IOVA - Earnings call transcript Q2 2020 | Iovance Biotherapeutics, Inc.

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

Operator

Good afternoon, and welcome to the Iovance Second Quarter 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] Now, I would like to turn the call over to Sara Pellegrino, Vice President Investor and Public Relations at Iovance. Please go ahead.

Sara Pellegrino

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

which Finance Maria on Finckenstein, and President issued call, President our afternoon, Officer. have today's we Fardis, of quarter XXXX release press and update. ended Vice June XX, Chief iovance.com, Swartzburg, Medical first well and be our financial as Principal results our website found we Officer; half Accounting a the on This Speaking Chief Michael and Executive Officer; Friedrich for as corporate can at that includes the second on

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

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

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

Maria Fardis

very Sara the first to afternoon good you, I to XXXX. Iovance everyone. of call half Thank today's lead second conference summarize am at and achievements and our pleased during quarter

priorities, our are manufacturing moving We closer and toward as we including clinical key activities. commercializing to execute TIL continue Iovance pre-commercial

of X in enrollment dedication by tumor-infiltrating We set the program. In We Overall, reported later our program our commercial believe year, that in we our license are on BLA to the XXXX. XXXX, launch to track in driven of more a data we tumors. and or the for melanoma team cervical pivotal therapy this first preparing and We pivotal of quarter cancer and updated for cancers continue early growing submit members and cell in lymphocyte in because biologics cervical TIL and our clinical application cancers. planned data patience completed our while external melanoma cervical second technology our as internal potential remain and therapies solid partners. TIL advanced lead broad of of lung and in or support recently advance recently platform Cohort X TIL data Cohort in further across melanoma

the successful With capitalized our well follow million we with in expand very pipeline. growing XXXX completion cash and approximately $XXX of our execute public on June to commercial are launch our initial offering,

great continue with also our research strides to We make efforts.

common type a skin and approximately each patients annually Further of process. on upcoming three data across to We the E-Posters abstracts to for beginning XX XX,XXX on will program for patients, Scientific in be Weekend the of this cancer XXXX. of or Medical as in manufacturing are TIL diagnosed reinvigoration is persistence details alone. using genetic release. They TIL TALEN in ESMO Iovance research TIL a of with deaths States accounting highlight technology to take bioinformatics melanoma. included advanced XX, year held and be our as modification the our of Virtual Gen-X during cervical lifileucel part few include Iovance to significant disclosing these accepted United would like of the of afternoon's September in cancer, some progress TIL melanoma Metastatic European Society for minutes I pivotal X,XXX press posters Oncology data

address to that of lifileucel. support We need pivotal quarter, C-XXX-XX to melanoma. believe unmet study metastatic the lifileucel X second we significant study a and from the Cohort from data in During announced our Cohort data efficacy X melanoma data X very of combined medical Cohort and X updated in our a early continue

is from designations study. lifileucel and melanoma program. in lifileucel We regenerative this advancement received the late the or FDA XXXX. also on the US supported clinical anticipate melanoma for has Iovance to submit data of organization were very reminder, track in and Cohort fast both from advanced which focused as BLA expectedly X a an FDA, As RMAT the the medicine meet by with therapy

completed Our patients second has pivotal Iovance USAN the study pivotal and metastatic for program X Adopted TIL C-XXX-XX cervical lifileucel of weeks. known lifileucel cancer. Cohort cervical is use as melanoma. and the last are enrollment to patient therapy recently LN-XXX this The in name in we Names in scheduled investigating the to published cancer describe the or study States coming formerly addition of the in council dose our with We've cervical United in to accepted

fast a reminder, referred and track As now designations lifileucel. has therapy to breakthrough granted for LN-XXX previously as both the FDA

since the completed approximately melanoma our two half months a So be the we indications submission for two the in pivotal of BLA and separate. ahead enrollment plan, Cohort may

later manufacturing anticipated BLA We and Transitioning proprietary Gen-X have patients Gen-X The process likely process. the for submission demonstrated we generation lifileucel the prepare protected by second be half BLA robust with we in submissions a most the cervical as for our success patents launch TIL to granted this or continue record track first solid of preparing XXXX. both continues XX a submission over to established for near using US to commercial our For for in the also all Europe throughout capabilities, to now year square state-of-the-art melanoma manufacturing the to shipment Center therapies the Philadelphia the in for airport The The AppTec CMO facility TIL Cell Philadelphia. Iovance our of within US own necessary. in lifileucel and our states foot XXX,XXX XX% iCTC we launch Navy of WuXi if above supply XXX transfer at called iCTC. allows partner provide iCTC Therapy Yard of location Philadelphia rate will until with is facility patients initial

