Adaptimmune Therapeutics (ADAP) 28 Feb 192018 Q4 Earnings call transcript

Company Profile

Participants

Juli Miller	IR
James Noble	CEO
Helen Tayton-Martin	Chief Business Officer
Adrian Rawcliffe	CFO
Rafael Amado	President, Research and Development
Jonathan Chang	SVB Leerink
Peter Lawson	Sun Trust Robinson
Michael Schmidt	Guggenheim Securities
Marc Frahm	Cowen & Company
Reni Benjamin	Raymond James
Soumit Roy	Jones Trading

Call transcript

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Operator

Good day, ladies and gentlemen, and welcome to the Adaptimmune Therapeutics Conference Call. At this time all participants are in a listen-only mode. Later, we will conduct question-and-answer session and instructions will be given at that time. [Operator Instructions]. I would now like to introduce your host for today’s conference, Ms. Miller. Juli begin. may you Ma'am,

Juli Miller

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

number As differ materially could and actual a reminder, results we anticipate to making of a projections during this call factors. due

reference followed name, to the you In our for T-Cell our addition, prefix by for specific update would target of to which I AX SPEAR we T-Cell, SPEAR a currently to our a company all trials SPEAR the to HLA make From type refer our aware a forward, antigen. to with here ADP a reference nomenclature. of the or an like then and will T-Cells

Noble, outlined is Noble. of portion is So call, members website our for ADP-AXMXX, call ADP-AXAFP. Q&A. MAGE-AXX is and available With will the of now management James James for This Chief over is ADP-AXMX, I'll is James? the that, be on other prepared our me AFP for turn our and to Executive also this MAGE-AX team reference. with Officer

James Noble

we our to and we transitioned allowing successful dedicated focus our January our T-Cells the wholly-owned program the everyone, GSK, us any last manufacturing open our plant By to treated other NY-ESO of you, had manufacture finalized way NY-ESO our came year, Navy we or in We wholly-owned product a first year announced program programs. in for XXXX, during agreement the with end and very at that the just our and a UK. MAGE-AXX. in targeting studies SPEAR XXXX. Good Thank partnered AFP. wholly-owned Juli. had on MAGE-AX joining had morning, trials vector to an In patients three with of long you two thank us. We facility Yard targeting We programs not had started patient

our cleared MAGE-AXX, with milestones T-Cells all trials targeting XXXX. throughout and and MAGE-AX AFP SPEAR safety Our major progressed

are we vector ADP-AXMXX dose at targeted Yard with ADP-AXMX, cohorts, and XXXX. have patient we doses we our expect tumors of facility billion addition, at us in first off-target alloreactivity with to to Navy to XX the and multiple In progress three for routinely patients the saw UK enabled or the to evidence solid which first cells. no In our in trials phase production our in treating up in product expansion toxicity manufacturing

dosing are of currently in all three We in enrolling phase the expansion studies.

we year. previously at a and are As in update our give clinical call plan May indicated quarterly full to of data accumulating this

first second target available a throughout patients the currently of be Later for will that provide study the conference, billion with dose cells. this on upcoming you on AACR online the study. plan we further will two first safety to We today, updates in update year. and X cohort in the where cohort provide cleared also are our We the find dosing ADP-AXAFP will doses abstract an

trials Our clinical to we planned have new continue as and add progressed clients.

were details. on We the also to USA, logjam data our of several in than research translational our at are SPEAR which the conduct active of clinical increased more in that features of and are working understand To the end, EU. sites leading this key to cancer trials. our believe Canada, with our fully XX we centers We’ve critical focus translation there

beneficial. of NY-ESO X and cohort intense regimen from Synovial preconditioning study in more X data the our indicated that First, be Sarcoma the partner a could

received in in of profile of the us current cytokines cytokine expansion pre-conditioning, data high pre-conditioning patients the found that promote growth compared further increase These levels from investigation X the patients. these who prompted the intensity we blood T-cell cohort upon of were our and to intense peripheral patients, that to trials. more cohort Second, the X of there

We inform our and learned trials. our have a current great to will and continue deal future to-date translation of research it

working our destroy T-cells how programs. time been some find on as ways generation for cells of to have cancer next We improve and our part can

initial already approaches have data next We shared namely, and with TGF two (inaudible) generation Beta.

TCR increase will data another next another which added CDX responsive later the with T-cells post along our believed broadening we will The coming element homodimer to have MAGE-X. be immune in targets. As addition is out seen our we thereby you’ve abstract SPEAR alpha for T-cell, response of AACR, against the today, infusion, and generation finding share targeting that a CDX expressed tumor engineered TCR promote CDX ability initial

our progress made with also good program off-the-shelf in XXXX. We

our have we In technologies addition, lead exploring therapy, This knowledge in are potential in area have actively which activity SPEAR advance with collaborations TCR partners in and been to only enhance fell in could the of positioned way the but we we is exciting employed fight and cancers. well one are that which T-cells. also not an TCRs which the to way our

capacity our month to and XX expenditure. facility patients scalable capital manufacturing; Yard at per XX to Navy without significant patients Turning at is additional now

PTT. We patients our for also per capacity had month CMO XX formally at HCAT,

XXXX. own of we to to dedicated till to implemented with sterility initiate are place late ADP-AXMXX, our next facility addition, the to patients. at for vector, party T-cells, The have and Navy in positioned manufacturing In trials and vendor facility as next are online suspension complete already vector With our SPEAR a at respect deliver to third has we Yard development. in manufactured we stage generation using better as vendor. production and vector well production well positioned funded our XXXX ADP-AXFP and remain well vector process coming anticipate proprietary We ADP-AXMX, T-cells rapid SPEAR our testing our

for continue patients. we up open way to questions. effective With future the can with to eye utilize call say for the I’d different examine trials in therapies like that to Operator? We most to our our the that

Operator

comes first our with Chang question Leerink. And from Jonathan SVB Instructions] [Operator

You may proceed.

