IOVA - Earnings call transcript Q4 2018 | Iovance Biotherapeutics, Inc.

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Operator

Good afternoon, and welcome to the Iovance Biotherapeutics Fourth Quarter and Year End 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 the call is being recorded at the company's request.

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

Timothy Morris

Barton, we fourth release that Good issued me and Thank Maria on Chief ended XX, Dr. quarter our and find you financial the a President operator. Clinical press which us XXXX, iovance.com, Fardis, for today. and year Debora and at Officer; includes With today’s a corporate Executive results VP afternoon, afternoon, you, of you Science. everyone. joining our Senior can on Thank This call website for update. the December is

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

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

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

Maria Fardis

Thank you, and good Tim, everyone.

the existing our through year treatment great past who treatment options. onetime we approval was Over company. the and this progressed advancing strides XXXX goal excellent forward took TIL in of bringing towards patients, for year therapy to have an cancer

XX cohort with with highlights an single end and of XX%. the program it that [ph] our response now as C-XXX-XX our FDA At lifileucel are We in of the clinical lead SITC treated in study XX arm ongoing objective of Some registration InnovaTIL known at our confirmed following. with had also held patients rate Phase X time for trial. melanoma passed that reported meeting results a the metastatic for We lifileucel, November.

melanoma. for received We for designation an lifileucel RMAT metastatic also

feedback FDA determined for endpoint to primary revised been as trial. Cohort study Phase our from to melanoma manufacturing for in The offerings day be BLA study to is X XX clinical well scalable over enroll commencement to established now X cash in sites blinded and public Since of melanoma hand the has active are current have is sufficient overall protocol the having meeting under several by for our raised The end firmly include, during have trials expected amended committee. million ORR optimized process $XXX complete Biologics FDA call and the or just of fronts. lifileucel. call Cohort metastatic XXXX protocol financed X IRC last are new independent The rate the XXXX. and to on provided patients. review based Since to our was the of make We registration or License in the XX clinical continue for area, our expected Application in we XX we agency. progress study rounds amendment. initiated. to last in enabling or the is of and been on provided response the file InnovaTIL In enrollment few updates the A two

complete enrollment We study enrolled patient X our XXXX. up to anticipated Cohort to first have an late in to early in XXXX

as an at treated head in in TEL patients than The for study providing this immunotherapy. have that patients three neck known combination enrolled XXXX. and a XXXX that as and study as or in study patients PD of now anticipates cohort has no melanoma been cancers from upcoming update pembrolizumab, carcinoma are update Basket full X with with melanoma data anticipates The well. the open has with enrollment limit lung the to United been sites also s InnovaTIL therapies medical to Spain. XX naïve amended The received of metastatic LN-XXX data monotherapy in X with number and study, the addition a in This active last medical company meeting The the private a to exclude to XXXX. fourth prior Cohort study patients and in in US. to cervical of company more providing countries States cancer six is quarter protocol the regulatory non-small meeting proceed For patient now was cell approval in at in four [ph]

As than drugs conditions chemotherapy. serious treat as process while designed get available The received Unmet medical or where from potentially purpose important medical patients expedite the to progressed to defined cancer fast-track designation designation be of better unmet the cervical to none for and drugs new patients is review or FDA therapy of which announced yesterday, need. who we fast-track is fill XXXX providing after development facilitate may FDA a in therapy exists care. on treatment have February the to for a cancer LN-XXX is earlier. an a providing need and

discuss the for XXXX meet FDA we to intend registration the cancer. of path During LN-XXX regulatory to with in cervical

the is raised an stages. facility the As manufacturing second location of to to location owned be we Iovance XXXX building final initiate XXXX. final our anticipates sufficient of announcement commercial This during selection The in the part commercial site able the manufacturing funds the process facility. quarter an new of financing, company for

collaboration, As had part previously two studies. of the MD clinical initiated we Anderson

is platinum-resistant treatment studying and study of Iovance with by patients manufactured XXXX-XXXX in sarcoma’s LN-XXX cancer. the ovarian first The

pancreatic patients enrollment and The XXXX-XXXX is in studies dosed been sarcoma’s Several TIL a both in Anderson MD study continues. second study manufactured of have and with by patients cancer.

report XXXX. in Ohio update product For solid blood potential the PBL. and The filing to I anticipates hematologic TIL candidate an beyond we therapy that in a to lymphocytes has peripheral applications University, company on are for explore of that or Ongoing called am pleased also tumor. collaboration research, IND Iovance an developed beginning State PBL indications

study title melanoma of metastatic for of XXXX. Association for was or AACR abstract American persistence LN-XXX lifileucel our that cryopreserved of to announce in advanced product, lymphocyte accepted the to pleased upcoming presentation meeting March are we Research in tumor-infiltrating Lastly, at Cancer C-XXX-XX or

update on an corporate As activities.

