Adaptimmune Therapeutics (ADAP) 9 Aug 232023 Q2 Earnings call transcript

Good morning, ladies and gentlemen and welcome to Adaptimmune’s Q2 Financial and Business Update Conference Call. I would now like to turn the meeting call over to Ms. Juli Miller. Please go ahead, Ms. Miller.

to financial call results welcome second discuss and XXXX quarter and morning, Adaptimmune’s 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.

team for call. is the prepared Adrian for Other of Rawcliffe, me members our available here Chief with will our management Executive Q&A. of the be Officer, portion

I that, over Adrian With turn will to Rawcliffe. it Ad.

Thank us. XX-months. you, that release, data for Julie, we and thanks catalysts In we everyone joining and next press this morning’s the anticipate over confirm

the past afami-cel priority, For achievements the I a highlight our to from quarter top few BLA. this next particular minutes, want with focus on

substantial commercially of approved, year, therapy engineered filing with the towards has for first made When for synovial solid for indication. sarcoma. Over the available Adaptimmune BLA be progress afami-cel people tumor T-cell a will this this course

of this We of we of portion have CMC already completed the final towards the preclinical been working have clinical BLA submission submission. and rolling modules, and submission

advantage have with the progress made CMC full the and opportunities requirements, designation. We and by taken have for with its interaction our afforded the we FDA module, RMAT significant of

In to recent interactions derisk months, file. B we agency have had key the the with two type areas of

agency approval Cohort confirmatory evidence SPEARHEAD-X the from this accelerated the with requirements that with from approval to full The trial. the first would alignment of to was convert file be X gain data to met

a conversion full to believe will similarly complete next has from Cohort fully is shortly. we mature Cohort to trending support this set and X which and cohort X, will we year, data approval. dosing Cohort enrolled will have X

constructive interaction for data including parameters very The with the plans Again, from cell confirmation of of to our for FDA our the required release, adequacy our the we with for commercial the received assay. feedback FDA the second was potency discuss B type BLA.

critical other completed. several have milestones been Recently,

and vector. comparability We commercial supply have afami-cel with demonstrated manufactured drug patches vector supply of trial clinical

In to the collaboration application diagnostic. diagnostic our we partner, of companion for FDA completed the submission Adjuvant pre-market companion with have the

method vector we Qualification We Performance for assays, or assay, completed have completed validation including lot and Process potency PPQ. the have release

to we have portion submission to the enable forward, Looking following of elements final complete BLA. CMC the the

remaining We completing are and close to PPQ, will wet all complete we shortly work. T-cell

the set experiments to weeks. in few With finish coming last

for submission. will which the agreed We Module will the module all the And review package sections overall and for of submit previously to FDA review X not of we to we delay finally, will vector the and submission. of agency the X, comparability submission out complete the prior with write

anticipate that our substantially updated to timeline. that the have XXXX. submission We will QX we we that in guidance submission complete feel have reflect confident the de-risked We now

with alignment on work have X. judgment of the module majority We areas have the wet key associated and agency vast completed the with

engineered solid set We in a submission approval next XXXX potential a therapy year and are a for of first the tumor. in for T-cell QX

the with the opportunity even from treat We more sarcoma of with later return year. this also have to lete-cel people GSK

people as been near data anticipate be with evaluated trial later could sarcoma for reminder, well this liposarcoma, This in a additional has pivotal and an and commercial treatment myxoid/round As sarcoma. in lete-cel another cell we IGNYTE-ESO, as Adaptimmune opportunity year. synovial a term for

of continues therapies the the progress commercial to our cancer. aim people delivering for with pipeline lete-cel, Behind and afami-cel cell with

and ongoing trial ovarian initiated cancer. trial in have patients nivolumab This platinum XXXX. monotherapy X combination a directed arm resistant through Phase the registration with and into enrollment recruiting is a surpass therapy XXXX We with

full taking surpass resistant approval the basis data opportunities RMAT the on plan advance ADPAXMXCDX the quickly of excellent treatment for offered as Phase ovarian RMAT X in received have clinical from cancer to by response with to the We of designation to with platinum on as we advantage a And this designation the product setting. our of agency possible. engage the that trial

with the solid to tumors. what strategic and three preeminent platform TCRX we form company Lastly, TCRX strategic have believe truck for programs enhancements. is our therapy we pipeline, have cell Through we gen in our combination, to technologies next along completed with combination added the cells

almost our $XX added retained total cash capabilities confirming We runway and have critical into liquidity to XX our colleagues million XXXX. with

our taken afami-cel filing launch significant PDUFA successful to next In The and top first critical we the to de-risk commercial year. have steps based on elements. priority summary, our is clock to would of product BLA,

have GSK of from opportunity treatment synovial process the MRCLS. in lete-cel, we afami-cel, and is the and another could near offer for the sarcoma back which Behind commercial of transitioning term