excellence design in or for report manufacturing initiate early division activities reached on and and anticipation at patients. the XXXX manufacturing alignment I commercial to to positive ensuring employees in patient therapy in XXXX construction rooms and with advance affairs continue extensive XXX cancers, medical melanoma experience. of we with experience including we on of more have DMPQ, cell The Quality commercialization. meeting team with during with lifileucel the cervical than In commercial pleased at Commercial Division Iovance US engagement facility. of facility the of meet multiple team Product Iovance a In with development to focused a with scheduled commercial lifileucel build launch, of a on are We clinical of track been the collaboration full across locations, and administering in remain capacity. HCPs, FDA the for groups site professionals strong on a during expected commercial iCTC with with in late operational by or active excellence; who the dialogue am in areas and a of with preparation Manufacturing to lifileucel working are we lifileucel, capacity that expected payers. Toward of of launch be the XXXX. close the provision thousands to be iCTC Clean communication completed healthcare following for demand will clinical is that operational with

key cancers their are and we centers prior partnering the experience launch. Among with to initial build that be will these service anticipate with melanoma capabilities. those First, cervical line TIL opinion our the sites target with US and centers leading cancer for for leaders we

and FDA cross for treatment train team, TIL hours' lifileucel to Based well regimen comprehensive can therapy. PD-X patients sites disciplinary administer time. a current within a XX therapy TIL Iovance our The over the site so melanoma offering enough we addressable Our few within be approval. that US. training is market lifileucel most X,XXX to drive designed per upon and goal targeting launch patients market ensure year to research, at can the program over to be on onboard to bring expand is is on over longer-term sites post estimate

In information advocacy to network works addition, medical our organizations. patient about available is and assure HCPs with groups interested treating team TIL that to affairs of a

patients. of patient the will can personalized case sites barriers have lifileucel be CMS also for Iovance and will Medicare managers understanding, to and reflects appropriate also to to well case and continued managers for for patient's commercial reimbursement we managed our with payers our and program centric individualized melanoma metastatic journey. process Through with we The under throughout life. intend are CMS of timely benefits We step anticipating dedicated Thus support allow infusion. through HCPs XX% needs, HCPs a and responsible to potential of or monitor dedicated IovanceCares, lifileucel, and to that or to We access with we elements have commitment for provide to with have Medicare unmet model, of lifileucel. treatment. hospitals. by cell today's and manufacturing meet resection and for centric believe private means far system value IovanceCares at support Medicaid IovanceCares Iovance and coordination and track the payers the of and that will payers, the the patient the a All centers ensure release, from process clinical as covered discussions and scheduled addressing to will communication And while HCPs a appreciate to place lifileucel patients delivery patients met until patient therapy. the approximately metastatic need reimbursement handle with of provide patient support press introduced removing the cancers. every patients. cervical order being care for and initial In Iovance as patient At needs

to Officer, on preparation recent for clinical would As Iovance. to like Finckenstein look Medical forward at other continues, updates our the Friedrich now well studies and plans to our as market our providing Friedrich? research our summarize as ask Chief you. the we year data I throughout commercial launch

Friedrich Finckenstein

data burden melanoma. and the need. best at reported characteristics through Maria. eight Thank presented from lifileucel, a X% X. overall data Cohort ASCO Cohort data offer for disease The for and XX% XXXX only Scientific high Chemotherapy rate survival patients include was clinical Cohort checkpoint available progressed new X seven our patient time only the and care some that updated who like is at and X Both would response C-XXX-XX an these Cohort This of from are with to most TIL update unmet you, months. have have to immune X our baseline on to therapy metastatic median inhibitors the spend to recent X Meeting. of Virtual significant data heavily pretreated they similar study walking from sets early I and

Cohort months ORR duration durable anti-CTLA-X up. of and Following was a not showed in XX one-time lifileucel that age analysis these treatment XX.X X onetime and treatment, high regardless new further showed to metastatic our patients have who across treatment and and targeted still response BRAF reached may responses status. patients' status as as sensitivity all demonstrate believe been metastatic patients, of to prior BRAF observed XX.X% at data follow received PD-LX of for in for mutation range lifileucel well wide also value melanoma with in TIL patients of melanoma. subgroups low study medium the that a ability response of in as have We The proposition equally

data conducted we X, recently Cohort an to Turning early analysis.

As as X care of for that at Cohort investigator showed assessment months ORR these with in X XX% data investigator. follow suggest results a up. Overall, as we patients endpoint that follow ORR review In March this were primary key cutoff. in showed of assessments of very at time available committee study reminder, is analysis presented SITC up with radiological data XX.X% independent and that population, improvement these pleased The as XX Cohort median endpoint XXXX significant preliminary X.X median patients remarkable Cohort by available is of consistency six an ORR the patient XXXX. early two at prior X secondary at study for over well lifileucel the our a months ORR included

future present medical data XXXX. details the the will of a at in We meeting

end arm as registration study non-small that a of Like patients encouraged call medical patients development the to our dose study in of a AACR cancer, study, Iovance were approach by cancer LN-XXX TIL our in as lung LN-XXX potential non-small in we the IOV-COM-XXX. lung we with We Iovance lung our continue cervical, TIL our single IOV-LUN-XXX. has XXXX. which pivotal the recent which IOV-LUN-XXX of Moffitt's responses significant well-defined cancer cohort, need. non-small provided lung to collaborator approval plan durable which cancer TIL therapy I, baskets toward highly two melanoma cell patient in therapy data lung by the and we we cell our both Moffitt the in cohorts and potentially treated the of in updates to two to The Turning cell population cancer We data enabling basket with call Meeting showed Moffitt's begin believe TIL. at investigate our the Virtual foundation and complete well studies unmet support own ongoing

