IOVA - Earnings call transcript Q3 2019 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon, and welcome to the Iovance Biotherapeutics Third Quarter 2019 Financial Results Conference Call. All participants are in a listen-only mode.

Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded at the company’s request.

Now I would like to turn the call over to Tim Morris, Chief Financial Officer at Iovance. ahead. go please Sir,

Tim Morris

our Good me and Maria on Chief Friedrich President operator. we This includes release and which nine joining Fardis, you well September XXXX, financial a months at press us. on as and website Finckenstein, and the as Officer; update. With you ended the that issued results a Executive Medical find afternoon, for could our you, Officer. thank afternoon, everyone, for our Chief iovance.com, Thank call the quarter company third is XX,

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

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

Our materially update We publicly projected no those undertake differ from during to call. forward-looking today’s obligation statements. any may results

that, the I’ll to over With call Maria. pass

Maria Fardis

Iovance Tim. in of of excellent to highlight for therapies cell-based solid I’d make Thank Good of tumors. development position treatment we’re a continues like cancers. briefly and therapies progress for in believe accomplishments. cell advancing you, T We few a afternoon. leadership to of the recent treatment

cohort cancer in and cohorts continue XXXX, completion with cervical in enroll mid-XXXX. pivotal cervical melanoma enrollment before the expectation studies melanoma of and pivotal for First, the our of to the of patients early

have BLA These with for disease lifileucel the progression treatment have track potential TIL currently LN-XXX of to patients be a with despite in to continue our of plans that options. XXXX. of on and thousands to lives available the experienced impact therapies late registration We for submit

follow continue Cohort patients X in our melanoma we program. our to Second, of

of this Immunotherapy presentation meeting results at Cancer Review for accepted as provides for the Independent of read upcoming cohort. Society four for abstracts IRC by or the One SITC or Committee

update an part provide SITC as will investigator well. presentation on response assessed the We of as

our internal first peripheral from named we and to the a polyclonal program our development cell cancers. result or developed FDA. or Third, Iovance for borne represents pleased of on of nine PBL blood newly in broad IND research today at XX PBL new in has manufactured application lymphocytes for Development application and investigation developing been and product cleared our therapy days product therapy announce This blood. drug IOV-XXXX IOV-XXXX of is by milliliters are efforts is that is

We leukemia expect to by chronic the with lymphocytic the begin of or of small trial clinical treatment end XXXX. for IOV-XXXX lymphocytic lymphoma a

License like update corporate would many may patients I’ll as pivotal make The work I our this to therapy to TIL approach. programs more you discuss on provide who in benefit detail. our Now an accessible also development Biological XXXX. broadly study before activities a well Cohort to the from in or metastatic XXXX of enrollment planned C-XXX-XX expected the progressing for of of in is melanoma BLA lifileucel of submission Application under lifileucel treatment with late March X study our complete of

IRC. at results as Independent have SITC, X will read As I Cohort Committee by beginning, mentioned the from Review we an or at

expect available tomorrow We that breaking the will Cohort on the data become late X detaining website. IRC abstract from SITC

ask our changes would the speak love cervical to to made on Friedrich? program, detail Friedrich further cancer to protocol. the to provide To I

Friedrich Finckenstein

Thank everyone. you, Hello, Maria.

patients and as GOG of We earlier broader in advanced the TIL cancer. protocol we pleased with our well from key populations. Further Gynecologic the is cervical Foundation to of on amendment patients tool therapy cervical pivotal of as such result new and patient patients, added also opinion offering study amended with or PD-X broader as This leaders post have progress expand the collaboration this Oncology patient cohort. for are Group evaluating line with cervical continued tool population

is The the systemic cervical Cohort registration pivotal registration. have the cancer. the size known in Cohort patients impact which pivotal timing XX progressed second study higher cancer is and chemotherapy. protocol cohort, no completion as who cohort X amendment on treat the now following X for has or The line program of metastatic of will cervical sample of

patient cohorts new address added of additional have We C-XXX-XX population. that the LN-XXX to