progressed product of MAGE-AX our for initiation have registration SURPASS-X the ovarian trial targeted RMAT directed, platinum have with We in which also designation. next-gen the cancer we resistant

updating the to a this forward have our and the press data next of data outlined over clinical We on deep look this pipeline numerous later we as basis catalysts in release pipeline across XX-months, year. with morning’s

like Lastly, it I with and you we would funded back questions. into to turn are Operator. [Maud] to that, XXXX, (Ph) for

is Our Securities. Schmidt from Guggenheim question Instructions] from Michael [Operator first

kind do required This what I be is I standard would of our for for CD-X you Kelsey MAGE-AX, care just treatment efficacy there? on to maybe had think a guess ultimately cancer. mainly taking SURPASS-X, guess profile few Michael. on of option I question. Thanks ovarian for

And building rate may gavo-cel And Adaptimmune And maybe MAGE-AX expectations that responses could mesothelin? and data the to of you cancer program, off we you this year? be how co-expression later the of for for to should about could then maybe the the set program? from maybe speak ovarian think in compared TCRX

the SURPASS-X that. So, our data ask expectations and and have the a to on on we I’m back come we questions and TCRX Dennis that, that talk to going after to Dennis? about for will profile then

responses the for to response the mean those accelerated dissimilar and be have we would one population rates cancer, clearly durable have In in in file We to six-month longer done to a XX% to previously durability. What ovarian want platinum or for general, we what to XX% is would durable. durable ideal for where resistant afami-cel. range the a to desire have range the responses, approval somewhere opportunity have for patients be not

to want update with gavo-cel And TCRX you have on we and tail respect to this going what to are do year? of Elliot the data. the end at

Sure. Thanks.

combination at be that respect anticipated we order patients the interim cancer need trial, have, to the treatment later to point, with would So II all an this year. of in with gavo-cel, that ovarian in would the the we nivolumab enrolled Phase data make in this of assessment with

what until to assess I advance that for the enrollment opportunity in be had for data. or program, to similar think required we have that, the At this And point, product SURPASS-X. we outlined have expectations paused further would Dennis to that that what

cancer, respect of mesothelin in With ovarian patients ovarian expressed with and to with expressed is more approximately of don’t cancer. mesothelin MAGE-AX XX% in I have co-expression, XX% a to MAGE-AX the resistance considerably closer platinum XX% But is analysis formal that. while patients of to

So related. that there would be overlap expect they think I some are don’t biologically. I that

it that. haven’t probably but we mathematical equivalence, So to a just specifically studied is close

Tony Butler Our from Hutton. following is EF question from

big picture. this more Adrian, is

wish have a is product or Adaptimmune’s any outlined to you. and some, partnering and about U.S. develop where importantly or the develop there any a that. otherwise? view on been to help appreciate submissions have XUS in opportunities opportunities partner discussions much You What EU very Thank may if potential

in So But that be about in people we I opportunity do think, global. all to right the conceptually, to are that therapies to we take also this have the thought cell recognize space we unlikely geographies.

where And so that are imagine in to are be in able going the you geographies primary interested obviously to can be we partner we commercialization to agent. not opportunities

is those I when pricing those are volume are think are associated think, obviously But solvable, you registration I of some some jurisdictions. and at challenges and of your commensurately lower. there particularly of with cost level challenges manufacturing with goods in

in is in and anticipate and a the that traction and of afami-cel, significant before I And U.S. opportunities other with so, I in be traction speak United broader to much our would specifically can’t States. United will will that a other we fully point States portfolio on pipeline the than gain due products available afami-cel time, at there our ex we in the basis launch course partnering parts that and this anticipate

from TD Cowen. from Frahm question Marc Following is

the Maybe the the as the X think with should today, being of - that confirmatory as BLA decision ultimately original enrolled provided part essentially first during data of get submission be serving we likely as Cohort regulatory the of to and on review and FDA is being of decision? kind that to

Dennis.

in Thanks, is data Ad. going the BLA a Cohort Yes. to perspective. X safety be from

a of been review not review. discussed the table the including data the provide be course to-date. that atypical, during course like has to have with efficacy something the Cohort is during That data X the FDA updated would that of We not on BLA

deemed So at is it point to this needed, not be right.

the I mature. we want for evolve the discussions with at approval, can FDA. is follow come this to For present initial the were options in data that when up but come discuss Cohort if would up, to X with DUR guess sufficiently We

MAGE-AX? is and of an targets in around generation up on you or just then some other and second Okay, broader questions And kind just from scale. Tony’s to either of or helpful. that maybe Do partnerships about you addition a following other ex there those some think of Todds -- comments data your in require given, Ad territories deal products

would might I me like. think specifics what inappropriate discussions look of constructs be for the it and on comment to deal --

deal the depending is, years. varies we will and potential the partner their with I it what and who that in think think interest coming on I is

