small in to Turning In the of lung and study as address study biopsies population cancer, studies, our cell cervical treated on not as a IOV-COM-XXX of the more we of anti-PD-X Iovance continue across sites. lung cohort advanced in non-small three with have activated us clinical our in head to including across with cancer, IOV-LUN-XXX we three In melanoma, trials recruit TIL ICI Iovance total four lung patients now chemotherapy broadly a the allow our in first line cell patients Iovance receive study patient XX cohort the cohort to clinical or TIL lung also and recruit that second non-small needs previously cancer plus believe dosed combinations unmet continue systemic core Recruitment and cancer. the our patient to TIL. cohort neck pembrolizumab. a basket than continues IOV-LUN-XXX cell study and plus in C-XXX-XX cancers. to well using we potentially the ongoing registration-supporting clinical We

in to over to We enrolling able our call study medical discuss are studies results. our these meeting. will quarter actively hope in second now at to SLL We to provide patients. additional IOV-CLL-XX CLL data be from hand Jean-Marc XXXX and I the also financial future

Jean-Marc Bellemin

second My Thank the reflect level comments quarter will results high of the XXXX. from you, Friedrich. financial

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

cash million XX, equivalents, well advance to manufacturing in plan, XXXX compared Iovance XXXX, strong restricted December $XXX commercial $XXX.X is to XXXX. investments expected launch position held June XX, including readiness preparations. into sufficient of operating cash pipeline As our development, cash, million be and on and to A cash

team research of $XXX.X XXXX. loss million million or quarter million second Moving XX, quarter loss $XX.X million for ended were for million for XXXX on million quarter primarily quarter XX, second for increase the cancer. were of by development the the $X partially cost same development general $XX.X the increase ended ended construction iCTC and administrative XXXX, manufacturing XX, period June of expenses of growth million year an $XX.X administrative and internal research XXXX. year lower was six June to quarter income expenses to expenses the costs of net per and $XX.X share The second of in to June second in increase prior quarter expenses General XXXX for June June cohorts share months prior to an primarily period prior a expenses stock-based the first in cervical XX, net for the million clinical XXXX and and over to $XX.X compared team $X.XX $XX.X million share for for periods the six in June compared XXXX second of attributable $XX.X in were and for in General $X.XX the to of to expenses development melanoma June Net XX, to statement, $XX.X $XXX.X the facility, million quarter the ended a June XXXX. the and the or which attributable $XX period year the compared cost manufacturing the and to in million in expenses increase of second was $X.XX million the half $XX.X XX, XXXX for general The ended XX, development several increase an increase June per net our half related ended loss of XX, were per XXXX. period increases offset ended were attributable $XX.X for facility. XX, the June million ended $X.XX and quarter XXXX, to expenses. research growth and of to an and internal per for June enrollment of for million same XXXX, first and XX, and research was compared completion ended June The administrative ended were million XXXX. and the was same period to the the following months to $XXX.X related or XXXX, second development the second increase administrative compared ended Research XX, team months the million compared completion at Research and our internal and the XX, growth primarily compensation six compared internal or loss of the the ended XXXX. share and over iCTC $XXX.X development higher

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

to confident back I Q&A our to call at our and with hand manufacturing priorities, session. that by priorities. focused the operator cash continue on investments ensure We our areas, focus continue clinical in construction advancement commencement which position of of previously, launch are to the key pipeline, growth strength of spending the and I the across to outlined transition expansion our stay these from four creation, remain value managing iCTC. corporate kickoff will as and align and to to we readiness, now investment a will strong

Operator

you. [Operator Thank Instructions].

Yee with comes Our first from Jefferies. question Michael

proceed question. with may your You

Michael Yee

Thank clarifying you When assay. potency submit We thank the when you. Thank the next steps meet meeting? calendar wait the into on get on a data a And explain walk us, us question. then focused that it, year, days minutes a question works, to come able progress. of you. that for to you just have then chronology street and through you the to submit for wait had update would And what and you'd and the you guys. And you're next end certain back be the because with FDA on actual tell that of through Maybe you Congrats number have meeting by fall say therefore to steps. going then you the and the you're to the XXXX? Hi, how on submitting? walk to when of can generally to the the do

