IOVA - Earnings call transcript Q2 2018 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon and welcome to the Iovance Biotherapeutics Second 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 go please ahead. Sir,

Tim Morris

Executive and Thank the results recent on joining for release June Good that and the a ended find for we everyone at you, afternoon, thank XXXX iovance.com, Chief President achievements. the us our our is you Maria quarter you This press financial and Dr. afternoon, issued operator. call Fardis, Officer. on today. website could With XX, me includes which

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

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

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

Maria Fardis

Tim you, and everyone. good Thank afternoon

for global TIL During we mission patients develop efforts treatment continued therapy setting. a cancer option as toward the to in a our our quarter, second

sites LN-XXX as In Lonza, important cervical clinical trials our our the call, manufacturing an patient last first dosed trials Netherlands earlier Activated development lines And the therapy. our milestone define third support initiated sites scheduled cervical regulatory and As initiated also and lifileucel. global Spain and part lifileucel. world-wide of two technology and development the since company-sponsored of for clinical Europe. XXXX melanoma with in for to of over of executing in path melanoma our new have countries conduct to sites Kingdom. the clinical the are interaction includes and quarter known across LN-XXX Netherlands, quarter making for Hungary, this a meeting studies and indications total XXX number countries TIL that four expanding in in registration program, with the in our XX five to to the of studies have we trials into Europe, across plan, United at FDA Europe, application the participating of we increase of To effect, and melanoma clinical France, with

lifileucel additional the For updates clinical for with trials, on me program, our let ongoing start lead melanoma.

active, of is of now metastatic squamous Currently active C-XXX-XX, for have and head Phase global patients in in and sites cell Europe. global in are XX the treatment dosed which are are neck. X Patient X our in with trial U.S. the recurrent LN-XXX for of dosing XX Europe enrollment continue XX the and/or study, melanoma Phase patients of continuing carcinoma C-XXX-XX. We metastatic and the

We For sites C-XXX-XX, in carcinoma, with of EU patients first and recurrent, near-term. the ongoing. metastatic U.S. at our screening in our cervical X Phase trial the persistent have treatment actively of we anticipate patient for European or dosing LN-XXX

study MedImmune, Iovance-sponsored durvalumab. TIL cancer part collaboration in arm our non-small of the fourth patients We a with with plus cell allowing also AstraZeneca, are conducting patients of of lung treatment R&D as

treating osteosarcoma clinical cancer. manufacturing two tissue with process manufactured the Phase study, Cancer the the ovarian with With new into enroll PD-X in lung respect to PD-LX we seeking XXXX-XXXX, landscape using activated technology, still development and will studies. X the first soft X our Anderson of Center, patients clinical cancer, indications intended although patients. of part program now as TIL we sarcoma, modify we LN-XXX changes recent MD our treatment be to Given in we on expanding In for activated have to design investigating plan or collaboration platinum-resistant study naïve Gen

will antibody the discuss Anderson or will we’ll agonist to This the investigation second of the product. urelumab TIL manufacturing study, on of that of our For continue half portfolio. X-XBB method TIL like I the utilization in begin institution. for MD manufactured core would different the by and enrolling use allows patients XXXX IP of second impact to

to a number have process and I’d of applications in We patent around the Gen IP portfolio like outline X.

the method, you XX last should cryopreserved provide owns associated are process protection product. Gen ongoing rights Iovance Gen a patent As XXXX. trials of our many granted, all is our and patent that yields know, utilizing days X for the application through X manufacturing

expensive that own we were field to Our and license leader patent are advanced our patent and and NCI in program of plan, rights in therapy. the TIL from development combination lead commercialization confidence rights the our the

products TIL The well next-generation pursuing potency continue also work as through to both as increase TIL process is research goal the the until development of We our product. of research.

