IOVA - Earnings call transcript Q1 2018 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon and welcome to the Iovance Biotherapeutics First Quarter 2018 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 this call is being recorded at the Company's request.

Now, I would like to turn the conference over to Mr. Officer Financial Chief Morris, at Iovance. Tim begin. please Sir,

Tim Morris

Officer; thank Thank brief us joining find the Dr. XX, Clinical Fardis, the Chief Science. and Medical Brown, the you, Good for afternoon, afternoon, for Maria Executive and financial updates we President operator. could This you our Dr. today. Director, are Robert Executive the issued year, XXXX, at for website quarter call everyone, and With on release press our a March recent results for achievements iovance.com and you ended that on which XXXX. includes me

turn business forecasts. statements Maria, and I made plans, and and results, clinical I Iovance's applications include would that conference call updates, cash this balance regarding everyone will trial our licensing call plans remind Before capabilities, over future technology, manufacturing during forward-looking collaboration potential the focus, like of future business to transactions, statements to goals,

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

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

Dr. Maria Fardis

everyone. afternoon, strong a left us good our pipeline. product position expand and TIL started in in to Tim January you, XXXX off with a We financing Thank significant that advance and

commence in to with manufacturing expanded size cancers, cervical have and tumor of both, than clinical of as the a cancer With received aspects on of enrollment initiated we of autologous platinum designation melanoma remains and and end, product the support greatly this centimeters drug cohort greater Center. from clinical for research in TIL for that infiltrating to as number cancer. therapy focus so tumor sarcoma, treatment study this and lead X year tissue lastly, new viable activated cancers, also Our osteosarcoma in our registration collaboration, commercial modifications. a cervical diameter, and melanoma Cancer TIL development Phase enrollment lymphocytes patients far LN-XXX, including soft as genetic a of over we The the X of ovarian sarcomas use respect ovarian in XX May XXXX-XXXX Iovance. Anderson with for of with gained of expanding will indications, MD and countries XX, site currently to one shoe company-sponsored manufactured have XX clinical the to patients potential trial, it's the expanded trials utilizing may in active our of of in trial in Europe resistant worldwide treatment by with clinical LN-XXX X and improving manufacturing MD in clinical potency X study had wanted early new via patients our initiated CXXXXX metastatic studies two study, is part active approval collaborative Anderson and into The for clinical four as Gen transient sites XX sites we trial studies, screening to for of LN-XXX treat

TIL manufacturing For agonist X-XBB of of be urelumab, second a Anderson, part by improve the antibody, used collaboration as to Anderson utilization the allows different method study growth MD for with which the MD of will products.

lead LN-XXX investigating the of for have Now across the Phase and TIL trial our X for sites development of the with treatment metastatic Iovance are XX active half turning to studies; we melanoma. sponsored program sites patients over approximately

the the manufacturing costs melanoma of trial TIL study, treatment Gen X lumi has Enrollment the open support may treatment patients, in of product. with patients for the choose patient Patient manufacturing study manufacturing for our potential X for utilizing of recurrent this patients XX recurrent expanded owns a it's use all metastatic patients the our to sample the trials Gen As last carcinoma many was of duration manufacturing increased minimizes for head the for Iovance and days yield also Phase of dosing are the ongoing was registration in property to study time system Phase the associated to trials X to size and that XX receive CX-XXXX and carcinoma. metastatic Iovance from CX-XXXX, and shorter in lower you of XX the the predecessors. cryopreserve and/or method a study as process to LN-XXX. know, LN-XXX want Gen is approximately the the cell with neck, LN-XXX continuing product. X intellectual X cervical our of waits than

AstraZeneca study are is TIL also alone for patients and not cervolumab anti-PD-LX. conducting cycle who Medimmune, arm or with cell study the of prior non-small XXXX, of Iovance the of collaboration with the in February treat received part sponsored have [ph]. first activated In this The R&D TIL will cancer an lung We plus study. our was anti-PD-X

have We patients currently this sites for active four recruiting study.

development, continue is The of as work increased next-generation We the TIL our through goal well potency both TIL product. of product, research as pursuing process research. TIL on

RXI TIL SCRX-RNA X-XBB, working Pharmaceutical we We of through this agreement uses pursuit as factors with material evaluate and a the types. well genetic we'll OXXD such in changing TIL for Corporation distribution cancer works. this therapies as of end, compound have different [ph] number been potential on product the as continue development to entered adding of To co-stimulatory transfer modification or with into a of

We of agreement [ph]. license adopter also agonist through property site rights therapy in non-exclusive have intellectual an small cancer to manufacturing center for with uses X-XBB of cell obtained including urelumab TIL the

to manufacturing. wanted on turn what's also I touch ahead, I to Before

in happy Europe, is a Group, active. in BV, is are now that EU, of Netherlands, manufacturing to operational PharmaCell The in report as fully We Lonza subsidiary

in expanding adequate footprint also assure for EU patient supply enrollment. We continue to future our manufacturing

well institutions or potent more collaboration collaboration MD indications, currently studies understanding for with ahead studies indication, the new continue modification TIL broadening planning well and to TIL, including of products. remainder ongoing support in as as Looking new as the of in of relationship of Anderson, patients genetic with the as of selection our of we're XXXX, considering enrollment a [indiscernible] our expand modified TIL under