Frederick Vogt

Michael, host can a a FDA. with and it’s And general, disclosing meetings timelines. FDA not it’s Fred. in after right hold for interaction They A FDA now have we're there's that days; for XX know, is different meeting, I for example, meeting, the responds as the The it's meeting, the what types you of you we're days. the timelines, process Type can a details FDA. XX of submission you then answer -- But you. those doing for Type with B

of feedback meeting. from FDA the the get You ahead

the XXXX, right FDA, which but half what of right have response these meeting. which And categories. the exactly later, of any the we are now disclosing executing not that You the written is then detail now. to we're have plan typically in of for the these get earlier, second a we're most doing with days of you FDA in from interactions we described We're XX on

we'll And we'll be significant information think soon it. as that communicate, certainly tuned. as stay please can communicating we get is can we -- So and we some

Michael Yee

of you've not end of saying by after stuff probably and back to street you But is result on the would of what with to come that, which this met them 'XX. you're all the until is clarify,

do that, 'XX. that So if just a Is on fair that’s I math conclusion? calendar

Frederick Vogt

very No, know I just don't could very we We right intention now. to have It in well fair. our communicating and be well don't that's think be in interactions is 'XX. could 'XX. -- And

Michael Yee

Got it.

you. Okay. Thank

Operator

you. Thank

Breidenbach comes Mark next Oppenheimer. question from Our with

You may question. your proceed with

Mark Breidenbach

thanks and taking Hi, the progress for guys. question. Congrats the on

wondering later clinical Just detailed you year, presentations? lining second part that any your manufacturing from to question wondering, COGS kind of should that And capabilities? reduction we regulatory taking are kind aside you silver synching translate expecting do this So you your for a see I'm lung basket once be like the guess guys the that of your in up the any data the of of additional we filings more sense Thanks questions. manufacturing a bulk how much sort from present is, from I own the the in-house can of of study with facility. expect

Frederick Vogt

Fred. to first then It’s take Mark. second and Why part. answer Hi, ask the I'll part don’t Igor the I

we're some there's the On for opportunities coming of communicate looking end always medical first at year. the and part, to up meetings

we're the, there it, year. to of haven't questions towards advantage more company, the anything use could. to specifically meetings We're some answer we that. this fact guided medical history availability yes, major cell the looking. in where always lung take -- data do made We of hope of we've you we But iCTC? all call to beyond trying want that And non-small are of the Igor, trying about seeing we XB do on the to present possibly

Igor Bilinsky

happy the Mark. Thanks Yes, Hi, question. to. for

mentioned at to accepted our start iCTC FDA on pleased we're ready the getting IND Philadelphia. clinical So the has we been and manufacturing facility by today, we that the call are in as

contract so reduce short, by we’re what with is achieve And goods could achieve to believe can we fate. facility. higher we for also our one compared importance indications capacity, We We support controlling And ready of really which of control and also manufacturing. potentially patients threefold. our that the can manufacturing in could the is the running quality cost control XXXX potentially getting We of can commercial the multiple thousands of commercially. industry are in in manufacturing in-house

So, cost the achieve you can than lower outsourcing. in-house allow specifically us facility to be as commenting imagine on wouldn't the Mark, COGS but can I percentages,

Mark Breidenbach

much. so Thanks

Operator

you. Thank

comes question next with Our Ben from Burnett Stifel.

question. You may with proceed your

Benjamin Burnett

assays I the cancer. both assume thinking regulatory rate guess right be I therefore to strategy limiting, much. was Hi. you Thank just cervical if about BLA a are are should And potency indications? about we of wondering that talk for the single covering sort very and could we you

Frederick Vogt

It’s Ben. about if Hi, to want think Fred. know I single BLA. a people don't

We the something I talked about clinical potency is before this haven't we the We of item and either with all the go assay us for little assay way. that Right think registrational our our a allow think. gotten all to could other that that's We once FDA programs. bit now, resolve that strategy. clinical programs, of should potency proceed issue melanoma, to with gating for

have bring evaluate multiple we However, registrational exactly of FDA. programs now how and to the we'd have front in to those

above melanoma. resolved first priority Our is potency getting all assay the for

Benjamin Burnett

Okay, just understood. cervical chance and guess like there results the submission? the the could we more one And I Is then to melanoma studies, pivotal, of question. BLA a see prior that

Frederick Vogt

Yes. around that we we the read IRC submission, -- the Well, read typically be get a the want would to where the do close of when an formal BLA IRC time data. cut would to plus more