agonist our We of cells different OXXX X-XBB our properties have been working the on in as co-stimulatory cytokines various utilization as addition growth as well TIL modifying of or through factors, such media. the of

our continue selective with of research genetically-modified utility on also We investigation RXi efforts TIL. and of

preclinical we we the new the potential other explore and terms preclinical therapy signed in will oncolytic In indication, Roswell collaboration Under Park in collaboration, with of bladder this Comprehensive agreement indication. a June, Cancer of Center. TIL

from us a XXXX, cancer autologous U.S. May the greater treatment than was with of On years two market size orphan-drug approved, in for company exclusivity infiltrating tumor front the with granted the for provides FDA seven tumor in designation designation centimeters diameter. of the the the regulatory in lymphocytes If cervical of early orphan-drug

with of The interaction. planned preparing for to interaction are scheduled, this third is We FDA are on we and the lifileucel year. registration for track define meeting quarter path the the this in

meeting of fourth We provide in quarter this XXXX. about update further will

Cohort for and we type our our collaboration X of Anderson, meeting first planning on of lines of in XXXX, understanding medical to corporations combination the with Looking new Phase melanoma a and from in tumor in like the upcoming the and remaining ahead Tim data broaden presenting are of I standard-of-care. an at institutions turn to our of TIL order discussion MD in to XXXX. expanding earlier other and TIL remainder part patient Tim? trial academic of the financials. the of X with would now Dosing call in with relationship expanding one therapy in our utilization over indication,

Tim Morris

was six consulting increase administrative XX, higher an million quarter and compared to for clinical trial a XXXX. The of costs. company million for XX, $XX.X The primarily months were XXXX. net ended XXXX, patient to period expenses were the share Net and and higher for was property costs million XXXX. intellectual increase $X in and attributed XXXX, of second quarter were The General you, and was and and an million million cost. related increase increase increase payroll development $XX.X $XXX.X ended share for million compared per for $XX.X XXXX. expenses second increase administrative a million, clinical $X.XX the $XX.X headcount Research was and same increase XXXX, this driven of primarily million and same to XX, XXXX, expenses and XXXX million in to expenses in Thank headcount development or primarily $XX.X an increase research six million million in increase legal at XXXX. the equivalents, compared held the million and General increase the million, compared million loss million compared second the by primarily $XXX.X increase The development an an $XX.X $X.X in loss the June attributable a sites. increase for an June XX, expenses for or June the in compared to XXXX, an $XX.X quarter million, compares to to XX, to was in trial expenses of investments, XXXX. XX, due ended period Maria. the in clinical was cash short-term period $X.X attributable for $X.X $XX.X in of million June research number increase for to to or the second per were quarter expenses. $X.XX quarter expenses in and XXXX million cash, second $X.XX and million $X.X for March for ended a in XXXX. months loss months $X.X net per in share, quarter $XX.X increase development $XX.X June the million expenses of same At loss share, headcount Net to million a $XX.X second or a to $X.XX $X.X Research increased six of for the per attributed $X.X enrollment the

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

your for operator Now the I’ll to the call over back turn questions.

Operator

Instructions] Thank is you. Cowen. from question Peaker [Operator with first Boris Our

Your line is open.

Boris Peaker

Great.

the melanoma. the are maybe with just And anticipate soon. know take? supposed that I'm curious, meet for with in start I I’ll long with assumption would XX target But you're for your sites FDA enrollment? internal the target So how enrolling, that do what you study pivotal to

Maria Fardis

a for Boris sample of the you, size Thank the discussion FDA. question. The subject be would with

numbers we would we before accelerate of active to not – but I having proposal to be sites that fairly from agreement purpose the have So of see able we this we agency a that and a provide certainly quickly. the if those them. hit was put get today, have agree can a enrollment specific that guidance number to

Boris Peaker

you. Got

So learn in with what post-feedback we this XQ from the timeline FDA?