anticipation in filing and organization and grow for of commercial we with team. our to continue the have registration lifileucel a completing cohort the starting commercial begun BLA staffing We strategy

X will staff and annual the included persistence encore in a noted critical at the the We to overall now employees we areas data in administration have data and ASCO-SITC of scientific of poster the Tim? Tim will look March after In a for in continued study over of have [ph] ahead Xst. Clinical melanoma the in the now add Iovance. the before meeting discussion presenting trial Immuno-Oncology for months the to we our also be be including of San abstract I've I This of at TIL over meeting, to March. forward [ph] taking XXX to at Francisco. place upcoming presentation Symposium Cohort melanoma an participating Friday, turn like call on metastatic patients end at would C-XXX-XX And financial the presented watch ACR our results.

Timothy Morris

XXXX loss the for research for trial development to driven share, Thank loss the net quarter by fourth increased Net clinical from and XXXX compared you, per spending the or of fourth quarter per XXXX the higher Maria. million loss in XXXX. the fourth in the XXXX. quarter activity versus increase of fourth $X.XX share was $XX.X million, or The net quarter was $X.XX $XX.X for fourth quarter

$XXX earlier additional the release on quarter December financial details of to due running year the million primarily million net trials net per short-term $XX.X in for full or compares the for results fourth for year initiation held refer spending to $X.XX investments, new of to compares increase equivalents full $X.XX cervical a or today XXXX. trials and loss and the share, year XX, December XXXX. XXXX, head clinical the For million in to XX, neck melanoma, the at to Please for cash of company was this loss share and in the in and R&D addition cash, because $XXX year XXXX, XXXX. was Again, the the million full At press this held per $XXX.X XXXX. increased issued

used million activities and $XXX In million. conferences. investor Iovance following March net December XXXX, at cash present participate investments will equivalents we XXXX At and was operating and For anticipates cash, the million. to $XXX between in cash $XXX XX, be

Cowen in China that, questions. the the Conference Medicine next for Alliance operator Cell the the ARM Oppenheimer then and turn Conference to we'll the York, New Shanghai. New Company the your and With in Boston, in Annual Regenerative Investor Annual Healthcare call And in Day Annual First, Healthcare Investment lastly, for Therapy Healthcare or over Conference Gene York.

Operator

Our you. from Thank Oppenheimer. Breidenbach Mark comes question with [Operator Instructions] first

line Your now open. is

Mark Breidenbach

that's analysis close tell protocol, of enrollment how Thanks for to taking expect built to if little cohort guys. need take questions. the to more bit wondering to afternoon, the events can trigger the was Good would just Maria, to about and interim it you analysis Hey. I place? us a happen in sort what full or you some

Maria Fardis

you Mark. the Thank Hi, for question.

about thinking a how that to then all fully the that order have follow-up BIRC with analysis In because interim of data. we enrolled. meantime the have cohort will in to the three patients enrolled use to be reality are in would do and We months assessment anything

fully it decision chances not will would enrolled that. The high based way able a are So that in to on not any be trigger make will that we you be because at point. cohort

Mark Breidenbach

Okay.

of size going will cohort, what? a that the we'd you’re chance – hit like there revise the as patients to to be So is XX to no matter this used

Maria Fardis

Yes.

Mark Breidenbach

prior the on have amendment, could choosing what you're why at – prior let with of some patients of us immunotherapy to carcinoma defining us than exclude greater Okay. color regard to give received lines as and sort And know treatment? protocol jus cervical who three you you're

Maria Fardis

Certainly.

of of mean data worth of shown of five. As response of an data for October last overall number we prior around XX% therapies had have financing and our we have was noted rate round we in XXXX, XX where presented patients

able population And to treatment had provide patients some long patient the enough from product data. wanted the we opportunity was the value and benefit make survive be and that an to in quite experience. to sure of refractory to terms So

therapies the patients are number the that and to them. able so So we reasonable are healthier get limited we from slightly of follow-up prior

immunotherapy approval. able not because an an We to limit accelerated full and because cancer not for patients. available considered prior immunotherapy KEYTRUDA has cervical are have care available is not fully does it approved, there thus approval approved

open patients from that is specifically who to that a to are better a better door anti-PDX lead better are fact the a that So we regulatory that to longer those know from the survive we have know and that little prior opportunity data. and patients naïve and perspective opportunity

patient bit. a we quite So The and them, that's [ph] the read population from open potentially limited doors TIL benefit can. we through why could

Mark Breidenbach

soon How might would final in-house one be capacity get you capabilities manufacturing, And for for you'll on support only new before on building to would a one we Okay. it your sense your the me, US primarily products to expect of regard rely facility that commercial out. or for a European party and third production? with this be in especially

Maria Fardis

Mark. you, Thank

terms of flexible In we something that capacity, building capacity. planning has on are

capacity will to So we later place we initial modular its build part and that this putting option together. disclose there we year, that fairly a plan very in are certainly perhaps as might the capacity we what But will agile and be. of an be expand that the quickly an will will have to

considerations whether U.S. location, or so disclosed. perhaps its can Those better are and considered. of our could selection, we disclose terms be In location EU

Mark Breidenbach

you questions. Thank taking Okay. for the

Maria Fardis

Sure. Thank you.