to cohorts are These potential help therapy. include earlier to of treatment the of lines intended evaluate broadening

who pembrolizumab. any radiation and or added. patients LN-XXX in two cohorts distinct have than with populations be surgery new experienced line combination not with patients. We’ll disease who first other enroll received to treated therapies Patients treatment of pembrolizumab Two have metastatic following chemo progression prior with

treated have patients who we retreatment addition, who product study with part patients which not enrolled, as may of into into separating program the Patients such patients cohorts, but created pivotal and a transforming X the registration are cohorts. two have population LN-XXX. within previously are benefit Gen with In by non-registrational other from been considered other

broader to the our broadly additional reflect cohorts summarize, accessible therapy To population. to a patient TIL make study commitment

Maria. to Back

Maria Fardis

you, Friedrich. Thank

tumors, treatment IOV-XXXX. of technology potential cancers in application IND received solid are platform we also hematologic the FDA the and of Beyond have see for for TIL clearance U.S. pleased our to

lymphocytic lymphoma. the with chronic We of an Iovance are proceeding and IOV-XXXX in leukemia lymphocytic sponsored small study

Phase X/X to XXXX. this of IOV-CLL-XX patient the study expect end before dose We in the first

IOV-XXXX for study is clinical a dose escalation program. The

Phase to of expand We portion expect Iovance as to during to well. heme, To be intends enrolling mantle PBL cell research further investigation hematologic and XXXX. lymphoma in its include expand X the

to TIL an oncolytic TIL therapy. entered therapy evaluate collaboration additional activity also We’re of with Recently, into with Lytix multiple LTX-XXX, of research study with in peptide, to pleased we help Biopharma the engage cell conjunction of TIL. that partners and us applications

TIL in triple tumor other negative breast oncolytic in intracellular Lytix LN-XXX in an Biopharma of investigate oncology have with and demonstrated established solid shown is developing LTX-XXX tumor cells has previously dangerous indication. to signal. indications, resulting proof-of-concept patient. have to tumor The In initiated Yale disintegrate cancer. antigens this study able Iovance molecules of components peptide Iovance in exposure successful growth investigator University of

initiate cleared with IND Toward of an in Yale in TNBC. enrollment that, to investigation LN-XXX to expected The from has patients is FDA begin XXXX. trial by been

to include three presentations will Iovance addition of modification in solid abstracts tumor and In covering upcoming from These therapy the manufacturing TIL abstracts X will breaking pre-clinical from SITC transient TIL meeting. presented results types. be highlighting genetic expansion late clinical results, biopsies, at several of core TIL PDX Gen

manufacturing open continued production to manufacturing on be facility exceed XXXX. manufacturing We Philadelphia I’m in commercial our our progress to continues pleased construction rate facility The and for our report results manufacturing continues favorable success of see and that to from the target to XX%.

to to would overview like I share Now, results. of Tim? ask Tim an our financial

Tim Morris

address you, Thank comments our My will Maria. few financial results. highlights from a

third per $XX.X found in earlier. loss X.XX share share quarter we for news to release be XXXX. $XX.X Net per Additional million that third compared the quarter the or was distributed XXXX, details can million XX, $X.XX ended the for September quarter or third

were pivotal manufacturing was the Research to and increase to for an primarily when $XX.X in support from expenses the XXXX, and of The compared last the added million quarter higher to of attributable development increased costs capacity $XX.X year. resulting increase $XX.X third clinical third for studies. million other enrollment quarter million

XXXX. expenses from third quarter quarter including and personnel to were higher to in an also XXXX. R&D in the third resulting The increase in General for due million comp G&A for stock-based $XX administrative XXXX. additional increase the increase quarter of to increased million the to costs, increase was $X.X an when the due headcount XXXX, $X.X of is added million employees attributable of compared compared costs the The third primarily as to personnel