I might given fairly something. filing, point are typical commit to example. on not could it's companies available process. strategies you can't we disclose at point, But that we that at where for to for where have so And regulatory anything foresee this long before the

Benjamin Burnett

sense. I makes it. you. Okay, appreciate Thank

Operator

you. Thank

comes with Kumar Our Goldman Madhu next from Sachs. question

question. your with proceed may You

Unidentified Analyst

Thanks. Rob for Madhu. on is This [ph]

assays? to do the to assays? are plans for degree size have the effect updated current assays To related versus wondering, to address use Just any or guys effect ranges actual points you what for the [indiscernible]

Frederick Vogt

partway repeating of you big there. part just off a is your there, blank first the through mind There Would it? in Rob. question cut got You

Unidentified Analyst

Sure.

data? So to degree to plans assays? versus assays And any the related effect to of head updated are for current what use the assay neck the actual and then size

Frederick Vogt

cut and got off. head part neck The

Sorry.

We're any opportunities now, medical on that always kind haven't present neck So that plans can where to do head we meetings for we and right indicated looking data. now. right of

assay So well, stay use which sort the on of and the evaluate with details that. sizes still assays, we're of assays or the conversation to would tuned FDA in The potency. we the effect about

by the assay, or measuring stimulation on the look method. systemically could depending actually the method as wildly we what vary So you're at, assay, the effect detection in what of we that choice for use whatever

So an including that criteria, Once in stuff asking you're quantitative out and assay, on we about. the think that's in Is to typically with acceptance later we start right? performance would assay of got process. I work still the talk agreement terms, about the that's FDA what we've that

Unidentified Analyst

sure. so That question. for answers Yes, my Thanks much.

Operator

from comes next with And Boris Peaker your Cowen. question

You with may your question. proceed

on line your is please unmute. mute, If

Frederick Vogt

I hear Operator, can’t anything.

Operator

our to Goldstein with Mara Mizuho. go question We’ll from next

You may with your proceed question.

Unidentified Analyst

Hi. This the status how you the Gabriel from about they have about you. I current I is around and Thank wondering was [ph] for that two Thank question into for generations we IOV-XXXX a generation Mara. are discussed, next when differentiated question. was the that XXXX. taking and should of think clinic? translating how

Frederick Vogt

product a IOV-XXXX that's offer Sure. designed alternative antibody monoclonal is to an to [indiscernible].

will a you it microenvironment. the improve cells -- in bit think inhibitory That's a whole of will of gene efficacy we because So or to if in fact an the is as help mechanism PD-X don't we has that help a carry genetic tumor silencing [ph]. think will that The regimen. its immunity, product. of TIL hope part TIL a of that a TIL will product. IOV-XXXX an It's knockout will,

Unidentified Analyst

you. Thank

Operator

Instructions]. you. Thank [Operator

comes Our Fargo. with next Wells question from Nick Abbott

question. with You your may proceed

Nick Abbott

Thank afternoon. my for Good you taking question.

be a you. perhaps second broadly, line And to steps could the ASCO, You I I management? the I have data line it first then So, ask but first the trial, doing melanoma the support are that I more think importantly, next on. and if in continue at lifecycle the might one example. is, to what the we to first anyways. of frontline Thank have But data? for see more When and more know answer scene a follow one,

Frederick Vogt

with at data about frontline the in for that Yes, be things more Nick, going melanoma XX% in X% Obviously, only to we're that that seeing looking another provide data and conference update hopefully ASCO, to reported we’re we always how rate. with study. information very response very was in population with the gets now really patient CR XX% significant check -- right rate XX% a promising CR that some in and ORR pembro data a rate, numbers

do or to So really, interesting these transitioning TIL early therapy the future to We are things really as of us. line are therapy. frontline that view

our we course, fast might we of However, economically routes. on approval designs to forward allow FDA bring with focus indications late then where the time, study And remains over think line the we have on frontline that studies us indication. develop the and work can

Nick Abbott

into then talk Just does this or is timeline And just what mentioned Thanks. And Gen integrated ago. process? look X? Gen XXXX? that that XXXX for inserted you Where how a that's is into step like minute we Can the process electroporation being being manufacturing Okay. X about occurring? overall type

Frederick Vogt

Yes.

disclosed haven't We that we're at we details that scientific exactly doing Hopefully, of can a conference. point what in yet. do some at process the

it don't assume is So electroporation.

is, in However, what of is we're similar we doing to timing there Gen terms very X. think

So Gen approximately for sort as a commercial of we -- manufacturing X timing product the these optimal days a with view XX-day cycle.

on. something hopefully XXXX focused more detail meeting. on future is this we're in provide a We’ll So

Nick Abbott

Okay. Thank you.