Operator

Thank you.

Boris Peaker from with Cohen. question comes next Our

Your line open. now is

Boris Peaker

the on is question that And will a data. of see would just we that first data. possibly so My review X when if curious Cohort centralized I'm Great. be?

Maria Fardis

Hi, Boris. you. Thank

it be couple to we months triggering next the Reid We aligned because [ph] are We process with [ph] sure Cohort the process. halted again. had X of that Reid and is the it wanted in just central our

presenting we up year, around when an we the will may the the say of second likely the year, Cohort it part be time. in X quarter If data up not So depends If this later end on presenting up data. opportunity. make we IRC data data there end end the presenting

presenting up the entirely So where sure I'm data. about end not we

Boris Peaker

from compare trial enrollment Cohort Cohort reason in is X, the Cohort you. there different that should believe from also And design X efficacy X? Got we be to the perspective, any if then significantly patient

Maria Fardis

so. We exact an patient population, think exact same same don't It's sites. the

patients meaningful selection We the of actual any the in changed way. haven't

would anticipate it don't difference, at we be minimum. any we So same a that the meaningful anticipate as

So no, not really.

Boris Peaker

lymphocyte. blood my And Right. novel on just question last peripheral your

just Just tumors? curious what specific tumors Or of will are of the is advanced kind considering. be study you typical basket liquid initial

Maria Fardis

there PBL with more data that I to a from CLL, is T-cells a particularly patients peripheral the will There CLL think blood have regular be about T-cells, shows in initially their we patient and of exposure we XXXX. it's better we grow T-cells have. thinking published T-cells primed blood with CLL. is priming enough method probably initial and that of you that ASH is But methods the to get if to significantly prior patient more them to this see ibrutinib data hard there's and at with available the that presented do

So we would focus on likely initially. CLL

Boris Peaker

you questions. Great. Thank much very taking my for

Maria Fardis

Boris. you, Thank

Operator

you. Thank

question next with Wells Our Fargo. comes Jim from Birchenough

Your open. line now is

Unidentified Analyst

Its on afternoon. Nick Jim. a Good great on for Congratulations XXXX.

beat? on just Just we the response that that, I is should the a by you see then, that the want of rate perspective bogie but KEYTRUDA seen cervical mean, more know than response rate you I to a XX% [ph] is at, to be competitive lot cancer looking from want kind

Maria Fardis

question. you for Nick. afternoon, Good Thank the

is be the From regulatory and the clinical bar, approval. accelerated bar has a product or So “available One I regulatory care”. considered immediate commercial two answer bar. ways. would That's not given will one it a

confidence has available From So regulatory care This why thinking, at care available still. And really who line The low that remains is %. received have to get for a their for rate in we able was with is to care patients end XX around because available precisely clears whatever that's response on X that's KEYTRUDA perspective approval. full XX% the role of fast-track designation that chemotherapy prior are chemotherapy. carrying %.

would patients for line unmet and that. And the reason patients therapies that's needs prior immunotherapy. We for the really we From available do limited like noted XX%. and part that's perspective, exposure limited cervical the we clearly is second I historical better before to a around are data. of significantly than rate clinical to of their we in prior So cancer quite as know response do that number still just care these medical

Unidentified Analyst

Thank the PBMC you you. tool for Thank Great. [ph].

that is to come You'll again that bespoke mean jazzy manufacturing the cover name a two have with up or it. something fact for malignancy? hematologic to Does from there

Maria Fardis

smart you different definitely need an actually short with a We a have name we Yeah. and - completely it's process. to But novel are email. a me process. A very up process. come one It's send if

Unidentified Analyst

you And I this mean, it's process? and better X great Did that its is short. Gen a

Maria Fardis

Because starting tumor. we are not with

lot starting We are blood. here. We to a with more had opportunity the do

than process it's an So X. different entirely Gen

Unidentified Analyst

Thank you. Okay.

Maria Fardis

Sure.

Unidentified Analyst

from head we what the expect then And should of updates trial? and neck

Maria Fardis

head indications subsequent that in this is the enrollment a have poor patients continue of neck We also and the very and anti-PDX. one survivable

priors patients to we that get So try assure we to to report to limit so able are able the enough survive number can data. who of long are we

considering expand trying So enrollment. we improving efforts increase the to sites increasing and to in perhaps our are enrollment

what report patients have year. really X - this be committed haven't that what of like hold-up before is our We I really data to able to would far. to sufficient number with providing Gen so data, we that's only that

Unidentified Analyst

Great.

very much. Thanks Okay.