also to well Moving These studies process, advance LN-XXX pembrolizumab in pre-clinical the neck additional product, and C-XXX on introduces therapy to naive based we cohorts selected Furthermore, in indications, our manufactured our TIL in TIL earlier our cell relapsed which clinic Iovance of which this melanoma other and in as third studies, non-small or basket to as new we therapy. lung cancer. the well we additional PD-X as in which continue T-cell with to include to with broader the The ongoing IOV-COM-XXX study refer refractory lines clinical LN-XXX-SX. call and evaluate as checkpoint our cancer, potential combination for therapy treatment non-small melanoma, in cell lines study study or neck head two proprietary earlier to the lung alone proprietary XX-day cancer. and generation and TIL has head study Gen-X as therapies also

activating lymphocytic hand lymphoma, and our Michael results. the therapy PBL or are relapsed chronic discuss leukemia and SLL. over now also our small first peripheral-blood in additional lymphocyte to half refractory CLL sites IOV-CLL-XXXstudy lymphocytic I financial and to XXXX quarter We second of or will the call for

Michael Swartzburg

second results Thank XXXX. you, comments Friedrich. half the My and from high-level first reflect financial our quarter

with Iovance December cash quarterly the as this XX-Q XXXX. investments begin cash, Additional report XX, million release, At with XXXX, details restricted XX, million shortly be position. $XXX.X at in June XXX.X in in press short-term I'll to can filed held found cash compared as be SEC. Form to on afternoon's our our and well equivalents, cash,

year June restricted current over We Our cash and public includes anticipate from of cash, common equivalents, end investments stock net cash cash of position balances proceeds million XXXX $XXX XXX.X million. short-term our maybe offering.

General and quarter team XX, and loss the fees $X.XX prior for research XX, trials, half to was attributable administrative ended XXXX, $XX.X development increase for of with increase compared enrollment increase million first or year the of patient per compared ended in compensation XXXX quarter XX, $X.X prior XXXX of June XXXX. expenses months and administrative expenses for the research of An expenses XX, billion share, development six June share, XX, ended million in was and XXXX, increase June million, growth quarter administrative attributable June million second second XX, million, expenses. development to for $XX for second $X.XX the primarily was Net second $X.X per the to increase June XX, the an quarter quarter increase compared June $XX.X were months quarter to expenses was for same and and for XXXX of $X.XX ended attributable were period for and and of over primarily year were $XX.X $XX.X increase Moving million $XX.X of expenses. higher and $XX internal and of year were and growth $X.XX research loss general The attributable $XXX.X to the June XXXX. the and period expenses licensing to $XX.X $XX.X $XX.X income the the higher net higher $XX June for XXXX. internal period the per primarily million, research were June growth quarter and period same the net a ending our over or million expenses in XXXX. statement, internal the team. quarter the $X.X six in XXXX. of the or net XXXX, ended the share for administrative was for XXXX costs or ended June General the half clinical share loss of of to in six an second per period ended period compared administrative prior a the in XX, ended periods in Development and associated to to XX, The second XXXX same the of for increase expenses Research were The of in to ended second loss to to million the internal the the growth stock-based second in XXXX. the million million development and June XX, stock-based the first over an second clinical compared XXXX and administrative $XX.X trials million XXXX, compared The million multiple the increase for million general XXXX. million the of prior expenses months quarter $XXX.X primarily first general an XXXX. compared second June the quarter development the XX, Research $XX.X of increase million quarter to team. $X.X million ended the year ended compared an of team million, compensation General for XX,

June XXX of there the million shares common XXXX, were XX, recent financing, approximately inclusive outstanding. As of

back Looking first the now kick Q&A year, ahead, the with operating I be to related we a of review expenses in expect expenses off upcoming will range of half and shift to commercial session. expenses. same readiness to as the XXXX clinical certain Maria hand from the the half the second to call in milestones

Maria Fardis

for the today. all call you attending Thank

BLA I and the TIL operator leadership Operator? call non-small progress Overall, of now development, goals execution XXXX year, expanding study look enabling towards questions. milestones continued and initiation pleased manufacturing We pre-BLA the already I'm cancer. forward lung our we for including have meeting, registration very remaining cell submission our to of a of achieved many to our the commercialization. and and turn our will and in over with

Operator

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

Peter Lawson

taking it's whether you for of or lung tumor data we how whether questions. it's therapy, should the thinking study? that, located on that be my from and study lines about should Maria, the think potential Thanks subsets how whether about from just Thank basket we cancer, target, the the is pivotal you.

Maria Fardis

Yeah.

