IOVA - Earnings call transcript Q3 2017 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon and welcome to the Iovance Biotherapeutics Third Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks, we will open the call for your questions. Please be advised that this call is being recorded at the company's request. At this time, I would like to turn the conference over to Tim Morris, Chief Financial Officer at Iovance. ahead. go please Sir,

Tim Morris

Good and Amanda. joining you us today. afternoon, you, thank everyone, for Thank

you other joined President the know, in of Igor and many As I and Officer; this Maria our Dr. With Chief Dr. includes you topics Executive the August our our Iovance year. website on Clinical me afternoon, issued are we find discuss on Vice for to Science. plan highlights call Gorbatchevsky, a iovance.com we Fardis, President of of could the which on This quarter, results, and press CFO release that as call. financial at today's

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

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

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

Maria Fardis

Thank you, Tim. Good afternoon everyone.

joined was few to the financing in He the biotech let Tim expand of roles. us public for in that details companies that As helping as quarter. closed will CFO. moments review finance $XX I on complete in we then of experience business over the results million a in and financial he team development around the September. offering Tim Tim mentioned, at August in Iovance decades comes to two Iovance instrumental and executive

progress the During TIL quarter, therapy. we of our our in the development continued clinical third

that the this generation process Patients melanoma as patients first recall, in ASCO may earlier cohort as process second to XX received This of X first from data cohort known patient quarter the SITC reduction the presented in late-breaker as new second Immunotherapy for from We patients cohort or Annual a cryopreserved started cryopreserved this Meeting TIL to that six to shipment entirely TIL investigate X their as flexibility weeks process study, provides We manufacturing and of the new cell new presented at the wait to shorter year. TIL time excluding the in requires product, gen added cohort at of duration gen five manufacturing metastatic Society in the in year. of X Iovance. days manufacturing manufacturing in with of first requires the of product results we to refer process metastatic study X. results a a a cohort encouraging at this dosing, product. Generation sure. developed study for on the of prepare a Phase decreased manufacturing this second Early receive to or non-cryopreserved melanoma of study A timeline For patient of often you the was LN-XXX enrolling approximately product. this to needs while The duration production cost the Cancer goods. November using takes this X The will be the has a product. minimizes

in in for clinical of currently active Hungary. UK, actively of study. still persistent metastatic expand and planned into in XXXX. neck cell competent six is trial sites sites in Company also the second are or Phase in U.S. enrolling. clinical U.S. squamous Also, patients the the during quarter, this are ongoing. we To-date globally. Netherlands, metastatic Currently X the head in carcinoma XX initiated approval We LN-XXX patients have from intend EU authority investigation clinical and in with submission The had LN-XXX received study X the the to of initiated up enroll current Phase we of study will which this third August sponsored Europe trial cervical our to on applications cancer Six and

published rate Rosenberg health continued In two work also response to on clinical additional with months get C-XXX-XX. and to TIL receive responses, Professor European with In cervical previously months. that continue We yielding duration evidence therapy. our closely the including melanoma TIL the EU authorities Clinical We XX with an prior complete in approval patients proceed to therapy for trial XXXX. patients NCI site two half a of study responded at in other first treated countries. in study of applications to could in activated of metastatic anticipate cancer trial were of nine data XX% cervical of which cancer overall his has three of XX submitted

including have representations at with data Maryland a upcoming previously XXXX For the in presence significant a as abstracts next week we announced late-breaker. will meeting six SITC

previously sample patient processing to I we our several data X on two versus cell vigilance in requires in various and gen as mentioned TIL of products. of therapy patient process of preclinical as addition the data identity chain well increase using programs to present of cohort a In manufactured clinical efforts ongoing manufacturing custody Managing the melanoma gen X will TIL cohort conditions.

