IOVA - Earnings call transcript Q2 2019 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon, and welcome to the Iovance Biotherapeutics Second 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,

Timothy Morris

a afternoon, Finckenstein, includes Good you me and Maria which on can Chief Dr. release President Operator. joining This Fardis, you well update. for results the us. our and Officer. Friedrich and Officer; With of press the at as XXXX company on as website that Executive Chief afternoon, issued we you, iovance.com, financial Medical thank everyone for find our our second Thank quarter call the is

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

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

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

to will over the call that, I With pass Maria.

Maria Fardis

you, and Thank afternoon, Tim, everyone. good

continues Iovance excellent development in TIL make progress therapy. of to

with excited to achievements. to first therapy the We market potentially I’d briefly tumors. company TIL for bringing to are highlight become a recent patients solid like products few

study. as have in duration the were show of rates results in limit we Oncology that a that ASCO both of stage options not patient cancer Clinical to in improvements benefit Society yet either or therapy take or results response results reported median The the from encouraging at our we Meeting. stage observed metastatic First cancer therapy long-term potential is American treatment June late advanced cervical melanoma showed reported response available cervical TIL relative ongoing TIL the studies the melanoma of of Annual also and objective and represent late The on populations.

TIL build commercial therapy in began to broadly manufacturing entered to in long to and In facility Second, construction. May, we production capabilities a accessible expand into a working to patients. scale our we agreement we to meet June prepare Philadelphia are lease term

cancer is pace. accelerated an Third, moving forward program our cervical and

from We received and XXXX. a are TIL or late plan BLA LN-XXX Therapy now we biologics designation extremely to therapy, submit for LN-XXX to license a FDA Breakthrough have application pleased for in

Now I of continue corporate an further update program activities provide potentially detail we to discuss will in broad the prepare these development cell on evaluate and our as commercialize potential while clinic. therapy in we to

with we metastatic and Our well. Rate melanomaC-XXX-XX ASCO The of Objective of Response ORR lifileucel shows progressing demonstrated the new of patients. has lifileucel important potential pivotal the that Response therapy rate strong an population treatment are or TIL in is results study which presented typically XX% treatment for at patient patients. a for XX XX%, lifileucel and option treatment means current X% an become to these between in that

median Response continues As durable we of had the been not a appear make data to Median one-time know responses Duration DOR that X.X-months treatment. At or the reached. sure follow-up, following

BLA a of end lifileucel submission expect to for continue We by XXXX.

study X% line These early reported progress ASCO is results seeing rate At XX%. demonstrating ORR chemotherapy an chemotherapy results We approximately available in very cervical population the patients of cancer this to advanced of of pleased response metastatic with have LN-XXX are includes cancerC-XXX-XX. our the cervical XX%. encouraging, care second that for patients we therapy are highly XX in TIL patient in

we from FDA, support ongoing that not June maybe median Breakthrough been LN-XXX the Responses met X.X study the of noted In the designation the DOR of to with follow-up. had maybe durable reached as median XXXX, sufficient months Therapy at received LN-XXX In C-XXX-XX May, LN-XXX to Iovance registration for agency of FDA.

our which using submission regulatory is enabling a pivotal for registration now plan to ongoing program. us study allow developments These

have recently or the for have plan in patients patients of to We progressed XX. who We number metastatic the disease. to include therapy the of BLA recurrent systemic to increase following protocol amended an issue

the believe addition with the TIL late a stage to observed TIL patients impressive therapy potential may we of in results there disease, we treatment. stages that therapy at patients with for clear have In of treatment be in also earlier

enrolling melanoma of patients neck Our including PD-X with are experienced naïve In evaluation study, the inhibitor is of with a LN-XXX basket we treatment in naïve therapy. patients head checkpoint several who evaluating stages inhibitors. of combination population therapy involved PD-X This have IOV-COM-XXX, and at cancers. early disease not currently are our TIL in patients study indications to or patients pembrolizumab with that

the announced to pembrolizumab. This we cohort arm of added combination indication patients treatment April, with will cell a allow basket lung and of of that a now PDL-X cancer be new non-small study LN-XXX with naïve active. for In is

the in Beyond hematologic we TIL cancers. our see for treatment solid tumors also technology of platform potential

University lymphocyte PBL the working cell State we comprehensive the on called of or a for blood part Ohio are peripheral product center, develop indications As collaboration, hematologic therapy. to therapy cancer

chronic the of different CAR-T Hematology and advanced leukemia. multiple targeting that IOV-XXXX and the a PDL described also EHA results At therapy manufacturing patient they lymphocytic than European or study the with preclinical as associated Association the the disease. called for are research Congress our are treatment approach antigens in PDL June, in

of its one cells targets antigen therapy with CAR-T CDXX. tumor

We of have PDL the nine no cells only use grow days. demonstrated blood from milliliters in for ability XX therapeutics to

the to plan disease for treatment. in begin has our of that patients development is Our progressed following the CLO in clinical population

IND before the application We of expect to file on on drug an year XXXX. end investigation an new

of pursue to further with improved TIL products developing refine continue of commercial therapy efficacy. goal also that may therapy TIL have the opportunities generations methods We to

of TIL to therapy that profile. these approaches good to investigate of with One a to believes Iovance potency safety refinement offer methods of selection is this may approach improved TIL paired therapy.

