ADAP - Earnings call transcript Q3 2019 | Adaptimmune Therapeutics plc

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2019 Adaptimmune Earnings Conference Call. [Operator Instructions].

I would now like to hand the call over to Juli Miller. Please go ahead.

Juli Miller

Good morning, and welcome to Adaptimmune's conference call to discuss our third quarter 2019 financial results and other business updates. release please morning, of review statements press ask I our a there. to you the issued earlier and this would forward-looking We full text

and making brief a to with factors, in during we the a outlined of could anticipate those latest As this materially reminder, number call our actual including due SEC. results differ projections filings

portion. Chief the our Adrian Patient be available Operating all Co-Founder; Bill Officer, are Medical after our acting Rawcliffe, Chief call. our Tayton-Martin, prepared our Q&A Chief Helen Financial our will Mike for this me Officer; Executive and prepared for Chief Officer; Bertrand, and Chief of and Lunger, Officer, John our Interim Elliot Norry, Officer Officer; portion with Supply Business Chief Garone, the

over With Rawcliffe. the Adrian I'll Ad? turn call to that,

Adrian Rawcliffe

morning, us. September. Thank since call the took you and everyone, the is you, first beginning thank Juli. at This CEO quarterly for Good of over as I joining

made One role I of and took focus the with our people benefit value the to short execution cancer to the shareholders was commitments to to in bring that when term. I on

Our clear people them sarcoma, at synovial is phenomenal. priority to truly ADP-AXMX our to as Van these presented a we cancer. sarcoma. benefit a Tine, with for devastating Dr. Recently, people ESMO, refer which And XXXX in demonstrating remains data bring presented results, market to for therapy with who

health interest this our witnessed professionals the acting I the about speak community been from will more later. care amongst reflective firsthand the this. CMO, excitement has and of Elliot, sarcoma

we believe rapidly. in our SPEARHEAD-X With has these well trial enrollment accelerate compelling and started will results,

to multiple clinical sites up screen treat and patients. opened We with others have lined

unmet patients. for these significant the need medical Given

this marketed T-cell to the are our granted in available our readiness tissue first are therapy towards conjunction achievements, encouraging Orphan of therapy FDA make with as SPEAR are we Drug the XXXX. soft We eager as quickly progress These ADP-AXMX to having that possible. for Designation sarcomas as commercial treatment in pleased initiatives,

want has to other out basis set forward how upon T-cell believe solid the applicabilities platform which sarcoma broader moving I and we SPEAR these are Next, in in tumors. that the we

in the responses, In data targeting successfully target, receptor bulk receptor of clearing T-cell MAGE-AX, tumor affinity-engineered T-cells. case, and engage to anti-tumor this period X our of cells heart the trigger sarcoma that large SPEAR T-cell with attack are can Firstly, T-cell demonstrates deliver the the tumor over a the compelling months. its the

well research, infiltration recruitment translational site. Through we tumors as the of tumor T-cell into our SPEAR have as T-cells to demonstrated other

patients versus T-cells seen and also data responders induction the of kill translational that in wealth synovial SPEAR have cytokine with isolated people that can properly nonresponders, target in sarcoma. MAGE-AX targeting in-vitro. are underscores functioning T-cells We from post cells SPEAR infusion The

with X at translational will SITC on an data sarcoma We I update the from case present of our patients ADP-AXMX Phase study a trial.