and T-cells of clinical manufacturing patient. clinical track organization. full organizations scheduling of with tool to for to couriers hospital electronic partnered manufacturing goal each implemented platform and and product a management. The Iovance This to software for therefore provides schedule therapy the to adoptive automates contract once each electronically our our TrakCel for is logistics and sites maintain transparency scheduling an supply patient cell have system cell for that sites with We implement orchestration ease chain

update CTA advanced for to our approvals -- the melanoma. previously a we for fast regulatory EU addition mentioned received in our a to As product designation LN-XXX track

high Acute CLL. lymphocyte AML The prognostic On collaboration Chronic medical the research State will Leukemia of or with unmet with technologies. until hematologic Lymphocytic we Marrow-Infiltrating side peripheral which areas a The is Leukemia into cancers collaboration include on research research initially agreement in and Ohio and University. collaboration focused entered need Lymphocyte focus malignancy poor MILL Myeloid blood-associated

selection lymphocyte to very of process have gen the we decision program; malignancies mythological OSU continues TIL still ESMO presented data as some our over Medical X as with data melanoma. of order a of to the our and TIL similar productive that investigation XXXX year at in are ESMO. preliminary hematologic initiated further with from tumor TIL our LN-XXX. allow be with the have functionality I present in intend of of from our X Oncology collaboration manufacturing generation will us versus year indications for lymphoma Tim such melanoma make Society events a demonstrated In Tim? the a on generated discussion or end of to FDA sources. like European to explore growth gen Our The the before from call the of A on or clinical the registration initiate summary, at TIL for turn for to to now discussions financial. regarding development pathway would associated

Tim Morris

for the the to the Thank quarter quarter, Maria. per $XX.X the you, charge $X.XX for issued for reported or share $X.XX to to $XX.X XXXX. in dividend XXXX. the The to preferred share. was reported the quarter This for attributable or beneficial a of stockholders $X.XX third net the share. loss XXXX, deemed per common million common loss company share in Last ended September quarter non-cash XX, in or million third compares or ended million $XX.X of third GAAP of of XXXX. $XX.X year, was feature related per million XXXX stock compares net to net $XX.X $X.XX Non-GAAP attributable non-GAAP the million XX, per conversion September This loss quarter stockholders

upon $XX in net million months nine non-GAAP for compares or $X.XX loss $XX.X share. compares or $XX.X shares share. $X.XX company per its exercise common X.X XXXX. full $X.XX to stock. The loss stock common or include a at and of issued the shares offering the $XX.X issued for the This share completed Non-GAAP the the of shares public period the net sold offering X.X In million approximately of in million to after other same XX, estimated underwriters loss million deducting in expenses discounts, to and payable approximately September, $XX net of or purchase option offering net per Iovance This XXXX, commissions, shares. $X.XX offering per period For The ended million per was by for was of share underwriter XXXX from XXXX. proceeds September same are to GAAP million. additional million the their the

financing. the approximately For and net to approximately usage $XX.X million. XXXX, we cash million our in short-term per usage of This proceeds the the $XX cash $XXX.X million quarter for guidance of with cash line quarter including ended quarter. We cash, approximately $XX with was the from million third equivalents, investments of had

For million. are of the to $XX million fourth quarter XXXX, cash usage projecting we $XX approximately

usage $XX year-end cash million For $XXX be the million. expect full-year to million. excess in cash balance to of be approximately XXXX, $XX We the we anticipate to

view Our analysts were of attended to to activities include and tour event fourth investors in a manufacturing group Aptech the Investor able Relation suite a questions. event Wuxi in our during production. Last from of Philadelphia. one were of answer quarter week the and facility management The week. Iovance also our TIL slides X-K manufacturing last and suites were hand an along this any with filed to on Wuxi representatives

inaugural would announce and And are present will that Healthcare to Jefferies to Conference holding Global our December London, we XX. New Analyst in Day at XX on York November attend be We the scheduled I in lastly like City.

details now date. the for to turn your call save but over We'll follow Additional questions-and-answers. will operator the please the

Operator

Instructions]. Company. line comes & [Operator And of you. Boris our the from question Peaker Thank Cowen first of

line Your open. is

Boris Peaker

Great.

parameters curious question to compare I'm gen you one cohorts? first my is therapies two X first to specific wanted just and advance different mentioned the which you and to what forward TIL So the you between second decide would compare

Maria Fardis

Thank you, Boris.

disease completely it human couple the response would for is patients. of one we see when your we TIL have So we you would manufactured that initial ineffective body, a product options, at progressive that the enters

reason we sure of that cohort. to we for decision we're minimum for there outcome for we by second have of proceeding in that -- and waiting December in and the would be is before that this bar certainly not at this an the that's data product. see would The This are fact this we the response the generation year. ASCO we are response present is internal like this This second responses that is will part cohort case with

Boris Peaker

So specifically driven anything by there response? or you immunologic response just parameters are else will any be that it’s comparing the is or other