XXXX, Montreal Centre In entered CHUM a Two conduct are clinical which the of selected to CHUM. internal direction study with lymphocyte TIL. an agreed tumor-infiltrating collaboration pursued being into collaboration or PD-X has July projects we therefore a or well PD-X positive Health with as positive with this in program University

represents look with this our into expansion collaboration. initiation forward CHUM agreement addition In We Canada. to of this

We potential also for and commercialization. as infrastructure our corporate build we prepare continue regulatory to submissions

We Board Medical expanded and team management Dr. Directors. Graf Chief of our by expanded adding Officer our Friedrich our Finckenstein, have

have our manufacturing current We have at now dosed increased capacity with patients our XXX CMO over and Iovance.

facility a broad be We pleased production into Philadelphia support have clinical are used in therapy. entered facility will for located to to commercial our own to for TIL lease manufacturing long-term This product. access TIL and autologous of agreement

of composition portfolio or of granted our related expanded property seven allowed and recently the use technology. treatment to also methods with have intellectual TIL We patents U.S. for

Security New Conference few including forward Regenerative next in in and Cantor for the the we Conference in the Cell Alliance Global New the Gene at Boston, Healthcare In California Conference Healthcare presenting months, to & Meeting Mesa Global look several York, York. [indiscernible] Medicine Wells Fargo in conferences in

Finally that for our we in product approval strong, cervical in financial both our advance position late for advanced we is studies and operating and melanoma sufficient have file believe complete capital regulatory pivotal to XXXX. cancer

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

Timothy Morris

Maria. you, Thank

last as for quarter for BLA or year. The million to loss was enrollment a $XX.X of our all these share few release financial and news the through second XXXX quarter share million results. eventually my address due the compared net than $XX.X $X.XX for read the in quarterly will or to was as details highlights. last comments filings quarter increase second per commercialization. higher prepare of a in we contains loss Net net per loss the the Rather Our pivotal compared details spending study continue $X.XX year for to

expenses XX in XXXX, end in patent estate research Europe. spending had and at worldwide, additions an increase higher June to compared XX, and and in both to increased the are on At approximately G&A. market manufacturing approximately Specific we employees both IP the and U.S. XXX increased to as due the in capacity for portfolio headcount U.S. melanoma and R&D cervical, quarter

Research expenses million million million had were second to XXXX an quarter second $XX.X the increase second as an $X.X to quarter the XX.X second compared XXXX. of XXXX. for the million million the for General $X.X for increase quarter were and million development administrative and of compared expenses $XX.X for quarter $XX.X we

Enrollment in as the compared increased first study year. and melanoma and to over quarter year this has last cervical the pivotal

capacity manufacturing this enrollment. increased to have support We

programs We these the XXXX. also level spending filings XXXX added headcount is will anticipate level and studies pivotal the that enrollment BLA in begun in pre-commercial for late in continue this anticipation basis completed. on activity second until the of quarter a quarterly at We for

June to capacity. compared Net in net to loss new for a or the employees, six of discussed first period $X.XX or the million June per loss market of XX, $XX.X for the $XX.X share is was million half XX, of for for the $X.XX ended months as share loss to due ended XXXX. compared XXXX reasons per net an XXXX IP The first XXXX additional manufacturing above half research, increase the

General million million for half development period million of to and the to in same were same million increase million XXXX Research first expenses of the $XX.X increase for administrative period X.X million expenses XXXX $XX.X in and compared $XX.X first half compared of were and $XX.X of $XX.X the ended for and for XXXX. XXXX. the

March $XXX equivalents, XXXX XX, had cash the million XX, and June cash to investments in cash, compared held we short-term million $XXX restricted At at company XXXX. as that

for million activities. year-end between million. second and The cash the operating During $XX be cash, may company million balance used restricted anticipates equivalents, of the the quarter cash and short-term $XXX investments that company $XXX

the back operator will turn I your to now call questions over the for

Operator

from we have Instructions] question Mark Oppenheimer. For Breidenbach first [Operator your

Your line is now open.