Of Thank question. you course. for Peter. the Hi,

We about LUN-XXX for the little we population writing study. population. basically about differently When a we patient patient the thought have the basket bit relapsed refractory study, were thought

possibly that support were about thinking when we were pivotal While LUN-XXX we thinking study, registration. more can a about cohorts

between the is difference the that's for So programs. registration. defined LUN-XXX toward one better two The

Peter Lawson

around data or I itself? the from, you pivotal either just and timing the the then guess, Thank basket the

Maria Fardis

Right, that pivotal started for the so study, of program. that expected against the year to registration is cell for not guarantee I have not basket we a time. a program non-small around start the later year the part study that noted the we committed have and there program, a to although and the flow until study, specific data supporting not cohort start was that same ago at basket

degree a Iovance cell have we patients TIL understanding up, make population. to in of better cancer we sure lung so follow So program that we some into non-small patient wanted of have with some

to data really indications specific not part I the to a also have in a to we committed able tumor flow. of So particularly there's good solid a the for setting note conference remaining that and be year present. not venue

have to our present we venue decision So better gone those have more a all of our and data. back hold to until we have into data considerations

Peter Lawson

and BLA pacing was on cancer, with be just better melanoma cervical to of cervical just COVID then to the seems was FDA? did cancer that potential finally of by or kind slowdown or related mosquito driven a kind it and there submit Thanks

Maria Fardis

by to we is March that melanoma thought going of sort timeframe program think up. sped program always that and I our enroll around

a program we our consented the of that's cervical it end came schedule. status. ahead clinical patient. and dosing in on think around thought program I The by That happened. about and months midyear always would two in it Patient has half what last always depends patient's fact

sort From between more they that the enrollment could dosed a to a timing around of set of has get all on mid-January. the melanoma the have been or So be together managed being the to by up on patients we point perspective, two close the saying do difference them separate. degree to BLAs we because and two go the got can

continue follow be last indication. the estimate best this patient. is necessary dosed dosing given possibly enrolled last at may our haven't point our patient, of for And we that degree up the patients. but cervical Our We've we

submission best into going this is of early was estimate perhaps likely part XXXX. Our

that gave we guidance So today.

Peter Lawson

you thank much. Perfect, so

Maria Fardis

Thank you, Peter.

Operator

Our next comes with Wells Fargo. Birchenough from question Jim

Jim Birchenough

progress. Hi, you sort agreement first to What Maria of meeting, what A and you you be most aspects areas just to touch already meeting the of on of a expect team. the Congrats focus will you questions, could on pre-BLA like filing? that on? have speak all on on or feel couple this

Maria Fardis

components. It FDA a Typical compile They structural Hi, the question. you Jim, intend around data to we large the with a second is have have that usually have thank is for the how document meetings pre-BLA and component as we two up. itself. to then one amount discussion of follow And document.

part and So of your question perspective, three as least to just questions. answer clinical questions, so from part, There's a sets there's data CMC different kind at questions of there's second trying the usually of pre-BLA as of part with of FDA. and a there's the dialogue part potential bucket of asked, usually regulatory so questions that of the those all usually be are may there are non-clinical,

Jim Birchenough

treat, launch patients there's thinking then proportion that the a XX to of terms if you're of initially proportion. you And just the number what those the about and sites XX in targeting, could sites stage or speak Maria, initial melanoma late

Maria Fardis

the I'm Commercial, our Jim Head Ziegler, going Jim? to absolutely. in room Yes, that us to with ask of address question. who's

Jim Ziegler

very thank question. for much Jim, your you Hi,

least existing allow have number earlier community. with launch the we include sites. the said patients experience, in et cover time, care. think access at greater of therapy based that we of And plan look of more Maria of experience, whether cetera. course, estimates, our to First, expand our clinical of sites we the the What that we'll geographies sites we'll to is XX that based upon majority upon based KOL But lines trial as we service over cell status prior they selection to

Jim Birchenough

just Peters Great what's were supporting extent some from and if that's cell you the to the up then with say move to those one on lung in registration the Moffitt can non-small final data? and the question experience have study? whether a takeaways been basket on early question Maria your following learnings What And study confirmed cancer.

Maria Fardis

Thank you, Jim.

I through that has academic I'll institutions for – strategies, lesson look step think the collaborations back second, indications a our of been strategies one with of into one our new always maybe to as signal seeking.

felt with And TIL non-small we of the that a program great seeking so, showed we it program signal very potential had concept cell Moffitt a proof in be was where powerful that therapy. can

TIL not patient the be or today's or be representative may manufactured Iovance's population by may The TIL. Now patients. not representative of of may Moffitt may

Gen-X study our get in trying the are Iovance's manufacturing COM that at protocol. And is are currently do community of seeking patients purpose to academic that, our process we're or look in the So of to institutions to clinical COM-XXX that sort trials.

biomarker from So think learned things remarkable that broad who patients was have What study. was population a a I had responded, that patient might few therapy. we a

received followed they a fact. still were able inhibitors, tyrosine reach nivolumab, kinase So and as responded their matter they of SCR they to had by

TIL. noticed an even also low percent are PD-LX opportunity zero respond that We to to have that patients or certainly

that study. And the us. great on those this based learned we from define the how in patient LUN-XXX lessons population from lessons that is So we are

Jim Birchenough

the taking questions. for thanks Great,

Maria Fardis

Jim. you, Thank

Operator

Burnett comes next Ben Our with from Stifel. question

Ben Burnett

focusing you ask I just right? want follow on I you manufacturing a you and Did study. Gen-X little Hey, process? more that terms the this And what registration so hear are of in for color leveraging to cell you up size? on just thinking study non-small you – are did thank lung guess, cancer around I on much.