Leerink from from Partners. is Jonathan question Following Chang

can SURPASS question, at you First update the for ESMO. expectations help set upcoming

to will our in on on at update update ask Elliot Elliot. ESMO. I to that Certainly, incremental answer

Jonathan. Thanks

granted pleased an the update have presentation of that SURPASS ESMO we First this trial. we’re for for been at all, oral

across year updated data As three of and urothelial focus, presented cancer, valuable at patients response we ovarian cancer, shortly from pretreated of you and a XX% after recall, areas heavily demonstrating may last XX and neck head our rate data cancers. ESMO, that

indications ESMO, data rate monotherapy This data of as that from update And around five incremental arm was original as response that arm. the in dataset in we provide at will patients months. median in more all overall response the an with few duration mature XX% additional showing across a year well

combination at patients is And There trial going and that look checkpoint translational translational to therapy the been early heavily arm. also who patients the approximately insights remember will from this show be data stage also previously. XX in in we and will combination of amended with as and presentation we have said previously We data late pretreated. inhibitors forward

in uh, these the treatment we inhibitors. trial forward an going will with line again and Phase neck in also X combination result head trial earlier platinum results, SURPASS-X designation. focusing we ovarian arm resistant urothelial cancer and cancers a initiated in, As with registration of checkpoint And directed be of

And be submission second towards submission. to? the question, the afami-cel the any you I around delay color all more attributed BLA what can Can color the around progress BLA appreciate provide specifically

Certainly.

understand I first that have the think, that the demonstrate isn’t and FDA important item. thing interactions to de-risked done the talking have the wet think, was or is that the me one purpose the with of thing I filing substantially to itself. And through it we we specific work

QX than And into that we gone extension longer have that been that de-risking, the a reason number, have as a have have of just little that number anticipated. through we a elements there been that have there the taken we taken is

Not obviously, you to do one, But significant. each each much, by sequence. things not these not need hugely in one,

example. can you before assays do the the validate for PPQ to need You

the so most of the although individual sequential the that have discharged we timelines to timeline. associated of that with And risk means those changes effect

now to us take XXXX it are confident to QX that. file, We XXXX, that quality a submit in will to do

of to to thing a areas specific of is to actually it get going and this one us remove, not QX potential done. lot but So risk take

question Mara Our Mizuho. from from following is Goldstein

indeed that closed, assume in Great. should the just programs gavo-cel Like, some the Does candidates, reviewing full you think to and that, you that from about how suggest of the is the so much. I did progress? Thanks of now but data, development guidance not not TCR we ask should will acquisition those be wanted XXX? candidates. TCRX other

talk how will a and about guidance I scenarios. of to covers the range Gavin Gavin? ask So, it

allocations variety Mara. that to each of so a there, year. be making products got resource we and think as want Hi as about we do that we will guidance, we Yes, our forward programs and bring across portfolio, we have

haven’t therefore, actually about each and that this ones And we forward the write as begin we we next pipeline of excited year we we which are exit and be taking plans have, whilst products for finalized, to year. will

Barclays. from is Lawson question Following Peter from

taking for This question. the [Alex] everyone. Peter. for Good on is you. morning, (Ph) Thank Thanks

Just two the we for patients cancer combination patients, patients, the the ovarian SURPASS. expect to specifically? me. in Do A XX quick ESMO update see should from on XX follow-up we,

don’t all patients but not guided of they have particularly patients present, I XX the indications, we types think specifically those type were that tumor for would one we that that to selected versus are across another.

types there range say the of one them. think all tumor of we in a point. So that trial, are cancer this at And ovarian can is I being

helpful. follow-up then And BLA, a here. Okay. That is on just the

just reiterate priority required here could you expect of the evidence FDA? your review? what you confirmatory agreement And will be do in with If terms a then

the second would review. first. be, would question Yes. answer Thanks, Ed. expect yes. will a The I answer We priority

an certainly designation priority have We expedited application and review. as designation RMAT a the justify would

response. Cohort duration confirmatory X so to with the was the X follow-up as evidence, sufficient utilize the proposal for far data complete to As Cohort

of in a cells quite reminder, durability responses ophthalmic of long. as the Just this

to come in time amount mature data, we data. patients duration the So for DOR response to have of with or follow appropriate

appropriate So X and sarcoma they timings with is for larger the full be set, we SPEARHEAD-X. than agreed a that And for this will slightly FDA, in discussed and FDA X as would come we when be for data the Cohort synovial an the discussing may we Cohort broad did which what plan.

you. Thank

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

the We everyone questions. with later progress. please well updating forward today. your on reach again. progress on Thanks our as XXXX hesitate out in on don’t Thanks BLA for you to time further any our In as other look to meantime,

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