Mark Breidenbach

thanks very Congrats rapid this on questions. taking for progress the and

Do that filings Just end tell? going this about either to be had to the melanoma both would If first ready too cervical. early they relative do at be point you of or XXXX? for to timing sound guess you one which they'd BLA are come could timing you like first of one towards versus

Maria Fardis

if work their is line dialogue. Hi, sample sure are We are I think with FDA question, want continue for the with you Mark numbers. can we I that know cervical to we to to that highlight continuing the I say do We don’t assure expectations. yet. quite close to fairly that also make necessarily want thank with size we in our

a we them. other good might is that that can XXXX of is which very want or that month of chance put combine a we two asks or within them each us agency to there frankly sort I so tell to late why combine and

that them filed. could XXXX both I of possibly late around Somewhere be think

Mark Breidenbach

accommodate? question us you this remind any facility can facility. when was you indication in timing can to fully manufacturing us per another respect just new year recently operational doses also and or have to you terms started for of batches And given of capacity be relatively the with Obviously it on expect construction number it

Maria Fardis

it the two expected have to this the expectation of of is of then can a is that patients two also to facility thousands up. be we initial the our facility can half about supported operational and or operational supporting year Yes, subsequent of design It that a in butterfly be expected sense our through opened years facility. in rest commercialization. to get is And the

So of necessary. capable as capacity increasing it's

Mark Breidenbach

so agreements before your by And manufacturers? but that’s approved in supported operational products have they meantime, if the with you third-party will be

Maria Fardis

That’s exactly while our be done CMOs so right, get plan manufacturing ready. facility the initial could existing through

Mark Breidenbach

presented plans And reviews initial just or at and cervical X responses you one of to from any data that Cohort okay, me that's trial independent from blinded ASCO? the conduct one melanoma internally the either last if

Maria Fardis

part maybe the can in likely that has anything study agency done forward the is I pivotal a not second the easily, setting. be will now more agreed going answer public

publication. something initially is X disclosed data will probably read So on Cohort we the FDA BIRC just by that make will very further to before clear BIRC. sure with be our we that have working a are BIRC process but cervical be to

that commitment Cohort in a We disclosing just given FDA that that made have X front is yes are well. a of data we supportive not of from perspective, working but as timing

Mark Breidenbach

congrats questions progress, Okay, fantastic taking again the all and the on thanks for

Maria Fardis

Mark. you, Thank

Operator

is from Amin Jefferies. from question next Your Biren

Your line open. is

Biren Amin

I disease? cervical very the XX taking patients for maybe presented could you you presented patients of who advanced had will on the said counted at Maria I have that previously not may that - pivotal the if you Thanks have because cohort towards be many just at that few cancer were ASCO. the How meeting trial, questions. may a think my start

Maria Fardis

we intent Almost all down, study when to very would little should have provide not broken as a noted FDA that pivotal release I’ve data first. really we we is qualify, to data,

with all we would qualify new this down definition. therapy not by line So have patient population broken specific of but it of them almost

Biren Amin

I want you enrollment, because patients with timelines, release XX press ask on around XX and previously your sample believe previously And think I its you should be commented now to cervical just then was size line in that just to XXX that the FDA it in patients. just a tightened

guess modification? I So drove this what

Maria Fardis

with to XX the continue in be alignment. we that FDA the sure the meantime, We we In complete itself dialogue and had there. want have study

So so dialogue. XX we sure that’s have it we be FDA, while continue we runway that with wanted continued amended enough discussion to the to we the why we while

Biren Amin

XXXX? And Okay. noticed one that the cervical timelines may with QX, cohort XXXX melanoma to enrollment overlapping then plan maybe QX we I across complete should cohort have indications, the you both complete more, assume you that in and in given enrollment for

Maria Fardis

the I XX but high size, the dialogue depends or a on Biren, assumption level completion expectation of to our we completion did with that FDA. are they reason pursuing agree with think right that with it do again, has of but discussion now, whether agency the sample with it It’s our

Operator

is Kumar question R.W. Baird. next from Madhu from Your

open. Your is line

Madhu Kumar

administration oncologist a So approved think and what of versus in it's of high-dose the one the and thing part the a is technologies, upon IL-X been through use standard the duration will TIL don't physicians when of on of procedure usage? feedback research, to as than of IL-X method dosing even the education to use between kind so consider you physicians lot has you kind perspective the market we've of the do of of IL-X use been they talk kind what degree at how your of thinking about improving if different rely in occur kind

Maria Fardis

Thank one before The Maybe melanoma couple hustle of sort about X. median of experience. doses and you, was cervical X.X a Madhu. points of for talking one number and the was