Maria Fardis

we'll second the in at be compare bit X easier safety little a a study terms are so just evaluate response update looking be that's numbers know and the of for parameter cohort based safety an those at have efficacy is. what to them. we that But the and because and we certainly certainly will we efficacy degree endpoints, We certainly we will comparing so on looking to be

Boris Peaker

their I'm my in ongoing Got it. Morphet outside may a of is when the sense last TIL and do number doing, by their curious does there the that what you’re of from the question actual doing Cancer is just approach NIH some Center, different you then TIL also And just process are a cell studies you trials have guys data? from how we of see of

Maria Fardis

Yes, definitely.

clearly clearly The So launch, are modified it’s but NCI process modify sites changes to parameters their CMO. not correct add we to there the some to is to it process. and order gen X our the implemented. NIH to fairly the that big similar in identical some NCI is did process five that you're our X We there's they of process have have process six individual transferred own tech to gen at Morphet we one that is to into what generation call what similar licensed approximately we other in similar

have patients. sponsor the I provide procedure you the want you think a provides a that's harmonious what exactly why and where through process CMOs to that's all a product central to

each can or and different have the their responses site comparable. processes may own not be may So

Boris Peaker

And ahead my part the go of sorry. last question,

Maria Fardis

a liberty their and the from whether studies? expect the TIL manuscript proceeded that I'm submission question fairly study putting we together some is studies. data Rosenberg to Morphet know it, and of data. out a AP maybe version or see the other aware not, Yes have is of Professor the is loves Keytruda will so certainly sophisticated NCI a putting then second not to of some we for results particularly their your it We from be early we provide part when do it they seeing combination know of plus was to data, they

of So I to plus that in expect the remaining a possibility. don't TIL but see AP the is the part combination year

if see they’re Morphet it. and submit with ready check can to You

Boris Peaker

much very you taking right, questions. all Okay, Thank for great. my

Maria Fardis

Well thank you, Boris.

Operator

Thank you.

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

open. Your line is

Jim Birchenough

all thanks the question and the on for congratulations progress. Hi taking guys,

and Just with you gen into it a a have out a gen to manufacturing foresee pivotal to gen how commercially that on like with gen pivotal turns understand following forward a about or then that starting working something need viable to Boris’s you that you think study X would manufacturing, if up X, scenarios go is trying to on question, with that just X advance process X?

Maria Fardis

question. Hi thank Jim, capability We X up as of for you have gen your certainly well. scaling the

I them. requires one the reproducible, perspective scaling the modules to a Wuxi try that we we was as the of of from think process key messages tour scalable, it is and part have convey additional and

be said up, our at process be could should we additional three Having development, optimize we them, we that add able pipeline that research we have would so on absolutely a working that that gen have we X certainly looking so We that is process not it's in are difficult. it necessary. continue be to can and scaled a

Jim Birchenough

X just you're then Maria. have many studies indication when rebiopsing detail been cohort. any of and there on in many see might of cohort a relative where re-dosing and patients And treated follow-up that on how data Any we the ongoing how to patients re-dosing some

Maria Fardis

Sure.

certainly we data my -- get to we haven’t guess question. cohort. haven’t can XXXX that you the out. guidance We around we be But yes sometimes how patients clear we put many So would have when for as can thank disclosed for

Jim Birchenough

one, final the breakthrough wondering table in the here one designation is is track LN-XXX looking might then that? you’re we here that Fast on on just something just when just designation, And and therapy into about

Maria Fardis

Absolutely something should about thank Really and we follow-up. think good you. certainly question,

have of the have that taking order we should product about type in think world ideal you review designation through when I a has to of for. your in nail for method a events an type and with to typically proceeding manufactured want is you’re that we process manufacturing down. a product approval method and of for helps a designation that think us our been That BLA

about we been generation think So for then we to next manufacturing can on what decision and designations of the request that’s decide it. which can are our regulatory

Operator

Thank you.

Our from the of next H.C. Joe question line Wainwright. Pantginis of is

line Your is open.