$XX.X $XX.X and to period increase for clinical loss additional and from XX, above same $X.XX the reasons nine Net the months million Research period quarter, for per ended a period share enrollment for $XX for attributable trial to was same in primarily development costs increase million were or an XXXX, an of $XXX compared namely higher of compared when for share XXXX. ended or manufacturing September XX, increased as million per XXXX increase the to the the as of nine personnel due XXXX. costs stated The and expenses million the employees XXXX. $X.XX resulting months $XXX.X loss net million to September in to the compared was same

expenses for higher the from million for XXXX, the XX, million increase to September in months the the $XX including increase an XXXX. above comp period to reasons namely resulting and an stock-based employees. were ended in $XX.X nine compared same number G&A Again, the General of personnel costs, primarily administrative stated $X.X of attributable was million increase

At to cash investments $XXX.X in as XX, million XXXX. $XXX.X XXXX restricted at December million September the held equivalents, compared cash, short-term XX, and company cash,

look company SITC, the in cash York, $XXX and at investments Phoenix. care XXXX million. from we health was $XXX the cash their credit cash conference forward Stifel the of For maybe used in mainly to At Suisse Healthcare balance the changing restricted at healthcare month, Jefferies The conference third in in New London. equivalents, to This cash in Conference operations. year-end, $XX.X quarter, million cash, addition presenting the short-term and between million, anticipates

the now call for will I questions. to turn over the Operator? operator

Operator

Stifel. from Thank Benjamin of Burnett the question first line Instructions] you. Your of comes [Operator

Your open. line is

Benjamin Burnett

Great. questions Thank me. quick you for Two much progress. the and so on congrats

cancer Just color wanted one just appreciate I to updates. cervical clarify thing. quickly but the this, on I the on one

at addition all the these to or file Cohort registrational these with these your is change complete strategy want changes for for that Like, for seek broader maybe to I this other to just other a cohort, cohorts. approval. understand So cohorts still would the does wait to don’t you X? strategy to filing But label? the impact

Maria Fardis

the our it not filing. Hi, strategy Ben, does for thank for you question. change No,

X be filing Cohort We will data. on based

Benjamin Burnett

Okay, future based all And your I with, for Or I the to about be then responses? responses, forward guess, be X going patients? the wanted is specifically, I future the plans the Review providing ask, the updates perfect. going guess, to what investigator-assessed also, are just messaging updates will Committee? Independent to melanoma Cohort investigator-assessed there on And

Maria Fardis

by duration We update as investigator will response response SITC well rate, disclosed on overall at which before. have as provide an of we

based be from updates data investigator-assessed on So there Cohort will X. at SITC

Benjamin Burnett

Thanks appreciate that. Got much. it, I okay. very

Maria Fardis

Sure, Ben.

one kind an maybe to of make update. just the update considered a that is either be may loop, Just reached, close them of so should not or sure number I

Benjamin Burnett

sense, okay. Makes Okay, thank you.

Maria Fardis

Sure.

Operator

from comes question from of Wells Birchenough next the Fargo. Jim Your line

open. line Your is

Jim Birchenough

on expect congratulations just could what progress. guys, from all from could on I’ve between typically melanoma, to investigator-assessed of maybe view studies secondly, tomorrow we an expected reference let us And submitted was then my then see Yes. the any set and if add Friday? we central Maria, appreciable me happens see just abstract to melanoma? and remind And in central you if in when we a you other for frame we investigator-assessed see maybe the the change erosion And what what comment Hi that follow-up. of got review? should

Maria Fardis

Sure. the Thank you for question.

So the updated see poster. data, be the which will for tomorrow you might Friday

with We that additional of are we to sort also investigator cutting to the regarding we time be have update DOR will it. information and data have an update. the street committed assessment There provide because any

This are with of very pleased out. obviously it why are the We putting data. is we part

going say, do of And want in strong metastatic for discordant. There’s everyone to data this in that to remind to says needless investigator and disease we terms see, was We concordance Cohort high. very we different further of IRC at X, very is that’s an to that literature lesions SITC. confirms these the than quite you’re the had a we the observation choose opportunity felt see have data abundance very for is the two that data and