Jonathan Chang

First the in first to on you and expect responses scans? question, the the AXX MAGE-AX experience, be two based achieved NY-ESO would on studies

James Noble

want you to do Rafael, it? call

Rafael Amado

the not I I’m of question, scales? true sort so you’re sure the saying heard

James Noble

The Rafael responses quite expect was, when clear NY-ESO to questions would scans it in have the just on you you two had to based experience see wasn’t repeat, patients?

Rafael Amado

XX% It’s responding, question, have to the have were a from good in didn’t on Many sarcoma first scans. their achieve in responded within patients perhaps scan resist. responders general two way first the threshold but their

you tumor size not in are these prominent responses large So see where away. decreases right

third and by patient the varies at threshold, So the then crosses perhaps second patient. with you the whereas eventually percentage or start the scan that

that by the have longest been patients I respond the of responded second to a majority six took first to And have say that occasionally think took the patient there’s that were would scan, the but I at responded. scan, months. patients that responded

scan later those so know XX one Now response. another confirm needs at unconfirmed days least you as that to responses, are

Jonathan Chang

you in Second confidence size the studies, measurement? about at and those being with current be dose for the question, can talk optimized could evaluated reasons high why responses achieved for

Rafael Amado

and knows of best those regimen I’ll and and I response just comments think two say I our by that nobody able in as but clinical our trials fludarabine the in to also think James. NY-ESO a T-cell shown studies we’ve of as drugs in on couple biomarkers choosing to then higher then in expansion, condition you Cytokines and terms promote it both been of measured are replicate well. doses But what’s such been and outcomes is that’s by pass mixed durability better

so of as numbers cyclophosphamide role verified such We upper to and sense because cells we whether dose authorized higher of think employed frankly doses of I doses definitely the are some billion in what past. the is, now minimum expansion of haven’t is higher cyclophosphamide X we and important didn’t contribute we also peak dose know XX limit cells conditioning of looking the in response the the cohort dose at make and higher

routinely relationship there we are our to we’re dose Now the so is term. response dosing range whether of in at cells make upper facility high number of to able planning see the and

I be it’s answered the slower a think a I rarely cells, think dose is see billion a still question we below billion. So higher to

James Noble

dose any cohort, Yeah, that to wasn’t I if number to of either players, of so back and of protocols, produced any the the with dosed the concept cells of get we we’ve other right, rising actually NY-ESO out the the authorized think actually systems. studies in a manufacturing of you’d had you’re previous always patient the

as dose in based on resistance cells. billion memory cohort none expansion the toXX Rafael that XX% cells out it from a XX transfused least but a fact billion between of million you got with patient cells at dose nothing In in billion XX the X way, that billion, was them XXX There anywhere of get designed fact seeing to in or coming about because but you one billion were and cells when wasn’t and if range X fact we decent any response don’t studies are information original said cells, in-vivo. patients see varied

best obviously effect. So we think is this the threshold

Rafael Amado

vector, of manufacturing some was this was used NCI, this [wild] was cells also process. it product different billion add ILX, tested when the a was a gave would at XX I they it medium they time and ago,

doses. routinely So for have condition there in same all the the The been but may the But same. whether are different. the they were caveats the details T-cells was many about TCR, TCR higher current administer

optimal the is, think knows the now really before this dose it I So really one is in and high time studies. I because the to dose to TRC do are during said what finding we no characterize it attempting as right

Jonathan Chang

of one of achieved (inaudible)? in Just investors sense a your response from ability will last question you me, get the have

James Noble

and patients six scan cells year, to have I happened take then another manufactured way and four that’s they the actually or weeks doesn’t either then towards place understand the cohort on that. end to expansion place for quite to treated, long that second to that four of have take because a protocol we period really for the then just of vary on wasn’t difficult you started those weeks what for have the last going of first the all that the the think after to scan first depending expect, weeks you very and the

the I there. that. have any first So meaningful we’ll work unconfirmed but don’t you for scan time second it’s you data response think gives to think confirm, gives stages, I don’t durability just in

Operator

with Trust Lawson Peter from Sun comes question Robinson. next our And

You may proceed.