Operator

you. Thank

from comes Goonewardene question Truist Asthika with next Our Securities.

You your with may proceed question.

Unidentified Analyst

Hi. This on Asthika. is Bill [ph] for

potency insights FDA good for given have You anecdotes and assays. on your some discussions

can anecdotes time? reactivity don't don't we you antigen example, any specific and need share But And there a also that. takeaways that appreciate really or you this you require study. at new For new are

Frederick Vogt

as put potency and our decade assay on effectively analysts ago what to FDA industry, the they all roughly potency have community we sole [indiscernible] what this whole especially now, We're from us said which about saying meetings they've they're with investor you that a we to guidance what telling in as assay can, hearing is potency statement solution at FDA, or we're you out can that when say have of situation are their guidance path we're the all the can or tell much they is possibly them, to And anything specifically. And we All think to you. any here find lot I a with we I in we've the reasonable situation, don't is want work I industry. a for them. on been as engaged tend with with can in to you the discussions you anecdotes new assay saying. collaborate they when that

and So forward them that moving with this forward. to looking we're collaboration having

Unidentified Analyst

Thank you. it. I appreciate

Operator

Thank you.

question Our next with from Colleen Kusy Baird. comes

question. your with proceed may You

Colleen Kusy

for taking so afternoon. questions. much Good Hi. Thanks our

guess process how I get process. evolve Gen process better? see What manufacturing do like? X Gen for manufacturing hypothetical the you underway well could manufacturing is work and X a look continuing obviously, to So,

Frederick Vogt

whether Colleen, this the was we're more little COGS I play process out. early trying Gen want Engineering Gen anything. patients lower be manufacturing to idea TIL we're can to But a possibly It's speed give achieve maximum or so obviously on we the in some also some exactly as that feature additional serve these efficient has trying something it is future. where that it it something table. the on been how like behind thoughts TIL we interested say But We know number to all our to that's exactly shorter we you shorten would would We're look can the up. don't X this. process. than the would I whether are integrated can more what of things like, make and be the as in manufacturing a in. X IOV-XXXX very

heavily announced we we as can NIH, invested first from to that the to game. and technology X continuing licensing make the answer the already if launched helps TIL other been change really something to in game don't change we've that modifications see, we're I but did recently. we've There's -- is can Gen Gen and that know question, it's X your therapy. you As

I'm sure right be to expect So in exactly going not here where more I just do now. it's innovation the future.

Colleen Kusy

patients any you. anticancer would Great, have the be received that's TIL dosing the retreatment helpful. And long interval other how basket arm in the therapies? and And will Thank for between study, redosing?

Frederick Vogt

For mean we basket the the LUN-XXX? you don't -- retreatment study, in do

Colleen Kusy

you. Thank sorry. Yes,

Frederick Vogt

happen information? you do to have Madan, that

Madan Jagasia

Yes, absolutely.

really strategy retreatment the a on basis. case-by-case So is

want and should have do that with response before they they that stabilized a may can may involve TIL. We they not patient patient subsequent a treatment the initially, definitely interim resection, had the or progression. can enough if for get have ready second So the therapy

the So it's case-by-case, very recommendation. depending treatment that's really and a -- upon

Colleen Kusy

Thanks taking our Great. for questions.

Frederick Vogt

you. Thank

Operator

to I'm now And questions like further remarks. you. Fred any further Thank back the Vogt over to this for not any call at showing I time. turn would

Frederick Vogt

financial and again we therapy thank for Thank Iovance work results you, as well employees contributions and half shareholders their develop you joining cell XXXX operator. hard for Iovance like for first analysts to We'd the cancer as patients. as the conference call. second Thank our and for support quarter covering

potential we TIL company I Relations unwavering Investor follow feel towards up. wish Please our approval. at and free you are to out to team pipeline an exciting the and expand think commitment time it's in to to the reach advance our if Thank you.

Operator

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

You may now disconnect.

Iovance Biotherapeutics (IOVA) 6 Aug 212021 Q2 Earnings call transcript