in patients seen targeting resist solid we patients other these in first-generation the in reductions sarcoma Secondly, tumor the MAGE-AXX solid no tumors beyond we responses different across have activity have In AFP. size types. have seen NY-ESO, lesions our MAGE-AX, other solid whilst of X target had date, and to measurable multiple tumors, with products

into to data outside approaches for we seen on X insights, meaningful activity we building convert this have and Thirdly, have patients. sarcoma these benefit

increasing cells the on to T-cells, all effectively CDX of the is of convert potency administered. The the program transfused or T-cell MAGE-AX our first killer designed approach targeting next-generation functionality

in with XXXX. currently product escalation half know, in data SURPASS As of the first expected you the initial trial, this a dose is trial,

to in the The the trafficking and to our designed study second trial enroll from we substudy of the this is at radiation Center. Again, demonstrate results increased anticipate benefit T-cells this approach MD tumor. low-dose continues is Cancer This Anderson of XXXX. to

on in to trial based And pathway translational a inhibitor be is finally, PD-X ADP-AXMX we at combining the SITC, presented clinical a data emerging third XXXX. that initiate with announced and approach, today, will as

of approaches, by in to the cells, X into we range seen these meaningful with tumor tumors activity the in rapidly are With the solid increasing their progressing we potency to of convert responses activity combination their broad checkpoint a inhibitors. the trafficking and have

in were half We of we to solid XXXX. to the company an a of range responses data the demonstrate We robust therapy solid efforts with with responses T-cell initial tumor. show believe leading in first in the expected first engineered tumors are

that, to to the provide Elliot? with open the I a and update I'll And Elliot over Q&A. conclude turn clinical call before

Elliot Norry

and everyone, for and developing Ad, focused been from on and colleagues importantly, data meaningful therapies them. most delivering our Thank clinical who patients joining My trials, and our us. thanks, I need for you, on group have clinical

there As population, in disease to even those options high patient of are younger like Ad very lines Sarcomas unmet available medical trials in sarcoma. their have with for typically people other few and said, patients need striking occur is patients with our a available that cancers prime. There fewer patients failed are are options in a therapy. treatment there in advanced who these

was the impressive patients. heavily given and in our of trial that evaluable seen To rate data XX% pretreated, ADP-AXMX with patients. is and are works synovial which date, were typical results synovial in presented age sarcoma median at trial. a Phase demonstrated the more older ESMO response sarcoma disease XX control our most impressive XX, These a we that in even We XX% I of rate patients from than have

and cell The responses therapy another sarcoma will rare synovial provide impressive addressed, resection sarcoma, We to is negatively to large of Phase become for smaller a enough our SPEARHEAD-X patient trial support which data and of durability have These updates type quality can of to available. bulky size myxoid/round often large have surgically a truly treatment sarcoma. Reducing and can be preclude goal that this this being mature, size the reduced, we tumors, also impacts as continues has these II to life potential tumors seen disease. the starting in data revolutionary a and be of been liposarcoma. in

reaching trial to centers presentation physicians our to we Following eager clinical out ESMO, at patients. in us had enroll have

therapy have in progress in in committee lead expressed trial. dose review ADP-AXAFP our can third was our the it cell-mediated receive cohort, or X.X move in this a In a had incredibly this that safety target cancer, toxicity also privilege of endorsement to for liver range will for the have recent cohort We to we the our To regimen. in the seen from to program as program. clinical in I've third be standard tissue, the made of to evidence T-cells that liver cells of target, important patients ensure billion dose this noncancerous SPEAR preconditioning toxicity to T AFP, X first billion given patients. would cohorts. with the And safe liver the dose X be serve also date, billion no with X

have decrease indications at node decreases with the and We preconditioning lower in necrosis, size in evidence less tumor activity of early of seen lymph with levels. a AFP anti-tumor of doses and intense metastases serum transient

patient who XX% with have solid a in including Beyond size reported seen there date, cancer ADP-AXMX, in are patient indications. X X XX% a we who sarcoma and other reduction. reduction ovarian X had head tumor with cancer, in lung the target reductions with seen neck cancer. who had had previously with and XX% To have X a and lesions, in of results, and melanoma lesions a liver we ADP-AXMXX, With with patient cancer XX% patient X reduction reduction,

SPEAR that the While response, our a indicate these resist data met none for T-cells of criteria active. these are