Unidentified Analyst

patient guess dimensions one, (inaudible) little staggering is talk for close It seems phase, you from a much of When progress that in expansion that can there to advantage so the about as because to take both be the target they to also a on upper questions increased patient characteristics there able to are bit a is cohort. manufacturing increase in you also seems billion. excluded certain take for the using upper but high around us manufacturing when on being of X the comment us few but the I and limit, (inaudible) billion dosage well? is you’ve range may the Peter. made XX the in it This expansion not from lack two an

James Noble

years a two to progress, comment million, way, of produce but we have Yes, I’ll of think and comment, Ad specifically a in charge actually made whether I general Rawcliffe, he’s since we manufacturing. but I’ll our Ad lot regularly no make that’s, said, X have CFO, we’d let

Ad Rawcliffe

Yes.

the its sort are to the to in been So routinely around getting own the manufacturing cell even end that lots of are months the capacity by for development the past established to that manufacturing some up moment. XX heading higher. of obviously a or the ranges dose cell XX of I you’re cells key cases over to billion that current and doses characterize top right performance as is patients for And the up cells of in and spoke month think site of new the we our organization out of so, they’re Rafael that setting and confidence

the that for of So the be far logical on relies top all But not not of of X to those able we’ve be to patients, function on to it in that characterized turn all either. efficiency thresholds cells first cohort different dose end seems the cells vector so eligible of which and that. that’s patients to we give new would things number like out get and billion the a the who

improvements it’s this manufacturing us number led point. a entire So of to the has that process across

James Noble

there patient that out being is for the starting remarked as incredible therapy before advantage success, we’re manufacture a for cells we’re same not know and to that’s own to actually and successful will and Say is at get patient biggest investment up the the was of enough variable your of facility. example, looking are days having patient and can point all manufacturing really know have the tell whether the would at We material, for a manufacturing facility. – I very we the T-cell justifies I to in going a learning sort of second of first the manufacturing initiate being close normally the think autologous was whether I of an and having going we’re part so think never on so. make that difficult. Yes, something there within end actually that end same round it own of the the or out four particular those just week (inaudible) then our And if of things of the

because an catastrophic so technology go only way process that now under T-cell far to to own the hands, your I having say still you have the right is as can evolution is and beholding for fact more own In that you the company not your under own is manufacturing autologous roof. control would

Unidentified Analyst

I the right and was you have patients what however do so patients, seen I may them how these XX from expansion you on have MAGE-AX So you dose? or from patients would then have guess treat, place, receive expansion, you of all the now three how to given in say probably billion also on may for many all many up in guess met of – you progress the

James Noble

billion. to not the (inaudible), in individual but get patients anybody We’re XX phase expansion is giving eligible

So if won’t. some will, some

Unidentified Analyst

thinking for may your about a for final to integrating about two and us can more combined (inaudible) little guess you I is give how be color Rafael, that role on and are R&D, your integrating question clinical in made you my bit the R&D clinic? the changes plan

Ad Rawcliffe

That’s great a question.

you how be to early how to with [TKPV] take for etcetera. think as have can regulatory to and disadvantage trials, develop to comparative of very eventually drugs, how working markers the use and people approvals to and early how relationships cross-pollination are I understand have you so have because how selective R&D oncology is understand surrogate want a to guidance integrated a know to trial. a write obtained on unmet and design very people scientists needs labels who and Those target they that the

and and of of just obviously And improvement now of exclusively products so discovery activities are making to group all characterization support that also the functioning line our sight is that and but focused opportunities product, on will not sciences translation medicines, the in tell discovery our have vivo. the that us how

also in is ones group better some second informed the the discovery described in persist we what’s that T-cells, and James likewise, site generation, the of deficits going are we designing as with traffic improvement whatever observing the to such So clinic, patient now are the to be to to in regards happening to tissue cells, when the potency of tumor kill cancer to their etcetera. other they’re tailored ability to so

cross to the of the back really of characterization going from choice patients that necessary of talk product. disease the improvement target it’s So, and T-cell TCR to in be to I the choice the the that’s to think

within of cancer legged T-cell instead they our stool if also causes its manufacturing cell will, integral are development of so what i.e. precision three very and you integrated we an aside And from killing to that development, do part is group. related because and [TCR] a discovery

market. I unify in So these groups really took strenuous job able the remove anything over get that really a that’s and three being to since to being emphasis is was the to

those So at high R&D moment. the so I of level are this fundamentals sort of the think organization answer, know is I

Operator

comes question from SunTrust. next Lawson with our Peter And

may proceed. You

Peter Lawson

beyond how about we as to potential venues the on think should we other May, thinking timing there, be the follow-ups, data? updates Just a the data couple for and of year potential

James Noble

give of update programs, time be So say going that of programs, trials to full at setting which in responses generation, going in and looking we’re when present. other the we’re we also second details any start trials also going give to an intend across a if words to to to and with we on what can and we’ll update give do where May, further we’ll we first we details be we’re obviously what give the up,

you is the very issues As these that presenting of are sometimes very patient times long one know, the conferences give small with numbers with lead unless you abstract. for the breaking difficult really

So we today, complete May and the the we’re and we’ll give at in of information that we confident to meeting today from of time. intend where we give if a can are sort going out overview

got the couple be out. on seen following a today, it will on feel you’ve we’ll and and published we’ve the later As the and which of online ATR, obviously abstract one profile on safety just today, CDX be one

intend in what do to we but in to a going happened credible data. we’ll So also trials, future, what what and better also and to saying in to the programs update respect try give we’re we implication present not type what just just going give of forward get May trials where to plan of be which expect