Maria Fardis

That’s guidance, our have if we intent yes. clear

Boris Peaker

to my just year? any other or do what SITC later last meeting anticipate data see maybe question, we this or And ESMO, Great. at

Maria Fardis

something seek typical response well. present. It would response well, have depth able would response of the of long waterfall we data this of stage be that and duration some that Biomarkers study might how be on, the would typical might be the could to patients at the be would sort the be of been as interest overall rate, those shows any that as of

Boris Peaker

could meeting you'll that now, where But any data? comment presenting right you be specific

Maria Fardis

our commented haven't in the is this remaining venue, it we XXXX of on So target. still would specific part be

Boris Peaker

my thank you. questions. for you Got Great, taking

Maria Fardis

you. Thank

Operator

Thank you.

Mark question next from Oppenheimer. with Our is Breidenbach

Your line is open.

Mark Breidenbach

are expand taking I what being naïve I If say PD-X was the be can going Maria. changes you're you Hi, for more to just changes on targeting I if could little made? lung you patients. trial still the bit to a so, Thanks think the protocol? that little on expand questions. you a bit cancer wondering heard

Maria Fardis

Hi one Sure. a itself study and initially another durvalumab was cohort randomized with TIL plus study and The TIL Mark. cohort. alone

shift, strong do What ASCO in remove response patients. the plus alone to trying fairly checkpoint with chemotherapy TIL potentially landscape cohort early-line to the showing of to we trying we're are Given as encourage enrollment. is

Mark Breidenbach

it, perspective the similar the of FDA from was conceptually And to into a in discussions a your or as view the to think and database. got FDA you sounds do regard group products? separate products you the enough Gen it, wondering and view with would Got safety for LN-XXX, X think just entirely I good. that LN-XXX these Gen X they Do BLA filing together two as with

Maria Fardis

would That’s early this is want question. number to the typically good of patients visibility studies we pre-BLA of to a well to FDA if other all And typically to have with therapies. ongoing. other again And that's do these agency. have studies as studies pull because compared highlight that as I cell subject like meeting respectable But you a dialogue. other together, to very and in a

a have of safety I concern don't set. in So terms

sufficient numbers the will to you provide have agency. think I to

Mark Breidenbach

in is arm trials just there using the trials rationale conducting TIL. One the they're extra are one MD know What's just I two as and final one having one And from basically, indications. same at opposed Anderson's one me, behind in to TIL, an separate two is your using trial? MD Anderson Okay.

Maria Fardis

Correct.

be and to particular wanted different separately. So slightly two there report products, able are them we to

fact, have a agencies. As be summarized a the of and that might matter study it's provided BLA. need The the LN-XXX to to time to might

having them else. operational So separated. anything than in more there are It's some benefits

Mark Breidenbach

Okay, all Thanks me. it the right. for question. That’s from taking

Maria Fardis

you, Sure. Thank Mark.

Operator

you. Thank

with Our from next is Amusa question Chardan. Gbola

Your line open. is

Gbola Amusa

more about Hi, thanks that the wanted your set of I terms time perspective a in for last taking can process And from that understand to questions. kind just my a you call. product? is the first question. MD little any or is TIL of of manufacturing And related Anderson And metrics? to the compares Center? I’ve regulators' process different two bit sets to considered that Cancer confirm how from other the relevant a

Maria Fardis

Gen that process We're claim to MD process the same not to to analogue our as our more on planning Their in is their fact, Anderson. making process is And the closest similar X. on they is their model, the process. publication and times, is is NCI in-process recently also, they And banking tumor used There method. an called a cryopreservation. a at put out what have

detail, difference Gbola. won't our go X their into Gen there and a process I but too process, So much is between

Gbola Amusa

Okay, great. there bladder are obviously, likely subpopulations with more cancer specific the to sense program other but in updates that then, then target the preclinical and the intrigued make on treat And are there any by cancers, there TILs?

