Adaptimmune Therapeutics (ADAP) 15 May 242024 Q1 Earnings call transcript

Good morning, ladies and gentlemen, and welcome to the Adaptimmune Q1 2024 Financial and Business Update Conference Call. I would now like to turn the meeting over to Ms. Juli Miller. Please go ahead, Ms. Miller.

to financial call results welcome first discuss and XXXX quarter and morning, our to conference our Good business updates. you from release. ask our would to full the I text forward-looking statements this press morning's review of could We anticipate this filings outlined due during making with those the several including our differ actual factors, call to in materially and projections results latest SEC. management available call, is the prepared Adrian Q&A. for and members Rawcliffe, me other our be here Chief with team of our Executive for of the will Officer, portion

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

the comprehensive about I held a us brief the on Thanks be towards to Juli, we PDUFA an Investor a for before date as status The everyone, August. brief and Q&A. T-cell therapy we important we we to the going afami-cel how solid also because approved this some as Day, the for thanks, and tumor of And a update for fairly comments joining indication. of for the our fourth first go field of engineered are into couple QX talked call. of provided TCR provide we comments ago, move regulatory plan weeks is

portion morning's In is the that Williams of release, feel the afami-cel We do development, of we'd BLA a for commercial head we call. also our would in beginning the this of provided sarcoma this said be for on press and the discussed afami-cel we commercial some late-stage a here approval this significant be value. underappreciated launch our And this of detail. update to Q&A progress, and preparations we further on that has of ready Dennis and franchise that

the looking in in We now commercialization requested a for the FDA as half Officer, FDA happy not also our second the labeling has review our our and forward are Commercial of Piccina, an to the confirm that in Cintia are meeting the commercial look and short, due customer-facing as fully we're or to REMS Ad I'm place. progressing In course, here month. Q&A team forward program. well. our far, this to discussions late is Chief to and Thus affairs cycle and interactions planned, with Comm med

As track I said, we be are to on approval. to ready on launch

have the XX We for focused in team to available And afami-cel you community to XX and Mihaela anticipation if within which is up high. a website, you approximately Dr. starting expectations course. centers and Investor the very X due on at revisit presentation our see the that ramping sarcoma by Druta, will Day treatment are

therapies President anticipation novel who I sarcoma. And this think for advocate the eloquently Philip lost Leider, highlighted he, and very Alliance, the patient that sense demand his of sister of by think, reinforced to was I space. Sarcoma in

our to And by is anticipated medicines worked the approval. of last volumes the meet scaling community. us half with are hard this afami-cel are the so eager this get in our very sarcoma all the to track for to launch of August anticipate summary, around manufacturing of be able to highly has into sarcoma. that in obviously, date hands is decade community over And develop PDUFA and we product launch afami-cel second expected And we in what we XXXX. the that's on So to for on be the for

an similar in sarcoma that they to of and than, previewed lete-cel, the I'll presentation and sarcoma BLA be MRCLS and Behind other synovial and for having by a place ASCO you look presented afami-cel, and in towards both from we a platform a MRCLS will These This high synovial as move liposarcoma of IGNYTE-ESO afami-cel Dr. the approval to therapy that at a we at towards sarcoma will lete-cel and data presentation the the interim are development people's continue in milestone in cell level Sandra in important also XXXX we pivotal XXXX. are course, trial cell of point the this in understanding derisking data be at progressing for last of anticipated myxoid/round analysis synovial D'Angelo. year. with very

You financing another Hercules will we've this up press see with Capital. to in million us that secured from release morning announcing $XXX debt

afami-cel the approval. available -- on closing the available million tranche $XX $XX and of additional With million first an on

well. The our of Wood, launch platinum-resistant executing that have And such the to secure with and here In Q&A the funds is priorities. Gavin ATM the projects approximately other in followed Phase as seen on raised into these for runway, Chief Officer, II million this our $XX the on our by position steps also with trial for We've addition, ] taken [ as QX, we runway on ovarian and cash inbound And the lete-cel inquiries. you will afami-cel of necessary XXXX. we execute financial based cancer. to Financial uza-cel have significant late pipeline have

to So Operator? for with to like it operator turn that, the I'd over questions.