We are of to activity indicators working these durable convert responses. early into

since trial with one earlier, colleagues trial progress of we been Ad a early my is ADP-AXMX next-generation and with targeting substudy days to the been trial trial. checkpoint combination plan eager for every ADP-AXMX and as and XXXX. to of see XXXX as Adaptimmune, with with are patients me difference have the MAGE-AX, and our And for Making we ongoing our of NY-ESO have in our T-cells where SPEAR to sarcoma the to start mentioned to are each We launch have at a now, up I in able inhibitor driving a cancer in an deliver. we I CDX passion XXXX. Phase well radiation as ADP-AXMX a SURPASS Adaptimmune from

And now back Ad. to call turn the I will

Adrian Rawcliffe

Elliot. Thanks,

Our first around we patients, delivering our believe indicating data and compelling T-cells will have is share we am And to frustration will I we price. patients. that execute work priority of investors. effectively. deliver By our current the to value SPEAR for continue aware

and tumors we're a the investors priorities evaluating SPEARHEAD-X deliver solid trial and our and preclinical efficacy XXXX, autologous to beyond timely in our sarcoma combination in continue portfolio. our our ADP-AXMX position in and across of T-cell we're cost-management by capabilities in believe SURPASS launch SPEAR by And of T-cells other through are the the for platform. demonstrating SPEAR trials to ADP-AXAFP value that to leveraging I clinical We of world-class current strong execution implementing initiatives enable through

call like I'd open Now questions. for up to Operator? the

Operator

[Operator Instructions].

Our first Bansal of comes question Citi. from Mohit

Mohit Bansal

Great.

of Just a couple questions.

point. these you actually this you SPEAR to require with are these it not seen all, us see have do self-care? ADP-AXMX, next-generation criteria Can your And you you doses with Or but resist the improving review mentioned therapy may, look, reaching at So I are you at first this responses? you remind how are just would point? that of what the your if more at T-cells [indiscernible], responses responses -- they seeing of some

Adrian Rawcliffe

Certainly.

want So a of be I clear, as referring to solid activity to across broad we seen range what are tumors. we've

a different clear, different X tumors, but RECIST -- been with have those the tumors in level tumors. rise across reductions responses, solid criteria have of to who patients do not range X of different they measurable solid are We

the the dose. range. T-cells. T-cells see question see patients of we're objective it those those believe to therefore, cell of billion the -- in we And is the patients, do we also the a with XX [indiscernible] so The not expansion we of X and necessarily billion antigen-driven expansion dosing that And of

see also of tumors we We where those biopsies. into infiltration the have T-cells

that to for believe the of approaches patients. activity I we outlined levels And that are take convert to approaches so approaches durable with we're the those taking second-generation responses the into that correct

low-dose are Those just combination patients. low-dose lack MD study, potent or from address of reiterate, radiation year. the initiate into durable X our substudy just we SURPASS -- the potential the to of the in approaches, study announced PD-X with using infiltration next further ADP-AXMX cells resistance tumor And with responses mechanisms and radiation which the CDX robust of all to the Anderson and more driving intend those that T

Operator

Our comes Marc Company. of Frahm Cowen from question and next

Marc Frahm

to be of to large maybe the centers? to kind as give then are how in or there you're set guiding a is of kind there half a are clarity of you're data and see present to Can of expect might bit overlap first SURPASS year. Just some how next data because robust that the Or thinking seeing at able some forward patients in you we'll little enrollment? there SURPASS out terms then? SPEARHEAD you competition of plenty that follow-up between of there and any And for of

Adrian Rawcliffe

Yes. Yes.