Jim Birchenough

move broader into And speak CLL, CLL hematologic the with but malignancies what cancers, initially PBL I like blood great What’s on any SLL, opportunity, why to with? you maybe broadly then you And do what – things point myeloma? you choose indication just separately, to like maybe Maria, guess, to makes at start thoughts myeloma? could more

Maria Fardis

the Yes, in We bit has expansion a a everybody present that the of find is and cells Thank in are T in question. This of to what of blood. great been cells are just not found grail, trying holy target they’re you. blood, sort cells for blood. recognize not these that frequently very

patient fact, as found in prior higher the has if are, However, received therapy, the frequency ibrutinib circulating cells in in blood.

post ibrutinib, couple So presented we we we with specifically ASH that they’re and that at once years started they process, either And ago. have a realized these patients that progressing are progressed. was patients are started or ibrutinib, finding this on of already the

is this today, ibrutinib in know noticed we because that CLL started we So cell. are well CLL. adopted very we type work interested also in in I of mantle And expanding

begin with. is which particularly broad hematologic population patient indications, So we are interested patients in quite and post-ibrutinib to a

Jim Birchenough

And a question. just maybe final

Just as on to to of implications be of some getting you implications patients ability in will a impact the easier, Maria, making the get patients to Just more of where biopsy? that core how the treat invasive core get at process terms the SITC, biopsy not sense your biopsy data able get might of trying data? could

Maria Fardis

I disease, would a patient what not where biopsy you. there may much as of exploratory expect as in would But that TILs after we into would these population, impacted. that we the went patients go critical to the that even would cervical. leading market be addressable tumor core line tumor such simpler. line, lot biopsy our become of a are four. Yes, A That’s work absolutely. that significantly Indeed, be ample our we of and that more as amount think believe something large. and bulk Thank melanoma think In excisional certainly I the late-line is is metastatic enthusiastic process I earlier is earlier about, be sufficient for disease and

Jim Birchenough

Thanks taking Great. for the questions.

Maria Fardis

Thank you.

Operator

question next from of Mark the Your Breidenbach. comes line

line open. Your is

Mark Breidenbach

afternoon, cancer cervical data cohorts? or was very academic if wondering Hey, you settings, the could line taking maybe speak cervical in of prior from thanks other Maria, new the on the and late-line the NCI either either on And progress. questions. sizes about for the or early I very centers? Congrats elaborate any until efficacy good

Maria Fardis

I maybe Finckenstein to to Well, this? why ask Dr. don’t speak

Friedrich Finckenstein

Sure, I’m happy to.

those additional the about the and described. are the efficacy Both in question. up to I’ll was profile the safety part of So in exploring settings your size of take XX patients cohorts. first that of This we the

cohorts into sample two other enrolling don’t not The a defined that actively are clarification a really because have these. sets we’re

Mark Breidenbach

to regard with newly that have And experience any say, of with we it. patients, TIL diagnosed Got seen prior in, before? cervical

Maria Fardis

NCI patients when the treatment-naive TIL the the Even bulk were patients. patients, radiotherapy. post-chemo absolute exploring Not therapy, of was

front-line has I’m having anyone degree offered So relapsed TIL the patient to population always refractory. I aware of. I’ve in been seen don’t believe the

Mark Breidenbach

Okay. us product basket to in there’s cohorts on the just I SITC. cancer. you. finally, of trial Moffitt some differences X be doing? evaluating and major from manufacturing that expecting between a that wondering TIL one can could just through if non-small cell has at remind Moffitt And lung you I TIL in if lung another meaningful and Moffitt’s we’re was trial what any your data see group at that’s that your there think Gen read ongoing trial you Thank And lung know between it?