[Operator Instructions].

is Jonathan Leerink question from from first Chang Our Partners.

current the agreement announced First on question, assumed understand better of cash the trying can what's to just today in your you guidance? I'm debt impact guidance. talk run the about rate

Gavin? So

and development the a gave of and Genentech sarcoma Jonathan, termination broader afami-cel changed last the We've had at progress Yes. of made broader terms still the through year. since so the start Clearly, we guidance that we have the agreement, the we're agreement. of significant termination franchise. of working on things the number of

bringing debt X/X to pieces Hercules. also we executed runway As Ad new thought those together, it money about by under our we've XXXX. late just raised moving and prudent cash mentioned, with Putting all ATM the facility we've a

there Got for what much assumptions being is down? drawn how are it. of the And debt

-- We available grew at down closed million XX million PDUFA and $XX closed the the date. $XX

then for presentation. the help expectations ASCO, And just upcoming it. can Got question, you second set IGNYTE-ESO

you want do that? Dennis, to take

sure. Yes,

on trial. the analysis interim the presenting ASCO pivotal IGNYTE-ESO be results So for presentation, to the we're of going

at So sarcoma least this filed synovial comprised of is that months. evenly It's with trial liposarcoma. myxoid/round patients cell XX X patients and for in

So efficacy data that the were interim present that available safety analysis. will data and at

TD from Frahm Marc from is Cowen. question following A

giving this first, nice the detail and meeting the just review that late-cycle Maybe way review the FDA of coming along up. you're

kind your what can may the information going conveyed glean review be of closure at of some that is by strategy be Just meeting. or to around you guys that you

disclosing we I the don't that? why focused So and we date and review the there's the to the if we're take I stab able run-up on and out towards actually will on anticipate that hard material going in with for late-cycle otherwise, on hard and at pushing labeling then being getting pretty think be be and anything So a the to the agency both that post-marketing meeting running commitments, the -- comes discussions PDUFA launch. we're from to discussions that, to that PDUFA we're

sessions, do Okay. and questions on-going kind you including kind the label. view mean, about include or [ And the things things then and of what to like the into as of maybe as ] I [ indications and not you get major answer ]

Yes.

So is this Dennis Williams.

the that down example we some I'll mentioned in we'll individual grade talking the I that label, wording example, think I Day it's syndrome, product would of right? comes the Investor sort give the how or of to in release for follow-up give in Like should So for what structured label. CRS. this really in recommend I gave like goes information at we that manage about tocilizumab be and cytokine Day, be how how how we the Investor

really label. it's points sometimes words So are about the how of the finer in the

or review. and a we less indication words statement, no at end this date as the the FDA with to had feel up we discussions to that the confident around have what We is of statement going the end more we're indication proposed very with few

Tony Rodman & Renshaw. Following question is from from Butler

calendar focus I respectful I in lete, whether or bladder, ask Phase anticipation through the at of on a the of cetera. least follow-up on to not, about but lesser uza-cel into I'm a there et year, or afami-cel any wanted on either with was in pass ovarian in to and the very extent

with So for thinking I that why we're don't uza-cel. cover what about

analysis, a we all to the in platinum-resistant therefore, trial. putting any at end ovarian up that enrolled SURPASS-X as that have be For with designed of won't the out cancer, patients on data And that's until potential least registrational in for we be at trial. being in until drug. a event. XXXX of we follow but the least that There we interim won't we've enrolled patients communicating are I the to data all futility enrollment that anticipate reads trial, which

we've head so in potentially a in other So to ovarian Phase with indications, to of and objective the indications other neck range a to that bladder X I anticipate anticipate we and what we on we're on respect which and combination the in now with update themselves. setting with the this data moving we've data in SURPASS-X data checkpoint of in those, end patients is about gather focused at as is down said year inhibitors of and the And forward cancer the well. the an the tail basis giving there gathered would include how

is Graig following Our from from Mizuho Suvannavejh question Securities.