Peter Lawson

And also of (inaudible) so do have versus have based mono kind of a far, change, pointing to you you what therapies and data think combination it’s on therapy? north landscape and

James Noble

interested are types. we in think I both

combination is I And an to scientific role that. combination initial a NY-ESO to and the study then GSK, it’s key adding there you program the them. a know a ran to think a and at always look important with monotherapy of in over with more combination see We’ve to handed we (inaudible) we study, we we interested for if actually that both. as effect for rationale (inaudible) ran remain which a was

think a I always that, with monotherapy. start rather So start we’ll than off with

context maybe grant didn’t a combination study that wouldn’t to we combination may that that disease, it and it’s as the a in second generation, add it appropriate like generation be study appropriate if sarcoma because in you of first instance. be in If then

is I as when I help, combination where disease might where a is soft with will we’re beneficial. keen just is there there So think the as disease role, where monotherapy say there with which a we’re and but can trials combination a ever, be

Peter Lawson

And pointers be then why couple and (inaudible)? we just thinking a any XXXX compensate about just Adrian, of how for not of on revenue, should expansion around questions

James Noble

last the total guidance XXXX fairly to as said think the we’ve what a we’ve takes XXXX. XXXX million will closed liquidity, that of rational we end given the that to outcome with produces for XXX versus of I and logic cash it burn the be or late and year us

So going basis we’re you line on in inbound materiality as like total, give likely time to to expense look by or expense I not a runway fairly indeed those think that is line certainly. what that but clear with to gives

work on of milestones complete option obviously associated the a to the well. revenue before I future is any we stage had line, we On I but And XXXX and think magnitude we’ve in the the GSK locate phase (inaudible) that but targets, large that, not development happened terms contract, that to the as XXXX relating payments as talked largely and and as they’re we might carry additional that GSK have revenue nominate programs. and the to be the that where think to fees to with able the a will we’ve in or in short the the the now through same in in contract from about preclinical anticipate getting

Peter Lawson

anything, there other that? timing was item, catch income is that, one I And expense the there line didn’t

James Noble

liquidity as our The other we balance. rate largely hold of the on investments that line losses expense gains or relates exchange total portfolio to and of part income the

when UK hold we back dollars. those of in the sheet So our to balance and subsidiary converted

gain or not is real an a is but accounting gain loss. it’s actually not expense or a there it loss, So – expense

Operator

Michael next Guggenheim the Schmidt with question Securities. And from

You may proceed.

Unidentified Analyst

development two. diversifying be we inform Two been the that on May ovarian. And mentioned was be This for potential your of AX the should over call steps Has on enrollment clinical hurdle. recruiting questions, secondly, those read last a you earnings kind update then XX and a study, actually focus further Kelsie or mix will mostly was quick cell through on to first, then in is expecting on Michael. the there cross-bow data how mostly had non-small

James Noble

Rafael, you answer do want to that one?

Rafael Amado

histology there and is one one lung embroiling expansion melanoma a one which and the then tumor mentioned for MAGE-AXX I histology and and that enrolling you’ll was tumor is trials, been three that’s in exclusively long at to phase diversified are numbers, is have head cancer the but obviously mostly, is think pretty two terms that’s as in triple neck before. look (inaudible) bladder, the there it’s types. those For of And and of

expansion suffered in and was had clustering a what of really haven’t from ovarian just we in patient, the we ovarian mostly cancer. the (inaudible) type a function NY-ESO initially we triple cancer particular So have the tumor. dose did study a in tumor Later of that

a tolerability, bonus had characterize keen patients we’ve knew of MAGE-AX so and efforts see qualify were for that therefore safety to we were very actually then the as investigators tumors. we the too histology that So of trying who we and we that got range expand to and the already positive and lot study, made would were Since the they patients of through critical. because came wasn’t to whether

number diseases And bladder, sarcoma had other NY-ESO. and that have of in the said head because added enrolling we have with it’s each in But the that north we a a one to been While trial, MAGE-AX sarcoma we centers in added we and and gastric quick a nine announced in center with of the finished. obviously are very we the which to types that patients working and by really melanomas, progress tumor and think recent neck, tumor very types study, the study representation others. have so of lot went by and of difficult there won’t past wouldn’t past we ahead I including so to made good have some in recently, that May May, the we

and we’re timing patients successful MRCLS in also we those been patient So patients. of synovia have recruit we’ve with trying to sarcoma very and runway

treated, treated call. talk Some be we’ll the are being some already, during some now some of and have have to main treated been hopefully about results them to

the be tell would we I but as sites, the we in enough to two specific trials in that, know sites were that’s disease to that to where to representation whatever when where we tumors diversity. gets we’ll would in of the it. we specific we would order to accomplish well. In to we X announce we tumors. phase launch something the we have a get that of will we MAGE-AX, in get last unit referred signal sites I from and number terms you registration So specific there And And like be are in from diversity to X see characterize mostly full I get to the phase what able think would go to will trials in would that think past before now or and emerge

resources make the histology then this if X/X year. will where phase on positions to try registration risk be characterize and those have in to invest so particular we we our And see to able to make enroll the and continue to benefit responses for decisions to we studies,