Maria Fardis

Thank you, Mark. Yes.

allows non-small So meantime, for protocol, Moffitt study get patient lung three is or cell approximately own The expansion clinical exposed progression, upon pre-rapid patients if weeks to patient for biopsy is has cancer design And of with been A The is come treated excisional patient, conducting so then which TIL. in the see benefit, the or conducted. a to in, study. generation is no they nivolumab. TIL. their

manufacturing longer. Their in studies on process. process manufacturing manufacturing associated so NCI is The Iovance differences both study and the process involved, Moffitt based between is more

that as they nivolumab tumor, banking what excise patient the using progression a patient receive tumor allow benefit, the they TIL. or to the model, study from Moffitt clinical fact where As no is upon is the expose they well to called their the

IL-X, And use which amount dose what study decrescendo uses IL-X what called Moffitt last lower called does the after IL-X administration. is is point of that and high what dose and between is of does what differentiation administered. a we Moffitt six IL-X Iovance is is

TIL about was cell with remain TIL no the first something data points do showed very what in point, concept So that proof for time. for Moffitt differentiators Moffitt. of that we to the this non-small between may we showing and non-small with There of up studies in theirs, see our three excited really cell.

cohort, the Based started patients offering the that in two where are option. where as monotherapy mono studies relapsed/refractory second for a in study, line on COM now we data, in of study, offering a and are – we with we combination cohorts have TIL or KEYTRUDA, our TIL COM-XXX of treatment basket in sort earlier patients

it’s representative as concept, exactly we of see the and that product. but somewhat proof the manufacturing same process maybe is this So not

the are sort those and of pros cons. So

Mark Breidenbach

that you at okay. for it, SITC. Got clarification. Thanks I’ll see And

Maria Fardis

Mark. you, thank So

Operator

question line next from Biren comes Your Jefferies. of from Amin the

open. is line Your

Biren Amin

questions. finishes thanks XXXX. the taking in think BLA the mentioned Hi you for cervical that expected Yes. and melanoma, But cervical melanoma for midyear re-submit my to guys, I completes it for on Maria, it enrollment, timelines, is at and early before year-end.

on follow-up shorter be that we cervical a trial? compared assume melanoma should by will the quarter at to So the least

Maria Fardis

for you thank question. Biren, Hi the

the excited really rates program. in the are about We enrollment melanoma

might had time be possible potentially think initially March we that at have we thought timeframe, think to we looking frame. maybe earlier we it’s so an And around

So them. that’s sort of the distinction between

don’t amount agency open how to of terms we the receiving. exactly follow-up follow-up, know be In of would quite much

about versus evaluation recognize two that cervical the follow-up, last is ways There landscape. a we of designation follow-up median thinking last patient have follow-up. in breakthrough We

a there’s follow-up that and periods between possibility cervical. open different FDA to melanoma be may So

– exactly kind for. answer, give going submission indications. are to quite ask much both on of we BLA to you a But don’t planning they’re our shorter for short XXXX for late know So we time how

Biren Amin

that agency median any cervical guess, with I trial, this addition on regulatory those I topic you’ve the cohorts? had had guess, Was of fall it you Maria, Was feedback? patient versus follow-up? – you drove in the the have then, And discussions last it added, of investigator feedback? additional regarding what cohorts

Maria Fardis

Sure.

acceptable what important that now had pre-BLA said not what and to are follow-up yes, agency meeting discuss discussion it’s a Having on right with is is we’ve and that, with perspective, some go we So exactly and to discussion. them. offering from preliminary what based is the

aligned FDA. with are is dialogue quite we prior with what offering So our

to additional a should question want wondering the or you Biren, I that for of were whether do your we maybe address? to population, expand comment cohorts, you So to wanted terms add this is patient In cervical?

Biren Amin

gone for setting. first-line PD-X clearly, into the into Yes, you’ve post cervical,

interested what I’m regulatory feedback? Or just was investigator it hear Was so to it feedback? And drove that?