planning comment the those comment X I'll the to and on And first what the of on half studies. ask year. I'll the data on point next maybe between Elliot out first put So in we're then to recruitment

with first So in announced in site point May. next to July. are the just trials. data the announced I this year, we visit escalation study out, dose in would respect initiation we We

escalation of in target cohorts. multiple target dose X billion dose of with is dose just to of billion at this each of patients recruiting are the We time. And everybody, point and cells, multiple, a a dose X in target a cells billion remind in X dose escalating, sites across the cells SURPASS

because cells and want efficacy see don't we staggers those I to obviously as will And within responses. we of don't patients what level prejudge well. There's know

escalation in to in And of up dose phase But and able patients, speed give number once anticipate expansion from from that so to obviously, from escalation we've on dosed a being we cohorts. depend the dose with ramp able potentially will data the small completed the cohorts that. those we're patients, which

the will to to studies? the be effects patients, answer, So the it the an data the seeing short saw I for whether many robust and there's of that SPEARHEAD that between recruitment product. excess in are purposes effect in not we useful want seeing first we of in on very those but you we're determining whether and going second-generation do the be generation in recruitment comment think Elliot, SURPASS is

Elliot Norry

Sure.

for different myxoid/round SPEARHEAD sarcoma SURPASS So to out to on and SURPASS specifically, multi-tumor important is respect with competition synovial point a and SPEARHEAD cell liposarcoma. between study tumor patients And is recruiting patients, in it's types. solely focused that several

as will of, -- think tumor to patients amount overlap the study. some may also be will to say, centers SURPASS study patients, a be they independent towards And traffic there of So are I the sarcoma that is you types. from each are predominantly but there competition but small other SPEARHEAD study. for for tend the There enroll that centers,

So X I patients to studies don't for see be between major those concern. competition a

Operator

from comes question Capital of next Tony Our Roth Partners. Butler

Tony Butler

CRs? Question in you that Adrian, control think is you Disease trial, registration be would ORR. responses, strong, that a solution XX% is, have great ORR do in SPEARHEAD, a rates, obviously. A what a very fileable comfortable as that Part the what FDA might and not, would would x PRs Part number be comfortable, feel Or hurdle B? and If be you it with? rate of feel

Adrian Rawcliffe

to talk design of to what think SPEARHEAD show. we we and the Elliot can ask to going I'm

Elliot Norry

question. the for thanks Yes,

do XX% that compared and SPEARHEAD we responses being And other approximately as be occurred that's programs is rate to demonstrate And hurdles show at relevant the able benefit with That therapies in ORR may other being to several indication. up best we a behind XX% think treatments in past. differences or statistically that second registrable clear response we that for see, seen study to said, are do respect indications chemotherapy. overall we set to the feel with So to this the to with need compared line that sufficient currently potentially we've available. design

that in -- believe I response about do response this as the answer a patients to on directly, So seen capability this able study that different believe XX% clinically from we're rate trial. currently registerable progress is the to based meaningfully available Phase achieve deliver through be question optimistic essentially, we to overall your overall an that And we we treatments rate the approach. also the that to to we is

Operator

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

Nicholas Abbott

It's Nick on Jim morning. this for

just ESMO. goes back to first from data The question the

who that you response partial response partial the responses had had relapsed. unconfirmed -- and achieved I also, two I think set, patients in of two data believe, a

you a what resistance provide I mechanisms the to are follow-up. duration a know those And that response PR to And able perhaps the about have So retreatment? induce update and of ability an data? a on you do limit the of of

Adrian Rawcliffe

are So going we updating going I'm just to data be to say shortly. CTOS that at those

I would to patients. So and potential treat like the to mechanisms to we Elliot, to progress any information of comment those give think opportunity of do you further -- first the resistance don't the want on -- second with you the cells? on have of dose

Elliot Norry

in seen First of all, with durability mature respect to mechanisms of resistance, I study don't of think the fully that yet. as Phase I we've the of response

diligently I So try that. translational And mechanisms ultimately, of is progress do working there that be will and are our progression believe important. to understand group patients and that

mechanisms to to potential with to inhibitor the going mentioned in relate resistance studies around had whether resistance ways of are tumor. with T-cells of might around employing there see information we by to Ad As and mechanisms combine earlier, potency relate we're the forward. And do traffic of plan that explore our our to that trafficking, to other which might that mechanisms translational the cells that PD-X a take

by I SPEARHEAD doses infusions, in treatment with think With ADP-AXMX respect not of -- to possibility design. durability second it looking a to cell second second so as mechanisms we trial, be I but study of which pursuing beyond patients other the extend think give for that part remains therapy that to are of infusions. just With the the we'll to