all on Congrats progress. the

analyst Just you FDA in particular, down Investor also the and have review in back process the or of wanted to event go to in light great Day Philly.

any other visits the CMC shaping there get there by progress? how expect to it up better Or FDA manufacturing been to additional a any related Just curious just things perhaps inspections and prior handle approval, has facilities. your Do any on maybe on other facilities? if manufacturing you wanted to were as

again. Williams Dennis is This Yes.

we I mentioned a trial And the point, were to has all during outcome. manufacturing I drug both at sites lentiviral been all utilize this that expected that from also own a standpoint be GCP supplies as product, drug all our think completed, the inspected the facility And had good yes, Investor Yard for that we had was here facility very manufacturing right? the are inspected. So afami-cel a facilities Day, are completed, they we vector So product inspections that manufacturing for It's good -- for Navy inspected. also clinical the outcome.

site inspections are But at point, this inspections a be think complete. clinical at the in are scenario this always review, So the think guess where point, another inspected. all completed. could the stage I I we at this but there's

latter with the REMS. company an to regards expecting not on a perhaps not to or the just Comm made anticipating Ad comments, regards with about REMS earlier maybe And a just program, or

part and happened is a of still that this from a now? discussion PDUFA. by potential have between is Or it discussion the perspective, would now Just calendar naturally something

Yes. Sure.

REMS not certainly we think REMS asked we've the this the at no for there time. I So a that that submit was at review BLA and discussion review decision about this at had time, Investor I the and they the ongoing, FDA with FDA had did time had during And was application. at in and one not discussions Day,

of weeks a that That few already. general, can that been requested in that had would don't product. we've meeting. elapsed the at I You're mid-cycle have say, conversations for have this we a correct the REMs had within anticipate occurred just with would FDA, time REMS the

last if Okay. And just I the could. maybe question,

assuming Just could on-time if revenue how remind about be perspective. all the from you of thinking an particularly we uptake curve, us shape the a approval should

launch. and is we essentially for afami-cel dosed then then we're the the be on -- would what is is it's of return it's PDUFA uptake like enroll and anticipate Which that's guidance So manufactured, on though to from the Whatever to we first by specific and targets patients the year, not first an why X/X looks we until we've would that this autologous we is shifted approval touch revenues part this coming the think that? to I to of starting the early patients -- and that given that important date guided and need patients. that patients the -- QX basically said from in frame understand have recognized revenues be to to product manufactured treated in August. you guiding because numbers so don't that we anticipate not through What the even from about first curve screened anticipate

Following question is from from Guggenheim. Michael Schmidt

is on This for Paul Michael.

on thinking up sites And targeting clinical early setting? for talked XX in had many across year, country? launch. for your to of But experience this you about the that looking launch, afami-cel X have the about to trial strategy on what's ATCs beyond all those with the XX centers how scaling current So afami-cel

I'll to to that. talk ask Cintia

Yes.

of and months with XX after there expectation experience X the the period, after afami-cel XX of those are sites And total, priority about Adrian available study launch. XX targeting some with up them, of XX the So the to to sites experience quarter to meaning clinical about Out we launch. already starting sites engage are are will which said, -- we during sites as launch also first have be lete-cel. sites have beyond with XX these we part additional the in have to the

XX all XX from lete-cel majority we all future, ATCs the of synovial will part sites the patients be clinical of those sightsee our country. and So of the the in our dose sarcoma of again, the afami-cel know and in

follow-up. just a Great. And maybe

As the us is what you a give of how early ahead a has you give look in to progressing? This sense launch, sense to Iovance. metrics that kind you're the the of an area can disclose of sort for to launch of planning months Amtagvi been for focus launch of

if updates likely a you're more early to provide or if on patients updates number months. So can identified expect curious versus the just we in qualitative of infused

next at updating on that plan our Q call. We

Following from He question from is Wainwright. Arthur H.C.