Maria Fardis

in certainly footprint Actually therapy broadening both. our in about TIL Regulators were excited cervical.

patients GOG, of and As decide dialogue with of can setting, gyn Friedrich as of is where sort excited had large about also is well. a line Oncology patients opinion very a which sort offer studies for key which noted, they sort we very they the setting were leader, Gynecological early a in they what Group,

advice from GOG took definitely we these well So health proposing cohorts. additional consideration as in as into both authority

Biren Amin

And last maybe the one Got then just on question it. cervical cohort.

company but the enrolled, manufacturing patients think that X, into those eligible you I already these mentioned for Cohort been as that received process enrolled could have not would the Gen such that be additional cohorts being that started. X

I question at of my So not be for the ASCO guess many is, eligible patients presented Cohort X? XX would how

Maria Fardis

new So part example, at Gen this X for is, manufacturing, what presented which cohort was ASCO. not we of

to is So up the showed the really X here registration. population, Biren, clean a defined unanimously study is this as effort at patient and supports Cohort which

So don’t as before bit Gen a did ASCO. we X not presentation. answer because little of presented know X I financing, mix part question was our ASCO of in not but was Gen how the part to the

Biren Amin

Got it.

counted data Gen guess strictly X? all XX ASCO still would be of those the And towards was patients So I Cohort X?

Maria Fardis

did that’s July as in you criteria and patients – release. most FDA feedback, that did in press the We our enrolled previous XX fulfill say the the would patients see of we

about So we that. talk did

Biren Amin

you. thank Great,

Maria Fardis

Thank you.

Operator

Your next the Joseph from from comes question Pantginis Wainwright. of line

open. is line Your

Joseph Pantginis

maybe working the Thanks luck provide the since if wondering now afternoon. the glad is programs. on Maria, for to could good obviously Ohio I differences what state? nuances you with just I’m was developed, curious, good you any between you’re internally question. heme XXXX, some was progress so with taking this I everyone, Hi, for see said about very

Maria Fardis

circulation thank is much however, with in T the Ohio question. This developed the on University. has where with OSU Joe, The you This Hi, entirely for more subsequent been researchers. the that Iovance very process, data, same has were collaboration. cells always showed ibrutinib. It’s been to the collaboration by based treatment State a however,

done entirely was the based this however, is TILs So study, this though. different method in Iovance. OSU. there’s was blood clinic will that to find use The the at manufacturing The a aspects the on company-sponsored development at data, product of study collaboration, where into findings

Joseph Pantginis

clarification. Got the it. Thanks for

Maria Fardis

Thank you.

Operator

next Your Kumar the of question Madhu from Baird. from comes line

Your open. line is

Madhu Kumar

our taking Hey, all. Thanks for question.

then in interactions present question TILs what TIL the step one thinking of So means for a ex maybe path regarding had is, the of or gene in knockdown is do TILs How think forward guys path with vivo you’ll regulatory to for production? What the Europe? for for permanent or the you And you secondly, potential transient a SITC. transient that approval inactivation do either as mentioned about for kind you’ve you next melanoma are TILs EMA for a the study kind of the at cervical?

Maria Fardis

for Hi, question. Sure. Madhu. you Thank the

filing In as we terms and the health of with have interactions had EU, in CTAs regional we have obviously authorities for active. either TIL been are CTAs

procedure, had meetings, we’ve as as we and central have number different intend dialogues to regional something a as that in just of a do spoken well that’s So but to part XXXX. not way of EMA we

dialogue that So expected be had. to is

countries We clear that aware product coming. very are very this of are various

data of modification, We at these of in of In one the genetic take profile. SITC knockdown properties of to transient that permanent might products safety data least versus of poster. subsequent XXXX, have we cells, terms about as the they terms our clinic I going hope the and sort a have. in different into see of to are very excited knockdown part some of to we the think knockdown potential you’re do

of one them and transient is is permanent. One

out behave So might whether in just find might we the clinic, they differently. you same or –

Madhu Kumar

Okay, Thanks. great.

Maria Fardis

multiple on from a efficacy have do Sure. that wanted safety both I shots perspective. goal and guess another add I we point to to want

consider permanent viable routes. well So as a modification as transient both as modification we genetic

Madhu Kumar

Okay.

Maria Fardis

Thank you.