Nicholas Abbott

that abstract XX% accordance your and by And to expressed myxoid/round to IHC, biomarker something is studies, -- positivity, further? cell samples is definition for that Okay. the AX process based positivity? of that as percentage you is abstract synovial back going XX% data SPEARHEAD-X. as The -- these modified that is likely coming of with be from CT And then an in the the MAGE-AX you develop of products stage

Elliot Norry

in don't rate. rates MAGE-AX the the in see you for sarcoma. the that very express the of reasonably for sarcomas the patients ones hurdle we a do inclusion many that conform We majority have so that the MAGE-AX MAGE-AX -- low in high So rates -- at positive almost quoted expressers The that to are study. all that

anticipate, don't that numbers got information sample change set the the sarcoma given obviously, we that on date. we patients a of that -- to done so decent those MAGE-AX latest in would we've have have. And with And based that we they're now expression on based have screening

have So for vast majority don't synovial robustly anticipate. who trial. patients, And it's think the MAGE-AX eligible XX -- on the that expressed sarcoma, criteria fair would patients say the to that be majority, I of

Nicholas Abbott

overlap expression my last NY-ESO And of for obviously, substantially. been there's expression MAGE-AX one diagrams fairly then is,

this As physicians an you you will or a choose how to bringing about think the marketplace, NY-ESO-X product? do think between MAGE-AX

Adrian Rawcliffe

the for they'll and the we the that, have any also they So antigens NY-ESO anticipate on relevant at with probably, other in MAGE-AX, anticipate available that's associated so due them. basis And we do course, products time. of data that test MAGE-AX, will

products the quickly they're that And AX of possible efficacy important to we're the why SPEAR as able will it's that's able as in the think that and will become SPEARHEAD demonstrate sarcoma product. compete part we And that targeting so battery with to of market get test then study, show. of that the with on continue these efficacy T-cell that the to

Operator

[Operator Instructions].

question Tony next of Capital Butler Our from comes Roth Partners.

Tony Butler

just enrollment I thoughts the a U.S. to exist that ClinicalTrials respect curious, around so. that and/or including sites, your not Adrian least according do to With to cost I'm one. SPEARHEAD. be last appreciate it. may one prohibitive Elliot, Sorry, none at outside But in

Adrian Rawcliffe

want Elliot, that? take you to do

Elliot Norry

Sure.

a be to and Without trial. U.S.-only SPEARHEAD greater intend into getting European just sites. not North it American do we will in So detail, conduct

Operator

of Our Guggenheim. Michael next Schmidt question comes from

Michael Schmidt

has target. date just program. the looking been I given on there have wondering Maybe to one how safety AFP the

as in are some AFP. potential there well the healthy as I cells expression think

Adrian Rawcliffe

that. of for CMO that? Elliot, program. the Do want you handles take to Thanks that lead

Elliot Norry

Sure.

we So Cohort of X evidence treated liver today. we've in any for dose have through seen Cohort toxicity X studies, and no and escalated patients those the of

So continue is of in our dose X T-cells, escalated monitor for range we'll of cell X X, obviously range to billion. the billion, billion Cohort to closely X.X target dose to where that billion SPEAR dose X

encouraged T-cell-related really for that we of evidence but are So dose we to monitor we're fact continuing cohorts, every in the earlier have no seen toxicity. that, the liver by

Michael Schmidt

a Okay, great. And just question. bigger maybe then picture

cash having about of to think in of guiding I funding company. X year worth you're the terms

you guess, curb that initiatives picture, it some curious reduce can example. -- better respect leverage about, I know. as in cash strategic and/or is infrastructure Is something about to there Just with your think I to maybe with thinking burn, the either, for of don't facility bigger I'm done leverage for how your manufacturing spend to example? be maybe partners, maybe platform

Adrian Rawcliffe

going Okay. Mike Garone, I'm CFO, Mike, ask to answer to that. Mike?