question. I I Wainwright. H.C. just This had is a broad picture for Arthur guess

see area, aiming the autoimmune [indiscernible] the I'm from curious you but on your educate for help we know you focusing us moving industry the autoimmune disease? the to the launch, potential guys could are the just laser platform business there. So potential I as on

Sure.

on as So said, laser-focused the we you've launch. are

in if autoimmune $XXX disease, therapies the autoimmune the see we the in addressed in TCR oncology very you'll have at we enough, We short I afami-cel a massive the pipeline, larger can into the rest and develop if very from of targeted we but be focused will need the on But franchise, with and years, that have on the for that company million think explored And the between over you obviously of long-term long to mostly space. is dig history T-cell maybe much only look also other the of our franchise as TCR -- our Treg you term, therapies and -- of just indications, sales populations. coming patient opportunity in sarcoma future the and programs. unmet X that the focus quickly move sarcoma launch products with into

And opportunity there's ovarian, bladder head neck. with in uza-cel and obviously, an and

data are and the with indications beyond which to XXX,XXX currently with right interesting that address HLA with that think the I PRAME, pipeline. type. preclinical patients in late recent their and are the dying And with of the opportunity that over the given CDXX, there right both target target, from

broad broaden tumors. cell mainstream and horizons. that making Short indications so term, terms in therapies into Longer And spaces potentially range in when the cell can of we And taking where sarcoma. other see therapies, this of out, curative term, long benefit then across non-oncology term. a patients in other

Peter from is from Barclays. question last Our Lawson

around about? variables I turnaround could time, patients think booking any time should the wondered your time, hospitals turnaround approval, initial between the also the kind be as the kind you the of turnaround would about be and we if talk the and that of revenues we thinking with time end

Cintia, do you that? want to talk to

Yes, absolutely. Yes.

are time a and few take material back the Then apheresis. the days. process, apheresis be sites. about from that it time, then turnaround think when which they perspective, HLA the they is MAGE-AX, need when the to process should days a for that identified, from manufacturing journey we And consider the scheduling then -- turnaround the to patients about then step need through tested go can receive is would a that when of that be we we So apheresis patient first XX and the shipping we

at at why launch, the our will diagnostics same same companion time that approved at approved. the is that that's that's So the time, afami-cel expectation be

the the we patients to as before, year. fourth expect dosed would first of mentioned quarter see, during So Adrian

you. Got

line of general there's variability. that? a you identified and Okay. apheresis, I around expect amount patients what's then And fair the time imagine the asking the

John, leading is This manufacturing. I'm Yes. the

So the from between the X release the from collection range time of typical site their to until material back the the time turnaround to apheresis it X of product weeks. send and to tends

of get, through Okay. should and and by control about you infused. outside front hospital end the And thinking we diagnostic And that how kind it back other sense long takes there being to your from be the get once get are are kind to actually end funnel for it of things the and patients that HLA. the identified end gets the for test then

Yes.

before referred So have be a they take that can patients testing, the a more early are, the identification, where could will checked of control, be potentially a treatment way mostly will back infusion, couple that it's then part bit of very that that We these but Reimbursement things little depending something to to apheresis are patient straightforward. center few all mostly Then days. the also journey. consider other on to will be a is from straightforward. ores patient the condition then have out it's of or getting things at to

final get kind And just guess, patients the Got those the year, we around coming later just and I you I out positive data bladder what and just, you. we the of around of data. sets. -- this and regard neck guess of head a question as see should that a SURPASS expectations number

Elliot?

Yes, thanks.

that would to We haven't specific patient guided we to it as numbers relates dosing. anticipate

that to the decisions having indications We make directional of both sufficient of year. anticipate have by data we the end said regarding those

Thank you.

questions turn We I further have at like to the time. meeting to Mr. no now this Rawcliffe. would over registered

at I lot. today. on and to approval move year. a updating everybody, your Take are forward you you So ASCO care. later and seeing questions. look who your time Thank of towards for we for this of look thank you, attending launch as forward to you Thanks afami-cel those

you time, has we lines conference this thank your you. your Thank now and participation. The disconnect at ended. for Please