Maria Fardis

strategy general been that has mutational from spectrum, load looking article starting immunogenic. diseases the at have also are might high you seen our you a end diseases highly So at that of are Schreiber look the and

of fits is looking very at When TIL that of manufactured. of activity to criteria at interfere start how investigating of description sort bladder that always they activity TIL, TIL, So our well. indication the is we that the properties first look on growth the

that very them this at direction. look we So and step first the in carefully, is

set who a always bladder looking are institution order in may at with we we be for So to that, agreement preclinical an us interested. and up do

Gbola Amusa

Okay.

how to might at bladder go it be determined let's is broad cancer, that So this you for how say, indication broad, remains point? that

Maria Fardis

that's a statement. Yes, That's statement. a fair fair

Gbola Amusa

you. great. Okay, Thank

Maria Fardis

Thank you.

Operator

you. Thank

Our from next Jefferies. with question Amin is Biren

Your is line open.

Biren Amin

QX Thanks for the And guys. share expect you data when to go with hi, before taking you FDA have wait the the also of on meeting? you my disclose Yes, we minutes to questions. meeting? should you for would and hope that details Maria, do what

Maria Fardis

Let agency. cut the question your as would minutes to yes, the of the disclose before answer outcome the late data course, and provided have we to we the like that, wait me I for possible the degree as public. to second could We, we to

could them. we provide most to that's So mature data the

Biren Amin

program? then are And planning European you regarding it. to with this the Medicines speak also Agency Got

Maria Fardis

European well. We health our to expanded strategy our trials authority EU part intend in a actually That's had This EU we a have interaction with why as of we the yes. clinical well. as and upon year, local certainly into last that expand region, is

Biren Amin

us that trial the And on of a I second that move study? give on can into can the cervical, status And then, guess, we you just when trial? to have expect stage

Maria Fardis

study so what have noticed were population treatment-exposed. enrolled is highly patients, we that refractory were cervical the Yes, the that patient very, very into

We have exposed have are that therapies ideally anti-PD-X. since that patients one three prior protocol the to they prior to and amended not to include

are So we are NCI that similar to hoping population. to the get more goal. our patients That's patient

Biren Amin

it, Got you. thank

Tim Morris

Sure.

Operator

you. Thank

Our next question Kumar B. Madhu with from is Riley FBR.

is open. line Your

Madhu Kumar

questions. my Yes, thanks for taking

on check you what would kind one line of with So my your the do has discussions initial to with FDA? first melanoma in post brain likely focus

Maria Fardis

nothing are and BRAF they that a for inhibitor if unmet post-anti-PD-X, them. medical mutation, post-BRAF patients clear So have are need, approved there is

mean, three enrolled would We a I that on and also have up would the meeting. this to that – subject question to would population like the out obviously also – is discussion label, patients I therapies. I'd at up we median a end patient pre-BLA end But are the – as that of point it's what prior

patient enrolled unmet and more we patient defining that What was one protocol the the time is I post-PD-X combination that medical just highlight the population as what in BRAF what up well criteria ends of be inclusion post-BRAF to the label. need want inhibitor. if patients, our mutant, population So as would

Madhu Kumar

so are there Yes, with post-PD-X, trials are in going while this Phase proofs there post-PD-X are there obviously Okay. X several setting. on that no

with So some guide what you even would of run guide either path? from or potential accelerated clinical kind the these have can to gain your existing trials confirmatory approval trial we discussion

Maria Fardis

indications as would both the accelerated they to more full same other an there two single-arm – of to requirement this a highlight trial. received heme, the have with the in on a And on a need a for approval – be approval have just X approval not had full for a have label. in trial, I therapies is So if They the Phase to that like that cell doesn't other and that discussion, your Phase path of confirmatory initial also received is the indication context approval. regulatory the use full be Phase to X to that U.S. approval for receive X

outcome them. companies' particularly other So negotiations that of agency I'm the pleased SBIR with are subject to negotiations see has to open-minded, the these very with and been

Madhu Kumar

So where of that's you therapy, there kind then are of interesting. evaluated cell versus how your is space differentiation be operating you're kind the think indication technology is drugs more of in? a that to going the guider Do

Maria Fardis

your you I'm not Would sure, mind little if I Madhu. rewording bit? question, understand it a