Operator

Cowen comes our from Company. question And Frahm next Marc with &

proceed. may You

Marc Frahm

You described update. the when agenda just earlier kind of clarified your the May you comment in

ASP fulsome or programs, have is going it said to well? the a we as programs to should just of You update on expect MAGE be kind still

James Noble

the study level. play on to are recruit, ASP, told but but recruiting going whatever much We’ll to as slower you patients is we’ve at a fit-in on we with happen it’s repeatedly

up. level, and haven’t X got have to been still there. It we So billion that recently we the at is centers speed recruit adding trying to not we’re slower

May. will far to until then So we’ve we’ll you there patients going be is and ASP. will it’s answer to MAGE-AXX, think tell there more MAGE-AX – I whatever got be But for come of be the

Marc Frahm

choice have to you you going one. is now about one (inaudible), the menu file right supporting that first or of generation generation level disclosed you data the what of the that’s construct next about talk different to a do and that You or think which could disclose for two that you’re

James Noble

man, MAGE-AXX, that which disclosing MAGE-AX higher talked had in reasons matter not in the present might has MAGE-AX go patients. say in think. This expressed on where CDA competitive which which and that fact pick more clear I but invasive meeting because inform many feature published programs, ILX we on than the was are about and great don’t it we’re to going or we before. patients going disclosed all tell for a us file the to the May the and MAGE-AX We’re general in be we we’re will one much (inaudible) I T-cells for one a will going than presentation telling MAGE-AXX IND people people now are an really actually one surprise even IND, today they It with the (inaudible) we do the different than third, as at what. we’ve for we’re what the to exactly, effect There’s more further we’ve is program, the four of going (inaudible) for from so fourth come of (inaudible) when to week details but is

timing do an selected one of So the and which the we’ve update we as IND be it to but MAGE-AX, main IND for will will with meeting.

Marc Frahm

in beyond XX the now and right you the And the there then term XXXX future? do plans to place one, to you our for think the is that in through kind expand for XXXX near there base. Are capacity ability per flexibility expand to you is of or this you roughly last month. patients the progress manufacturing XX mentioned do have the and in-house Yeah,

James Noble

built month of most capacity. capital actually and in the affectively. essentially this facility. XX We’ve the just trial need of terms expenditure more in of more suites Obviously, a It’s effect to the suites the a of number we lot Yard Navy easy to equip for get us quite

month a building closed much the of involve (inaudible). I’d a is So go for that fatality people XX there magic a is stage. half don’t the that doesn’t XX you the next XX relatively that XX, But empty insignificant in to to we’ve get the essentially facilities of place and relatively significant XX to order get carry XX we a we is simple, in the involve and we and If could beyond would pounce expand. a requires to have - to got to series get plus our say to month, forget building which expenditure to or We’ve expenditure. half

Operator

And Reni from with comes Benjamin our Raymond James. next question

may You proceed.

Reni Benjamin

kind about XX% talked is can boogie done can below just one else kind I we’ve or to response a and to not any it that boogie be seem sense from decision. you be has can the great. rates tinkering in response – let’s James there’s indication, data of that going get rate isn’t looking somewhere that per the range can if talk billion XX of when be say does far, of at, seen in XX% for else the that maybe a so we’re that’d wanted go that now, and go if and more about we you are it can all you’ve sure that what past the met done, about if still I’m our based say came no-go do, cells. on like at that we all forward the changed doesn’t what

James Noble

on clinicians payers rate. it a is don’t XX came for reasonable something a the so far from. you And and having that’s I fair thetX wouldn’t it one response the patients. something procedure think projects favor If where in would to complex and forward for market, think really without I patients expect be

came see mustard, of in patients a responding, (inaudible) I so from. really have the one cells XX you sort that’d where don’t just that’s that cutting be If

of that the do, doses. mentioned you So as in the is changed you much that that’s you with very up what second actually has can the than put based exactly MTI isn’t your don’t question general I sentiment half think well that billion the XX but yeah much, but that agree don’t cells, to do. earlier more I tinkering Rafael can

just cells less we different are if they really address etcetera things whole your of make the or is the other induce or spreading and epitope to like which cells different that think the microenvironment in which as it’s active things. they tumor you second that process and see CDX of later word to sealed, may make a for actually issues CDX do program you’ll today generation of about, sort I case affective could cells CDX designed ACR the that’s the series characteristics,

on at we think one therapy, cells said series dose – keenly there very before, think mentioned numbers the complicated combination So the we I’d appropriate the alloreactivity. And technology. large maybe are looking protectivity are, safely that, add few that companies. I there without the personal been it that’s performance fantastically things cell exploring is on and bit or foothills comfort technologies which in how and I I can of that deals the – out cells enhance apparently any to signed actually that and also many I have are earlier is astounding times and last we of with we many a pleased of I’ve to as two a of were very I’m technology

do, lot its And so can the of different things a are you cells. I think there characterizing whether

the whether cells combination, You tumor enhancing whether activation look to to its micro-environment. increasing back deal the or the its good its with people track patients, in to the of in a whether ability tumor

routes looking to could of coordinating are getting see in engine at patients in we’re both with better to there making taking finger the by response and account medicines research essentially the different from his that consolational many the it And getting data said and question think back to is he on enhance put the the or characterization Rafael the it. earlier how data to we’re that’s data cells back now, doing what this response is research go, about I development.