We also FDA melanoma. dialogue registration like for in would in Tim? over defining to our turn now plan with metastatic call for the discussion to continue I financials. our LN-XXX of our Tim a

Tim Morris

to million by to of was a in compared XX, of as patents. an million by you, was for metastatic XXXX of to expenses $X.X held to support quarter the count share Thank million to the million increase increase costs million $XX.X the was consulting expanded period The our and attributed filling $X initiation activities. the an $X an primarily LN-XXX additional expenses were to related At may options, increases in clinical year. enrollment, million of our cervical, million research $X.X programs, between $XX.X consultants million first quarter million, in in cash costs We were count, common of increase offset for trials head compared in of million transfer to cash increase for the quarter primarily public and for due increase These $X in melanoma, per net a cancers tech from in and and and increase last of partially in last increase million $X.XX stock comes cash, payroll million warrants of $XX.X operations March expenses and million. loss million to were payroll and costs and first $X.X $X.X to used professional this an efforts of $XXX clinical related Maria. to of due exercise manufacturing in $XXX.X and same neck million cash the due that $XXX increase XXXX. anticipate year. to LN-XXX in netted $X.X in in sites the January $X.XX net dedicated cash and trial share, XXXX. The balance increase treatment legal quarter, R&D this $X.X to the head to of attributed increase service Net be due $XX.X G&A higher XXXX, for related XXXX $X from higher Company in a increase in the attributable increase XXXX. million, balance for the loss $XXX.X clinical proceeds, equivalents, as of decrease and compares million fees or higher the the quarter, expenses per $XXX equivalents of treatment million offering $XX.X investments the the expenses offset in December clinical short-term an and for development stock and our patient million the year-end at we R&D in number The million. in cash expenses XX, as head which or of compares and

the would in over questions. New present relations the on Jefferies May Securities will for Conferences conferences Life participate operator at call turn XX. York following Conference the the on lastly, investment front, on now Science Healthcare Healthcare XXXX City; investor June XX, UBS Conference On Global Global and X, your the Company to JMP and upcoming the the June I the

Operator

comes from question Boris [Operator Cowen. Instructions] the [ph] line of Your from first

Unidentified Analyst

First, some on study I Was increased just other with or size? at to arrive analysis? the based you know FDA want did this discussion how

Maria Fardis

on was based It not discussions FDA. with

use the we patients size sample X from because thought study XX reached believe of increase do in we which cohort to our of manufacturing patients. support the so a predefined method the increase study we why we in XX we that's As protocol, registration of the to is LN-XXX, choice intend enrollment to

Unidentified Analyst

adequate are that when kind approved? discussion study agency? maybe, more answer, an the that definitive think plan amount or hear with big regulatory a for more you of with would So this is to I what get broadly; how or discuss we FDA required would be of guess, And to a the back the

Maria Fardis

planned it's final had to and this that with It's discussion the for we might that year sample and possible dialogue for will have is inform settled. once FDA, discussions this increase is thought. quarter once have not size we we further, itself XXXX It's final certainly third the a

Unidentified Analyst

can question, updates last about year studies? expect my cervical neck additional some this and when and later data for melanoma, head And we

Maria Fardis

could We indication upcoming we as part of as consider had disclosed the later to have other in and XX target, that would for as certainly well to there additional the for intend hope small we one melanoma, follow-up conferences that year, we example. is

Operator

comes of from Your Oppenheimer. from line the Mark Breidenbach next question

Mark Breidenbach

that cohort the the does what do LN-XXX Is retreatments trial, in Phase not cards retreatment cohort? for to anymore this or this X With mean the expansion going of still we in the in X? are

Maria Fardis

trying a that to They thinking the what and administration in to a more are response independent about have is patient They the original population. itself plan also other, we are to cohort want in rather independent is clarify mode much understand in patients still them get cohort that X order of retreatment an the The could of of the is X offer they deteriorating. each if patient for qualify are protocol for that exploratory in registration of terms to but their to retreated. sense arm

very But they and are late progressing For qualifies that the start a of to population make if independent that need in rapidly, all we patient ongoing, still are line X. protocol sure for other. they patient each that they cohort

Mark Breidenbach

you all U.S.? that going manufacturing, manufacturing? in is trial With will the fed manufacturing or we site or on also the sites the versus can assume support facility U.S. European started regard to European by EU now online manufacturing the And the be EU, the online that capacity to you European can comment in the

Maria Fardis

Sure.

intending drug are provide to manufacturing not patients. for various for the to right EU to in intending oceans EU patients. We cross We're order use now

certainly for is are demand supply and In terms capacity of adequate balanced the what here. capacity,

concern we patient need, enrollment capacity we that So contingency don't order and that maybe. we to for have population maybe, recognize the have currently for into If what activating backup additional we front. patient as are project we on increase is we sites a heading population in so what have plans we summer, the also we go watching forward, are adequate our are we capacity,