Maria Fardis

Hi, using Ben, forward definitely in Yes, our we most are studies. the thank you question. of for Gen-X going

study. in exploratory Although, that into very interested Gen-X are introduced manufacturing LUN-XXX clinic but other as given Gen-X in will have and our – manufacturing in still methods, continue landscape, we a commercial methods much we with we

you looking further really on we terms that question? In That's at terms that need study? of question are our medical patient for patient the that a in answer Do strategy. population. population of population your patient Does have

Ben Burnett

I support I extent if color study any provide the disclose of To the registration would kind of it, to that wondering on was here. the guess size prepared you that you're can

Maria Fardis

Yeah, I to a have that have a think first unmet explore stage and program two, as the make look we signal where strength that. that's well in certain identified expand. and I we and there's the we very always that sure And unmet this believe designed of very medical our been population, potential the general registration, done can need we then smartly in we a and is strategy we arm is that for Simon's a population study program, interested always but enough will that such if find patient need we ideally think feel signal and strong use two-stage define is single a strategy.

Ben Burnett

up one understood. just the that's study. Okay, melanoma question great, And maybe pivotal follow on

the providing XX before this provided Do assessment, you endpoint? think update something – an on investigator you So endpoint secondary which patients. primary dataset get a we was, another the with I fuller like year update on the plan

Maria Fardis

a think package. that to to FDA our with medical going Ben, is we we those have there's then good about reach timing in conferences. not medical question where and submission of in in very conference. terms in do lot of the we There but data, are And the wasn't to data size can the this, of have make we present the sure always release what year, left a a agreement want we earlier I then of venues full the ideally,

data, time the registrational XXXX the go to a a timeframe, I'm this make program with presenting agreement we and in event. XXXX the the By have data, would So likely of melanoma conference. we full committing the then sure not FDA necessarily read medical be to the

Ben Burnett

lot of much. Thank makes you That sense. clear. very Okay, very

Maria Fardis

Thank Ben. you,

Operator

Mara comes question Our Mizuho. Goldstein from with next

Mara Goldstein

thanks Hey, much. so

a So I allocation fully been your are manufacturing over running, you think how a that had operational, startup of it's Iovance a I just completion about question spend there able costs your the change Center now the top we for question And perspective. around around next the from will you cash have then should Therapy manufacturing and be a to cost coffers and and have Cell you've kind the of perceptible months? and capital XX up when fully XX, up when able to XX, for

Maria Fardis

good, sounds you, Mara. Sure, thank

Mara Goldstein

Thank Maria. you,

Maria Fardis

thank we would of something Yes, but that we when of think a component course, part facility increase yield time. that always pay of COG CMO. you're with much human And a certainly for that's the we working not payment necessarily you. manufacturing Of have capital as lower COGS raw a that you because our how material, and ultimately

So we further and be speak reduce we facility to should allocation, that capital once Michael? Michael team, own I'm think to COGS. to have our the ask own going to our our we Swartzburg able

Michael Swartzburg

Yes, thank you.

talked ongoing. as the the also of completed operating you the to for that spend, So had And mentioned we year. imagine Cell And be in mentioned ongoing clean as that rooms expected construction XXXX. is our of year half the will rest, Center, Therapy are continue Iovance which about half will look in we the similar our second first I expenses the to

guidance any that As XXXX, haven't of given it yet. relates to we

programs. $XXX.X believe cash to existing We also stated execute pipeline activities, of sufficient us for we launch that our position commercial million including our and is

Mara Goldstein

Thank you, I appreciate that.

Maria Fardis

Thank you, Mara.

Operator

next comes with from question Oppenheimer. Our Mark Breidenbach

Mark Breidenbach

are don't that wondering solid won't any heard afternoon. tumor this good year I'm just Thanks left have the a implies data. Hey, that venues for presence the say and year you couple Maria, if in SITC. since questions congrats times a at the Iovance on much of progress. there think good for taking that I've you

Maria Fardis

light that have of And you you the the couple abstract melanoma. have pivotal was that the a – is in for think thank submission It I weeks the data ready. don't given program light and a I've in timing will the but and Mark. of literally that was of be, of for have read all consider have program. good could to data abstracts pivotal not I program. doesn't mean melanoma SITC you what nothing else. It a committed from venue just to

probably think release. XXXX data I would look we for into

Mark Breidenbach

there Is this a working we'd ASH blood for your of terms in year? chance lymphocyte early later now. that's you've a And data been I something Okay. know at that peripheral that from on see program, while