Joe Pantginis

Good afternoon. Thanks question. the for taking

regard obviously you remind checkpoint. refractory relapsed to breaking regard to changed path us ground whether protocol potential really only to Melanoma this include the benchmark the First just is Can there really in Maria the you the here? with patients for you with any or population new

Maria Fardis

question. this for thanks Joe, Hi

You’re the post once that anti-PD-X nothing correct, protocol go we progressed changed patient for the medical population, patients it’s approved is unmet this checkpoints have need. checkpoints. There so definitely the is to on

Joe Pantginis

their are quick not driving you. in but well And the what’s right flow news really necessarily thank I CAR-T industry quick now the and Perfect, apologize advance. since welcome

cells for to you that's TILs versus discuss an one of number that’s bit CAR-Ts can a why oranges Beyond the your come to think the differentiated dosed I basically and that the you guess of apples up comparison. questions to is seems safety patients

Maria Fardis

as the range Thanks a dose low that’s I in a We into number high questions. of lot has cells. terms sub in the product But definitely and within are X at billion. Iovance. $X of as were for work billion therapy, Rosenberg terms around detail where on of billion dosed we into somewhere go of billions sometimes as Professor administered Great. of obviously in we CAR-T XXX typically that as terms of not number cells TILs won't

is to briefly of asking in my million. that touch dosed on you’re therapy it's question understanding Just the CAR-T

definitely of cells terms number of is of the orders magnitude So in different. there

Joe Pantginis

I to of fact more have with the cells number you tumor obviously the lower solid what and going presumably all that for that do liquid you, are that’s And to substantially these have with really with able more the in especially trauma the to cells CAR-Ts tumors fact and need attack this on environment assume. be

Maria Fardis

but why difference know I data that a seen to That’s that don’t good there support them. a if assumption I’ve any I pretty is between you tell would have

into is that high find low trying he massive tolerated a tried of sort I think billions he was Rosenberg he find is to to number dose. that started with, Professor a responses there he found tested dose,

math dose processes might slightly to compared CAR-T. to toxicity the in it be not do to think So million. said any tries in he numbers, the into he the that be bring sure the and seen limiting down I’m there you wasn’t ever to one different requires body, multiple those if if is about to replacing dose human able billion, And T-cells

Operator

of question Biren open. is And our the of line from your next you. Amin is line And Thank Jefferies.

Biren Amin

Yes questions. my taking thanks for

for baseline vast X on PD-X cohort expect I cohort X to gen majority in be patients to the patient LN-XXX X fail and Maria fail do Just all cohort compared in you believe comparable X, CTLA-X.

Maria Fardis

thank protocol mean I Biren, see. be hi you Yes I going to do that's patient population for the they’re the there question. will written

on one have have that well it experience. whether we feedback of as If the defined to also Anti-PD-X. mostly -- as prior we going fairly earlier on recall that patients subsequent we are patients therapy, Head terms Anti-CTLA-X ask Clinical these Anti-PD-X it to had Igor? enrolling clearly have progressed the have a from FDA our you on patients patients speak to of to are in I’m Tools based

Igor Gorbicheski

X. and anti-PDX of kinase as treatment CTLA-X will in majority but situations and in everybody X cohort just thank majority are anti-CTLA-X it's received Maria. Yes, information cell and data therapy at [indiscernible] prior with patients cohort antibodies cohort later received of ASCO all well data received if you, on them those regarding patients of you is not There treatment presented similar [indiscernible] see X cohort

patient see in difference dispositions don't or So here. demographics the we

Biren Amin

ASCO, us X update will from patient should we the And you should that expect as well? on Maria see on group patient the data cohort

Maria Fardis

us Biren, data we share is the So because focus that eminent we decision an thought have our currently for with X before to cohort on and community.

the comparisons be So with X, because on on decisions to maybe some bulk likely cohort of draw going be data and cohort what bulk our going the the see cohort right to X really that's now. on to X data is we going you're that the of is but focus

Biren Amin

gen a hypotheses? it. And the you for for all so then do have cohort rely X Got threshold to X on

Maria Fardis

question the that dissimilar sponsors I I pursuing We a patient haven’t good that the viewed a but that could have away point it. walk they’re population Really of and product question, disclosed have today. earlier disclosed as too not was XX% asked don't think -- of to something in had really this approved other be nature

So what looked product away type saying as at can pharma a not while of sponsors have large our a that developed. walk is, should I’m response and other I’m saying point that that be

Biren Amin

to start Got it. European about sites is which process think And LN-XXX? then on the on, use you do come for sites those just plan that to for the

Maria Fardis

be after prepared able So both on decision to a process. Europe we’re our on we into we have in just take decision and decision decision available and first would making make given XXX and that dosing prepared the patient whichever product clarify are take Europe in for will internally, that a make we we process we are to LN-XXX Europe, the whichever question, be

Biren Amin

And that’s tumor types? for all

Maria Fardis

LN-XXX as well It’s Europe is cancer for are into LN-XXX. Europe for two the indications We're on into products the for. melanoma cervical that metastatic as going going we which

Operator

Thank you.