Mark Breidenbach

that trials readouts complete many more you sponsored any ASCO partial investigator medical being or aware run, in later the are plans or conferences for all these trials are to regard With of XXXX? at of for

Maria Fardis

as until titles under they to on decision Sure. data the we embargo and released. their Yes, certainly review submissions plan putting they out, their the remain when are definitely

but it impact F&E that on we considering data to the are maybe the until [ph] have aware year they potential part of in be might I So able proceeding. release remaining won't be confirmation of I that comment

Operator

Fargo. Your comes from next [ph] line Jim question from the of Wells

Unidentified Analyst

producing online, sites month, balance the all mean, they a hard to if With So obviously is there patient going you supply XX a just to and that that's meet -- demand. easy demand. it meet are said to be how say, for kind between one you demand of to I is

yet? you are for at [ph] stamp having risk So patients away

Maria Fardis

We it be low certainly project a don't project such should demand and a we just for standby demand, are we so much necessary. for higher ready

We rampup quickly. also and increase the project for demand being able to very

So ahead into saying on front, might scenario what manufacturing in we away. the about run we clinical that we stay well the to of trying are not we're what regions, you're They need a stay to do. that's need, turning patients talking

Unidentified Analyst

than on supplying rates; expected any now historically? -- what been have done success barriers more comment a there just run you you've into -- if can you've an lot so patients And that

Maria Fardis

Are you about manufacturing asking rate? success

Unidentified Analyst

Yes.

Maria Fardis

XX% our success improving actually had able and address do to have we proactively to around So rate in a that and have come adequate of up issues place and lot we SOPs being been so course with being and see them. what to this -- able has -- manufacturing having

success manufacturing the rate So quite high remains well remains north at XX%. of quite success rate the high,

Unidentified Analyst

you yet for orphan LN-XXX news drug you've designation; can assignment cervical, boundary on in On crossed state cervical? obviously the the two-stage whether good the

Maria Fardis

have not. We

Operator

Your from next Madhu from the Kumar comes question Riley line of B. FBR.

Madhu Kumar

will about want -- third the you about and the natural discussion is sense to do of emerges question thinking get what the of CTLA-X initial So kind an how go therapy to the that are think you that it of a mean, FDA; quarter of line when kind registrational feels which I'm with line like is, thinking of for pursue best study and I [ph]? melanoma line you this [indiscernible]. post-PD-X therapy you after

Maria Fardis

thought with FDA. as melanoma inclusion BRAF BRAF to study metastatic optimized we LN-XXX our well subsequent a have The some we ago, our based a to you criteria Certainly, subsequent fine-tuned on it that anti-PD-X, notes that had around criteria but dialogue might inclusion are not if and we preliminary only inhibitor. recall they with about mutant, therapy current have year are that patients and for as [ph] [ph] discussions

propose of that continue the of idea as to mean have a also population think with we're FDA. that criteria the pretty upcoming going inclusion that the necessarily patient discussion a subject we part them Both we about patient that's We had good is but with fast-track, FDA. part we with discussions doesn't discussion a as population; definitely of

Madhu Kumar

in And kind affect how the does cell chemo PD-X lung data in presented marked the AICR the of non-small bigger cancer? strategy

Maria Fardis

option line. seeing so that for anti-PD-X It them our seeing post all be separate offer have them number say they have front chemo certainly the of now patients to would were I and already, seen who a together. in patients

would for it would the I late option so patients, early options population to front our tough late that's a early So for I necessarily there -- good if recognized difficult, good recruit that. don't in in line population lung recognize the know patient of make we non-small lot patient was and line more cancer, matter. line, cell a and course strategy of a In pre-PDL-X, it pre-PD-X in line it very offers certainly

and seen have prior new TIL have firmly potential still immunotherapy, of has a that We the rates therapy can that melanoma remain in what does we very general great However, lines. that of our in response patients about you into all when in move are we don't Rosenberg quite earlier much of believe the indication product well. TIL seen case do excited lines think [indiscernible]

Operator

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

Biren Amin

and presented data response you've that durational earlier from get the year? we topline do neck this head data When

Maria Fardis

about, haven't that to other we remaining and intend in talked melanoma one part part what the that we do year. of for decided that's our we put quite indication be strategy So the indication publication other would of

as So on. will cut, whenever the DOR out, we put would one data report next our be part we of of that the that parameters data

Biren Amin

a where little talk accessed what their you some of can Pharma hoping about achieve then RXI to this are with compounds; And you RX-RNA bit that? you've agreement

Maria Fardis

Yes, certainly.

further TIL mentioned under further order are the we potency. research to I've in into before moving modifying front, As gain

We we from [ph], are TIL some of genetic of are get a into apostles modification, looking equilibrium shifting are and modifications. growth, various selection product looking looking maybe modifications into the we to transient into genetic different genetic

immune in of RNAi So June, looking to technology the us, we considered that's interest particular at we co-inhibitory landscape better have agreement. to PD-X regulation order be the in modifying are impacting prepare this receptors In a of the tools, scope potentially would TILs.

Operator

We questions. more no have

call attending So thank all now disconnect. for will call. The you today's

Iovance Biotherapeutics (IOVA) 10 May 182018 Q1 Earnings call transcript