Maria Fardis

Thank you question. for the

COVID. PB-L be extremely low affected were able have chances for But this safety get to our enrollment. set first of And sites very be patients expedite additional in looking of enrolled, we given program, may patients able typically data that efficacy to expanding is this you into officer being to hard are to in the sites and pretty fact year to Frankenstein and Our are an medical by a just appreciation when speak of that the be PB-L chief understanding have study sense Frederick design early available. is ask high-level stages. going different to a design see display the I'm so maybe our data to in for to

Friedrich Finckenstein

Yeah.

of high the the the thanks that safety to after a dolt think that at question. small a which And confirmation very profile by And So dose first designers sequentially describe Maria. you, finding design thank with part, patients of for level. being level of really regimen sufficient it's treated I cohorts dose is are escalation

goes that small might be on sample into worth dose most have Maybe that that be only really basically hope profile. So level be that idea and done addresses while an appropriate, then available, and expansion takes the on for focused the we question. find And to a relevant size that be it cohort that more cohort And would the sufficient I what safety. data. when that design that we would presenting describing is around efficacy mostly a focused at it showing. would and gives we going with to the small that's you then an definition probably be by be a would by

Mark Breidenbach

No, super the for questions. Thanks helpful. taking

Maria Fardis

Thanks Mark.

Operator

Reni JMP comes Benjamin from question Securities. with next Our

Justin Walsh

was on Justin with for hoping on how with to achieve is IOV-XXXX, with Bioservices you're Reni. Based Walsh Avid comment to this if you're agreement what I your and over improve or to native could you're that wondering trying trying Hi, you what on IL-X.

Maria Fardis

Absolutely. Yeah.

was beta-gamma JP right IL-X if is to but taken a Novartis IL-X release announced from we around Morgan analogue. around when Justin, I novel had commercialize license don't CDR know earlier a subunits. targets – IL-X receptor seen, which we think an you've This really it press had grafted, that we I an

novel So a it's preclinical we're stage. pursuing that in and IL-X it's a

that enabling GMP to was as go through the with Avid manufacturing material GLP development their well try your and preclinical as answer Does the process program. program IND So agreement really question? and for that supports

Justin Walsh

sense. that Yeah, makes

export how look guess how in you the So your – would would I preclinical would you at actually you into would – you that exploration, incorporating consider treatment programs.

Maria Fardis

Yeah.

a profile, a profile differentiated So it it's product as compared on better expectedly PK, of to an – a and nature administer there CDR this which this co-administer to therapy. allows idea certainly favorable potentially has explore CMC IP around better TIL The I the and available But very develop are noted characteristics plenty own one, well. better a we its IL-X as was analogue, something of to graft. with it has opportunities certainly particularly IL-X. this for safety as It is

way have to in IND I be We as or not the expect committed other, an program have one committed enabling what we XXXX.

Justin Walsh

taking Thank Perfect. you for the much questions. very

Maria Fardis

Justin. Thank you,

Operator

question from comes next Baird. Our Madhu Kumar with

Madhu Kumar

taking for thanks questions. our Yeah,

along. So and macro and I'll micro more all go start see then

on micro So you cohort enrollment correct? so a that's completing cervical patients in XX the basis,

Maria Fardis

Hi, good when may don't always Approximately, Madhu. patients because enrollment, we close screen exactly be there Approximately, typically we how many afternoon. failures. know

is had approximately protocol. Yes. we So in defined what the XX

Madhu Kumar

what in Europe? in going to question, is then And approved so Okay. second get little and a to melanoma take it loose, cervical

Maria Fardis

that be make to might same I have think parallel existing the to the dialogue supportive health authorities need with EU FDA, the the we depends of with to that talking really that sure we on that way authorities. health European been The they program. dialogue

to answer when with is a appreciate it's the the with think dialogues, do And medical yes, they authorities be agree usually arm The agree for or unmet submission time had Does which needs What to in region? care authorities, some think health what that the first now. they It they successful they for EU is FDA definition? can have and with is that entire dialogue that think package? they be And your available hard about that could that that I and need? size And do those that registration? answer see discussion. then supportive need single do to a be What starts package to with is do appropriate do dialogue with So agree if if they then Madhu our the EU? talk health question? of what percent we've I of we with response typically

Madhu Kumar

is, of guess question cervical? and in you both I Okay. development given that clinical I mean, discussions, those so when the pretty far melanoma my you're lifileucel along into do have

Maria Fardis

Yeah.

sort to EU a and on part the have through items going the requirements planning later support that assure of to in of ground to interaction get EU, EU So year. There every make success, particularly program to place that's those had to not that and we the of the that sponsor of with has with has starting assumption we a product sure in one initiated are list been we on we of are the potential that review, need list dialogue agency. have we specific a the commercial have before need in

Madhu Kumar

Okay, and a to take and cervical it of frontline of program line what's kind or thinking moving of in frontline cancer? started both the cervical pursues either up to and then clinical cancer melanoma how about to going get you melanoma trial are really depth therapy kind in