Operator

B. FBR. George Instructions] Riley Next comes Thank Zavoico with from [Operator you. question

line Your is now open.

George Zavoico

first, for and guess couple the update regarding everything. afternoon. for for Thanks PBLs. of Hi. Maria questions I A Good the

from this that comes to cells able why your much blood, I guess, it. blood I to pretty to which with so much potential access means is it you've do obviously is unlimited, said imagine lymphocytes. You transform been peripheral that

out growing like are it preparation as is it you too about there even is I'm you curious that? it's just modifying answer just shorter, but much time, maybe or for steps, the you was So is and said many just to them the my those, shorter early question cells

Maria Fardis

T-cells course is think question. you We Hi, George. over has learned amount of I significant to happened time. we the about have the grow for a Thank what how -

again, this generation figured other even And products better. the have in have some we that TIL into we to do to the in of just to bring out front other happens efforts. our PBL of intend That space we of the landscape. So be how clinical

of we that pipeline PBLs more date research our process. took and the So to of in growing shortening advantage the terms TIL significantly and grow to has how collective in knowledge options

So it. into a lot gone has

able of to in haven't how provide in to the medical that well. We an really upcoming we that XXXX hoping be disclosed and details as do to are conference managed we information

George Zavoico

this that multiple Is just to much the solid that to a for the also possibility as considering tumor a as you're question, treatments. blood, And to well? follow opens access having better opposed up as TILs for by something this

Maria Fardis

yes, in It's But certainly we of the start human, an more presents timeframe initial, a an of opportunity ranging be it a that because about opportunity QX to We in one first option to definitely sense maybe considering are it's little and in a how course program. details. consider. itself. that that can we disclose but It's can the bit consider certainly it in our terms would dose quarter

George Zavoico

Okay. which PR cool. patients, not to including even not And with disease the X, may your stable since - a have you've may the [ph] the patients last standard of responding got of update. into gotten regard Cohort some or

durability to You've chart got presentation as is primary play you of How link in they're response, of from response your primary are they endpoint, ORR two So the X. in because the Cohort XX is going secondary be to got endpoint? to months it are therapy? you've do endpoint, a durability at X, good important the Cohort on the looks still certainly for going view months, this patients on into

Maria Fardis

It's Yes, of I Thank important agree. you, for course hugely secondary the us. you commercial Yeah, endpoint. are George for that also question. endpoint

that protocol space part is will it very monitor of and closely. So our we

of in months [ph] noted. patients study two you as you had a noted our within exactly months As XX distribution broad and timeline pretty terms

to X Cohort So certainly follow-up X. be monitoring and lessons very we from are the X applicable much learned will Cohort Cohort from

George Zavoico

finally what for of maybe you million refit one of scratch? burn imagine it you that that is lot And can a say versus an for also ‘XX. building potential for in how regard, that goes take XXXX cost you're In or would can say, long end I including what Okay, the think in from be great. existing if $XX to Tim, the do it the for that, you more manufacturing of example the out build somewhere ‘XX manufacturing fraction projecting would the facility? the plant space. into for neighborhood there's And

Timothy Morris

George. Yeah,

to would terms increase be five in for majority of Cohort XXXX $XXX the have on of and running in the the R&D. potential is up So with burn obviously a of new We about the one million, now - studies X going breakdown that board. be coming

bulk So There lot mainly I R&D. a the do for in Most not other monies expect would this to initial increase come of of predominantly is looking for be in well. the will of design facility ground some some bulk break engineering as some that bulk the new there. just There's to there there. moneys year, new and and year we're the as next facility,

I start So know, we details facility probably not, about obviously if more we'll the as talking and could don't stuff there. but and that end know or helps you get and we give that closer - up

George Zavoico

and appreciate No, that. you. does Tim. that Thank I Thanks, Sure. for help for That's now. all me

Operator

Thank you. questions. showing more no And I'm

will Fardis to like for remarks. any I closing Maria now So to return

Maria Fardis

Thank you, operator.

the past in treatment these stockholders would year. in a forward the to that by who providing acknowledge encouraged provided trials able option. We participate further the those of join and we the of the patients to support remaining today progress the accessible appreciate love call who are we contribution our broadly investigators to you were us the look over TIL the and you the therapy We clinical quarters seen trials, resources have and updates make to who the enable of growth that year and have who

Operator

your you in thank you Ladies have This all day. conclude your gentlemen, And may program. does conference. for today's disconnect. a great Everyone and participation

Iovance Biotherapeutics (IOVA) 27 Feb 192018 Q4 Earnings call transcript