Operator

line the Jaffray. Joseph Piper of Catanzaro from comes question from next Your

Your line open. is

Unidentified Analyst

pembrolizumab from can the whether say, on for expect This about XXXX? speaking, that of first-line cohort noticed update Charles any wanted not, you I a in quickly approval how cancer enrollment ask you and in data there? could adopted is had cohort Or neck? more and in if had of to change we the sense being neck and Or if is generally since you in head Joe. any if whether ongoing pembrolizumab specifically head

Maria Fardis

And the for I has we agree, would these landscape a Thank because rate. a it to able anti-PD-Xs, short of allows Anti-PD-X the to changed, median have you in therapy. receive these them to used patients response But subsequent patients of offer XX% TIL Yes, see follow-up think, care would would the for that patients fact. question. see to patients we get actually that had to chemotherapy. a so with very and they in OS. XX% benefits rate, to around the change potential the much Upon receive something sure enrollment do It to be progression, anti-PD-X. I been patients difficult make that fairly us are and has offer

trials. patients definitely – changing receiving and Today’s slowdown these line, progress, by are path a enrollment, see to the now they They’re into lot because see perhaps pembro they’re And beginning which plus our of trials. landscape in them, they’re then is coming to they in beginning clinical front and ultimately, changing. we’re when a we to do come chemo

The neck, great for So do observation. change that’s we in head a see landscape the very that. and

Unidentified Analyst

say do you this at can in see possible is then as we any And updated to for it that? early it Okay. point? expect Is data, have to XXXX? too guidance when for Or

Maria Fardis

early a think too I to little say. it’s

yet. a time data study We that committed frame flow for for not have to

Unidentified Analyst

Or have Should SG&A and then, And some at expect OpEx I point? question it operating we R&D to increase? we Tim, forward. a Okay, off expenses should level to on thanks. continue to for going expect

Tim Morris

continuing you’re but into that any going they’ll plants think up XXXX, BLAs, down. preparing go the hard-pressed say given be build are yet for mode I and haven’t and we file Yes, your guidance when precommercial to to it’d to

some on for – So year-end XXXX. in cash guidance the call give we’ll but

Unidentified Analyst

thanks. Okay,

Operator

Boris line from Cowen. Your comes next question from Peaker of the

Your line is open.

John Scott

anticipate capacity. comment John scale R&D increased estimate And Good you you give on cost the you’ve further evening. the on This mentioned up patient On you of given discussed? now is quarters, if you of change? do cohorts Can previous And manufacturing to then used? being you secondly, that rose for rough saw capacity per is Boris. costs, versus proportion because on Scott manufacturing can a need your what Thanks. a study the

Tim Morris

enroll is Sure, to don’t make both in John. had the Europe to we enough we sure capacity, done, Yes, Tim. and is in What cost breakdown have the we we we had at for though, these some pivotal We additional the there’s fixed studies components two added to earlier cost suite. on patient, CMOs. cost time. can U.S. had a we’d that given But per patient. ensure disclosed This a remember, Wuxi. the There’s capacity per

And could in cost fixed so was consistent still associated patient a cost the The probably relatively that there you per materials terms assume labor of remains that. that. with and the component of

any see or need of now. we I additional least I think I second as XXXX, the essentially up to relates suggestion your the the and finishing part question not, is have think the first a in timing right capacity sufficient In don’t or it pivotal first pivotal. capacity for I at additional given needed capacity, think is the terms the – up to if half scale

John Scott

Thank right. questions. very for much you my All taking

Tim Morris

Okay. you, Thank John.

Operator

questions, more we would now Maria? to over for to no call have like Maria we turn As closing the Fardis remarks.

Maria Fardis

operator. you, Thank

us without allowed the the groups. these our ongoing coordinated our are helped progress and industry. that our to to us opportunity position shareholders, We investigators our and achieve a including reach this the point, We like reach this studies in to to many of invaluable, the efforts work partner our leadership patients, from to employees, researchers individuals reflect We at who institutions. acknowledge would on would pleased have the in this has not have goals hard the able our supporters be of

at providing to call to on dates. progress our we good us joining updates a today Have the thank would forward future you Finally, day. like future and look for the of

Operator

Ladies participation your and today’s gentlemen, thank you for conference. concludes This in today’s program.

disconnect. may now You

Iovance Biotherapeutics (IOVA) 4 Nov 192019 Q3 Earnings call transcript