Madhu Kumar

Sure.

how So on trials studying you approval melanoma, discussed single-arm on got Phase like in other kind some know X Phase post-PD-X study. against competing the CAR – drugs We T full companies existing got agents. approval of X

to approval, mentioned, shorter drugs advantage other is, open have the you over of for kind And therapy as kind cell setting? have – kind so that tumor that's ultimately, I time more this is technologies solid question an T Schreiber of of does in is the might frame

Maria Fardis

SBIR comment what of may I both BLAs the All I Kymriah. do as highlighting two future. they on was certainly were well therapies, in can't the for receptive that as was Yescarta cell last two particularly

I'm to would to what an well So is approval discussion. into program of all that they have X as I discussion confirmatory be open path meeting that as pre-BLA subjects terms exactly end And a accelerated as be dialogue. think see been that pleased well an as turning for to what Phase would that

to post-marketing requirement. I FDA we open-minded all open, to of be is have asking very be remain pre-submission both their a think So that sort rights within or

Madhu Kumar

you landscape in think first One last treatment approvals for so the space? one, the the of has checkpoint with cancer drugs cervical do the how changed

Maria Fardis

you. Thank very Yes, good.

the therefore So agency patient PD-X were that open. remains as from approval, an cervical population It received and that that population particular high-expressors in well patient regulatory the post-chemotherapy. and door as for approval product, Kymriah, the accelerated just was

Madhu Kumar

you. Thank great. Okay,

its think I not Keytruda, Kymriah.

Operator

you. Thank

with is Birchenough Jim question Fargo. Our Wells from next

line is open. Your

Nick Abbott

afternoon. this for Good afternoon. It's Nick in Jim

in obviously, criteria So Phase in trial, head neck met maybe so stage criteria simultaneous of off terms we and while should that the of that XXXX in for another Maria, type X a meeting expect end first the the back, program?

Maria Fardis

Nick. Hi, the you for question. Thank

and are enrolling, superiority are looking enough in we line in. continue is at that – at we assure data to there We certainly that the and

As you had might recall, of patient we prior four the population median a therapies. had

further even patients melanoma along than there our progress – So are. more were progress

really It that comment. data, and the cannot to we're I data. So monitor on continuing depends

Nick Abbott

of have that trials, And restricted obviously, in you. traditionally just two and back thank to they this a the prepared to trials number in Anderson Okay, the you to platinum-refractory enrollment. of sites going and running very then well? run sarcomas terms going their ovarian, you're their across would MD out trial. sites runs number be roll as obviously, own Is trial of the clinical

Maria Fardis

manufacturing, at have Anderson now. Both clinical collaboration around as preclinical well which which studies have to two conducted should that agreement, studies the alone of as MD are with prove method part This includes a of them, better. be is broader IP certain being for to we their rights access agreement,

So MD currently, are for Anderson both planned studies the alone.

also And subject fast arise. we are this have get time At certain just enough, need to they We moment, are the approach and frame is we the them activated enroll not that should them if that. can around able started. trying to

Nick Abbott

in of expand you this on Okay, as then just And you. please? of lines sense. think okay. milestone treatment prepared your TIL half early the comments year, that, you of I terms looking second makes mentioned forward, can in the a Thank for study That in

Maria Fardis

move broader potentially is TIL are an this certainly. part we that to undertaking And line. how earlier can our Yes, about of we thinking

have started earlier already looking line. additional and indications in be setting, the also within We at will lung in we

provided TIL the potentially move speak information I much we with and care. to but provided really all to line during But not earlier have in is can the call to. in We combination available I that information, intend

Nick Abbott

much. very you Thank great. Okay,

Maria Fardis

Sure.

Operator

joining I'm call. to further for Have would Everyone day. Thank showing today's you. I questions. thank And like may disconnect. great a no everyone

Iovance Biotherapeutics (IOVA) 6 Aug 182018 Q2 Earnings call transcript