years very quite but (inaudible). are probably There lot. development, things know Quite more a it is XX of lot the thing. We but still to. it’s we about I’d of it’s say attention it of So increasing complicated do, answer isn’t lot a long can pay cells something just a only you and a a

Reni Benjamin

just kind I manufacturing, suspension mentioned bringing of understand the vector importance production That think first would be makes cell curious, to I’m I sense. the switching And XXXX. you using process in-house. the and it in-house in the was in-house are manufacture. why and contract just of the under gears curious depend manufacturing that that product pretty so I parts pretty assumption versus advantages bring that what much I’m of kind the vector standard was

James Noble

actually advantages, very that that lot all, cost you a of vector part title of to that There get effective ability good are make question. which first improve. Actually the the a to a is certainly need is continuing is to

improvements process to inherently fixed. process to from of actually more you how back a substantive made a It’s be make a the clearer massive as away efficient. much movement whole not in as it is just there’s So terms still actually to

won that you process do. you and know actually the know If rocky exactly the (inaudible) that you (inaudible) you’ve can

make which then If do efficient improve you continuously and actually characteristics been want process and want in-house that have to brining we has it you fantastic. to more certain

So we team manufacture. development process responsive cell to have a is effectively which

some vector to years We where It cost down some that spend already. vector. the is have gastronomical of And have you vector can its in things point. patient, it if therapy that you it’s the a absolutely effective at of use can radically you now, at nothing but a cost rather which are a looks second prior actually team And $XXX,XXX three ago cost. and will going $XXX,XXX be come improving make had cell cannot below to obviously sometimes

it you to few So most have concern before it’s at why for and and dollars you down thousand a that about that’s that. write But got down to come in-house. patient

Reni Benjamin

a a it back party, So go stage. out lack to third a not plan of then just just, production license word, in-house would process can’t even and best the to the vector a with make it really at for all commercial the as is follow-up, game the be better

James Noble

a and different similar the a for cell have moment, that’s option. we current would at that since our commercial what process those But time. including much regulatory you of and have not plan what the supplier supplier production dual therapy. for to to running a our out then we the that’s for different supply and to plan in-house vector think changed or process from think And Whether in similar third our the for capacity. do party vector do characteristics at trials, on then processes I (inaudible) very vector two depends we – plan have we’d has supply trial that’s we development the absolutely the or I an parallel you have and

I supply. very at from party are think what cost James is for third effective therapy whether entirely is end like cell process very difficult reliant you and is to an advance referring difficult, that it’s to if it up

the of I with commoditized. people at because way become haven’t that near time it mentioned by you Whatever will have many factor I think say moment. do mentioned agree, which it so way no I you there inventories, are slots will say, when unlike them. you want promise can in we become if you the But it’s issues also obtaining I’d to (inaudible) commoditized.

For (inaudible) example, bit and complicated a more a certainly successful at switch half in more of tends than vector slots. program can you suddenly. We is more it some becoming as drop where hat, more part in obviously be need the to a

it’s the cell manufacturing that unlike think commoditized, way I So, no near yet. become but will it

Reni Benjamin

you the little could made think in so more one final good you product, with and you provide that one off-the-shelf mentioned when you do the from me, clinic? progress color a can regarding just product be and then off-the-shelf bit And the an that

James Noble

probably one I you do progress on table, thought comment Rafael want for but this to commenting we time Rafael you. are that’s the on off-the-shelf? about the

Rafael Amado

Sure.

two aspect, to are therapeutic the immune carry editing to that make [grapher] off-the-shelfs from prevent host want their cell One make there the your to we disease stem (inaudible) is induced making so what to genetic cells aspects fluid the and to to modifications cell genome So, to invisible system officially cells. also TCR.

that X [HLAE] class done. to out knock multiple editing to One So and the out linkage be do there (inaudible) and class cell X can susceptibility including can are endogenous TCR. and knock avoid a number of

So to there’s cost but editing is steps, TCR do cells [GBH]. because otherwise has minimum the set the a of one many to will endogenous that remove

with Cells that But minimally gene is process cell depend timelines in-house. choice excited and very likely closely it to a that we’re on discussion the so them. line go around editing of this have And would steps look the we is done which to a editing we do, have partnership initially and line how obviously and and edited regulatory of Astellas on and the the subsidiary supplementing the would clinicians Universal that working to is editing like. the on we’re on with the will much all company and amount AAV now chose expertise They that we’re very in of

to do So done to have pillar stem in T-cells something and in to the this addition editing, that functional, the being to differentiate able are cells we is is that other that in-house.

cells that very with positive going happy are the and single TCRs Hematopoietic there differentiating T-cell for to and Progenitor be therapy. CDX have double the express cells made a to we we’re could progress in numbers So in used progress in and tremendous then to positive to which from positive

this work and for billions first of will hundreds of therapy Gene think the I also then the So and cells, time. we’re the Society showing all cells these of be functionality of presented American at

but put guiding on first working been to are that’s we’re said, the being timing necessarily on this not James our we hard pretty it, again system to TCR So in responsible. of able

Operator

Soumit comes with next our Roy from question Trading. And Jones

You may proceed.