IL-X tolerance hospital both of be the didn't as the well infrastructure. patients perspective administration issue an to So seem as for

of It’s the hospitals many type or five in are as years note hospital clinical using XXX these past our we sites already important have we has all about the at years. more been that trials fact sites in that so setting ago. and have XXX or for of been been At in sites IL-X just different about IL-X as five of IL-X using late and footprint most

they So lot a IL-X most hospitals comfortable with of of staff there’s trained administered are at and the that it. have

come no into issue and us. most to also administration site for of as run IL-X as where IL-X.We well, really been help we issue any to staff have trained so support that want showstopper that an seems that training a had to terms training staff that not refreshments have with administration. definitely of hospitals on that we So hasn’t an up activate in the It of they had really in the a we're

Madhu Kumar

anything speak the any clinical the any next ongoing other or And there expectations mean, you then year from six next fast my is reasonable, be XX for over data in can't there to obviously data question that months would be would so? more hard are but I and programs

Maria Fardis

the studies We indications programs. information do any X or have Cohort ongoing. two have other new code data is Yes. pivotal if other certainly all on there be to beside We shared

I we of you we particularly So that’s months like not to excluded to data have it. that haven’t trying some there was helped when at the a but anything put out, look XX guess timeframe, possibility committed more

Madhu Kumar

you from Cohort you information, said, have new cohort? as melanoma you When if X there define information data is point. last that on new would up that follow Okay, more a additional what

Maria Fardis

further a have reached biomarkers a specific is is investigation appearing define that upon we at if maybe we two least that of of at. we example, couple are different for things example, clonality all can distribution DOR cervical I directions or of about of cervical, exciting looking for interesting the continue have case the those that of still of even clonality in thinking

is in of conferences. maybe institutions a in data, what for is much hearing interested There sort investor in brand available are various venues may well the I data new the very research combination more of of interested them. community be academic that as interested know as putting details out how in about the coming are directions

be respective to published a is deal that that something have different conference just than The before. we may more ORR

disclose there needs a be is as well there are new feel But venue data. where could to definitely other our them we day. We Cohort X we and the a think that to every in out. ongoing exciting So is indications investigation appropriate as we something learn that about information put

Madhu Kumar

the of absence because the has Cohort X then - [indiscernible] DOR we X this that would not haven’t recently opt below been the DOR corollary reached? Cohort

Maria Fardis

a that and a vis-à-vis also enough conference adding into to could DOR not It adequate just have was conference seen the did considered might conference. get

So it. into read much wouldn't too I

Operator

is question Piper next Jaffray. from Joe Catanzaro Your of

open is line Your

Joe Catanzaro

Maybe more and differently little a just about thinking near I’ll follow-up ask and disclosure. question data term the

you deadline today believe to is I regular [SIPSI] abstract for guys submission anything actually the So submitted have SIPSI?

Maria Fardis

comment on what titles itself released. abstract intended we or is to I usually don't submit we or submitted until have

I Joe, the we to wait until out. titles okay. what if We’ll prefer we Sorry, come talk that’s can know that

Joe Catanzaro

Fair enough.

question, lines I maybe Just thought that believe X? that. the is melanoma interim taking if Cohort My cervical later interim I'd then into of agree so look lower that Was opportunity a an ask. to had idea an intervals FDA as to built the your take would down look you at whether year along you Cohort next mentioned confidence XX% similar in there hurdle? last believe will exceed X ever those And

Maria Fardis

for Yes, time. a moment we about it just in think

we potentially think multiple to is of a all on data. not the prefer I component them package cervical cost have becoming this of together that transfer as to

and at the the totality studies data. provide a So both us. would if preferred same of path for the read time be me be for would of to more today’s studies, with can That try and we the see cohorts preference FDA both

Joe Catanzaro

maybe just I And involvement one wondering more the one you've data since noticed disclosure? if any cervical your pickup then trial here. am into quick ASCO

Maria Fardis

we patients study so coming our and going, increased weighs operations enthusiasm. see In seen definitely of the typically we’ve

think generally TIL reflective been in a one made is the that increase lot say. enthusiasm I of our of that our can recently in spend have points increase program I R&D. There entire more Tim in

Joe Catanzaro

the same I’ll and in had one the with still I squeeze regards there trial. know in neck you guys know maybe lines the struggle some I here enrollment more And head the wondering seeing of to window along days Okay. it's in have just and just so head right the around early extension label comments am if you what any KEYTRUDA short. recent I just line is the neck front and in setting, you're now?