Maria Fardis

Yeah. Excellent question.

things the requires available the to for patients. of order one product and effect going one, So lifileucel to care of line couple the earlier usually their these the of to has – of two, in define given magnitude a understand standard

the and/or able a to of peel is to study the see where magnitude of And to sponsors you undo go or randomize registration magnitude care see effect, you available. might of the off care have into what once have you is agent go patients a So to single be the have the effect. because on typically, it. the standard add to the standard to Usually the step top of first of

is step to are early exactly early Cohort plus patients. that the in which So study combination in melanoma, is in run our basket our doing X pembrolizumab and line, we TIL for the in study is line first cervical toward what own offering

in correct see is steps triggered early these and So you're combination available completely in patients in with of the already the magnitude care. effect what line we order have to

Madhu Kumar

of how Okay and blockade? you beyond say PD-X in finally, you combining kind one How that? envisioning want that Like, then agents next years? five you thinking the to would TIL are pursue like, to with how about are

Maria Fardis

in question clinical as for sponsored is our be and strategy development scope about is for it is Excellent well. think program, investigator Yeah. well part but in our to clinical our what development out what scope program. our program in scope of It may of very

in are which these course studies. investigator So combinations, when we some interest think of of at we put high Iovance, typically sponsor those of about

very part might things pivotal relevant well a in know, strategies. carefully. resources And our our that indications program, very in typically be As as focus is landscape you choose IST non-pivotal, as so may our we new the of yes, or treatment

Madhu Kumar

investigator where TIL? say, how that, on companies run having So an positioning with then kind interesting collaborate development trial of of compared from to following that be plus assets that just have A to look, the be positioning being could a as much other you business a investigator with sponsored drug trial

Maria Fardis

that market as open for most of in consideration definitely already. alternative the to is are well. we're out scenario these one that public Absolutely, drugs The

that commercial portion for is intellectual of either particularly with then its And so very an to having anything up is property financial that. sort up to a IST. sort other certainly its the side, ideally on it's commitments to If product if and want don't the we everybody considerations Iovance a market collaboration our IP, go those a have I then drug with if to pure give or open of Iovance want financial our give into of But we're to making ends rather be certainly a already don't who up sponsors, would bringing we collaboration sponsor or product. do a commitments win-win as to decision to

Madhu Kumar

Okay, great. Thank you.

Maria Fardis

Thank Madhu. Sure. you,

Operator

Piper Catanzaro Joe with Our next comes Sandler. question from

Joe Catanzaro

so for questions Hey, from ones here, two taking guys, quick me. my much thanks just maybe

so, also meeting cancer? pre-BLA frame your from receive need in would cohort And cervical the pivotal this around So you would to year, look that later alignment you if discussion? cut a data to

Maria Fardis

An Hi, excellent question as well. Joe good afternoon.

possible. best and answer if necessarily don't give the can you debating been have I We this know I

be would on the to what really part as meeting. division dependent discuss of it that think wants the I

as the is responsible that is meeting division IND the However, just with clarify, IND. a kind that that therefore, is we of request cervical the for the that to under program melanoma – is division of program. usually the And review IND, a different

in may not team So the meeting. when room be have members or the pre-BLA we a may cervical

whether So meeting. the this topic or may little up team come be review in unclear because cervical it's a not going is may the to

Joe Catanzaro

the got cancer, fact Okay, read not about and how neck of quick you're and one seen head committing an means rates in be you're but what reflective Maria, this then head may you're that you've response And it. should that where as lung into cancer we program how just seeing of and cancer registration more up follow lung a in cancer. about kind the early activity to neck XX% thinking

Maria Fardis

they're opposing not other. think necessarily that I Yeah, each

the design, for you'll Let's just see to allows Simon's them one time distribute non-small provide and at are make a the ready design, – take the study to the what sponsors they a two-stage the cell once and decision. study

in of In manufacturing clinic into which to selected a the we While a introduced way. the XX-day decisions the pursue has we head head and was the we products we indication, we the of and Gen-X, are earlier landscape introduced Gen-X. duration more to on TIL, other process we we we different based – a response. while PD-X have want certainly a not The introduced been product. slightly We felt large literature something In make very particularly response be to year. which opportunity neck be that way thought neck with potent should a along have we have to had committing part that and the

trying of slightly Does different solve are them. problems one each make sense? to for that we So

Joe Catanzaro

that durable, but if I cancer wondering are I'm guess helpful. responses that you been that's No, you've that. we you seen fact should if in into that assuming lung they've read the answer Yeah. I'm won't committing any

Maria Fardis

from CRs promising. that the think and really really is XX quite went seeing past XX have seen I to that sign we continued has PR a been perspective, from Moffitt my out study promising had that what months from months

I also above is we care, available care, thinking see that So we are not it. above indication, well which that's on what only ORR, which about DR think see we available how maybe the in but and is

Joe Catanzaro

Okay, much for Thanks my so taking got it. questions.

Maria Fardis

you, Thank Joe.