Soumit Roy

TCR guys two to Curious variety memory unique to sarcoma? you long is, you’re are the these solid looking or bladder difference had – of see thoughts mutational immunological cell when just you in number could indications others. question different amongst you tumors, synovial formation, questions, around spreading, data you is, different to several a first in like are memory. second at different collecting are of tumor melanoma I you’re look durability, stroma, kind difference or any to seeing (inaudible) quite of and seeing of we back groups expansion compare epitope the make position these to it with patient T-cells what And all patients burden, of kind if a are characteristic, between effect marked at some expect some to

So a what it out immunological long we to the day, comes of data before expect see year now? when from could kind durability

James Noble

you. one for that’s Rafael, probably

Rafael Amado

in differences expansion there whether think were first I question the the histology. along was Yes,

to initial I whether Clearly question. expansion that to to think higher the other in at analyze is the any we higher do significance that everything with more it’s a have we’ve dose expansion parameter But been that target cell able those than are conclusion. answer in can and there make have to expression. There that enough that see evidence patients we’ll correlations too to early differences be is we to-date. able take anecdotal look make with

more know of is that think the resetting those And expansion parameters due expansion. this the I of expansion together with seeing what Sarcoma. and large and between tumor probably dose the histology T-cell come role true to not in with similar sudden to antigen really expression think play numbers than itself. of the set a type different cell the we the differences that’s by is antigen-driven versus I that of hemostatic But is only dose, expansion including we’re given

a So statement. that’s general just

of giving. of that all we terms were the in of think the are the we makeup I that we’re looking data first collecting; product at logical

then that this in I obviously as expansion TCR tumor patients in mentioned many and by memory this in patients. what and/or the [summer]. factorize to So, that resetting. this of cells early (inaudible) then many the progresses To that have stop how we so And the we versus persistent you them continue tumor them when mention we long type, increases, and we very not them that need CDX, grind we being you follow-up but see the there’s periodically correlation we long CDX CDX, cell doing do unfortunately have look type do available differentiated cells along to this try cell experience the responses of yet a cells and in a obviously But versus this. past NY-ESO the have stop terminally manufacture have is and samples, product, because being those memory to tumor collecting type. the and cells arise stem what’s the How survives at when by and probably most because to And and prospect we what’s have. stem identify if in many the shown are how on think of are obviously of in that, the that, persistence as persist have what We’ve we patient, in don’t patient to and which are long data. able

you X% identify be or that’s good TCR If believe carry developed. stem may can T-cells in has a that memory of X% the cell there the predictor that cell we that memory, persist, immunological that

that types need For these tumor verified in were will they be to these products. all of treating the new with new

Soumit Roy

way. later to Is half episode reason look you there T-cells a year forming this in the second to to memory update? update matter or stage the really like to wouldn’t earlier a to a of T-cells the with are of The the doesn’t and later affected Don’t give in versus try that durability how on it look a why mere versus in that look much response would even spreading or (inaudible) better product. think you

Rafael Amado

T-cells. the swallowed I as and that the will of be progression the without makeup before we’ll said continue obviously remain continue patients factorize So to again

seen that would we’ve time, the see in few shift able cell to We expect that beginning to continue and sector follow that there we’ll be do and we’re cells something from (inaudible) NY-ESO or patients in for been stem longest the phenotype. That’s a we’ve to that.

the is T-cells in make [chronometry] carry we to inferences reacting that published and are it prior not an – thing that there multiple that there we I will the to definitely have but epithelial by not about on NY-ESO. do some are suggesting do studies. T-cell infusion And that than in clonal current are were older TCR that of not that clones epitopes our myeloma some you’ll think can doing epithelial see study is easy T-cell discern, spreading emergence shown that to spreading which you

that no epithelial therefore testis In fact with is slightly be cancer the cells because have there testis this we epithelial has a antigen you’ll get and cells antigen think and expect antigen durable one negative all survival express cancer there will to responses spreading not that spreading to that resistance.

for it’s collect based to where at early analyze these just too the and what will with chronometry time on do cells. are we So, and point different looking said, exactly samples detailed we we you

Operator

comes Fargo. And Jim Wells our next from Birchenoug question with

may You proceed.

Unidentified Analyst

Can clarify times of Navy a release without expand just press the couple expansion; XXX heard believe. you investment. investment I can significant per you month, that says I’ve say XX month you now as The far as significant now, so Yard per

Rafael Amado

It’s building under administration. scalable patients the significant to expenditure without month per XXX a capital

James Noble

significant that patients few XXs capital million. and without a a market it’s But a the It is facility. month expenditure of XX within cost patient will XXX

We’ll employee a correct reader Our future. has proof that.