Maria Fardis

seen we very hopefully of and and observation. ideally third opposed good head the line or the and coming that point. at the as the line the have to when study late Yes, was for I for fourth patients that chemo front neck would line are changing immunotherapy in I to agree have quite patients better the is believe landscape patients, patients then hopefully

are So a in to landscape we to see as is beginning that that is pattern. it in But see beginning meaningful shift that early we are you yes, trend, noted, way. although it

Operator

is from [indiscernible]. question next Your

line open. is Your

Unidentified Analyst

Congrats again on the progress question. and thanks for taking my

then after? you’re theme speak bit follow-up So for filing kind there to extent and melanoma the two Could a overlap of programs same searching is making that a you I and kinds BLA for the of place. in the potential the on have and for filing for what the preparation with cervical

Maria Fardis

you I a question. [indiscernible] organization that It’s understood kind going for asking to of I but through you, are what anticipation your filing? Thank preparation you, little the think hard is in for hear

Unidentified Analyst

Yes.

Maria Fardis

maybe a perspective about as infrastructure to organization year quite both - growth procedurally from and that a there next an both thinking through you, long-term Thank short-term filing has an a go well perspective. is as and that - bit from

access, that different procedural of members documents to undertaken. put So you imagine medical commercial place. be hiring be is had And in need needs a finalized, perspective to be market can research team from being affairs need to the expanded, various including market in lot

many well activities those of filing track amount initiation significant works as potential certainly of of of a as anticipation a for are we And undertaken So stream. are in commercialization. both on

Unidentified Analyst

there sense next towards a Is on And then visibility kind Great. Europe kind Europe two programs regulatory separately? putting in together plans in of U.S. path them of advance terms might of versus of there the that U.S. consideration the mentioned in you’ve the that on steps are be different the that or now and might the we have a together horizon. any for that the is whether what some you further

Maria Fardis

second It’s protocol in in the so agreement we when on but a we we before agreement to FDA been cervical the our sample thinking procedure, Definitely, one It’s at very size we of more authority of that to easier wrap much discussion always a before go want have around we we engage around least about up our the EMA. EMA have centralized health all sure authority. make set horizon. health engaging

fairly in are more we clinical our likely footprint we of but And fact this we and broad XXXX. procedure that the part for about think earlier a that’s towards excited very later have year of centralized a part in Europe, program

Operator

Your is Boris next Peaker from Cowen. from question

is line open. Your

Boris Peaker

at question - patients FDA that am some specific first we of ASCO? to the on cervical ended I see criteria the pivotal enrollment excluding that in saw want the is ask up curious indication. the study that want just So patient what I

Maria Fardis

have Our setting, in the everybody initial a of therapy while these who setting. patients a metastatic systemic systemic patients seen prior one are received bulk metastatic criteria has enrollment was necessarily therapy. not in And

that they So seen that have the discussion definition FDA was a the assure was with clarity. therapy one in that metastatic to tighter setting after systemic the their prior little

Boris Peaker

And non-systemic that adjuvant surgery just means just it is is? treatment that what what’s localize therapy a without

Maria Fardis

for or could radiotherapy a It been localize can surgery therapy. with combined systemic be example it in setting surgery along have A be for curative therapy applied a example. could with

curative not setting. the and So is here stay in definition in the metastatic setting the

Boris Peaker

and for involved your about facility, question you My manufacturing? becomes manufacturing it or break of kind you in on ends and two that Lonza operational is outlined when still time years. be own Would will is relationship any off next of once you’ve the on Lonza way

Maria Fardis

Thank that. you for

Lonza EU. manufacturer in is So our

your question presume may if So rephrase I you’re asking about [WuXi]? I

Boris Peaker

Yes that’s that’s the sorry, I forgot U.S. right? for

Maria Fardis

to it Sure. tech helpful with for relationship our WuXi. our and particularly the We continue process transfer, development clinical program. intend WE find

as initial now for They to program them that and commercial don't relationship. discontinue development cover that program see I landscape see have will engaged just is stay commercialization no because it. there I Iovance will landscape their are as for with like of ending well. So commercial we reason us behind our would I a we always this

Operator

we no now As for like closing would more we have questions, to return to remarks. Maria Fardis

Maria Fardis

you, Thank Operator.

glad We individuals reflect dedicated would employees, sincere many our are the to to have our opportunity on We our work like and extend support patients, appreciation our progress. to this for talented including who shareholders, and our us therapy. researchers investigators studies for us working refine Operator? you to on already call this clinical And their TIL of today. thank all in ongoing application with of joining partners you institutions at

Operator

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

now may disconnect. You

Iovance Biotherapeutics (IOVA) 1 Aug 192019 Q2 Earnings call transcript