Operator

question Jefferies. Amin from with next Biren Our comes

Biren Amin

progress. questions my the on and taking maybe with for I'll thanks indication. all melanoma start congrats guys, the Maria, Hi,

Given payers X Cohort discussions for interim the lifileucel? up from regarding and you data follow have from the with had Cohort pricing X,

Maria Fardis

Biren. Hi,

Let pricing to me Jim, ask speak to the comment.

Jim Ziegler

price Yes, a but price for we have Biren, not have set nor payers lifileucel. a discussed we engaged

As you know, until establishing value, there are many to to will factors both consider which we evaluate continue approval. product in and price

which support As compelling are high that believe no you know, these for treatments value. we need potential areas indications unmet viable there of and are lifileucel will in

Biren Amin

cancer, Okay, follow have plan separate FDA and that data do driving FDA have on But with second expect the a then to the what guess up this of period on pre-BLA of side. to XXXX like that I BLA And released type or discussion I XXXX? to early in clarify, meeting at be is I cervical we going a see? X guess the from want can the submission to is you're I had, regarding end And cervical just or melanoma guess you to is and understood going cervical, I Cohort XXXX? that you've would

Maria Fardis

correct. lot interactions I the think completely Yeah, FDA, a with of dependent that on is you're

If the it which own IND. XXXX And their of our the BLA move a in dialogue amount up. the participating under chances in it's under a approached regarding up the is ends up. BLA follow dose that if patients, time be then with we need earlier, – noted staying then absolutely they we I follow meeting around can precisely the then why potentially the have a think them, pretty on early dialogue defines XXXX. discussions, division I timeline thought ended is review them up, follow own have This as with in cervical, IND, by the safer depends a good expected melanoma their the to are might agency, we we to it because we So up a different similar separate

Biren Amin

we the the it a August should out from XX. announcement think to for end more Got the Moffitt regarding expect expect and additional an –given ESMO, are at from posters late-breakers couple and can we me, on just then late-breakers I update ESMO? be anything going maybe at

Maria Fardis

Moffitt I am not whether submitting SITC. something aware to is

So I that. on can't comment

be I or from an ESMO think comment late-breaking perspective, not what let me in might not.

already what really for we XXXX data not presented, flow I think want that we to remind just ourselves. committed to any clinical beyond have

Biren Amin

What's used PD-X approach poster think with in you between just r the the terms PD-X presented Got regards knockout. PD-X – on last of it knockout and difference compounds PH-XXX. the the and silencing that ESMO year? Cos you the to then I the

Maria Fardis

RNAi in The ESMO Yeah. that is of There's a transient Phio genetic knocking being presented at knockout. that's expected technology which permanent and out. was difference an method is The is using knockout. the a a to a TALEN something be product one product,

Biren Amin

Got it, thank you.

Maria Fardis

Thank you.

Operator

Chardan. Our next Geulah question comes from Livshits with

Geulah Livshits

on Thanks for the taking my progress. questions and congrats

So how for following you maybe considerations regards i.e., different in how question to discussions speak and potentially? relate with settings, to other indications in Can pricing stakeholders. response might you that particular, melanoma on cervical, to the pricing up might in and about thinking different durations your payers be

Maria Fardis

Geulah. Thanks Yeah.

on comment the to pricing. Jim ask me Let

Jim Ziegler

profile. or We're as we factors cervical. setting value. looking efficacy forward at on pricing clinical profile both you considering measures evaluate decision. to we're launch the to as we're the need, melanoma Yeah. you out, prepared having our Thank are at unmet more many approach for also as metastatic pricing individually factors about safety There you, we pricing. And this mentioned into pricing earlier Maria. talk we continuing and specifically deal as point, around And other pricing. look that go to with in well point We're as ORR dialogue metastatic well as But the not

Geulah Livshits

the launch up it's you a Europe, about Got and strategy strategy strategy some the US. and terms then commercial it similar an of time structured potential just towards in – be in versus or thinking needs those that for the envision planning early follow infrastructure, on maybe maybe the of do differently to

Jim Ziegler

and out as a and question that Thank on might practices the evaluating both and best as early in and finalizing the based US. one, it right imagine, we'll potentially going our very forward upon dynamics. ex scenarios; the we're three look one the we the three; will still again, are But strategy considering, team's US what or scalable market you. the We're working approaches process. you now alone; great licensing. partnering to be making and the real go-to-market And data much two; That's in in assessment

Geulah Livshits

Great, thanks

Maria Fardis

Geulah. Thank you,

Operator

like And turn to further I'm over this to at the I not I'm back showing Maria. further showing sorry, time. any – questions any not call will

Maria Fardis

Thank forward Iovance call development, item. the leadership again to year to quarter as half to the feel and free productive you commercialization. joining up you, XXXX. further of solidify to on operator. wish Please out manufacturing team if TIL first look for follow end of our reach any and half and Thank We we a our second you

Operator

today's concludes Ladies and presentation. gentlemen, this

day. wonderful a have and disconnect now may You

Iovance Biotherapeutics (IOVA) 6 Aug 202020 Q2 Earnings call transcript