Mark line of from Oppenheimer. Breidenbach the of is Our next question

Your open. is line

Mark Breidenbach

COGS during factor process, manufacturing guys, just had two gen or congrats in with progress on prepared reduced remarks X mentioned you slight that is the reduction a quarter. the some just much Hi comes by a that us X on the of relative Maria can gen color the process to COGS. for give you how the

Maria Fardis

for to Mark are Yes Sure. we of similar question. indeed, Thanks the it’s the that duration fairly times reducing.

now needle optimized. is approximately reduced XX% and of of or even this the so X COGS As not gen the have to

and confident if gen that X we once can is a So COGS optimize that we decide back further. certainly go fairly product are the we

Mark Breidenbach

preservation X wondering gen And in similar in given has the appears that to noticed that actually why gen to past. in didn’t set your you which understood. include X just your process implements that is process I’m hands NCI? it Okay, or of I prior work the process implemented NCI preservation prior

Maria Fardis

as it at product. of had tech been gen with some Professor think When it is non-cryopreserved had company arrived Rosenberg backed transfer Mark. using I the in historical, I Lion, of X

and and our we to goal gen changing transfer back decided list at As into going that in of the process X. the instead shortening also put the into our process, point of into and wish we going time that redoing cryopreservation gen process set X, we X we’re gen

certainly So stopper. think and X Jim noted don’t some of to go it you back want a to is I back gen X historical, we go if gen as that's to go cryopreserved earlier can product, still

Mark Breidenbach

question Got own down it investing me, three looking of CMOs future kind at facility final in consolidation the for relying or facility? a consider on a it, in a would even your single got currently Are you’re at and manufacturing. you to manufacturing from different you down the road

Maria Fardis

we As past of forward my ever all would be doing disasters process year. consolidate have sort something certainly I'm if to should in will down one, go sure national we'll happen contingency happen that. this we seen fact plans to not in we will go have always concern of we’re

So it be have we nice very but be site until is second to could a need at separated. have co-located they preparation it in to least

VLA under decision to clear be. It our consideration. and In our what would regulatory want that is. Iovance there patient would strong know a have to what have terms and are of far making be be We we from away facility we point population and at cons where taken very pros regarding a would a how path is certainly

driver to factors the position to and as So make those decision how a to would how be of two ourselves.

Operator

the is FBR line line of Markets. of Madhu is next And our open. question And Capital you. Thank Kumar from your

Madhu Kumar

taking my for thanks Yes, question.

head transitioning gen would capacity manufacturer. So you XX what first in cervical the your and neck gen programs if so, would cancer be if to and X set estimate demand data consider X TILs you the among scenario process the assume sky effect over you melanoma on the and would and blue the for a existing

Maria Fardis

world the fairly questions. capacity response and that last if little to comfortable a into going neck comfortable us it's is have studies. it responses order Rosenberg gen ongoing ample we type perspective you give Okay, ES gave manufacturing in month, bit to would a an But The Madhu. to at of blue move make product X have everybody In because fairly Thank you month-and-a-half taking cervical time have to into gen ample similar of setting similar would sky be decided Head process see to the X that final be to ideal and capacity hi I’d with X that still that another and able not over we cervical. if decision. point time. in everybody concerned for in I'm capacity all we gen provide we in for

Madhu Kumar

lower with of that XX% can much reduction gen compared around of scales length scale COGS. on length earlier has in reduction manufacturing the COGS COGS a you mentioned and reductions And then with X the time. effect kind to X that further And Okay. the gen of how of manufacturing at

Maria Fardis

variable cost is part. for correctly staff processes for same reduced, impact this The is the from If the time still the the in that the is two material shorter the the so, anything most still reduced being I of most reduced. understood between fact time. being -- duration That your question being that material and

Operator

call. more and no attending we have we And everybody questions you. Thank today’s thank for

We will now disconnect.

Iovance Biotherapeutics (IOVA) 31 Oct 172017 Q3 Earnings call transcript