Michael Garone

funded our plan previous XXXX of half while XXXX. quarter first for clear points the per through the has As remain which now, coming during to data been out. clinical third key as guidance, have we of That's a beyond we

cost-management by preclinical ADP-AXMXX ceasing example, implementing and end the portfolio, enrollment are of we and across year. for priorities Additionally, clinical initiatives evaluating our of this

due strategies yet this As or you currently are of public will the imagine, course. in at information we in point, and can not are we have some place update that exploring

Operator

Leather Our of next from question comes Polygon. Daniel

Daniel Leather

questions. Two

Or just the trial side manufacturing PD-X, any will that have two secondly, are happy things, Stevenage And somebody to the else Center? have one that? be you others On paying on done the the cost? for with disruption you might you like have of towards contribute had Catapult or

Adrian Rawcliffe

John manufacturing Chief Catapult. I'll one, talk over about So I'll with and the to our Patient the Officer, second to Supply then and deal Lunger, hand

the we've second So any PD-X to of with combination given the one, details respect structure that further not study. to as

me inappropriate say, be we've would everybody will something John, in due it once got to course update we for but to Catapult? respect about. And tell So to with

John Lunger

Yes.

So as vector you we Catapult, might there. know, our on do viral

of first viral of GMP vector. matter a As completed batch our just our fact, a manufacturing for we

we the of seen out have So not other answer facility. that seen is no, have the same short that companies disruptions

Operator

Our Jonathan SVB comes from Chang of next question Leerink.

John Barrett

Jonathan. John have I on is just Barrett this for --

low radiation see expect might of from to substudy Can that provide and couple a study? we update questions. status you when a for Just the data

Adrian Rawcliffe

Yes.

up So enrolling. that I cohort study a just at to to single-center Center. is -- Anderson a know, out, XX-patient it's as you university, And MD Cancer XX-patient want point

can enrolling out, data have the is so And particular thing on indicate for dosing if drive study, you will radiation after data that given this tumors, administration. we has the will -- And often patients, level point months T-cell come us in data confidence at we to setting infiltration from the and other the only it I but radiation look just purposes that XXXX. responses that that those many low-dose

line X you're I line our warning within so a might that the to And seeing XX be the where classical time not time seeing we give in weeks, just are responses. sarcoma want that studies weeks,

John Barrett

one additional tumor you your that the in would in on future? types type of in what Can for the Interesting. And for on expand combo? reasons PD-X one. trial focusing confidence And envision you

Adrian Rawcliffe

are will the be the about that So poster shortly. at presenting confidence the for we we talking of reasons some SITC that

And would this. to me for so be inappropriate on comment it

think is Friday presentation Friday. poster SITC I that -- is on

so nature going we've or to -- on obvious reasons. yet not study. And And not that tumor not of that been types the we've the for stated comment I'm

Operator

to the Adrian turn for Rawcliffe any no to I'd like are questions. back over call remarks. There further closing

Adrian Rawcliffe

today. Thank ongoing on your the first to trial look and enjoy our therapies time for effective your thereby, for you to in to interest to you, on forward rest and and -- XXXX. T-cell half SURPASS people also emerging thank data I investors. deliver I value of of for study the day. your our journey bring you the Thank updating everyone, and the everybody the cancer, with ADP-AXAFP in again,

Operator

call. this concludes for you participating. today's Ladies and Thank gentlemen, conference

disconnect. now may You

Adaptimmune Therapeutics (ADAP) 10 Nov 192019 Q3 Earnings call transcript