Unidentified Analyst

thing target is XX for the page off was the sort And to jumped here with really expansion the that billion. the other dose X of that billion up

patients level it’s X billion. make I billion dose hard or was X you So to the heard I think say, X cell. while some And

the this really don’t you just it is you know whereas get billion patients give and then the have flexibility these get So to if good really don’t time yet X whether takes I’m X a to long billion, is sorry you say they enough. to

James Noble

it X.X we rest. X or bit tend to seems X.X system to you give the way give all them a We’ve it little so billion, ridiculous billion the actually designed the means not example, billion, designed (inaudible) The just billion XX way made actually, and the X billion is the don’t X to billion away yourself. let’s a take the throw them give

frequently. billion, we that think that gives we I really every this get do at I’m – think think We XX XX So flexibility. looking the billion us time it

in you lower, the cell method if even though the specify specify – extra just a them it’s just protocol So give sitting can’t something is a there. you then you what and just dose have to of they’re just

to really flexibility. it’s So give that us

produce they XX ones available. and So billion, get anywhere that between billion that are number the if X of cells we will

Unidentified Analyst

to really not question is billion X? the expansion My X and

James Noble

can can of and up only to majors but XX. the we second X rising, is X, X, cells, is high that target dose target ASP it’s X we dose the The give (inaudible) for currently majors allowed the is the low X.X billion target as the we’re expansion. are billion give the for the as for level, X.X. The is is the X at

Unidentified Analyst

the X, Again XX it target up the bullet. third press to but on release dose of says

James Noble

They are --. and and XX (inaudible) major X, major X

Unidentified Analyst

So, billion of treating patients phases of doses cells. billion with MX with doses target up the expansion X cells MXX, to XX of

Helen Tayton-Martin

It’s X.

James Noble

We are (inaudible). getting year full of

Unidentified Analyst

release. I question us of what And can the ask phases? of patients remind the read in I’ll that maybe of to in So going expansion each number of you press the also are

James Noble

try? Rafael you want to

Rafael Amado

vary by the third to are XX trial, essentially but They patients dose. they between inclusive of XX

between the XX patients billion, and many to would on however various we patients last So, the that XX dose, put a (inaudible) which under target has patients study. of in have to we the expansion X treat

Unidentified Analyst

just to get be trials much May said I’m how completed. when – you think really won’t So I the wondering you’ve

will we’re to registration efficacy trial next to enabling more define steps we want think to we a to X is going able move So potential combination for while to concrete initiating or or we gen levels say it the to see. get approach

James Noble

the May from in that. about to patients do, to these it take either, as talking So need to come answer small are of what that’s the exactly are going It’s could the these we’re data, number anything we’ll patients. be to to know

we’re gently or going we now going with need and move to what We’re (inaudible). registration to talk exactly the trial that’s to forward move about

Operator

next question Merrill of Huang [Operator Instructions] And our from Lynch. Bank comes Ying America from

may proceed. You

Unidentified Analyst

a question. on guys question cash burn this on Hey of clarification couple Thanks Ying. Alex had our guidance. the for for I it taking

to patients So Yard HCAT Navy you roughly better capacity, the on does in XXXX is budgeting you cash what that. current and look in this was person patient a of XX Is in manufacturing the are per manifestation this balance. month buildout the A, in or expansion to to XX sort your how mentioned well? XX from the much slight included capacity the with of and physical and expansion previously. is increase up manufacturing due your guidance a And terms XXXX as vector like And baked towards plant, this this efficiencies

Adrian Rawcliffe

a that. borne actually comment was plant vector because detail, capital were so whatever companies If UK they their the for just (inaudible) UK government in land I where various in large to I dedicated very (inaudible) as vector money the in manufacture a expenditure then facility, a is largely to and that’s on cell fulfilled GSK the tax we the just which incredibly of is by reason or payers on lucky either the vector start activity lucky respect vector think (inaudible) the are facility the decided building to out host production, actually and that clarify with we actually that

didn’t dedicated have to to build but thing its we So us believe I (inaudible). a

James Noble

per question throughput the Taking patients timing is sort of short of we’re is how the to with Navy eight thinking sort a end XX month of month patients capacity week, you with Yard get that’s your first you depending and X and two so patients the longer you facility roughly end patients, on that or the up slightly XX of about.

to mind do the are have of and month that numbers with to roughly existing Yard should pivotal actually in at it noted (inaudible) that pilot as in in some the HCATs the place employ out we would those well. the ongoing. the to Navy Navy the move quarters number able to is that in at we same the of the do would in service infrastructure and is same. demands in be we trials patients of capacity with to do and Yard, between XX trial But So go be clinical are The cases a the trials, capacity (inaudible) but about that people

need in not are is to moment pointed we flow significant externally trials commenting I’d if on we for versus those as that both out choice we’re vector. costs at a on how going the vector be expect detail the as internally, the there opposed requirement, the have in much cash you in or for the CapEx. So The complete and

Operator

gentlemen, session may to proceed. for call would Ladies turn today’s James Noble the conference. now this back Sir, and remarks. closing concludes you Q&A over for our I

James Noble

us Thanks this questions. joining us giving some one again every very for interesting morning,

our potential to general remains you diligently T-cells very May. our update to to to with work we’ll options, of other giving patients commitment the in patients therapies much. continue and more Our Thank realize few we to forward strong and cancer look a treat

Operator

day. thank Ladies attending program you great and Everyone conference. conclude a the and may does all today’s This disconnect. gentlemen, you for have

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